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Evaluation of the efficacy of allogeneic umbilical cord derived hematopoietic and mesenchymal stem cells on developmental functions of spastic cerebral palsy patients between 4-14 years old in comparison with control group , A Clinical trial phase II

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# Registration date Revision Id
2 2018-12-27, 1397/10/06 90423
1 2017-07-12, 1396/04/21 7342
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  • Protocol summary

    Cerebral palsy(CP) consisted of a group of nonprogressive disorders of brain injuries . and is one of the major problems of pediatric neurology and at the present time there is no standard medical or surgical treatment for it .Stem cell therapy is one of a new and hopeful therapeutic methods of CP .This study designed for the evaluation of therapeutic effects of intrathecal hematopoietic and mesenchymal stem cells derived from allogenic umbilical cord in improvement of developmental functions of spastic CP patients between 4-14 years old . Developmental conditions consisted of GMFM88 , GMFCS and Denver and spasticity according to Ashworth scale and brain imaging findings documented at the start and during the study period . The patients referred to neurology clinic of Children’s Medical Center . Suitable cases selected from patients with remarkable cerebral damage of non congenital origin in imaging .If parents after awareness of etiology and study design and even probable adverse effects have a consent , recruited . 108 cases will be recruited and randomly divided to 3 groups of 36 cases : hematopoietic stem cells derived from allogenic umbilical cord , Mesenchymal cells derived from allogenic umbilical cord and control group without injection and appearance simulating lumbar puncture without awareness of the patients and evaluators .
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    فلج مغزی شامل گروهی از اختلالات غیر پیشرونده منتج از صدمات مغزی است که یکی از مشکلات عمده در طب اعصاب کودکان است ودر حال حاضر هیچگونه درمان استاندارد دارویی یا جراحی جهت آن وجود ندارد، یکی از روش های جدید و امیدوارکننده امروزه استفاده از سلول های بنیادی است . این مطالعه با هدف بررسی توانایی اثربخشی درمانی در بهبود وضعیت تکاملی و اسپاستیتسیته بیماران فلج مغزی 4-14 ساله اسپاستیک با تزریق اینتراتکال سلول های بنیادی خونساز و مزانشیمی مشتق از بندناف طراحی شده است .معیارهای تکاملی شامل جی ام اف ام 88 ، جی ام اف سی اس و دنور و شدت اسپاستیسیته بر اساس مقیاس اشورث و یافته ها ی تصویربردری مغز در شروع درمان و طی مراحل ارزیابی ثبت میشود . گروه مورد مطالعه، جهت اقدامات درمانی به کلینیک نورولوژی بیمارستان مرکز طبی کودکان ارجاع داده شده ا ند . از بين بیماران کودکانی که در تصویر برداری مغز ضایعه غیر مادرزادی قابل توجیه با فلج مغزی داشته با شند به عنوان نمونه مناسب در نظر گرفته می شوند. چنانچه والدین پس ازآگاهی از علت و نحوه انجام مطالعه و حتی احتمال وقوع عوارض جانبی ، برای شرکت کردن فرزند خود به عنوان یک داوطلب رضایت داشتند، وارد مطالعه میشوند.در این مطالعه108 بیمار شرکت خواهند داشت که به طور تصادفی به 3 گروه 36 نفری تقسیم می شوند:- گروه دریافت کننده سلول های خونساز مشتق از بند ناف ، گروه دریافت کننده سلول های مزانشیم مشتق از بند ناف و گروه شاهد بدون تزریق با ظاهری شبیه تزریق اینتراتکال به گونه ای که بیمار و ارزیاب مطلع نباشند .
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    This study designed for the evaluation of safety and therapeutic effects of intrathecal hematopoietic (MNC) and mesenchymal stem cells (MSC) derived from allogenic umbilical cord in change of developmental functions of spastic cerebral Palsy (CP) in comparison with control group .
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    این مطالعه برای ارزیابی ایمنی و اثربخشی تزریق اینتراتکال سلولهای بنیادی خونی و مزانشیمال مشتق از بند ناف در مقایسه با گروه شاهد در ایجاد تغییر در معیارهای تکاملی بیماران فلج مغزی طراحی شده است .
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    Two arm parallel group , double blind , randomized controlled trial
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    مطالعه با دو بازوی موازی ، دو سو کور وانتخات تصادفی با گروه کنترل
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    108 cases of Spastic CP patients between 4-14 years that have our inclusion criteria will be selected and randomly divided in 3 groups of MNC and MSC derived from umbilical cord and control of no injection .The trial is double blind and the participants and clinical evaluators are unaware of study groups .
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    108 بیمار فلج مغزی اسپاستیک بین سن 4-14 سال که معیارهای ورود به مطالعه را دارند انتخاب و به طور تصادفی به سه گروه سلولهای خونی ومزانشیمی مشتق از بند ناف و کتترل بدون تزریق تقسیم میشوند . این مطالعه دو سو کور است و شرکت کننده ها و ارزیابها از گروه های مطالعه آگاهی ندارند .
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    Inclusion criteria:Diparetic and quadriparetic spastic CP between 4-14 years old and Gross motor function classification ( GMFC) between 2 -5 ٍExclusion criteria : Other types of CP
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    شرایط ورود : بیماران فلج مغزی دی پارتیک یا کوادری پارتیک بین 4-14 سال و ارزیابی عملکرد حرکتی درشت بین 2-5 . شرایط عدم ورود: سایر انواع فلج مغزی
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    Intervention group 1: one intrathecal injection(ITI) of MNC . Intervention group 2: one ITI of MSC. Control group: without injection ,that after insertion of needle into the skin without entrance to CSF space needle withdrawn and only simulation of ITI without the awareness of the participants . All of the participants had a baseline brain neuroimaging , that will be repeated after 12 months . Patients will be evaluated by predicted scales during the 12 months and will be followed for similar rehabilitation protocol .
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    گروه مداخله 1: یک تزریق اینتراتکال سلول بنیادی خونی .گروه مداخله 2: یک تزریق اینتراتکال سلول بنیادی مزانشیمی. گروه کنترل: بدون تزریق بعد فروکردن سوزن در پوست بدون ورود به فضای مایع مغزی نخاعی سورن خارج شده وتنها با ظاهری شبیه تزریق ایتتراتکال بدون آگاهی شرکت کننده ها. .برای تمام شرکت کننده ها در شروع مطالعه تصویربرداری ام ار ی مغز انجام شده است که در پایان 12 ماه تکرار میگردد .بیماران در طی 12 ماه با مقیاسهای پیش بینی شده مورد ارزیابی قرار میگیرند و از نظر توانبخشی با پروتکل مشابه پی گیری میشوند .
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    Motor development alteration with GMFM 66 score Change of motor function with GMFCS score Spasticity change of patients according to Ashworth scale Developmental status according to Stanford Binet test
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    تغییر وضعیت ارزیابی عملکرد حرکتی درشت66، تغییر فانکشن ارزیابی عملکردحرکتی درشت، تغییر اسپاستیسیته در بیماران بر اساس مقیاس اشورس، وضعیت تکاملی بر اساس تست استنفورد بینه

