Safety and efficacy evaluation of intra-articular knee transplantation of three consecutive doses of Platelet-Rich Plasma in patients with knee osteoarthritis: Interventional clinical trial, Phase II
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Protocol summary
• Determining the safety of intra-articular injection of three consecutive doses of platelet-rich plasma derived from non-autologous umbilical cord blood in patients with knee osteoarthritis
Determining the safety of intra-articular injection of three consecutive doses of platelet-rich plasma derived from non-autologous umbilical cord blood in patients with knee osteoarthritis
• Determining the safety of intra-articular injection of three consecutive doses of platelet-rich plasma derived from non-autologous umbilical cord blood in patients with knee osteoarthritis
• تعیین بی خطری تزریق داخل مفصلی سه دوز متوالی پلاسمای غنی از پلاکت مشتق از خون بندناف غیرخودی در بیماران مبتلا به استئوآرتریت زانو
تعیین بی خطری تزریق داخل مفصلی سه دوز متوالی پلاسمای غنی از پلاکت مشتق از خون بندناف غیرخودی در بیماران مبتلا به استئوآرتریت زانو
• تعیین بی خطری تزریق داخل مفصلی سه دوز متوالی پلاسمای غنی از پلاکت مشتق از خون بندناف غیرخودی در بیماران مبتلا به استئوآرتریت زانو
Patients are injected 3 times at intervals of 0, 2 and 4 months in the operating room of Royan Clinic. Patients will be monitored for up to one year. For the purpose of blinding, the biological product will be prepared in the form of disposable 5 cc syringes that look exactly like each other with a special label. Only the doctor and the person in charge of the transplant will know the type of treatment received.
Patients are injected 3 times at 0-, 1-, and 2-month intervals in the operating room at Royan Clinic. Patients will be monitored for up to one year. For the purpose of blinding, the biological product will be prepared in the form of disposable 5 cc syringes that look exactly like each other with a special label. Only the doctor and the person in charge of the transplant will know the type of treatment received.
Patients are injected 3 times at intervals of 0-, 21-, and 4 months2-month intervals in the operating room ofat Royan Clinic. Patients will be monitored for up to one year. For the purpose of blinding, the biological product will be prepared in the form of disposable 5 cc syringes that look exactly like each other with a special label. Only the doctor and the person in charge of the transplant will know the type of treatment received.
بیماران در سه نوبت با فواصل 0، 2 و 4 ماه در کلینیک سلول درمانی رویان تحت تزریق قرار میگیرند. تا یکسال بعد از شروع مطالعه بیماران تحت نظر خواهند بود. به منظور کورسازی، فرآوردهی بیولوژیک به صورت سرنگهای 5 سی سی یکبار مصرف و کاملا" شبیه به هم حاوی برچسب اختصاصی، آماده خواهد شد. تنها پزشک و مسئول تزریق از نوع درمان دریافتی اطلاع خواهد داشت.
بیماران در سه نوبت با فواصل 0، 1 و 2 ماه در کلینیک سلول درمانی رویان تحت تزریق قرار میگیرند. تا یکسال بعد از شروع مطالعه بیماران تحت نظر خواهند بود. به منظور کورسازی، فرآوردهی بیولوژیک به صورت سرنگهای 5 سی سی یکبار مصرف و کاملا" شبیه به هم حاوی برچسب اختصاصی، آماده خواهد شد. تنها پزشک و مسئول تزریق از نوع درمان دریافتی اطلاع خواهد داشت.
بیماران در سه نوبت با فواصل 0، 21 و 42 ماه در کلینیک سلول درمانی رویان تحت تزریق قرار میگیرند. تا یکسال بعد از شروع مطالعه بیماران تحت نظر خواهند بود. به منظور کورسازی، فرآوردهی بیولوژیک به صورت سرنگهای 5 سی سی یکبار مصرف و کاملا" شبیه به هم حاوی برچسب اختصاصی، آماده خواهد شد. تنها پزشک و مسئول تزریق از نوع درمان دریافتی اطلاع خواهد داشت.
Control group: patients receiving 3 doses of PRP. Test group: patients receiving 3 doses of hyaluronic acid
Control group: patients receiving 3 doses of hyaluronic acid; Test group: patients receiving 3 doses of PRP.
Control group: patients receiving 3 doses of PRP. Test group: patients receiving 3 doses of hyaluronic acid; Test group: patients receiving 3 doses of PRP.
