]>
IRCT2015101823298N2 IRCT 2016-03-16 Vice Chancellor For Research Of Tehran University of Medical Science Mesenchymal Stem Cells In Treatment Of Knee Osteoarthritis The Effect And Safety Of Allogenic Placental Mesenchymal Stem Cells In Treatment Of Knee Osteoarthritis, Pilot Study 2015-11-22 anticipated 20 Complete https://irct.ir/trial/19908 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment. 1-2 osteoarthritis. Intervention 1: 10 patients in case group will receive 50 million placental mesenchymal stem cells in a single intraarthicular injection. Intervention 2: 10 patient in the control group will receive single intraarthicular injection of PBS (Phosphate Buffered Saline) in a sterile setting.
public Doctor Shayesteh Sadat Khalifesoltani
Firoozgar hospital,Beh-Aafarin alley,Valiye-Asr square
Tehran Iran (Islamic Republic of) +98 82141229 shayesteh_khalifesoltani@yahoo.com Iran University of Medical Science scientific Doctor Bijhan Forough
Iran University of Medical Science, Hemmat highway,Tehran
Tehran Iran (Islamic Republic of) +98 21 8862 2600 bforough@tums.ac.ir Iran University of Medical Science Iran (Islamic Republic of) inclusion criteria: knee osteoarthritis based on ACR (American College of Rheumatology) criteria and grade 1,2,3 based on Kellgren-Lawrence grading scale; Ability to follow during the study period exclusion criteria: age <18 and >75 years; presence of any acute or chronic infectious process; knee deformity (varus >10 ° or valgus >20° ); impaired renal function(creatinine>2.0 mg/dl); impaired liver function(Bilirubin > 2.0 ㎎/㎗, AST/ALT > 100 IU/L); Pregnancy or lactating; neoplasia; BMI>35; Immunosuppressive state; Systemic autoimmune rheumatic disease or secondary osteoarthritis; intraarthicular injections in last 3 months; history of knee surgery; Poorly controlled diabetes mellitus 18 years 75 years Both M19.0 Primary arthrosis NOS Treatment - Other Placebo 10 patients in case group will receive 50 million placental mesenchymal stem cells in a single intraarthicular injection. 10 patient in the control group will receive single intraarthicular injection of PBS (Phosphate Buffered Saline) in a sterile setting. KOOS value. Timepoint: before,2 months and 6 months after injection. Method of measurement: KOOS questionnaire. VAS value. Timepoint: before,2 weeks,2 months and 6 months after injection. Method of measurement: VAS. Knee range of motion. Timepoint: before,2 weeks,2 months and 6 months after injection. Method of measurement: goniometer. Radiologic MRA parameters. Timepoint: before and 6 months after injection. Method of measurement: MRA(magnetic resonance arthrography). Clinical sign and symptoms of inflammatory and allergic reactions. Timepoint: before,30 minute,2 weeks,2 months and 6 month after injection. Method of measurement: physical examination(swelling, erythema, skin rash, fever, effusion). Vice Chancellor For Research Of Iran University of Medical Science Vice Chancellor For Research Of Tehran University of Medical Science Vice Chancellor For Research Of Iran University of Medical Science Approved 2015-07-06 Ethics committee of Iran University of Medical Science Medical faculty, Iran University of Medical Science, Hemmat High way,Tehran Tehran Iran (Islamic Republic of)