Mesenchymal Stem Cells Derived Exosomes in Osteoarthritis Patients

NCT06466850 | Recruiting DMC

• 1 other identifier: Isfahan med
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Treatment

EXPERIMENTAL

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

Biological: Exosome

Interventions

Exosome BIOLOGICAL

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

Also known as: EVs

Treatment

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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;

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Leila Dehghani

Isfahan, Iran

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Leila Dehghani, Dr

  Isfahan University of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leila Dehghani, Dr

CONTACT

36202020; l_dehghani2002@yahoo.com

Masoud Soleimani, Prof

CONTACT

03136202020; a70.leiladehghani@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 20, 2024
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 25, 2026
• Study Completion (Estimated): December 25, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

IR (1)