گروه کنترل: بیماران دریافت کنندهی 3 دوز PRP گروه تست: بیماران دریافت کنندهی 3 دوز اسید هیالورونیک
گروه تست: بیماران دریافت کنندهی 3 دوز PRP; گروه کنترل: بیماران دریافت کنندهی 3 دوز اسید هیالورونیک.
گروه تست: بیماران دریافت کنندهی 3 دوز PRP; گروه کنترل: بیماران دریافت کنندهی 3 دوز PRP گروه تست: بیماران دریافت کنندهی 3 دوز اسید هیالورونیک.
General information
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This update is being made to correct administrative data-entry errors in the trial registration. During registration, some information from a separate but similar MSC study was inadvertently entered into the record of this PRP study. Specifically, the investigational product was incorrectly described as MSCs in one section, whereas the correct intervention is platelet-rich plasma (PRP). In addition, the injection interval was incorrectly recorded as every two months, whereas the ethics-approved PRP protocol specifies one injection per month.
These corrections do not represent changes to the approved protocol. The ethics-approved protocol has consistently specified PRP as the intervention and monthly administration as the treatment schedule. The registry is being updated solely to ensure that the registered information accurately corresponds to the protocol approved by the Research Ethics Committee.
This update is being made to correct administrative data-entry errors in the trial registration. During registration, some information from a separate but similar MSC study was inadvertently entered into the record of this PRP study. Specifically, the investigational product was incorrectly described as MSCs in one section, whereas the correct intervention is platelet-rich plasma (PRP). In addition, the injection interval was incorrectly recorded as every two months, whereas the ethics-approved PRP protocol specifies one injection per month. These corrections do not represent changes to the approved protocol. The ethics-approved protocol has consistently specified PRP as the intervention and monthly administration as the treatment schedule. The registry is being updated solely to ensure that the registered information accurately corresponds to the protocol approved by the Research Ethics Committee.
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این بهروزرسانی با هدف اصلاح خطاهای انسانی در ورود اطلاعات هنگام ثبت کارآزمایی بالینی انجام میشود. در زمان ثبت مطالعه، بخشی از اطلاعات مربوط به یک مطالعه جداگانه اما مشابه با مداخله سلولهای استرومایی مزانشیمی (MSC)، بهصورت سهوی در پرونده ثبت مطالعه حاضر با مداخله پلاسمای غنی از پلاکت (PRP) وارد شده است. بهطور مشخص، در یکی از بخشها، فرآورده مورد مطالعه بهاشتباه MSC ذکر شده است؛ درحالیکه مداخله صحیح، پلاسمای غنی از پلاکت (PRP) است. همچنین، فاصله زمانی بین تزریقها بهاشتباه هر دو ماه یکبار ثبت شده است؛ درحالیکه براساس پروتکل PRP تأییدشده توسط کمیته اخلاق، تزریقها باید ماهی یکبار انجام شوند.
این اصلاحات بهمنزله ایجاد تغییر در پروتکل مصوب نیستند. در پروتکل تأییدشده توسط کمیته اخلاق، از ابتدا PRP بهعنوان مداخله مطالعه و تزریق ماهانه بهعنوان برنامه تجویز آن تعیین شده است. اطلاعات سامانه ثبت کارآزمایی صرفاً بهمنظور انطباق دقیق اطلاعات ثبتشده با پروتکل تأییدشده توسط کمیته اخلاق پژوهش اصلاح و بهروزرسانی میشود.
این بهروزرسانی با هدف اصلاح خطاهای انسانی در ورود اطلاعات هنگام ثبت کارآزمایی بالینی انجام میشود. در زمان ثبت مطالعه، بخشی از اطلاعات مربوط به یک مطالعه جداگانه اما مشابه با مداخله سلولهای استرومایی مزانشیمی (MSC)، بهصورت سهوی در پرونده ثبت مطالعه حاضر با مداخله پلاسمای غنی از پلاکت (PRP) وارد شده است. بهطور مشخص، در یکی از بخشها، فرآورده مورد مطالعه بهاشتباه MSC ذکر شده است؛ درحالیکه مداخله صحیح، پلاسمای غنی از پلاکت (PRP) است. همچنین، فاصله زمانی بین تزریقها بهاشتباه هر دو ماه یکبار ثبت شده است؛ درحالیکه براساس پروتکل PRP تأییدشده توسط کمیته اخلاق، تزریقها باید ماهی یکبار انجام شوند. این اصلاحات بهمنزله ایجاد تغییر در پروتکل مصوب نیستند. در پروتکل تأییدشده توسط کمیته اخلاق، از ابتدا PRP بهعنوان مداخله مطالعه و تزریق ماهانه بهعنوان برنامه تجویز آن تعیین شده است. اطلاعات سامانه ثبت کارآزمایی صرفاً بهمنظور انطباق دقیق اطلاعات ثبتشده با پروتکل تأییدشده توسط کمیته اخلاق پژوهش اصلاح و بهروزرسانی میشود.
