Mesenchymal Stem Cells Derived Exosomes in Osteoarthritis Patients

NCT ID: NCT06466850

Last Updated: 2025-09-15

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-12-25

Brief Summary

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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

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type EXPERIMENTAL

Exosome

Intervention Type BIOLOGICAL

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

Intervention Type BIOLOGICAL

Other Intervention Names

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EVs

Eligibility Criteria

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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;
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Leila Dehghani

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Leila Dehghani, Dr

Role: CONTACT

36202020 ext. 031

Masoud Soleimani, Prof

Role: CONTACT

03136202020 ext. 031

Facility Contacts

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Leila Dehghani, Assisstant Prof

Role: primary

36202020 ext. 031

Masoud Soleimani, Prof

Role: backup

36202020 ext. 031

Other Identifiers

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Isfahan med

Identifier Type: -

Identifier Source: org_study_id

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