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Mesenchymal Stem Cells Derived Exosomes in Osteoarthritis Patients

The Efficacy of Allogenic Mesenchymal Stem Cells Derived Exosomes in Osteoarthritis Patients

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06466850
Enrollment
20
Registered
2024-06-20
Start date
2024-01-01
Completion date
2026-12-25
Last updated
2025-09-15

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

Conditions

Osteoarthritis, Knee

Brief summary

Present research focuses on the potential of exosomes, which are small vesicles secreted by mesenchymal stem cells (MSCs), as a therapeutic approach for osteoarthritis (OA). OA is a degenerative joint disorder characterized by the destruction of cartilage and loss of extracellular matrix. It's associated with pro-inflammatory cytokines and increased expression of matrix metalloproteinase (MMP) and a disintegrin and metalloproteinase with thrombospondin motifs (ADAMTS). MSCs have been explored as a new treatment for OA over the last decade1. It's suggested that the paracrine secretion of trophic factors, in which exosomes play a crucial role, contributes to the mechanism of MSC-based treatment of OA. Exosomes derived from MSCs may suppress OA development. They carry bioactive molecules of the parental cells, including non-coding RNAs (ncRNAs) and proteins and anti-inflammatory factors. These exosomes have shown a significant impact on the modulation of various physiological behaviors of cells in the joint cavity. This research provides hope for developing more effective and predictable methods of using MSC-derived exosomes for OA treatment.

Interventions

BIOLOGICALExosome

intra-articular injection is suggested for two times: day 1and day 90

Sponsors

Isfahan University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Chronic history (for at least 3 months) of knee joint pain * Body mass index (BMI) between 21.5 and 29.5 * Radiographically documented knee osteoarthritis of grades 1 to 3 (Kellgren-Lawrence (K-L) radiographic classification scale)

Exclusion criteria

* Rheumatoid arthritis and other rheumatic diseases * Varus or valgus more than 10 degrees; lateral subluxation of the patella * Deformity at the joint levels or adjacent to the knee due to fracture or any other injury * Complete rupture of the ligament and meniscus leading to laxity or locking * Serious systemic, oncohematological, autoimmune diseases; history of severe allergy; serious failure of vital organs, inability to walk * Hyaluronic acid infiltration within the previous six months * Hemoglobin levels \<10 g/dL;

Design outcomes

Primary

MeasureTime frameDescription
Western Ontario and McMaster University Osteoarthritis index (WOMAC)1, 3, and 6 months. The second injection is repeated in day 90 after first injection.Filling out the WOMAC questionnaire, evaluating the measures related to knee function

Countries

Iran

Contacts

Primary ContactLeila Dehghani, Dr
l_dehghani2002@yahoo.com36202020
Backup ContactMasoud Soleimani, Prof
a70.leiladehghani@gmail.com03136202020

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026