رنج سنی 45-70 سال
تشخیص استئوآرتریت زانو با گرید 1 و 2 طبق طبقه بندی جدید Kellgren-Lawrence با MRI
داشتن درد زانو به مدت حداقل 4 ماه که به درمانهای دارویی و فیزیکی رایج پاسخ نداده باشد.
VAS درد زانو: ≥4
تکمیل فرم رضایت آگاهانه
رنج سنی 45-70 سال
تشخیص استئوآرتریت زانو با گرید 1 و 2 طبق طبقه بندی جدید Kellgren-Lawrence با MRI
داشتن درد زانو به مدت حداقل 4 ماه که به درمانهای دارویی و فیزیکی رایج پاسخ نداده باشد.
VAS درد زانو: ≥4
تکمیل فرم رضایت آگاهانه
رنج سنی 45-70 سال تشخیص استئوآرتریت زانو با گرید 1 و 2 طبق طبقه بندی جدید Kellgren-Lawrence با MRI داشتن درد زانو به مدت حداقل 4 ماه که به درمانهای دارویی و فیزیکی رایج پاسخ نداده باشد. VAS درد زانو: ≥4 تکمیل فرم رضایت آگاهانه
Pregnancy or lactation
Presence of any concomitant knee injury that causes pain or swelling (eg, ligament damage or meniscal tear)
Intra-articular injection of hyalgan or steroid drugs during the last 2 months
Malalignment of the knee joint more than 15 degrees (diagnosis with triple joint view radiography)
Documented uncontrolled underlying diseases (including diabetes (HbA1c ≥ 8), heart failure (EF<45%), kidney failure (Cr>2), liver failure (AST, ALT>100)
The existence of blood or cardiovascular diseases, infections and weak immunity, neoplasm, etc., which interfere with the evaluations.
History of orthopedic surgery in the spine or lower limbs
osteoarthritis of the hip or ankle joint
Known allergy to hyaluronic acid products
Taking aspirin one week before cell injection
History of coagulopathy or use of anticoagulant drugs
Pregnancy or lactation
Presence of any concomitant knee injury that causes pain or swelling (eg, ligament damage or meniscal tear)
Intra-articular injection of hyalgan or steroid drugs during the last 2 months
Malalignment of the knee joint more than 15 degrees (diagnosis with triple joint view radiography)
Documented uncontrolled underlying diseases (including diabetes (HbA1c ≥ 8), heart failure (EF<45%), kidney failure (Cr>2), liver failure (AST, ALT>100)
The existence of blood or cardiovascular diseases, infections and weak immunity, neoplasm, etc., which interfere with the evaluations.
History of orthopedic surgery in the spine or lower limbs
Osteoarthritis of the hip or ankle joint
Known allergy to hyaluronic acid products
Taking aspirin one week before cell injection
History of coagulopathy or use of anticoagulant drugs
Pregnancy or lactation Presence of any concomitant knee injury that causes pain or swelling (eg, ligament damage or meniscal tear) Intra-articular injection of hyalgan or steroid drugs during the last 2 months Malalignment of the knee joint more than 15 degrees (diagnosis with triple joint view radiography) Documented uncontrolled underlying diseases (including diabetes (HbA1c ≥ 8), heart failure (EF<45%), kidney failure (Cr>2), liver failure (AST, ALT>100) The existence of blood or cardiovascular diseases, infections and weak immunity, neoplasm, etc., which interfere with the evaluations. History of orthopedic surgery in the spine or lower limbs osteoarthritisOsteoarthritis of the hip or ankle joint Known allergy to hyaluronic acid products Taking aspirin one week before cell injection History of coagulopathy or use of anticoagulant drugs
احتمال بارداری
وجود هر گونه ضایعه همزمان زانو که باعث درد یا تورم شود (به عنوان مثال، آسیب رباط یا پارگی منیسک)
تزریق داخل مفصلی هیالگان یا داروهای استروئیدی طی 2 ماه گذشته
Malalignment مفصل زانو بیشتر از 15 درجه (تشخیص با رادیوگرافی triple joint view)
بیماریهای زمینه ای کنترل نشده مستند (شامل دیابت ( HbA1c ≥ 8(، نارسایی قلبی ( EF<45%)، نارسایی کلیوی (Cr>2)، نارسایی کبد (AST, ALT>100)
وجود بیماریهای خونی یا قلبی عروقی، عفونتها و ضعف ایمنی، نئوپلاسم و غیره که در ارزیابیها اختلال ایجاد کند.
