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Mesenchymal Stem Cells Derived Exosomes in Osteoarthritis Patients

Not Applicable
Recruiting
Conditions
Osteoarthritis, Knee
Interventions
Biological: Exosome
Registration Number
NCT06466850
Lead Sponsor
Isfahan University of Medical Sciences
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
20
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;

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
TreatmentExosomePatients with moderate to severe osteoarthritis, Kellgren-Lawrence grade 2,3 in both knees; accompanied by mild to moderate pain and swelling are included.
Primary Outcome Measures
NameTimeMethod
Western Ontario and McMaster University Osteoarthritis index (WOMAC)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

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Leila Dehghani

🇮🇷

Isfahan, Iran, Islamic Republic of

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