ClinicalTrials.gg
RecruitingNCT06466850Updated Sep 15, 2025

Mesenchymal Stem Cells Derived Exosomes in Osteoarthritis Patients

An interventional study of Exosome in Osteoarthritis, Knee, sponsored by Isfahan University of Medical Sciences. Recruiting at 1 site in Iran. Open to participants aged 45 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Isfahan University of Medical Sciences · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Jan 2024, registered Jun 2024).
  • Started Jan 2024; still recruiting 2 years 10 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
45 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Osteoarthritis, Knee
03

In context

Osteoarthritis, Knee

3,292 studies on the registry are indexed under Osteoarthritis, Knee; 623 are open to participants now.

This study's planned enrollment of 20 is below the median of 68 across 2,714 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Isfahan University of Medical Sciences is the lead sponsor of 150 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Chronic history (for at least 3 months) of knee joint pain
  • (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

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, diseases; history of severe allergy; serious failure of vital organs, inability to walk
  • Hyaluronic acid infiltration within the previous six months
  • levels \<10 g/dL;
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    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.

    Biological: Exosome

Interventions

  • BiologicalExosome

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

    Also known as: EVs

06

What researchers measure

Primary outcomes

  1. Western Ontario and McMaster University Osteoarthritis index (WOMAC)

    Filling out the WOMAC questionnaire, evaluating the measures related to knee function

    Time frame: 1, 3, and 6 months. The second injection is repeated in day 90 after first injection.

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06466850
Responsible party
Leila Dehghani (Dr, Isfahan University of Medical Sciences) — Principal investigator
First posted
Jun 20, 2024
Start date
Jan 1, 2024
Primary completion
Dec 25, 2026 (estimated)
Completion
Dec 25, 2026 (estimated)
Last update
Sep 15, 2025

Study contacts

Leila Dehghani, Dr
Contact
l_dehghani2002@yahoo.com
36202020 ext. 031
Masoud Soleimani, Prof
Contact
a70.leiladehghani@gmail.com
03136202020 ext. 031
Leila Dehghani, Dr
principal investigator · Isfahan University of Medical Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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