  • General information

    3
    4
    1
    1
    Used
    Not used
    2017-09-23, 1396/07/01
    2017-11-22, 1396/09/01
    2017-12-22, 1396/10/01
    2018-10-23, 1397/08/01
    effectes of umblical blood stem cells injection in the treatment of children with cerebral palsy
    Effects of umbilical cord derived stem cells injection in the treatment of children with cerebral palsy
    Evaluation of the efficacy of allogeneic umbilical cord derived hematopoietic stem cells and mesenchymal stromal cells in patients with spastic cerebral palsy on developmental function , A Clinical trial phase 2
    Evaluation of the efficacy of allogeneic umbilical cord derived hematopoietic and mesenchymal stem cells on developmental functions of spastic cerebral palsy patients between 4-14 years old in comparison with control group , A Clinical trial phase II
    بررسی اثربخشی تزریق اینتراتکال سلول های بنیادی خونساز و مزانشیمی مشتق از بندناف روي عملكردهای تکاملی بیماران دچار فلج مغزی اسپاستیک ، کارآزمایی بالینی فاز 2
    بررسی اثربخشی تزریق اینتراتکال سلول های بنیادی خونساز و مزانشیمی مشتق از بندناف روي عملكردهای تکاملی بیماران دچار فلج مغزی اسپاستیک 4-14 ساله در مقایسه با گروه شاهد ، کارآزمایی بالینی فاز 2
    Spastic cerebral palsy (Diparetic , Quadriparetic)
    Ages between 4 - 14 years
    Gross motor function classification (GMFC) between 2 -5
    No seizure disorder or with controlled seizure
    Evidence of definite acquired abnormal imaging findings compatible with Cerebral Palsy
    Informed consent taken from their parents
    بیماران فلج مغزی نوع اسپاستیک (دی پلژی، یا کوادری پلژی)
    سن 14-4 سال
    ارزیابی عملکردحرکتی درشت بین 2-5
    فاقد تشنج و یا با تشنج کنترل شده
    وجود ضایعه مشخص اکتسابی قابل توجیه با فلج مغزی در تصویربرداری مغز
    فرم رضایت والدین داشته باشد.
    Normal brain MRI
    Progressive neurological diseases ( for example leukodystrophy or neurometabolic disorders)
    Congenital Cortical malformations
    Toxoplasmosis Others Rubella Cytomegalovirus Hepatitis (TORCH) infections
    Other types of cerebral palsy including athetoid , atonic , ataxic , and mixed type
    Acute intercurrent infections such as Hepatitis C Virus ( HCV), Hepatitis B Virus (HBV) ,Human Immunodeficiency Virus (HIV)
    Hemorrhagic diathesis
    Severe anemia ( Hemoglobin less than 8 )
    Ventilator dependent pulmonary diseases
    Renal insufficiency
    Severe liver dysfunction
    ام آرآی مغزنرمال
    یماریهای پیش رونده عصبی (مانند لکودیستروفی و بیماریهای نورو متابولیک )
    ناهنجاریهای کورتیکال مادرزادی
    عفونتهای تورچ
    دیگر انواع فلج مغزی از جمله اتتوئید ،اتونیک، آتاکسیک و نوع ترکیبی
    وجود عفونت های حاد مثل اچ ای وی ، هپاتیت بی و هپاتیت سی
    زمینه خونریزی دهنده
    آنمی شدید (هموگلوبین کمتر از8)
    بیماریهای ریوی نیازمند حمایت ونتیلاتور
    اختلال عملکرد کلیه
    اختلال عملکرد شدید کبد
    For the first time in our country , intrathecal injection of mesenchymal stem cells derived from umbilical cord for the treatment of CP applied .
    تزریق اینتر تکال سلولهای بنیادی مزانشیمی مشتق از بند ناف برای اولین بار در کشورمان در درمان فلج مغزی بکار برده شده است
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    The patients are randomly allocated into three groups of intervention and control using a balanced block randomization technique. To do that, they were divided into blocks of 6 and 9. All subjects randomly allocated with online randomization software to generate random-number sequences. {Sealed Envelope Ltd. 2015. Create a blocked randomization list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 15 Dec 2015]}. Coordinator and Physician responsible for assessing inclusion / exclusion criteria and registering individuals are blind. Due to necessity of HLA matching of hematopoietic stem cells derived from allogenic umbilical cord (MNC) group we selected 150 cases of referred patients with our inclusion criteria and HLA analysis were done for these patients and then 36 cases of class 6 matched patients enrolled to the MNC group and 72 cases among the remaining patients randomly divided to Mesenchymal stem cells derived from allogenic umbilical cord (MSC) and control group . Therefore 108 cases enrolled in 3 divided group of 36 patients .
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    با استفاده از روش تصادفی سازی بلوک بندی شده و با در نظر گرفتن تعداد نمونه مورد نیاز از فرمول حجم نمونه افراد به سه گروه مساوی تقسیم می شوند. (گروه دریافت کننده سلول های تک هسته ای مشتق از بند ناف،گروه دریافت کننده سلول های مزانشیم مشتق از بند ناف و گروه شاهد بدون تزریق ) فرایند با استفاده از بلوکهای 6 و 9 تایی صورت می پذیرد. بلوک بندی قبلا توسط نرم افزار آنلاین تصادفی سازی صورت گرفته است. لیست گروههای مداخله مشخص شده در این فرآیند نزد هماهنگ کننده محفوظ باقی می ماند. پزشک مسئول ارزیابی معیارهای ورود/ خروج و ثبت نام افراد از این فرآیند اطلاعی نخواهد داشت. محتوای سرنگ ها به منظور تزریق به رنگ ، اندازه و شکل یکسان قرار می گیرند. بعلت ضرورت سازگاری اچ ال ای در گروه سلولهای بنیادی خونساز بند ناف از بین بیماران ارجاعی حائز معیارهای ورود 150 بیمار آنالیز اچ ال ای شده و 36 بیمار با سازگاری کلاس 6 انتخاب و 72 بیمار باقیمانده بصورت تصادفی سازی در دو گروه دیگر مزانشیمی مشتق از بند ناف و کنترل تقسیم میشوند . بنابر این 108 شرکت کننده در سه گروه 36 تایی وارد مطالعه شدند.
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    As this study designed as double blind , In the control group after insertion of the needle into the skin with an appearance of simulation of lumbar puncture no injection were done without the awareness of the patients or their parents and clinical evaluators . at the end of the study if safety and effectiveness of cell therapy will be proved , for ethical consideration cell therapy will be performed for control group .
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    از آنجا که این مطالعه به روش دوسو کور انجام خواهد شد، در گروه کنترل نیز با فروکردن سوزن در پوست و ظاهری شبیه انجام پونکسیون لومبار بدون تزریق و بدون آگاهی بیمار و گروه ارزیاب صورت خواهد گرفت اما در پایان مطالعه چنان که ثابت شود تزریق این سلول ها در سایر گروه ها بی خطر بوده و اثرات درمانی نیز به دنبال داشته است در گروه کنترل نیز تزریق سلول انجام خواهد شد تا از لحاظ اخلاقی قابل توجیه باشد.
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  • Secondary Ids

