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IRCT20210103049925N1 IRCT 2021-05-20 Celltech Pharmed Company The effect of mesenchymal stem cells on osteoarthritis recovery Therapeutic and immunogenic effects of implanting Wharton’s jelly-derived mesenchymal stem cells into the knee joint of osteoarthritis patients in grade 2 & 3 Kellgren Lawrence scale: an interventional randomized double-blind placebo controlled clinical trial, phase I 2021-08-23 anticipated 40 Complete https://irct.ir/trial/53453 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using SAS 9.1 software, a random number table will be designed. The participants will randomly receive the random numbers placed in similar, sealed, and non-transparent envelopes. They will choose an envelope once visiting the doctor. Accordingly, the participants will be divided into control and intervention groups. The envelopes will be kept with a researcher who is neither participating in the study nor is aware of the study design until data collection phase. Only in case of emergency and sever complications, the principal project executor asks the researcher to open the related envelope. 1 Osteoarthritis. Intervention 1: Intervention group: Receiving 40 million Wharton’s jelly-derived mesenchymal stem cells loaded on 5CC hyaluronic acid via injection into knee joint (20 patients). All the required elements and ingredients such as cells are provided by Celltech Pharmed company. In this study, only one intra-articular injection will be done into knee using sterile G22 syringe and the patients will be followed-up for 3 months post injection. Intervention 2: Control group: Receiving 5CC hyaluronic acid via injection into knee joint (20 patients). All the required elements and ingredients are provided by Celltech Pharmed company. In this study, only one intra-articular injection will be done into knee using sterile G22 syringe and the patients will be followed-up for 3 months post injection. Yes - There is a plan to make this available What will be shared: All the data and observations will be published after analysis. When: After follow up and data gathering, evaluation of immunogenicity and efficiency of cell injection, and writing the paper which is approximately 3 months after follow up, the data file will be released. To whom: Activity in cell therapy domain is the only parameter to provide eligibility for access to our data and documents. The access is not limited to researchers and experts working in places other than universities or research centers can also have access to our documents. Conditions: Since the immunogenicity is evaluated in phase 1, there is no need to perform analysis other than items mentioned in proposal. Both Chamran Hospital and Celltech Company must be referenced in case of any use of our documents and data. Where to obtain: Contact documentation section of CellTech Pharmed company via m.ziraksaz@outlook.com or Dr. Mahdavi Health Research Centre via mahdavi.ag@gmail.com How to obtain: The applicants must provide us with documents indicative of their activity in cell therapy domain and prove their need to have access to the documents related to this study. Comments:
public Yunes Panahi
Baqiyatallah University of Medical Sciences, Mollasadra Ave., Vanak Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8821 1524 yunespanahi@yahoo.com Bagheiat-allah University of Medical Sciences scientific Yunes Panahi
Baqiyatallah University of Medical Sciences, Mollasadra Ave., Vanak Square, Tehran, Iran
Tehran Iran (Islamic Republic of) 1435916471 +98 21 8821 1524 yunespanahi@yahoo.com Bagheiat-allah University of Medical Sciences Iran (Islamic Republic of) Knee osteoarthritis (OA) (grade 2 & 3 Kellgren Lawrence scale) Radiography indicative of knee and femur malalignment of less than 30 degree Pain level of 4-7 measured in visual analog scale (VAS) 24 hours prior to referral Age range of 40-65 years Female/Male Given informed consent 40 years 65 years Both Inflammatory disorders Metabolic disorders (e.g : diabetes mellitus) Autoimmune diseases Immunodeficiency Cancer or other severe diseases Contagious viral infections Psychological disorders History of renal or hepatic failure Body mass index (BMI) >30 Fever Oral corticosteroids in the last 4 weeks Injection of corticosteroids in the last 6 months History of protein or other related allergies Coagulation disorders Pregnancy or planning for pregnancy in the last 12 months Participating in other clinical trials at the same time Septic arthritis Addiction to opium, alcohol,  painkillers, and/or anesthetics M17 Osteoarthritis of knee Treatment - Other Placebo Intervention group: Receiving 40 million Wharton’s jelly-derived mesenchymal stem cells loaded on 5CC hyaluronic acid via injection into knee joint (20 patients). All the required elements and ingredients such as cells are provided by Celltech Pharmed company. In this study, only one intra-articular injection will be done into knee using sterile G22 syringe and the patients will be followed-up for 3 months post injection. Control group: Receiving 5CC hyaluronic acid via injection into knee joint (20 patients). All the required elements and ingredients are provided by Celltech Pharmed company. In this study, only one intra-articular injection will be done into knee using sterile G22 syringe and the patients will be followed-up for 3 months post injection. Lysholm score. Timepoint: 3 months post injection. Method of measurement: Lysholm questionnaire. International Knee Documentation Committee score. Timepoint: 3 months post injection. Method of measurement: International Knee Documentation Committee (IKDC) Questionnaire. Disability index. Timepoint: 3 months post injection. Method of measurement: Health Assessment Questionnaire. Pain index. Timepoint: 3 months post injection. Method of measurement: Visual Analogue Scale questionnaire. Cartilage thickness. Timepoint: 3 months post injection. Method of measurement: Magnetic resonance imaging. Range of motion. Timepoint: 3 months post injection. Method of measurement: Goniometer. Walking distance in six minutes. Timepoint: 3 months post injection. Method of measurement: Meter. Side effects. Timepoint: 3 months post injection. Method of measurement: Clinical symptoms, questionnaire, peripheral blood and urine samples. Celltech Pharmed Company Approved 2021-02-28 Shahid Chamran Hospital Chamran Hospital, Langari St., Nobonyad Sq., Pasdaran Ave., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)