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IRCT20080728001031N23 IRCT 2018-04-24 Royan Institute Allogeneic stem cell transplantation in knee joint osteoarthritis Evaluation of safety and efficacy of intra-articular transplantation of allogeneic adipose derived mesenchymal stromal cells in patients with knee joint osteoarthritis An interventional randomized triple-blind placebo controlled clinical trial phase I/II 2017-03-14 anticipated 100 Complete https://irct.ir/trial/46 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Block randomization, Randomization description: Randomized allocation to intervention and control groups, Blinding description: Participants would be allocated in case and control groups according to a confidential table of accidental numbers which will be just available for the lab responsible. Care provider, investigator and outcome assessor are not aware of the substance which injected. In order to eliminate data analyzer's errors, group types would not be uncovered until the results are determined. 1-2 cell therapy in osteoarthritis. Intervention 1: Phase I and case group in phase II: intraarticular transplantation of single dose 100 millions of allogeneic adipose derived mesenchymal stem cells. Intervention 2: Control group (phase II): intraarticular transplantation of single dose 3 to 5 ml normal saline as placebo. 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 There is no further information
public Shahedeh Karimi Torshizi
Eastern Hafez St, Northern Banihashem St, 45 m Resalat highway
Tehran Iran (Islamic Republic of) 1665659911 +98 21 2356 2000 karimi58shah@gmail.com Royan cell therapy center scientific Nasser Aghdami
Royan Institute, Eastern Hafez St,Northern Banihashem St, Resalat highway 45 meters
Tehran Iran (Islamic Republic of) 1665659911 +98 21 2356 2000 nasser.aghdami@royaninstitute.org Royan Institute Iran (Islamic Republic of) Patients in the range of 18 to 65 years old osteoarthritis diagnosed by MRI 18 years 65 years Both Pregnancy or lactating Positive tests for HIV, HCV, HBV Active central or peripheral neurologic disorder End organ damage or Uncontrolled endocrine disorder Active respiratory disorder and reaction to sedative drugs history of cancer M15.9 Polyosteoarthritis, unspecified Other Placebo Phase I and case group in phase II: intraarticular transplantation of single dose 100 millions of allogeneic adipose derived mesenchymal stem cells Control group (phase II): intraarticular transplantation of single dose 3 to 5 ml normal saline as placebo Side effects. Timepoint: One week, one month, 3, 6 and 12 months after transplantation. Method of measurement: Physical examination, adverse effect questionnaire. Joint function. Timepoint: Before, 3, 6 and 12 months after transplantation. Method of measurement: WOMAC and KOOS questionnaires for osteoarthritis. Cartilage thickness. Timepoint: Before and 12 months after transplantation. Method of measurement: MRI. Molecular and cellular indexes (IL-6, IL-10, TNF-α, IFN-γ, COMP, CTX-II, HA, CS846, CD4, CD3, CD8, CD25). Timepoint: Before, one week, 3 and 6 months after transplantation. Method of measurement: Blood test. Subchondral edema. Timepoint: Before and 12 months after transplantation. Method of measurement: MRI. Joint effusion. Timepoint: Before and 12 months after transplantation. Method of measurement: MRI. New cartilage formation. Timepoint: Before and 12 months after transplantation. Method of measurement: MRI. Shafa Yahyaeian Hospital Royan Institute Shafa Yahyaeian Hospital Approved 2017-10-10 Ethics committee of Royan infertility institute Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway Tehran Tehran Iran (Islamic Republic of)