    #1
    در حال حاضر ندارد در حال اقدام هستیم
    Clinical trials.gov
    ندارد
    NCT03795974
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    2019-01-08, 1397/10/18

  • Health conditions studied

    #1
    Cerebral Palsy , Unspecified
    spastic cerebral palsy
    Spastic Cerebral Palsy

  • Primary outcomes

    #1
    motor development alteration with GMFM 88 score
    Motor development alteration with GMFM 66 score
    تغییر وضعیت حرکتی 88 GMFM
    تغییر وضعیت ارزیابی عملکرد حرکتی درشت 66
    begining , 1 month , 3 month ,6 month , 12 month
    Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention
    شروع 1 ماه، 3ماه، 6 ماه و 12 ماه
    قبل از مداخله ،1 ماه بعد از اتمام مداخله، 3ماه بعد از اتمام مداخله، 6 ماه بعد از اتمام مداخله و 12 ماه بعد از اتمام مداخله
    #2
    improvement of motor function with GMFCS score
    Change of motor function with GMFCS score
    بهبود فانکشن حرکتی GMFCS
    تغییر فانکشن ارزیابی عملکردحرکتی درشت
    begining , 1 month , 3 month ,6 month , 12 month
    Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention
    شروع 1 ماه، 3ماه، 6 ماه و 12 ماه
    قبل از مداخله ،1 ماه بعد از اتمام مداخله، 3ماه بعد از اتمام مداخله، 6 ماه بعد از اتمام مداخله و 12 ماه بعد از اتمام مداخله
    #3
    spasticity improvement of patients according to Ashworth scale
    Spasticity change of patients according to Ashworth scale
    بهبود اسپاستیسیتی در بیماران بر اساس Ashworth scale
    تغییر اسپاستیسیته در بیماران بر اساس مقیاس اشورس
    begining , 1 month , 3 month ,6 month , 12 month
    Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention
    شروع 1 ماه، 3ماه، 6 ماه و 12 ماه
    قبل از مداخله ،1 ماه بعد از اتمام مداخله، 3ماه بعد از اتمام مداخله، 6 ماه بعد از اتمام مداخله و 12 ماه بعد از اتمام مداخله
    #4
    developmental status according to Denver screening test
    Developmental status according to Stanford Binet test
    وضعیت تکاملی بر اساس تست غربالکری دنور
    وضعیت تکاملی بر اساس تست استنفورد بینه
    begining, 1 month , 3 month ,6 month , 12 month
    Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention
    شروع 1 ، ماه، 3ماه، 6 ماه و 12 ماه
    قبل از مداخله ،1 ماه بعد از اتمام مداخله، 3ماه بعد از اتمام مداخله، 6 ماه بعد از اتمام مداخله و 12 ماه بعد از اتمام مداخله

