]>
IRCT20181205041860N2 IRCT 2023-06-10 Shahid Beheshti University of Medical Sciences Evaluation of the safety of t-SVF in osteoarthritis Evaluation of the safety of intra-articular injection of t-SVF in patients with osteoarthritis of the knee: a clinical trial, controlled and phase I 2023-06-22 anticipated 20 Complete https://irct.ir/trial/70054 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomization is performed using the block method using SAS software. twenty patient will be involved in the study, which will be classified into two groups. to avoid identifying the last patient by medical staff, 5 blocks with 6 wells will be designed that only 4 wells per each block will be considered. To conceal randomization, each block will be placed in an envelope and all researchers will unaware of the contents of the envelopes. Therefore, a non-study individual was selected to perform all these steps to inform the physician of the result. 1 Condition 1: Osteoarthirits. Condition 2: Osteoarthritis of the knee. Intervention 1: The intervention group includes 10 patients who receive autologous and intra-articular t-SVF isolated from adipose tissue. Intervention 2: The control group includes 10 patients who receive hyaluronic acid hydrogel commercially and intra-articularly. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is Still undecided - no release schedule yet
public Mahboubeh Bohlouli
No. 53, West Qabadian Alley, above Vanak Square, Valiasr St
Tehran Iran (Islamic Republic of) 1688747564 +98 21 8866 6149 bohlouli98@gmail.com Shahid Beheshti University of Medical Sciences scientific Adel Ebrahimpour
Shahdari St, Tajrish Square
Tehran Iran (Islamic Republic of) 1985717443 +98 21 0000 0000 a.ebrahimpour@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Unilateral or bilateral knee osteoarthritis is diagnosed using MRI imaging and is class II, III according to Quaterbridge criteria. There is complete damage to the thickness of the cartilage tissue, whose size is less than 1.5 cm in terms of surface. WOMAC test of the patient should be less than 8 The age of the patient should be between 50 and 75 Body mass index of patients should be between 22 and 37. 50 years 75 years Both Damage to Minsk There is a complete damage to the thickness of the cartilage tissue, which is more than 1.5 cm in terms of surface. Osteochondritis dissections Parameniscal and Bakers or ganglion cysts Lipoma arborescens Hoffa'spad syndrome Severe swelling and inflammation in the knee area Rupture of knee ligaments Pain caused by dislocation or fracture of kneecap The classification of knee injury should be based on Quterbridge Class IV criteria. Classification of knee injury should be based on Quterbridge class IV criteria, but the size of the lesion should be more than 1.5 cm. People who have been injected with drugs such as corticosteroids, Vasosupplementation and cell products including SVF, stem cells, platelet-enriched plasma in the last 6 months. People who have had knee surgery in the last 6 months. People who have a history of systemic diseases, including diabetes, bleeding disorders. Women who were pregnant during the study or were planning to become pregnant. People who have received oral steroids for a long time. History of any chemotherapy or radiation therapy in both parts of the knee and the fat tissue donor area M15 M17 Polyosteoarthritis Osteoarthritis of knee Treatment - Other Treatment - Other The intervention group includes 10 patients who receive autologous and intra-articular t-SVF isolated from adipose tissue. The control group includes 10 patients who receive hyaluronic acid hydrogel commercially and intra-articularly The primary outcome of this study is safety, which will be evaluated with the occurrence of side effects in patients. Timepoint: The patient will be visited one and six days as well as 1 and 6 months after injection. But during this time, if patients have any abnormal clinical symptoms, you will be counseled or visited by telephone or in person. Method of measurement: In order to check safety, different parameters such as infection, inflammation, formation of fibrotic tissue, local edema, local erythema, pain and mortality will be evaluated through clinical evaluations, blood tests, MRI. Cartilage regeneration. Timepoint: After 6 months of injection. Method of measurement: Clinical evaluations, blood tests, MRI. Shahid Beheshti University of Medical Sciences Approved 2022-05-15 Ethics Committee of Shahid Beheshti University of Medical Sciences Arabi St, student Blvd, Velenjac Tehran Tehran Iran (Islamic Republic of)