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Protocol summary
Inclusion criteria:1-Traumatic thoracic spinal cord injury 2-Complete loss of sensory and motor function below the injury (ASIA Category A) 3-Time from injury up to 6 months 4-No mental disturbances in patient 5-Good patient motivation and cooperation and confirmation of written informed consent
Exclusion criteria:1-Coexisting lesion of the nervous system 2-Transection lesions of the spinal cord due to sharp objects 3-Spinal stenosis in parts other than the damaged area 4-Muscle atrophy or joint ossification 5-Severe systemic disease such as neoplasm and diabetes 6-Chronic sinusitis, tumors or polyps of nasal cavities and presented hyposmia which can prevent from mucosal biopsy
Inclusion criteria:1-Traumatic thoracic spinal cord injury 2-Complete loss of sensory and motor function below the injury (ASIA Category A) 3-Time from injury at least 6 months 4-No mental disturbances in patient 5-Good patient motivation and cooperation and confirmation of written informed consent
Exclusion criteria:1-Coexisting lesion of the nervous system 2-Transection lesions of the spinal cord due to sharp objects 3-Spinal stenosis in parts other than the damaged area 4-Muscle atrophy or joint ossification 5-Severe systemic disease such as neoplasm and diabetes 6-Chronic sinusitis, tumors or polyps of nasal cavities and presented hyposmia which can prevent from mucosal biopsy
Inclusion criteria:1-Traumatic thoracic spinal cord injury 2-Complete loss of sensory and motor function below the injury (ASIA Category A) 3-Time from injury up toat least 6 months 4-No mental disturbances in patient 5-Good patient motivation and cooperation and confirmation of written informed consent Exclusion criteria:1-Coexisting lesion of the nervous system 2-Transection lesions of the spinal cord due to sharp objects 3-Spinal stenosis in parts other than the damaged area 4-Muscle atrophy or joint ossification 5-Severe systemic disease such as neoplasm and diabetes 6-Chronic sinusitis, tumors or polyps of nasal cavities and presented hyposmia which can prevent from mucosal biopsy
شرایط ورود:1-آسیب های ناشی از ضربه به بخش صدری طناب نخاع 2-کامل بودن ضایعه به معنای تایید از دست رفتگی کامل حس و عملکرد حرکتی پایین تر از سطح آسیب (دسته A طبق استانداردهای ASIA) 3-گذشت حداکثر 6 ماه از تاریخ ضربه به نخاع 4-عدم وجود اختلالات ذهنی در بیمار 5-انگیزش و توافق کامل بیمار با فرآیند پیوند و تایید فرم رضایت آگاهانه
شرایط عدم ورود:1-وجود هرگونه آسیب دیگر در سیستم عصبی 2-آسیب های منجر به قطع شدگی طناب نخاع ناشی از برخورد اجسام تیز و برنده 3-تنگی مجرا طناب نخاع در نواحی غیر از بخش آسیب دیده 4-تحلیل ماهیچه ای یا کلسیفیه شدن مفاصل 5-بیماری های سیستمیک شدید هم چون نئوپلاسم و دیابت 6-سینوزیت مزمن، تومور یا پلیپ های حفره بینی و مشکلات بویایی که مانع از بیوپسی از مخاط بینی شود
شرایط ورود:1-آسیب های ناشی از ضربه به بخش صدری طناب نخاع 2-کامل بودن ضایعه به معنای تایید از دست رفتگی کامل حس و عملکرد حرکتی پایین تر از سطح آسیب (دسته A طبق استانداردهای ASIA) 3-گذشت حداقل 6 ماه از تاریخ ضربه به نخاع 4-عدم وجود اختلالات ذهنی در بیمار 5-انگیزش و توافق کامل بیمار با فرآیند پیوند و تایید فرم رضایت آگاهانه
شرایط عدم ورود:1-وجود هرگونه آسیب دیگر در سیستم عصبی 2-آسیب های منجر به قطع شدگی طناب نخاع ناشی از برخورد اجسام تیز و برنده 3-تنگی مجرا طناب نخاع در نواحی غیر از بخش آسیب دیده 4-تحلیل ماهیچه ای یا کلسیفیه شدن مفاصل 5-بیماری های سیستمیک شدید هم چون نئوپلاسم و دیابت 6-سینوزیت مزمن، تومور یا پلیپ های حفره بینی و مشکلات بویایی که مانع از بیوپسی از مخاط بینی شود
شرایط ورود:1-آسیب های ناشی از ضربه به بخش صدری طناب نخاع 2-کامل بودن ضایعه به معنای تایید از دست رفتگی کامل حس و عملکرد حرکتی پایین تر از سطح آسیب (دسته A طبق استانداردهای ASIA) 3-گذشت حداکثرحداقل 6 ماه از تاریخ ضربه به نخاع 4-عدم وجود اختلالات ذهنی در بیمار 5-انگیزش و توافق کامل بیمار با فرآیند پیوند و تایید فرم رضایت آگاهانه شرایط عدم ورود:1-وجود هرگونه آسیب دیگر در سیستم عصبی 2-آسیب های منجر به قطع شدگی طناب نخاع ناشی از برخورد اجسام تیز و برنده 3-تنگی مجرا طناب نخاع در نواحی غیر از بخش آسیب دیده 4-تحلیل ماهیچه ای یا کلسیفیه شدن مفاصل 5-بیماری های سیستمیک شدید هم چون نئوپلاسم و دیابت 6-سینوزیت مزمن، تومور یا پلیپ های حفره بینی و مشکلات بویایی که مانع از بیوپسی از مخاط بینی شود
