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The effect of exosomes in the treatment of knee osteoarthritis

Evaluation of therapeutic effect of placental mesenchymal stem cell exosome injection in improving clinical symptoms and MRI changes in patients with knee osteoarthritis

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210423051054N1
Enrollment
30
Registered
2022-05-11
Start date
2022-06-22
Completion date
Unknown
Last updated
2022-05-30

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

Conditions

Knee osteoarthritis. Bilateral primary osteoarthritis of knee

Interventions

Intervention 1: Intervention group: Injection of 5 cc of placental mesenchymal stem cell exosome into the knee with anterolateral approach in the flexed position, isometric strengthening exercises for

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 65 Years

Inclusion criteria

Inclusion criteria: Pain in both knees over the past 6 months, which is related to the degenerative process of the knee, requires pain medication and has lasted for more than a month. Graphical confirmation of bilateral knee osteoarthritis with grade 2 or 3 based on the Kellgren-Lawrence classification. The knee pain intensity should be greater than or equal to 4 according to the VAS.

Exclusion criteria

Exclusion criteria: Younger than 45 years or older than 65 years Rheumatic or collagen vascular disease History of malignancy Coagulopathy or taking anticoagulant drug Any injection into the knee joint during the last 3 months A history of recent severe knee trauma in the past 1 month Septic arthritis of the knee or active wound of the knee joint Genovarum or genovalgum greater than 20 degrees Total knee replacement Cardiac pacemaker Cochlear implantation Existence of fragments or foreign metal object in the knee or around the arteries, nerves and brain

Design outcomes

Primary

MeasureTime frame
Tibiofemoral cartilage volume. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Magnetic resonance imaging.;Knee joint synovitis. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Magnetic resonance imaging.;Medial and lateral meniscus disintegration. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Magnetic resonance imaging.;Patellofemoral cartilage erosion. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Magnetic resonance imaging.;Tibiofemoral cartilage erosion. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Magnetic resonance imaging.;Anterior cruciate ligament injury. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Magnetic resonance imaging.;Pain intensity. Timepoint: Before intervention, 2 and 6 months after intervention. Method of measurement: Visual Analogue Scale.;Pain intensity, stiffness, and physical activity. Timepoint: Before intervention, 2 and 6 months after intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthritis Index.;Pain or discomfort, maximum distance walked, and activities of daily living. Timepoint: Before intervention, 2 and 6 months after intervention. Method of measurement: Lequesne Index.;Patellofemoral cartilage volume. Timepoint: Before intervention and 6 months after intervention. Method of measurement: Magnetic resonance imaging.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactRasa Salmani Oshnari

Shahid Beheshti University of Medical Sciences

rasa_salmani@yahoo.com+98 21 25719

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 6, 2026