سابقه جراحی ارتوپدی در ستون فقرات یا اندام تحتانی
ابتلا به استئوآرتریت مفصل لگن یا مچ پا
آلرژی شناخته شده به محصولات هیالورونیک اسید
مصرف آسپرین یک هفته قبل از تزریق سلول
سابقه کواگولوپاتی یا مصرف داروهای آنتی کواگولان
احتمال بارداری
وجود هر گونه ضایعه همزمان زانو که باعث درد یا تورم شود (به عنوان مثال، آسیب رباط یا پارگی منیسک)
تزریق داخل مفصلی هیالگان یا داروهای استروئیدی طی 2 ماه گذشته
Malalignment مفصل زانو بیشتر از 15 درجه (تشخیص با رادیوگرافی triple joint view)
بیماریهای زمینه ای کنترل نشده مستند (شامل دیابت ( HbA1c ≥ 8، نارسایی قلبی ( EF<45%)، نارسایی کلیوی (Cr>2)، نارسایی کبد (AST, ALT>100)
وجود بیماریهای خونی یا قلبی عروقی، عفونتها و ضعف ایمنی، نئوپلاسم و غیره که در ارزیابیها اختلال ایجاد کند.
سابقه جراحی ارتوپدی در ستون فقرات یا اندام تحتانی
ابتلا به استئوآرتریت مفصل لگن یا مچ پا
آلرژی شناخته شده به محصولات هیالورونیک اسید
مصرف آسپرین یک هفته قبل از تزریق سلول
سابقه کواگولوپاتی یا مصرف داروهای آنتی کواگولان
احتمال بارداری وجود هر گونه ضایعه همزمان زانو که باعث درد یا تورم شود (به عنوان مثال، آسیب رباط یا پارگی منیسک) تزریق داخل مفصلی هیالگان یا داروهای استروئیدی طی 2 ماه گذشته Malalignment مفصل زانو بیشتر از 15 درجه (تشخیص با رادیوگرافی triple joint view) بیماریهای زمینه ای کنترل نشده مستند (شامل دیابت ( HbA1c ≥ 8(، نارسایی قلبی ( EF<45%)، نارسایی کلیوی (Cr>2)، نارسایی کبد (AST, ALT>100) وجود بیماریهای خونی یا قلبی عروقی، عفونتها و ضعف ایمنی، نئوپلاسم و غیره که در ارزیابیها اختلال ایجاد کند. سابقه جراحی ارتوپدی در ستون فقرات یا اندام تحتانی ابتلا به استئوآرتریت مفصل لگن یا مچ پا آلرژی شناخته شده به محصولات هیالورونیک اسید مصرف آسپرین یک هفته قبل از تزریق سلول سابقه کواگولوپاتی یا مصرف داروهای آنتی کواگولان
Patients will be randomly assigned to the control and MSC groups. The method of random assignment of these two groups is block randomization. The size of the blocks is 6 people and using Random allocation software, the sequence of assigning patients to the groups is determined, and this sequence will be kept by the transplant manager.
Patients will be randomly assigned to the control and PRP groups. The method of random assignment of these two groups is block randomization. The size of the blocks is 6 people, and using Random allocation software, the sequence of assigning patients to the groups is determined, and this sequence will be kept by the transplant manager.
Patients will be randomly assigned to the control and MSCPRP groups. The method of random assignment of these two groups is block randomization. The size of the blocks is 6 people, and using Random allocation software, the sequence of assigning patients to the groups is determined, and this sequence will be kept by the transplant manager.
