Mesenchymal Stem Cells Derived Exosomes in Osteoarthritis Patients

Isfahan University of Medical Sciences

Status: Enrolling

Conditions: Osteoarthritis, Knee

Treatments: Biological: Exosome

Study type: Interventional

Funder types: Other

Identifiers

NCT06466850

Isfahan med

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Treatment

Experimental group

Description:

Patients with moderate to severe osteoarthritis, Kellgren-Lawrence grade 2,3 in both knees; accompanied by mild to moderate pain and swelling are included.

Treatment:

Biological: Exosome