  • Secondary outcomes

    #1
    Decrement of brain lesion
    Probable Change of brain lesions
    کاهش وسعت ضایعات مغز
    تغییر احتمالی در ضایعات مغزی
    at onset of study , end of study ( 1 year )
    Before intervention , 1 year after intervention
    در ابتدای مطالعه، 1 سال
    قبل از مداخله ، 1 سال بعد از اتمام مداخله
    MRI , MRS , DTI
    Brain Magnetic Resonance Imaging (MRI) , Brain Magnetic Resonance Spectroscopy (MRS) , Brain Deep Tensor Imaging (DTI)
    MRI , MRS ,DTI
    تصویربرداری مغناطیسی مغز ، طیف نگاری مغناطیسی مغز، تصویربرداری عمقی راههای مغز
    #2
    fever
    Fever
    وقوع تب
    تب
    24 hours , 48 hours , 72 hours
    24 hours after intervention , 48 hours after intervention , 72 hours after intervention
    24 ساعت ، 48 ساعت ، 72 ساعت
    24 ساعت بعد از اتمام مداخله ، 48 ساعت بعد از اتمام مداخله، 72 ساعت بعد از اتمام مداخله
    axillary thermometer
    Axillary thermometer
    #3
    aseptic meningitis
    Meningitis
    مننژیت اسپتیک
    مننژیت
    first 3 days or any time signes occured
    First 3 days after intervention or any time after intervention
    در سه روز اول تزریق ودر هر زمان که علائم بروز کرد
    در سه روز اول بعد از اتمام مداخله یا در هر زمان از اتمام مداخله
    LP
    Lumbar Puncture
    LP
    پونکسیون کمری
    #4
    hyper sensivity reactions
    Hyper sensitivity reactions
    واکنش های افزایش حساسیتی
    واکنش های افزایش حساسیت
    first week of injection
    First week after intervention
    هفته اول تزریق
    هفته اول بعد از مداخله
    physical exam
    Physical exam

  • Intervention groups

    #1
    Other
    Treatment - Drugs
    the group who would be injected intrathecally HSC o rmononuclear hematopoietic stem cell derived from umbilical cord ( 5 millions per Kg )
    Intervention group 1 one intrathecal injection of hematopoietic stem cell derived from umbilical cord ( 5 millions per Kg ) prepared by Royan stem cell Technology Company . Intrathecal injection will be done under anesthesia via lumbar puncture . After taking 5 milliliter of cerebrospinal fluid prepared stem cells will be injected with a syringe . The patient will be admitted for one day of probable adverse reaction observation . One year followup and evaluation with regular similar rehabilitative therapy will be done .
    - گروه دریافت کننده سلول های تک هسته ای (HSC) مشتق از بند ناف ( سلولهای هماتوپویتیک) که مقدار آن 5 میلیون سلول به ازای هر کیلو گرم وزن وبه صورت تزریق اینتراتکال میباشد
    - گروه مداخله 1 دریافت کننده یک تزریق اینتراتکال سلول های بنیادی خونی مشتق از بند ناف به میزان 5 میلیون سلول به ازای هر کیلوگرم وزن تهیه شده توسط شرکت فناوری های بن یاخته های رویان . تزریق اینتراتکال زیر بیهوشی و از طریق پونکسیون کمری انجام شده وبعد از گرفتن 5 میلی لیتر از مایع مغزی نخاعی سلولهای بنیادی با یک سرنگ تزریق میشود . بیمار یک روز به جهت مشاهده واکنشهای ناسازگار بستری میشود .پیگیری و ارزیابی یکساله همراه با درمانهای توانبخشی منظم و مشابه انجام میشود .
    #2
    Other
    Treatment - Drugs
    the group who would be injected intrathecally MSC or mesenchymal stem cellls derived from umbilical cord ( 5 million per kg)
    Intervention group 2 one intrathecal injection of mesenchymal stem cellls derived from umbilical cord ( 1 million per kg) prepared by Cell Thec Pharmed Company. Intrathecal injection will be done under anesthesia via lumbar puncture . After taking 5 milliliter of cerebrospinal fluid prepared stem cells will be injected with a syringe . The patient will be admitted for one day of probable adverse reaction observation . One year followup and evaluation with regular similar rehabilitative therapy will be done .
    - گروه دریافت کننده سلول های مزانشیم (MSC) مشتق از بند ناف (سلولهای بنیادی مزانشیمال) مقدار سلول 5 میلیون به ازای هر کیلوگرم وزن و به صورت تزریق اینتراتکال میباشد.
    - گروه مداخله 2 دریافت کننده یک تزریق اینتراتکال سلول های مزانشیمی مشتق از بند ناف به میزان 1 میلیون سلول به ازای هر کیلوگرم وزن تهیه شده توسط شرکت سل تک فارمد. تزریق اینتراتکال زیر بیهوشی و از طریق پونکسیون کمری انجام شده وبعد از گرفتن 5 میلی لیتر از مایع مغزی نخاعی سلولهای بنیادی با یک سرنگ تزریق میشودو بیمار یک روز به جهت مشاهده واکنشهای ناسازگار بستری میشود .پیگیری و ارزیابی یکساله همراه درمانهای توانبخشی منظم و مشابه انجام میشود .
    #3
    N/A
    Treatment - Other
    attempeting for intrathecal injection simulating lumbar puncture without awareness of patient and evaluators
    Control group without injection , that after insertion of needle into the skin without entering into the cerebrospinal fluid space , needle will be withdrawn without any injection and only with an appearance of simulation of lumbar puncture without the awareness of the patient or their parents. The patient will be admitted for one day of probable adverse reaction observation . One year followup and evaluation with regular similar rehabilitative therapy will be done .
    اقدامی در حد فرو کردن سوزن و یا حداقل با ظاهری مشابه انجام ال پی ، به گونه ای که ارزیاب و بیمار متوجه عدم تزریق سلول در این گروه نشوند
    گروه کنترل بدون تزریق بعد فروکردن سوزن در پوست بدون ورود به فضای مایع مغزی نخاعی سوزن خارج وتزریقی انجام نشده وتنها ظاهری شبیه تزریق ایتتراتکال بدون آگاهی بیماریا والدین آنها ایجاد میشود .بیمار یک روز به جهت مشاهده واکنشهای ناسازگار بستری میشود .پیگیری و ارزیابی یکساله همراه درمانهای توانبخشی منظم و مشابه انجام میشود .