بیماران به صورت تصادفی به دو گروه کنترل و MSC تخصیص خواهند یافت. روش تخصیص تصادفی این دو گروه تصادفی سازی بلوکی می باشد، سایز بلوک ها 6 نفر در نظر گرفته شده و با استفاده از نرم افزار Random allocation software توالی تخصیص بیماران به گروه ها مشخص، و این توالی نزد مسئول پیوند نگه دار خواهد شد.
بیماران به صورت تصادفی به دو گروه کنترل و PRP تخصیص خواهند یافت. روش تخصیص تصادفی این دو گروه تصادفی سازی بلوکی می باشد، سایز بلوک ها 6 نفر در نظر گرفته شده و با استفاده از نرم افزار Random allocation software توالی تخصیص بیماران به گروه ها مشخص، و این توالی نزد مسئول پیوند نگه دار خواهد شد.
بیماران به صورت تصادفی به دو گروه کنترل و MSCPRP تخصیص خواهند یافت. روش تخصیص تصادفی این دو گروه تصادفی سازی بلوکی می باشد، سایز بلوک ها 6 نفر در نظر گرفته شده و با استفاده از نرم افزار Random allocation software توالی تخصیص بیماران به گروه ها مشخص، و این توالی نزد مسئول پیوند نگه دار خواهد شد.
Primary outcomes
#1
2, 4, 6, 9, and 12 months after intervention
0, 1, 2, 6, 9, and 12 months after intervention
20, 41, 2, 6, 9, and 12 months after intervention
2، 4، 6، 9 و 12 ماه پس از شروع مداخله
۰، ۱، ۲، ۶، ۹ و ۱۲ ماه پس از شروع مداخله
2۰، 4۱، 6۲، 9۶، ۹ و 12۱۲ ماه پس از شروع مداخله
#2
Baseline and 2, 4, 6, 9, and 12 months after intervention
Baseline and 1, 2 , 6, 9, and 12 months after intervention
Baseline and 21, 42 , 6, 9, and 12 months after intervention
قبل از شروع مداخله و 2، 4 ، 6، 9 و 12 ماه پس از شروع مداخله
قبل از شروع مداخله و ۱، ۲، ۶، ۹ و ۱۲ ماه پس از شروع مداخله
قبل از شروع مداخله و 2۱، 4 ۲، 6۶، 9۹ و 12۱۲ ماه پس از شروع مداخله
#3
Baseline and 2, 4, 6, 9, and 12 months after intervention
Baseline and 1, 2 , 6, 9, and 12 months after intervention
Baseline and 21, 42 , 6, 9, and 12 months after intervention
قبل از شروع مداخله و 2، 4 ، 6، 9 و 12 ماه پس از شروع مداخله
قبل از شروع مداخله و ۱، ۲، ۶، ۹ و ۱۲ ماه پس از شروع مداخله
قبل از شروع مداخله و 2۱، 4 ۲، 6۶، 9۹ و 12۱۲ ماه پس از شروع مداخله
#4
قبل از شروع مداخله، 6 و 12 ماه پس از شروع مداخله
قبل از شروع مداخله، 12 ماه پس از شروع مداخله
قبل از شروع مداخله، 6 و 12 ماه پس از شروع مداخله
Secondary outcomes
#1
2, 4, 6, 9, and 12 months after intervention
0, 1, 2, 6, 9, and 12 months after intervention
20, 41, 2, 6, 9, and 12 months after intervention
2، 4، 6، 9 و 12 ماه پس از شروع مداخله
0, 1، 2، 6، 9 و 12 ماه پس از شروع مداخله
20, 1، 42، 6، 9 و 12 ماه پس از شروع مداخله
Intervention groups
#1
Control group: Patients receiving 3 doses of normal saline + Hyaluronic acid The procedure will be performed in such a way that patients are injected intra-articular injection of 2 cc of hyaluronic acid in three times at 0,1 and 2 months intervals in the operating room of Royan Clinic. At the time of injection, the patient's knee is sterilized and the orthopedic surgeon will inject into the joint space under sterile conditions. After the injection, the patient is monitored for 2 hours and after this period, if there is no problem with the necessary medication and care instructions and explanation of warning signs will be discharged.
Control group: Patients receiving 3 doses of Hyaluronic acid. The procedure will be performed in such a way that patients are injected intra-articular injection of 2 cc of hyaluronic acid in three times at 0,1 and 2 months intervals in the operating room of Royan Clinic. At the time of injection, the patient's knee is sterilized and the orthopedic surgeon will inject into the joint space under sterile conditions. After the injection, the patient is monitored for 2 hours and after this period, if there is no problem with the necessary medication and care instructions and explanation of warning signs will be discharged.