General information
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the lack of a sufficient number of patients with the specified age range and the opinion of the neurologist on the safety of performing this procedure on chronic patients due to their stable condition
the lack of a sufficient number of patients with the specified age range and the opinion of the neurologist on the safety of performing this procedure on chronic patients due to their stable condition
empty
کمبود تعداد نمونه ها با محدوده سنی تعیین شده و نظر پزشک متخصص این طرح دال بر ایمنی بالاتر انجام این پروسه بر روی بیماران مزمن به سبب وضعیت پایدار شده ایشان
کمبود تعداد نمونه ها با محدوده سنی تعیین شده و نظر پزشک متخصص این طرح دال بر ایمنی بالاتر انجام این پروسه بر روی بیماران مزمن به سبب وضعیت پایدار شده ایشان
Traumatic thoracic spinal cord injury
Complete loss of sensory and motor function below the injury (ASIA Category A)
Time from injury up to 6 months (acute and intermediate phases)
No mental disturbances in patient
Good patient motivation and cooperation and confirmation of written informed consent
Traumatic thoracic spinal cord injury
Complete loss of sensory and motor function below the injury (ASIA Category A)
Time from injury at least 6 months (chronic phase)
No mental disturbances in patient
Good patient motivation and cooperation and confirmation of written informed consent
Traumatic thoracic spinal cord injury Complete loss of sensory and motor function below the injury (ASIA Category A) Time from injury up toat least 6 months (acute and intermediate phaseschronic phase) No mental disturbances in patient Good patient motivation and cooperation and confirmation of written informed consent
آسیب های ناشی از ضربه به بخش صدری طناب نخاع
کامل بودن ضایعه به معنای تایید از دست رفتگی کامل حس و عملکرد حرکتی پایین تر از سطح آسیب (دسته A طبق استانداردهای ASIA)
گذشت حداکثر 6 ماه از تاریخ ضربه به نخاع (فاز های حاد و میانی)
عدم وجود اختلالات ذهنی در بیمار
انگیزش و توافق کامل بیمار با فرآیند پیوند و تایید فرم رضایت آگاهانه
آسیب های ناشی از ضربه به بخش صدری طناب نخاع
کامل بودن ضایعه به معنای تایید از دست رفتگی کامل حس و عملکرد حرکتی پایین تر از سطح آسیب (دسته A طبق استانداردهای ASIA)
گذشت حداقل 6 ماه از تاریخ ضربه به نخاع (فاز مزمن)
عدم وجود اختلالات ذهنی در بیمار
انگیزش و توافق کامل بیمار با فرآیند پیوند و تایید فرم رضایت آگاهانه
آسیب های ناشی از ضربه به بخش صدری طناب نخاع کامل بودن ضایعه به معنای تایید از دست رفتگی کامل حس و عملکرد حرکتی پایین تر از سطح آسیب (دسته A طبق استانداردهای ASIA) گذشت حداکثرحداقل 6 ماه از تاریخ ضربه به نخاع (فاز های حاد و میانیمزمن) عدم وجود اختلالات ذهنی در بیمار انگیزش و توافق کامل بیمار با فرآیند پیوند و تایید فرم رضایت آگاهانه
Recruitment centers
#1
Name of recruitment center - English: Shohada Tajrish Hospital
Name of recruitment center - Persian: بیمارستان شهدای تجریش
Full name of responsible person - English: Dr.Saeed Oraee Yazdani
Full name of responsible person - Persian: دکتر سعید اورعی یزدانی
Street address - English: Shohada Tajrish Hospital,Tajrish Sq., Tehran, Iran
Street address - Persian: بیمارستان شهدای تجریش، میدان تجریش، تهران، ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1989934148
Phone: +98 21 25719
Fax:
Email: Pr_shohada@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Shohada Tajrish Hospital
Name of recruitment center - Persian: بیمارستان شهدای تجریش
Full name of responsible person - English: Dr.Saeed Oraee Yazdani
Full name of responsible person - Persian: دکتر سعید اورعی یزدانی
Street address - English: Shohada Tajrish Hospital,Tajrish Sq.
