Osteoarthritis, KneeNCT06466850
Mesenchymal Stem Cells Derived Exosomes in Osteoarthritis Patients
A study testing Exosome in people with Osteoarthritis, Knee, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Exosome
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2024to 25 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Iran1 site, 1 recruiting
- Recruiting
Leila Dehghani
Isfahan
Leila Dehghani, Assisstant Prof, 36202020 ext. 031, l_dehghani2002@yahoo.com
Masoud Soleimani, Prof, 36202020 ext. 031, a70.leiladehghani@gmail.com
About this study
Official title: The Efficacy of Allogenic 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).
Read more
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Exosome
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExosomeBiological
Also called EVs
intra-articular injection is suggested for two times: day 1and day 90
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Patients with moderate to severe osteoarthritis, Kellgren-Lawrence grade 2,3 in both knees; accompanied by mild to moderate pain and swelling are included. Receives: Biological: Exosome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster University Osteoarthritis index (WOMAC)
Filling out the WOMAC questionnaire, evaluating the measures related to knee function
Measured: 1, 3, and 6 months. The second injection is repeated in day 90 after first injection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start1 Jan 2024
- Primary completion25 Dec 2026 (estimated)
- Study completion25 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leila Dehghani, Isfahan University of Medical Sciences
- Investigators
- Leila Dehghani, Dr, Principal investigator, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466850
- Sponsor's protocol ID
- Isfahan med
- Status last verified
- Sep 2025
- First submitted
- 14 Jun 2024
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Allogenic Mesenchymal Stem Cells Derived Exosomes in Osteoarthritis Patients
- ClinicalTrials.gov ID
- NCT06466850
- Acronym / sponsor ID
- Isfahan med
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 25 Dec 2026 (estimated)
- Study completion
- 25 Dec 2026 (estimated)
- First posted
- 20 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: ExosomePatients with moderate to severe osteoarthritis, Kellgren-Lawrence grade 2,3 in both knees; accompanied by mild to moderate pain and swelling are included. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExosomeAlso: EVsintra-articular injection is suggested for two times: day 1and day 90 | Biological | Treatment |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Leila Dehghani, Dr principal investigator
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exosome in people with Osteoarthritis, Knee, run by Isfahan University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Leila Dehghani, Dr (36202020 ext. 031, l_dehghani2002@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.