Control group: Patients receiving 3 doses of normal saline + Hyaluronic acid. The procedure will be performed in such a way that patients are injected intra-articular injection of 2 cc of hyaluronic acid in three times at 0,1 and 2 months intervals in the operating room of Royan Clinic. At the time of injection, the patient's knee is sterilized and the orthopedic surgeon will inject into the joint space under sterile conditions. After the injection, the patient is monitored for 2 hours and after this period, if there is no problem with the necessary medication and care instructions and explanation of warning signs will be discharged.
Recruitment centers
#1
Name of recruitment center - English: مرکز سلول درمانی رویان
Name of recruitment center - Persian: Royan Cell Therapy Center
Full name of responsible person - English: دکتر مسعود وثوق
Full name of responsible person - Persian: Masoud Vosough
Street address - English: No.9, Shaghayegh Dead End, Bani Hashem Sq., Bani Hashem St., Resalat St.,
Street address - Persian: تهران، خیابان رسالت، خیابان بنیهاشم، میدان بنیهاشم،بن بست شقایق،پلاک
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1665665514
Phone: +98 21 2233 9949
Fax:
Email: info@rctc.ir
Web page address:
Name of recruitment center - English: Royan Cell Therapy Center
Name of recruitment center - Persian: مرکز سلول درمانی رویان
Full name of responsible person - English: Dr. Masoud Vosough
Full name of responsible person - Persian: دکتر مسعود وثوق
Street address - English: No.9, Shaghayegh Dead End, Bani Hashem Sq., Bani Hashem St., Resalat St.,
Street address - Persian: تهران، خیابان رسالت، خیابان بنیهاشم، میدان بنیهاشم،بن بست شقایق،پلاک
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1665665514
Phone: +98 21 2233 9949
Fax:
Email: info@rctc.ir
Web page address:
Name of recruitment center - English: مرکز سلول درمانی رویانRoyan Cell Therapy Center Name of recruitment center - Persian: Royan Cell Therapy Centerمرکز سلول درمانی رویان Full name of responsible person - English: دکتر مسعود وثوقDr. Masoud Vosough Full name of responsible person - Persian: Masoud Vosoughدکتر مسعود وثوق Street address - English: No.9, Shaghayegh Dead End, Bani Hashem Sq., Bani Hashem St., Resalat St., Street address - Persian: تهران، خیابان رسالت، خیابان بنیهاشم، میدان بنیهاشم،بن بست شقایق،پلاک City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1665665514 Phone: +98 21 2233 9949 Fax: Email: info@rctc.ir Web page address:
Sponsors / Funding sources
#1
Other
Industry
otherindustry
Person responsible for updating data
contact.organization_id:
Name of organization / entity - English: Royan stem cell technology company
Name of organization / entity - Persian: شرکت فناوری بنیاختههای رویان
Full name of responsible person - English: Elaheh Afzal
Full name of responsible person - Persian: الهه افضل
Position - English: Research Assistance
Position - Persian: کارشناس تحقیقات
Latest degree: master
Area of specialty/work: 51
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 24, East Hafez Alley, Bani Hashim Square, Bani Hashim St, Resalat Highway, Tehran, Iran.
Street address - Persian: تهران، بزرگراه شهید سلیمانی (رسالت)، خیابان بنی هاشم، بعد از میدان بنی هاشم، نبش حافظ شرقی، پلاک ٢٤
City - English: تهران
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 166566311
Phone: +98 21 2763 5735
Mobile: +98 919 222 7703
Fax:
Email: e.afzal@rsct.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Royan stem cell technology company
Name of organization / entity - Persian: شرکت فناوری بنیاختههای رویان
Full name of responsible person - English: Elaheh Afzal
Full name of responsible person - Persian: الهه افضل
Position - English: Research Assistance
Position - Persian: کارشناس تحقیقات
Latest degree: master
Area of specialty/work: 51
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: No. 24, East Hafez Alley, Bani Hashim Square, Bani Hashim St, Resalat Highway, Tehran, Iran.
