The effect of mesenchymal stem cells on osteoarthritis recovery

Therapeutic and immunogenic effects of implanting Wharton’s jelly-derived mesenchymal stem cells into the knee joint of osteoarthritis patients in grade 2 & 3 Kellgren Lawrence scale: an interventional randomized double-blind placebo controlled clinical trial, phase I

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

IRCT

Registry ID

IRCT20210103049925N1

Enrollment

Registered

2021-05-20

Start date

2021-08-23

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

Osteoarthritis. Osteoarthritis of knee

Interventions

Intervention 1: Intervention group: Receiving 40 million Wharton’s jelly-derived mesenchymal stem cells loaded on 5CC hyaluronic acid via injection into knee joint (20 patients). All the required elem

Eligibility

Sex/Gender

All

Age

40 Years to 65 Years

Inclusion criteria

Inclusion criteria: Knee osteoarthritis (OA) (grade 2 & 3 Kellgren Lawrence scale) Radiography indicative of knee and femur malalignment of less than 30 degree Pain level of 4-7 measured in visual analog scale (VAS) 24 hours prior to referral Age range of 40-65 years Female/Male Given informed consent

Exclusion criteria

Exclusion criteria: Inflammatory disorders Metabolic disorders (e.g : diabetes mellitus) Autoimmune diseases Immunodeficiency Cancer or other severe diseases Contagious viral infections Psychological disorders History of renal or hepatic failure Body mass index (BMI) >30 Fever Oral corticosteroids in the last 4 weeks Injection of corticosteroids in the last 6 months History of protein or other related allergies Coagulation disorders Pregnancy or planning for pregnancy in the last 12 months Participating in other clinical trials at the same time Septic arthritis Addiction to opium, alcohol, painkillers, and/or anesthetics

Design outcomes

Primary

Measure	Time frame
Lysholm score. Timepoint: 3 months post injection. Method of measurement: Lysholm questionnaire.;International Knee Documentation Committee score. Timepoint: 3 months post injection. Method of measurement: International Knee Documentation Committee (IKDC) Questionnaire.;Disability index. Timepoint: 3 months post injection. Method of measurement: Health Assessment Questionnaire.;Pain index. Timepoint: 3 months post injection. Method of measurement: Visual Analogue Scale questionnaire.;Cartilage thickness. Timepoint: 3 months post injection. Method of measurement: Magnetic resonance imaging.;Range of motion. Timepoint: 3 months post injection. Method of measurement: Goniometer.;Walking distance in six minutes. Timepoint: 3 months post injection. Method of measurement: Meter.	—

Measure

Time frame

Lysholm score. Timepoint: 3 months post injection. Method of measurement: Lysholm questionnaire.;International Knee Documentation Committee score. Timepoint: 3 months post injection. Method of measurement: International Knee Documentation Committee (IKDC) Questionnaire.;Disability index. Timepoint: 3 months post injection. Method of measurement: Health Assessment Questionnaire.;Pain index. Timepoint: 3 months post injection. Method of measurement: Visual Analogue Scale questionnaire.;Cartilage thickness. Timepoint: 3 months post injection. Method of measurement: Magnetic resonance imaging.;Range of motion. Timepoint: 3 months post injection. Method of measurement: Goniometer.;Walking distance in six minutes. Timepoint: 3 months post injection. Method of measurement: Meter.

—

Secondary

Measure	Time frame
Side effects. Timepoint: 3 months post injection. Method of measurement: Clinical symptoms, questionnaire, peripheral blood and urine samples.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactYunes Panahi

Bagheiat-allah University of Medical Sciences

yunespanahi@yahoo.com+98 21 8821 1524

Outcome results

None listed

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