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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210307050611N1
Enrollment
80
Registered
2021-05-22
Start date
2021-04-22
Completion date
Unknown
Last updated
2021-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee osteoarthritic. Osteoarthritis of knee

Interventions

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 p

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNaser amini

Iran University of Medical Sciences

Amini_ot@yahoo.com+98 21 8608 3674

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026