Street address - Persian: میدان تجریش، بیمارستان شهدای تجریش
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1989934148
Phone: +98 21 25719
Fax:
Email: Pr_shohada@sbmu.ac.ir
Web page address:
Name of recruitment center - English: Shohada Tajrish Hospital Name of recruitment center - Persian: بیمارستان شهدای تجریش Full name of responsible person - English: Dr.Saeed Oraee Yazdani Full name of responsible person - Persian: دکتر سعید اورعی یزدانی Street address - English: Shohada Tajrish Hospital,Tajrish Sq., Tehran, Iran Street address - Persian: میدان تجریش، بیمارستان شهدای تجریش، میدان تجریش، تهران، ایران City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1989934148 Phone: +98 21 25719 Fax: Email: Pr_shohada@sbmu.ac.ir Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Tarbiat Modares University
Name of organization / entity - Persian: دانشگاه تربیت مدرس
Full name of responsible person - English: Yaghoob Fatolahi
Full name of responsible person - Persian: یعقوب فتح الهی
Street address - English: Tarbiat Modares University, Jalal AleAhmad Highway
Street address - Persian: دانشگاه تربیت مدرس، بزرگراه جلال آل احمد
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713116
Phone: +98 21 8288 0000
Fax:
Email: pres@modares.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Tarbiat Modares University
Name of organization / entity - Persian: دانشگاه تربیت مدرس
Full name of responsible person - English: Yaghoob Fatolahi
Full name of responsible person - Persian: یعقوب فتح الهی
Street address - English: Tarbiat Modares University, Jalal AleAhmad Highway
Street address - Persian: بزرگراه جلال آل احمد، دانشگاه تربیت مدرس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713116
Phone: +98 21 8288 0000
Fax:
Email: pres@modares.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Tarbiat Modares University Name of organization / entity - Persian: دانشگاه تربیت مدرس Full name of responsible person - English: Yaghoob Fatolahi Full name of responsible person - Persian: یعقوب فتح الهی Street address - English: Tarbiat Modares University, Jalal AleAhmad Highway Street address - Persian: دانشگاه تربیت مدرس، بزرگراه جلال آل احمد، دانشگاه تربیت مدرس City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1411713116 Phone: +98 21 8288 0000 Fax: Email: pres@modares.ac.ir Web page address:
#2
contact.organization_id:
Name of organization / entity - English: Stem Cell Technology Research Center
Name of organization / entity - Persian: مرکز تحقیقات فناوری بن یاخته
Full name of responsible person - English: Masoud Soleimani
Full name of responsible person - Persian: مسعود سلیمانی
Street address - English: No. 9, East 2nd St, Farhang Blvd, Saadat Abad St.
Street address - Persian: 24 متری سعادت آباد، خیابان دوم شرقی ، پلاک 9،
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1997775555
Phone: +98 21 2208 2120
Fax: +98 21 2235 1460
Email: info@bonyakhteh.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Stem Cell Technology Research Center
Name of organization / entity - Persian: مرکز تحقیقات فناوری بن یاخته
Full name of responsible person - English: Masoud Soleimani
Full name of responsible person - Persian: مسعود سلیمانی
Street address - English: No. 9, East 2nd St, Farhang Blvd, Saadat Abad St.
