]>
IRCT20211102052944N1 IRCT 2021-11-09 Royan Stem Cell Technology Company Intra-articular transplantation of umbilical cord stromal mesenchymal cells in patients with knee osteoarthritis Evaluation of safety and efficacy of intra-articular knee transplantation of three consecutive doses of allogenic umbilical cord mesenchymal stromal cells in patients with knee osteoarthritis: interventional clinical trial, phase I/II 2021-11-22 anticipated 30 Complete https://irct.ir/trial/59735 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, 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. 1-2 Knee Osteoarthritis. Intervention 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 normal saline with 2 cc of hyaluronic acid in three times at 0, 2 and 4 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. Intervention 2: Intervention group: Patients receiving 3 doses of normal saline containing 20 million Mesenchymal cells derived from allogenic umbilical cord tissue + Hyaluronic acid The method of intervention will be that patients in three times at intervals of 0, 2 and 4 months in the operating room of Royan Clinic, injected with 2 cc of normal saline containing 20 million mesenchymal stem cells derived from non-native umbilical cord tissue with 2 cc of hyaluronic Acids are placed. On the day of cell transplantation, it is sent to this center for injection by the clean room of Cell Tech Pharmed factory in a vial and inside a box. 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. Yes - There is a plan to make this available What will be shared: The information and data will be published as an article after reviewing and verifying them. All data is potentially shareable after unidentified individuals. When: 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: 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. Conditions: Designing similar studies in other academic centers Where to obtain: e.afzal@rsct.it How to obtain: 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. Comments:
public Morteza Zarrabi
No. 24, East Hafez Alley, Bani Hashim Square, Bani Hashim St, Resalat Highway, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1665665514 +98 21 2763 5000 m.zarrabi@rsct.ir Royan Institute scientific Mohsen Emadedin
No. 9, Shaghayegh Alley, Bani Hashim Sq., Bani Hashim St, Resalat Highway, Tehran, Iran.
Tehran Iran (Islamic Republic of) 166566311 +98 21 2233 9949 mohsen.emadedin@royaninstitute.org Royan Institute Iran (Islamic Republic of) 40-70 years Unilateral knee osteoarthritis Kellgren and Lawrence grade of both knees between 2 and 3 Evidence of x-ray imaging findings compatible with knee osteoarthritis knee pain for at least 4 months that has not responded to common medical and physical therapies. Visual analogue score ≥ 4 Informed consent 40 years 70 years Both Pregnancy or lactation Inflammatory or infectious arthritis Intra-articular injection during the last 2 months Body Mass Index ≥ 35 Haematological and biochemical analysis with significant alterations that contraindicates intervention Known and uncontrolled chronic disease (including diabetes (HbA1c ≥ 8), heart failure (EF <45%), renal failure (Cr> 2), liver failure (AST, ALT> 100) History of any type of neoplasm Take aspirin one week before the cell injection History of coagulopathy or use of anticoagulants Positive viral tests (HIV, CMV, HTLV1 & 2, HBV, HCV) Having a movement disorder Having serious illnesses with a life expectancy of less than 1 year Drug or alcohol abuse History or clinical diagnosis of any psychological disorder Arthroscopy in the last 6 months Rheumatoid arthritis or other autoimmune diseases that affect the joints. Immunosuppression or taking systemic immunosuppressant Allergy to proteins or substances in culture medium (gentamicin, bovine or equine serum) History of corticosteroid use 3 months before enrolment Knee joint misalignment ≥15 degree M17 Osteoarthritis of knee Treatment - Drugs Treatment - Other 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 normal saline with 2 cc of hyaluronic acid in three times at 0, 2 and 4 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. Intervention group: Patients receiving 3 doses of normal saline containing 20 million Mesenchymal cells derived from allogenic umbilical cord tissue + Hyaluronic acid The method of intervention will be that patients in three times at intervals of 0, 2 and 4 months in the operating room of Royan Clinic, injected with 2 cc of normal saline containing 20 million mesenchymal stem cells derived from non-native umbilical cord tissue with 2 cc of hyaluronic Acids are placed. On the day of cell transplantation, it is sent to this center for injection by the clean room of Cell Tech Pharmed factory in a vial and inside a box. 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. Adverse events and severe adverse events. Timepoint: 2, 4, 6, 9, and 12 months after intervention. Method of measurement: Clinical signs and questionnaire. Visual analog scale. Timepoint: Baseline and 2, 4, 6, 9, and 12 months after intervention. Method of measurement: Visual Analogue Scale Questionnaire. Western Ontario and McMaster Universities Osteoarthritis Index. Timepoint: Baseline and 2, 4, 6, 9, and 12 months after intervention. Method of measurement: ٌWOMAC Questionnaire. Disability index. Timepoint: Baseline and 6, 9, and 12 months after intervention. Method of measurement: Short Form Health-36 Questionnaire. Articular cartilage thickness. Timepoint: Baseline and 6, 9, and 12 months after intervention. Method of measurement: Magnetic resonance imaging. Cell-Tech Pharmed Royan Stem Cell Technology Company Cell-Tech Pharmed Approved 2021-09-21 Research Ethics Committees of Royan Institute- Academic Center for Education, Culture and Research No. 24, East Hafez Alley, Bani Hashim Square, Bani Hashim St, Resalat Highway, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)