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NCT Number: NCT06466850

Mesenchymal Stem Cells Derived Exosomes in Osteoarthritis Patients

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

45 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Exosome

Biological

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

Other names: EVs

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Leila Dehghani, Dr

CONTACT

[email protected]

36202020 ext. 031

Masoud Soleimani, Prof

CONTACT

[email protected]

03136202020 ext. 031

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jun 20, 2024
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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