Mesenchymal stem cell injection in patients with knee osteoarthritis compared to a randomized controlled trial

Phase 3

Recruiting

Conditions: Knee osteoarthritic.
Osteoarthritis of knee
M17,

Registration Number: IRCT20210307050611N1

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

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 ?/?)

Exclusion Criteria

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.