  • Recruitment centers

    #1
    Name of recruitment center - English: Children's Medical Center Hospital
    Name of recruitment center - Persian: بیمارستان مرکز طبی کودکان
    Full name of responsible person - English: anahita majmaa
    Full name of responsible person - Persian: آناهیتا مجمع
    Street address - English: end of keshavarz Boulvar Gharib Street children's Medical Center
    Street address - Persian: انتهای بلوار کشاورز بیمارستان مرکز طبی کودکان
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Children's Medical Center Hospital
    Name of recruitment center - Persian: بیمارستان مرکز طبی کودکان
    Full name of responsible person - English: anahita majmaa
    Full name of responsible person - Persian: آناهیتا مجمع
    Street address - English: end of keshavarz Boulvar Gharib Street children's Medical Center
    Street address - Persian: انتهای بلوار کشاورز بیمارستان مرکز طبی کودکان
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1419733151
    Phone: +98 21 6612 9252
    Fax: +98 21 6612 9252
    Email: majmaaa911@yahoo.com
    Web page address:

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Tehran University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: masood yunesian
    Full name of responsible person - Persian: آقای دکتر مسعود یونسیان
    Street address - English: Keshavarz Boulvar , Ghods Street , Central organization
    Street address - Persian: بلوار کشاورز نبش خیابان قدس ساختمان مرکزی دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Masood yunesian
    Full name of responsible person - Persian: آقای دکتر مسعود یونسیان
    Street address - English: Keshavarz Boulvar , Ghods Street , Central organization
    Street address - Persian: بلوار کشاورز نبش خیابان قدس ساختمان مرکزی دانشگاه علوم پزشکی تهران
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1417653761
    Phone: +98 21 8163 3686
    Fax:
    Email: yunesian@tums.ac.ir
    Web page address:
    empty
    40
    empty
    Public
    empty
    Domestic
    empty
    Academic
    Tehran University of Medical Sciences
    Tehran University of Medical Sciences
    #2
    contact.organization_id:
    Name of organization / entity - English: stem cell iranian science and technolgy institute
    Name of organization / entity - Persian: ستاد توسعه علوم و فناوریهای سلولهای بنیادی ریاست جمهوری
    Full name of responsible person - English: Amir ali Hamidie
    Full name of responsible person - Persian: آقای دکتر امیر علی حمیدیه
    Street address - English: Sheykh Bahaee street, Ladane street NUM 20
    Street address - Persian: خیابان شیخ بهایی شمالی خیابان لادن پلاک 20
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: ROYAN stem cell technology Co
    Name of organization / entity - Persian: شرکت فناوری بن یاخته های رویان
    Full name of responsible person - English: Morteza zarrabi
    Full name of responsible person - Persian: آقای دکتر مرتضی ضرابی
    Street address - English: No. 24, East Hafez Alley, Bani Hashim Square, Bani Hashim St, Resalat Highway, Tehran, Iran.
    Street address - Persian: بزرگراه رسالت خیابان بنی هاشم -بعد از میدان بنی هاشم -نبش حافظ شرقی پلاک 24
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1665666311
    Phone: +98 21 8978 1307
    Fax:
    Email: crm@rsct.ir
    Web page address:
    empty
    30
    empty
    Private
    empty
    Domestic
    empty
    Industry
    stem cell iranian science and technolgy institute
    ROYAN stem cell technology Co
    ستاد توسعه علوم و فناوریهای سلولهای بنیادی ریاست جمهوری
    شرکت فناوری بن یاخته های رویان
    #3
    contact.organization_id:
    Name of organization / entity - English: ROYAN stem cell technology
    Name of organization / entity - Persian: شرکت فناوری بن یاخته های رویان
    Full name of responsible person - English: Morteza zarrabi
    Full name of responsible person - Persian: آقای دکتر مرتضی ضرابی
    Street address - English: No. 24, East Hafez Alley, Bani Hashim Square, Bani Hashim St, Resalat Highway, Tehran, Iran.
    Street address - Persian: بزرگراه رسالت خیابان بنی هاشم -بعد از میدان بنی هاشم -نبش حافظ شرقی پلاک 24
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Welfare Organization of Iran
    Name of organization / entity - Persian: سازمان بهزیستی کشور
    Full name of responsible person - English: Zahra Noparasst
    Full name of responsible person - Persian: خانم دکتر زهرا نوع پرست
    Street address - English: Emam khomeyni square , Shaheed fayazbakhsh street Num 1121
    Street address - Persian: میدان امام خمینی (ره) خیابان شهید فیاض بخش پلاک 1121
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 418711356
    Phone: +98 21 6670 2001
    Fax:
    Email: z.noparast@gmail.com
    Web page address:
    empty
    20
    empty
    Public
    empty
    Domestic
    empty
    Other
    ROYAN stem cell technology
    Welfare Organization of Iran
    شرکت فناوری بن یاخته های رویان
    سازمان بهزیستی کشور
    #4
    contact.organization_id:
    Name of organization / entity - English: Welfare Organization of Iran
    Name of organization / entity - Persian: سازمان بهزیستی کشور
    Full name of responsible person - English: Zahra Noparasst
    Full name of responsible person - Persian: خانم دکتر زهرا نوپرست
    Street address - English: Emam khomeyni square , Shaheed fayazbakhsh street Num 1121
    Street address - Persian: میدان امام خمینی (ره) خیابان شهید فیاض بخش پلاک 1121
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Hormozgan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی هرمزگان
    Full name of responsible person - English: Dr Alireza moaedi
    Full name of responsible person - Persian: دکتر علیرضا مویدی
    Street address - English: Shahid mohammadi Hospital , Jomhori eslami Boulvar
    Street address - Persian: بیمارستانشهید محمدی ،بلوار جمهوری اسلامی
    City - English: Bandarabass
    City - Persian: بندر عباس
    Province: Hormozgan
    Country: Iran (Islamic Republic of)
    Postal code: 7916613885
    Phone: +98 76 3333 7192
    Fax:
    Email: armoyedi@yahoo.com
    Web page address:
    empty
    10
    empty
    Public
    empty
    Domestic
    empty
    Academic
    Welfare Organization of Iran
    Hormozgan University of Medical Sciences
    سازمان بهزیستی کشور
    دانشگاه علوم پزشکی هرمزگان
    #5
    contact.organization_id:
    Name of organization / entity - English: Hormozgan University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی هرمزگان
    Full name of responsible person - English: Dr Alireza moaedi
    Full name of responsible person - Persian: دکتر علیرضا مویدی
    Street address - English: Shahid mohammadi Hospital , Jomhori eslami Boulvar
    Street address - Persian: بیمارستانشهید محمدی ،بلوار جمهوری اسلامی
    City - English: Bandarabass
    City - Persian: بندر عباس
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    empty
    Yes
    empty
    empty
    empty
    Hormozgan University of Medical Sciences
    empty
    دانشگاه علوم پزشکی هرمزگان
    empty