Street address - Persian: سعادت آباد، خیابان دوم شرقی ، پلاک 9
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1997775555
Phone: +98 21 2208 2120
Fax: +98 21 2235 1460
Email: info@bonyakhteh.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Stem Cell Technology Research Center Name of organization / entity - Persian: مرکز تحقیقات فناوری بن یاخته Full name of responsible person - English: Masoud Soleimani Full name of responsible person - Persian: مسعود سلیمانی Street address - English: No. 9, East 2nd St, Farhang Blvd, Saadat Abad St. Street address - Persian: 24 متری سعادت آباد، خیابان دوم شرقی ، پلاک 9، City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1997775555 Phone: +98 21 2208 2120 Fax: +98 21 2235 1460 Email: info@bonyakhteh.ir Web page address:
Protocol summary
Study aim
Safety assessment for co-transplantation of autologous olfactory ensheathing cells and mesenchymal stem cells in complete human spinal cord injury
Design
A non-randomized open-labeled controlled trial with a sample size of 10, based on 5 patients in the main intervention group (cell transplantation) and another 5 patients with similar characteristics as control (without intervention)
Settings and conduct
Patient recruitment, mucosal biopsy, and bone marrow aspiration are performed in Shohada Tajrish Hospital. Olfactory Ensheathing Cells (OECs) and Mesenchymal Stem Cells (MSCs) isolation, characterization, and culture for transplantation are done in Stem Cell Technology Research Center.The injection of both types of cells prepared for spinal cord injury is also done by a neurosurgeon at Shohada's Tajrish Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria:1-Traumatic thoracic spinal cord injury 2-Complete loss of sensory and motor function below the injury (ASIA Category A) 3-Time from injury at least 6 months 4-No mental disturbances in patient 5-Good patient motivation and cooperation and confirmation of written informed consent
Exclusion criteria:1-Coexisting lesion of the nervous system 2-Transection lesions of the spinal cord due to sharp objects 3-Spinal stenosis in parts other than the damaged area 4-Muscle atrophy or joint ossification 5-Severe systemic disease such as neoplasm and diabetes 6-Chronic sinusitis, tumors or polyps of nasal cavities and presented hyposmia which can prevent from mucosal biopsy
Intervention groups
1-Main group: Co-transplantation of autologous Olfactory Ensheathing Cells and Mesenchymal Stem Cells into lesioned area of spinal cord
2-Control group: Without intervention
Main outcome variables
Type and amount of observed side effects due to the co-transplantation of autologous olfactory ensheathing cells and mesenchymal stem cells
General information
Reason for update
the lack of a sufficient number of patients with the specified age range and the opinion of the neurologist on the safety of performing this procedure on chronic patients due to their stable condition
Acronym
IRCT registration information
IRCT registration number:IRCT20160110025930N2
Registration date:2018-09-29, 1397/07/07
Registration timing:prospective
Last update:2020-07-29, 1399/05/08
Update count:2
Registration date
2018-09-29, 1397/07/07
Registrant information
Name
Masoud Soleimani
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4508
Email address
soleim_m@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-06, 1397/07/14
Expected recruitment end date
2019-03-05, 1397/12/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety assessment for co-transplantation of autologous olfactory ensheathing cells and mesenchymal stem cells in complete human spinal cord injury
Public title
Safety investigation of simultaneous injection of olfactory ensheathing cells and mesenchymal stem cells in treatment of spinal cord injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Traumatic thoracic spinal cord injury
Complete loss of sensory and motor function below the injury (ASIA Category A)
Time from injury at least 6 months (chronic phase)
No mental disturbances in patient
Good patient motivation and cooperation and confirmation of written informed consent
Exclusion criteria:
Coexisting lesion of the nervous system
Transection lesions of the spinal cord due to sharp objects
Spinal stenosis in parts other than the damaged area
Muscle atrophy or joint ossification
Severe systemic disease such as neoplasm and diabetes
Chronic sinusitis, tumors or polyps of nasal cavities and presented hyposmia which can prevent from mucosal biopsy
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
10 enrolled patients of the study are divided into two groups: the main treatment group is transplanted with autologous olfactory ensheathing cells and mesenchymal stem cells and there is no cell therapy intervention in the control group.
Type and amount of observed side effects due to the co-transplantation of autologous olfactory ensheathing cells and mesenchymal stem cells in patients with complete spinal cord injury in order to safety assessment for this intervention.
Timepoint
1, 6, and 12 months post cell transplantation
Method of measurement
1-General physical assessments and laboratory tests like blood, serum, and urine analysis 2- Spinal radiological assessments with MRI imaging
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with complete spinal cord injury who are co-transplanted with autologous Olfactory Ensheathing Cells (OECs) (isolated from olfactory mucosa) and Mesenchymal Stem Cells (MSCs) (isolated from bone marrow aspirate) which is injected into lesioned spinal cord in a ratio of 50:50 and cell dose of about 20-30 million.
Category
Treatment - Other
2
Description
Control group: Patients with complete spinal cord injury who are under routine cares and no extra action is performed on them.