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IRCT20211102052944N2 IRCT 2023-02-09 Royan Stem Cell Technology Company Effect of PRP derived from umbilical cord blood in the treatment of knee arthritis PRP : Platelet Rich Plasma 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 2023-04-21 anticipated 30 Complete https://irct.ir/trial/68273 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 2 Knee Osteoarthritis. Intervention 1: 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. Intervention 2: 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. 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) 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 45 years 70 years Both 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 M17 Osteoarthritis of knee Treatment - Drugs Treatment - Other 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. 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. Adverse events and severe adverse events. Timepoint: 0, 1, 2, 6, 9, and 12 months after intervention. Method of measurement: Clinical signs and questionnaire. Western Ontario and McMaster Universities Osteoarthritis Index. Timepoint: Baseline and 1, 2 , 6, 9, and 12 months after intervention. Method of measurement: WOMAC Questionnaire. Visual analog scale. Timepoint: Baseline and 1, 2 , 6, 9, and 12 months after intervention. Method of measurement: Visual Analogue Scale 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 12 months after intervention. Method of measurement: Magnetic resonance imaging. Adverse events and severe adverse events. Timepoint: 0, 1, 2, 6, 9, and 12 months after intervention. Method of measurement: Clinical signs and questionnaire. Royan Stem Cell Technology Company Approved 2023-01-29 Research Ethics Committees of Royan Institute- Academic Center for Education, Culture and Research No. 24, Research Ethics Committee, Royan Research Institute, East Hafez Alley, Bani Hashim Square, Bani Hashim St, Resalat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)