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IRCT20210307050611N1 IRCT 2021-05-22 Iran University of Medical Sciences Mesenchymal stem cell injection in patients with knee osteoarthritis compared to a randomized controlled trial Mesenchymal stem cell injection in patients with knee osteoarthritis compared to a randomized controlled trial 2021-04-22 anticipated 80 Complete https://irct.ir/trial/54834 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: After being selected according to the entry criteria, individuals receive a numeric code from one to eighty, then to form blocks of 4, eligible individuals are randomly divided into 20 groups by naming the letters of the alphabet. In each block with letters alphabetically, one person is selected randomly and the third person is selected by lottery, and this person is selected as the control group of each block, and in each block, the remaining three people are considered as the intervention group. It should be noted that this type of random selection is done by lottery method and blind, Blinding description: The study is a double-blind clinical trial. Primary blinding: Outcome evaluation tests are performed by an expert before and after the intervention. The relevant expert is unaware of how to block, select the subjects and the tests related to them. The relevant expert is unaware of the studied groups and this test is performed by a physical medicine and rehabilitation physiatrist. 3 Knee osteoarthritic. Intervention 1: Cell therapy is a branch of modern regenerative medicine that uses autologous or allogeneic stem cells to treat many untreated diseases, including knee osteoarthritis. Stem cells are prepared for cell therapy in a sterile and clean environment. In this study, 8 million adipose-derived stem cells in two milliliters of normal saline were injected into each patient's knee under an ultrasound guide. Before the stem cell injection, a two-hour session is considered to explain and teach the patient the treatment method, satisfaction as well as post-injection care. After selecting the patient to study, the time required for patient availability is eight months. adipose-derived stem cells after isolation, culture, characterization and quality control tests are performed in a clean room with grade A and B clean room of Motahhari Hospital and under sterile conditions, by experts in this field. Intervention 2: Control group: A quarter of all patients in the control group will be evaluated clinically and radiologically at intervals of one and six months. These patients will be given knee care training in daily life activities and to participate in this The project must be submitted so that during this period they will not receive any other therapeutic intervention. If they receive any therapeutic intervention, inform the project manager to remove them from the project. Tests for goniometry, pain, cartilage thickness will be taken at intervals of one to six months. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Naser amini
Mottahari Hospital.Yasemi avenue. Valiasr street
Tehran Iran (Islamic Republic of) 1996714353 +98 21 8608 3674 Amini_ot@yahoo.com Iran University of Medical Sciences scientific Naser Amini
Mottahari Hospital. yasemi street. Valiasr avenue
Tehran Iran (Islamic Republic of) 1996714353 +98 21 8608 3674 amini_ot@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Knee Osteoarthritis Based on American College of Rheumatology Criteria in Grades 1, 2, and 3: Lowrence - Kellergan Knee pain for at least six months Proper liver function (Bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L) Proper renal function (Creatinine ≤ 2.0 ㎎/㎗) 18 years 60 years Both Any acute or chronic infection Pregnancy or decision to become pregnant Any intra-articular injection during the last three months Inflammatory joint disease or secondary osteoarthritis History of knee surgery Severe underlying disease such as uncontrolled diabetes, taking anticoagulants Daily use of opioid and non-opioid analgesics M17, Osteoarthritis of knee Treatment - Other Treatment - Other Cell therapy is a branch of modern regenerative medicine that uses autologous or allogeneic stem cells to treat many untreated diseases, including knee osteoarthritis. Stem cells are prepared for cell therapy in a sterile and clean environment. In this study, 8 million adipose-derived stem cells in two milliliters of normal saline were injected into each patient's knee under an ultrasound guide. Before the stem cell injection, a two-hour session is considered to explain and teach the patient the treatment method, satisfaction as well as post-injection care. After selecting the patient to study, the time required for patient availability is eight months. adipose-derived stem cells after isolation, culture, characterization and quality control tests are performed in a clean room with grade A and B clean room of Motahhari Hospital and under sterile conditions, by experts in this field. Control group: A quarter of all patients in the control group will be evaluated clinically and radiologically at intervals of one and six months. These patients will be given knee care training in daily life activities and to participate in this The project must be submitted so that during this period they will not receive any other therapeutic intervention. If they receive any therapeutic intervention, inform the project manager to remove them from the project. Tests for goniometry, pain, cartilage thickness will be taken at intervals of one to six months. Pain: The pain assessment scale is performed by the VAS test. In this questionnaire, which is filled in by the participant before the intervention and six months after the intervention, the least pain in the last trimester is zero and the number 10 is considered as the highest pain in the last trimester. Scores between zero and 10 for the amount of pain. Timepoint: Before intervention and 6 months after injection. Method of measurement: VAS questionnaire. Pain due to inflammation in the knee joint in the last 6 months. Timepoint: Before the intervention and 6 months later. Method of measurement: The VAS questionnaire is filled out by the patient for the amount of pain and the patient scores from 0 to 10 according to the amount of pain. The range of motion of the knee joint from the extent position to 140 degrees is measured in both active and passive forms. Timepoint: Before intervention and 6 months after injection. Method of measurement: Goniometer. Knee cartilage formation using MRI image. Timepoint: Before intervention and 6 months after injection. Method of measurement: MRI image of the knee in a supine position. Iran University of Medical Sciences Approved 2021-04-18 Ethics Committee of Iran University of Medical Sciences Iran University of medical science. beside of Milad tower. Hemmat highway Tehran Tehran Iran (Islamic Republic of)