Mesenchymal Stem Cells Derived Exosomes in Osteoarthritis Patients

Osteoarthritis, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06466850
• Other study ID #: Isfahan med
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 25, 2025

Study information

• Verified date: June 2024
• Source: Isfahan University of Medical Sciences
• Contact: Leila Dehghani, Dr
• Phone: 36202020
• Email: l_dehghani2002[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: January 25, 2025
• Est. primary completion date: December 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Leila Dehghani	Isfahan

Sponsors (1)

Lead Sponsor	Collaborator
Isfahan University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Western Ontario and McMaster University Osteoarthritis index (WOMAC)	Filling out the WOMAC questionnaire, evaluating the measures related to knee function	1, 3, and 6 months. The second injection is repeated in day 90 after first injection.