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Tehran university medical science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Anahita Majmaa
    Full name of responsible person - Persian: آناهیتا مجمع
    Position - English: pediatrician
    Position - Persian: متخصص کودکان
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: end of Keshavarze avenues , childrensmedicalcenter hospital
    Street address - Persian: تهران انتهای بلوار کشاورز بیمارستان مرکز طبی کودکان دفتر معاونت پژوهشی
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 6612 9252
    Mobile:
    Fax:
    Email: majmaaa911@yahoo.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Anahita Majmaa
    Full name of responsible person - Persian: آناهیتا مجمع
    Position - English: Pediatrician
    Position - Persian: متخصص کودکان
    Latest degree: specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Children's Medical Center Hospital , No 62 , Gharib Street , End of Keshavarze Blvd , Tehran
    Street address - Persian: بیمارستان مرکز طبی کودکان ، تهران ، انتهای بلوار کشاورز خیابان قریب پلاک 62
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1419733151
    Phone: +98 21 6612 9252
    Mobile: +98 915 120 0868
    Fax:
    Email: majmaaa911@yahoo.com
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Tehran university Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Mahmoudreza Ashrafi
    Full name of responsible person - Persian: محمود رضا اشرفی
    Position - English: Professor of Pediatric Neurology
    Position - Persian: فوق تخصص مغز و اعصاب کودکان- استاد
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: children's Medical Center
    Street address - Persian: تهران انتهای بلوار کشاورز بیمارستان مرکز طبی کودکان معاونت پژوهشی
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 6612 9252
    Mobile:
    Fax: +98 21 6612 9252
    Email: ashrafim@tums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Mahmoud Reza Ashrafi
    Full name of responsible person - Persian: محمود رضا اشرفی
    Position - English: Professor of Pediatric Neurology
    Position - Persian: فوق تخصص مغز و اعصاب کودکان- استاد
    Latest degree: sub_specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Children's Medical Center , No 62 , Gharib Street , End of Keshavarz Blvd , Tehran
    Street address - Persian: بیمارستان مرکز طبی کودکان ، تهران انتهای بلوار کشاورز ، خیابان قریب ، پلاک 62
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1419733151
    Phone: +98 21 6612 9252
    Mobile: +98 912 345 7668
    Fax: +98 21 6612 9252
    Email: ashrafim@tums.ac.ir
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Tehran University Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Anahita Majmaa
    Full name of responsible person - Persian: آناهیتا مجمع
    Position - English: pediatrician
    Position - Persian: متخصص کودکان
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: end of Keshavarz Boulvar ,Gharib Street children's Medical Center
    Street address - Persian: انتهای بلوار کشاورز مرکز طبی کودکان
    City - English: Tehran
    City - Persian: تهران
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 21 6612 9252
    Mobile: 00
    Fax:
    Email: majmaaa911@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Tehran University Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی تهران
    Full name of responsible person - English: Anahita Majmaa
    Full name of responsible person - Persian: آناهیتا مجمع
    Position - English: Pediatrician
    Position - Persian: متخصص کودکان
    Latest degree: specialist
    Area of specialty/work: 74
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Children's Medical Center No 62 , Gharib Street , End of Keshavarz Blvd , Tehran
    Street address - Persian: مرکز طبی کودکان ، تهران انتهای بلوار کشاورز ، خیابان قریب ، پلاک 62
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 1419733151
    Phone: +98 21 6612 9252
    Mobile: +98 915 120 0868
    Fax:
    Email: majmaaa911@yahoo.com
    Web page address:

  • Sharing plan

    yes
    yes
    undecided
    yes
    yes
    no
    na
    empty
    IPD collected for the primary outcomes and secondary outcome measures
    empty
    اطلاعات مربوط به پیامد اصلی و ثانوی
    empty
    Dec 2019
    empty
    دی ماه 1398
    empty
    people working in academic institutions , people working in businesses and patients
    empty
    محققین شاغل در موسسات دانشگاهی و علمی ، افرادی که در صنعت مشغول هستند و بیماران
    empty
    Publications of study
    empty
    انتشارات طرح
    empty
    Contact persons
    empty
    نام و نشانی افراد پاسخگو .
    empty
    Telephone or email
    empty
    درخواست از طریق تلفن یا ایمیل

Protocol summary

Study aim
This study designed for the evaluation of safety and therapeutic effects of intrathecal hematopoietic (MNC) and mesenchymal stem cells (MSC) derived from allogenic umbilical cord in change of developmental functions of spastic cerebral Palsy (CP) in comparison with control group .
Design
Two arm parallel group , double blind , randomized controlled trial
Settings and conduct
108 cases of Spastic CP patients between 4-14 years that have our inclusion criteria will be selected and randomly divided in 3 groups of MNC and MSC derived from umbilical cord and control of no injection .The trial is double blind and the participants and clinical evaluators are unaware of study groups .
Participants/Inclusion and exclusion criteria
Inclusion criteria:Diparetic and quadriparetic spastic CP between 4-14 years old and Gross motor function classification ( GMFC) between 2 -5 ٍExclusion criteria : Other types of CP
Intervention groups
Intervention group 1: one intrathecal injection(ITI) of MNC . Intervention group 2: one ITI of MSC. Control group: without injection ,that after insertion of needle into the skin without entrance to CSF space needle withdrawn and only simulation of ITI without the awareness of the participants . All of the participants had a baseline brain neuroimaging , that will be repeated after 12 months . Patients will be evaluated by predicted scales during the 12 months and will be followed for similar rehabilitation protocol .
Main outcome variables
Motor development alteration with GMFM 66 score Change of motor function with GMFCS score Spasticity change of patients according to Ashworth scale Developmental status according to Stanford Binet test

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT201706176907N13
Registration date: 2017-07-12, 1396/04/21
Registration timing: prospective

Last update: 2019-05-18, 1398/02/28
Update count: 1
Registration date
2017-07-12, 1396/04/21
Registrant information
Name
Mahmoudreza Ashrafi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6612 9252
Email address
ashrafim@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences , Social welfare organization of Iran,Royan stem cell Technology , Hormozgn University of Medical Sciences, Stem cell iranian science and technolgy institute
Expected recruitment start date
2017-11-22, 1396/09/01
Expected recruitment end date
2018-10-23, 1397/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of allogeneic umbilical cord derived hematopoietic and mesenchymal stem cells on developmental functions of spastic cerebral palsy patients between 4-14 years old in comparison with control group , A Clinical trial phase II
Public title
Effects of umbilical cord derived stem cells injection in the treatment of children with cerebral palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Spastic cerebral palsy (Diparetic , Quadriparetic) Ages between 4 - 14 years Gross motor function classification (GMFC) between 2 -5 No seizure disorder or with controlled seizure Evidence of definite acquired abnormal imaging findings compatible with Cerebral Palsy Informed consent taken from their parents
Exclusion criteria:
Normal brain MRI Progressive neurological diseases ( for example leukodystrophy or neurometabolic disorders) Congenital Cortical malformations Toxoplasmosis Others Rubella Cytomegalovirus Hepatitis (TORCH) infections Other types of cerebral palsy including athetoid , atonic , ataxic , and mixed type Acute intercurrent infections such as Hepatitis C Virus ( HCV), Hepatitis B Virus (HBV) ,Human Immunodeficiency Virus (HIV) Hemorrhagic diathesis Severe anemia ( Hemoglobin less than 8 ) Ventilator dependent pulmonary diseases Renal insufficiency Severe liver dysfunction
Age
From 4 years old to 14 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
Sample size
Target sample size: 108
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are randomly allocated into three groups of intervention and control using a balanced block randomization technique. To do that, they were divided into blocks of 6 and 9. All subjects randomly allocated with online randomization software to generate random-number sequences. {Sealed Envelope Ltd. 2015. Create a blocked randomization list. [Online] Available from: https://www.sealedenvelope.com/simple-randomiser/v1/lists [Accessed 15 Dec 2015]}. Coordinator and Physician responsible for assessing inclusion / exclusion criteria and registering individuals are blind. Due to necessity of HLA matching of hematopoietic stem cells derived from allogenic umbilical cord (MNC) group we selected 150 cases of referred patients with our inclusion criteria and HLA analysis were done for these patients and then 36 cases of class 6 matched patients enrolled to the MNC group and 72 cases among the remaining patients randomly divided to Mesenchymal stem cells derived from allogenic umbilical cord (MSC) and control group . Therefore 108 cases enrolled in 3 divided group of 36 patients .
Blinding (investigator's opinion)
Double blinded
Blinding description
As this study designed as double blind , In the control group after insertion of the needle into the skin with an appearance of simulation of lumbar puncture no injection were done without the awareness of the patients or their parents and clinical evaluators . at the end of the study if safety and effectiveness of cell therapy will be proved , for ethical consideration cell therapy will be performed for control group .
Placebo
Not used
Assignment
Parallel
Other design features
For the first time in our country , intrathecal injection of mesenchymal stem cells derived from umbilical cord for the treatment of CP applied .

