The Efficacy of Allogenic Mesenchymal Stem Cells Derived Exosomes in Osteoarthritis Patients
Overview
- Phase
- Not Applicable
- Intervention
- Exosome
- Conditions
- Osteoarthritis, Knee
- Sponsor
- Isfahan University of Medical Sciences
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Western Ontario and McMaster University Osteoarthritis index (WOMAC)
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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.
Investigators
Leila Dehghani
Dr
Isfahan University of Medical Sciences
Eligibility Criteria
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;
Arms & Interventions
Treatment
Patients with moderate to severe osteoarthritis, Kellgren-Lawrence grade 2,3 in both knees; accompanied by mild to moderate pain and swelling are included.
Intervention: Exosome
Outcomes
Primary Outcomes
Western Ontario and McMaster University Osteoarthritis index (WOMAC)
Time Frame: 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