Street address - Persian: تهران، بزرگراه شهید سلیمانی (رسالت)، خیابان بنی هاشم، بعد از میدان بنی هاشم، نبش حافظ شرقی، پلاک ٢٤
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 166566311
Phone: +98 21 2763 5735
Mobile: +98 919 222 7703
Fax:
Email: e.afzal@rsct.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Royan stem cell technology company Name of organization / entity - Persian: شرکت فناوری بنیاختههای رویان Full name of responsible person - English: Elaheh Afzal Full name of responsible person - Persian: الهه افضل Position - English: Research Assistance Position - Persian: کارشناس تحقیقات Latest degree: master Area of specialty/work: 51 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: No. 24, East Hafez Alley, Bani Hashim Square, Bani Hashim St, Resalat Highway, Tehran, Iran. Street address - Persian: تهران، بزرگراه شهید سلیمانی (رسالت)، خیابان بنی هاشم، بعد از میدان بنی هاشم، نبش حافظ شرقی، پلاک ٢٤ City - English: تهرانTehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 166566311 Phone: +98 21 2763 5735 Mobile: +98 919 222 7703 Fax: Email: e.afzal@rsct.ir Web page address:
Protocol summary
Study aim
Determining the safety of intra-articular injection of three consecutive doses of platelet-rich plasma derived from non-autologous umbilical cord blood in patients with knee osteoarthritis
Design
Randomised controlled trial, with parallel groups, double-blind, phase 1/2 on 30 patients, randomized using Random allocation software
Settings and conduct
Patients are injected 3 times at 0-, 1-, and 2-month intervals in the operating room at Royan Clinic. Patients will be monitored for up to one year. For the purpose of blinding, the biological product will be prepared in the form of disposable 5 cc syringes that look exactly like each other with a special label. Only the doctor and the person in charge of the transplant will know the type of treatment received.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range 45-70, years of knee osteoarthritis with grade 2 and 3 MRI diagnosis, knee pain ≥4, completion of informed consent form Exclusion criteria: pregnant, lactating women or disabled adults, intrachondral injection within the last 2 months, Abnormal hematological or biochemical tests, History of any type of neoplasm, Aspirin consumption one week before cell injection, History of coagulopathy or use of anticoagulant drugs, Positive viral tests, Rheumatoid arthritis or other autoimmune diseases involving joints, History of corticosteroid use in 3 last month
Intervention groups
Control group: patients receiving 3 doses of hyaluronic acid; Test group: patients receiving 3 doses of PRP.
Main outcome variables
Adverse events (AEs) and severe adverse events (SAEs), WOMAC, VAS, SF-36, Articular cartilage thickness
General information
Reason for update
This update is being made to correct administrative data-entry errors in the trial registration. During registration, some information from a separate but similar MSC study was inadvertently entered into the record of this PRP study. Specifically, the investigational product was incorrectly described as MSCs in one section, whereas the correct intervention is platelet-rich plasma (PRP). In addition, the injection interval was incorrectly recorded as every two months, whereas the ethics-approved PRP protocol specifies one injection per month.
These corrections do not represent changes to the approved protocol. The ethics-approved protocol has consistently specified PRP as the intervention and monthly administration as the treatment schedule. The registry is being updated solely to ensure that the registered information accurately corresponds to the protocol approved by the Research Ethics Committee.
Acronym
PRP : Platelet Rich Plasma
IRCT registration information
IRCT registration number:IRCT20211102052944N2
Registration date:2023-02-09, 1401/11/20
Registration timing:prospective
Last update:2026-07-14, 1405/04/23
Update count:1
Registration date
2023-02-09, 1401/11/20
Registrant information
Name
Elaheh Afzal
Name of organization / entity
Royan stem cell technology company
Country
Iran (Islamic Republic of)
Phone
+98 21 2763 5735
Email address
e.afzal@rsct.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy evaluation of intra-articular knee transplantation of three consecutive doses of Platelet-Rich Plasma in patients with knee osteoarthritis: Interventional clinical trial, Phase II
Public title
Effect of PRP derived from umbilical cord blood in the treatment of knee arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
45-70 years
Kellgren and Lawrence grade of both knees between 2 and 3
knee pain for at least 4 months that has not responded to common medical and physical therapies.