Secondary Ids

1

Registry name
Clinical trials.gov
Secondary trial Id
NCT03795974
Registration date
2019-01-08, 1397/10/18

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran university of Medical Sciences
Street address
Keshavarz blvd Ghods street devision 6
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-06-06, 1396/03/16
Ethics committee reference number
IR.TUMS.VCRREC.1996.2506

Health conditions studied

1

Description of health condition studied
Spastic Cerebral Palsy
ICD-10 code
G80.9
ICD-10 code description
Cerebral Palsy , Unspecified

Primary outcomes

1

Description
Motor development alteration with GMFM 66 score
Timepoint
Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention
Method of measurement
questionairre

2

Description
Change of motor function with GMFCS score
Timepoint
Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention
Method of measurement
questionairre

3

Description
Spasticity change of patients according to Ashworth scale
Timepoint
Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention
Method of measurement
questionairre

4

Description
Developmental status according to Stanford Binet test
Timepoint
Before intervention , 1 month after intervention , 3 months after intervention ,6 months after intervention , 12 months after intervention
Method of measurement
questionairre

Secondary outcomes

1

Description
Probable Change of brain lesions
Timepoint
Before intervention , 1 year after intervention
Method of measurement
Brain Magnetic Resonance Imaging (MRI) , Brain Magnetic Resonance Spectroscopy (MRS) , Brain Deep Tensor Imaging (DTI)

2

Description
Fever
Timepoint
24 hours after intervention , 48 hours after intervention , 72 hours after intervention
Method of measurement
Axillary thermometer

3

Description
Meningitis
Timepoint
First 3 days after intervention or any time after intervention
Method of measurement
Lumbar Puncture

4

Description
Hyper sensitivity reactions
Timepoint
First week after intervention
Method of measurement
Physical exam

Intervention groups

1

Description
Intervention group 1 one intrathecal injection of hematopoietic stem cell derived from umbilical cord ( 5 millions per Kg ) prepared by Royan stem cell Technology Company . Intrathecal injection will be done under anesthesia via lumbar puncture . After taking 5 milliliter of cerebrospinal fluid prepared stem cells will be injected with a syringe . The patient will be admitted for one day of probable adverse reaction observation . One year followup and evaluation with regular similar rehabilitative therapy will be done .
Category
Treatment - Drugs

2

Description
Intervention group 2 one intrathecal injection of mesenchymal stem cellls derived from umbilical cord ( 1 million per kg) prepared by Cell Thec Pharmed Company. Intrathecal injection will be done under anesthesia via lumbar puncture . After taking 5 milliliter of cerebrospinal fluid prepared stem cells will be injected with a syringe . The patient will be admitted for one day of probable adverse reaction observation . One year followup and evaluation with regular similar rehabilitative therapy will be done .
Category
Treatment - Drugs

3

Description
Control group without injection , that after insertion of needle into the skin without entering into the cerebrospinal fluid space , needle will be withdrawn without any injection and only with an appearance of simulation of lumbar puncture without the awareness of the patient or their parents. The patient will be admitted for one day of probable adverse reaction observation . One year followup and evaluation with regular similar rehabilitative therapy will be done .
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Children's Medical Center Hospital
Full name of responsible person
anahita majmaa
Street address
end of keshavarz Boulvar Gharib Street children's Medical Center
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6612 9252
Fax
+98 21 6612 9252
Email
majmaaa911@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Masood yunesian
Street address
Keshavarz Boulvar , Ghods Street , Central organization
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3686
Email
yunesian@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
40
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
ROYAN stem cell technology Co
Full name of responsible person
Morteza zarrabi
Street address
No. 24, East Hafez Alley, Bani Hashim Square, Bani Hashim St, Resalat Highway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1665666311
Phone
+98 21 8978 1307
Email
crm@rsct.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
ROYAN stem cell technology Co
Proportion provided by this source
30
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Industry

3

Sponsor
Name of organization / entity
Welfare Organization of Iran
Full name of responsible person
Zahra Noparasst
Street address
Emam khomeyni square , Shaheed fayazbakhsh street Num 1121
City
Tehran
Province
Tehran
Postal code
418711356
Phone
+98 21 6670 2001
Email
z.noparast@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Welfare Organization of Iran
Proportion provided by this source
20
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other

4

Sponsor
Name of organization / entity
Hormozgan University of Medical Sciences
Full name of responsible person
Dr Alireza moaedi
Street address
Shahid mohammadi Hospital , Jomhori eslami Boulvar
City
Bandarabass
Province
Hormozgan
Postal code
7916613885
Phone
+98 76 3333 7192
Email
armoyedi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hormozgan University of Medical Sciences
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Anahita Majmaa
Position
Pediatrician
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Children's Medical Center Hospital , No 62 , Gharib Street , End of Keshavarze Blvd , Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6612 9252
Fax
Email
majmaaa911@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mahmoud Reza Ashrafi
Position
Professor of Pediatric Neurology
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Children's Medical Center , No 62 , Gharib Street , End of Keshavarz Blvd , Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6612 9252
Fax
+98 21 6612 9252
Email
ashrafim@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University Medical Sciences
Full name of responsible person
Anahita Majmaa
Position
Pediatrician
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Children's Medical Center No 62 , Gharib Street , End of Keshavarz Blvd , Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6612 9252
Fax
Email
majmaaa911@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
IPD collected for the primary outcomes and secondary outcome measures
When the data will become available and for how long
Dec 2019
To whom data/document is available
people working in academic institutions , people working in businesses and patients
Under which criteria data/document could be used
Publications of study
From where data/document is obtainable
Contact persons
What processes are involved for a request to access data/document
Telephone or email
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