Mesenchymal Stem Cells Derived Exosomes in Osteoarthritis Patients
NCT ID: NCT06466850
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2024-01-01
2026-12-25
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Treatment
Patients with moderate to severe osteoarthritis, Kellgren-Lawrence grade 2,3 in both knees; accompanied by mild to moderate pain and swelling are included.
Exosome
intra-articular injection is suggested for two times: day 1and day 90
Interventions
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Exosome
intra-articular injection is suggested for two times: day 1and day 90
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
45 Years
75 Years
ALL
No
Sponsors
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Isfahan University of Medical Sciences
OTHER
Responsible Party
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Leila Dehghani
Dr
Principal Investigators
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Leila Dehghani, Dr
Role: PRINCIPAL_INVESTIGATOR
Isfahan University of Medical Sciences
Locations
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Leila Dehghani
Isfahan, , Iran
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Isfahan med
Identifier Type: -
Identifier Source: org_study_id
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