Visual analogue score ≥ 4
Informed consent
Exclusion criteria:
Pregnancy or lactation
Presence of any concomitant knee injury that causes pain or swelling (eg, ligament damage or meniscal tear)
Intra-articular injection of hyalgan or steroid drugs during the last 2 months
Malalignment of the knee joint more than 15 degrees (diagnosis with triple joint view radiography)
Documented uncontrolled underlying diseases (including diabetes (HbA1c ≥ 8), heart failure (EF<45%), kidney failure (Cr>2), liver failure (AST, ALT>100)
The existence of blood or cardiovascular diseases, infections and weak immunity, neoplasm, etc., which interfere with the evaluations.
History of orthopedic surgery in the spine or lower limbs
Osteoarthritis of the hip or ankle joint
Known allergy to hyaluronic acid products
Taking aspirin one week before cell injection
History of coagulopathy or use of anticoagulant drugs
Age
From 45 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to the control and PRP groups. The method of random assignment of these two groups is block randomization. The size of the blocks is 6 people, and using Random allocation software, the sequence of assigning patients to the groups is determined, and this sequence will be kept by the transplant manager.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind study. Patients and study analysts will be unaware of the type of treatment assigned. To achieve this goal, by using a biological product in the form of disposable 5 cc syringes that are already filled by the nurse and are completely "similar" to the type of treatment received, to blind the participants in the study. Also, the people who apply the treatment will be different from the people who are responsible for examining and evaluating the patients, and the biological product packages will be labeled according to a specific code. Only the doctor and the person in charge of the transplant will know the type of treatment the patients receive.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Royan Institute- Academic Center for Education, Culture and Research
Street address
No. 24, Research Ethics Committee, Royan Research Institute, East Hafez Alley, Bani Hashim Square, Bani Hashim St, Resalat Highway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1665666311
Approval date
2023-01-29, 1401/11/09
Ethics committee reference number
IR.ACECR.ROYAN.REC.1401.110
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Adverse events and severe adverse events
Timepoint
0, 1, 2, 6, 9, and 12 months after intervention
Method of measurement
Clinical signs and questionnaire
2
Description
Western Ontario and McMaster Universities Osteoarthritis Index
Timepoint
Baseline and 1, 2 , 6, 9, and 12 months after intervention
Method of measurement
WOMAC Questionnaire
3
Description
Visual analog scale
Timepoint
Baseline and 1, 2 , 6, 9, and 12 months after intervention
Method of measurement
Visual Analogue Scale Questionnaire
4
Description
Disability index
Timepoint
Baseline and 6, 9, and 12 months after intervention
Method of measurement
Short Form Health-36 Questionnaire
5
Description
Articular cartilage thickness
Timepoint
Baseline and 12 months after intervention
Method of measurement
Magnetic resonance imaging
Secondary outcomes
1
Description
Adverse events and severe adverse events
Timepoint
0, 1, 2, 6, 9, and 12 months after intervention
Method of measurement
Clinical signs and questionnaire
Intervention groups
1
Description
Control group: Patients receiving 3 doses of Hyaluronic acid. The procedure will be performed in such a way that patients are injected intra-articular injection of 2 cc of hyaluronic acid in three times at 0,1 and 2 months intervals in the operating room of Royan Clinic. At the time of injection, the patient's knee is sterilized and the orthopedic surgeon will inject into the joint space under sterile conditions. After the injection, the patient is monitored for 2 hours and after this period, if there is no problem with the necessary medication and care instructions and explanation of warning signs will be discharged.
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group: patients receiving 3 doses of PRP. The procedure of the intervention will be that the patients will be injected with 5 cc of PRP derived from non-autologous umbilical cord blood in the operating room of Royan Clinic on three occasions with intervals of 0, 1 and 2 months. . On the day of the knee transplant, the patient's knee will be sterilized and the orthopedic surgeon will inject into the joint space under sterile conditions. After the injection, the patient will be observed for 2 hours and after this period, if no problem occurs, he will be discharged with the necessary medication and care instructions and an explanation of the warning signs.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The information and data will be published as an article after reviewing and verifying them. All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
After following the patients and collecting data, checking the safety and efficiency of cell injection and then writing the article, which is done about 3 months after the follow-up, the data file will be published.
To whom data/document is available
Access to the documents of this research is not limited to academic and scientific researchers, and specialists working in other centers can also access these documents.
Under which criteria data/document could be used
Designing similar studies in other academic centers
From where data/document is obtainable
e.afzal@rsct.it
What processes are involved for a request to access data/document
Within 1-2 months after application. Applicants for access to the research documents must provide evidence of their activity in the relevant field and their need for this data along with their application email.