Injection of stem cell-derived exosomes for knee osteoarthritis
Administration of sEV Derived From UC-MSC in Patients With Osteoarthritis of the Knee: Safety Determination in a Pilot Dose-escalation Study
EARLY_PHASE1 · Universidad de los Andes, Chile · NCT06431152
This study is testing if injections of stem cell-derived tiny particles can safely help people with mild to moderate knee osteoarthritis feel better.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 30 Years to 70 Years |
| Sex | All |
| Sponsor | Universidad de los Andes, Chile (other) |
| Locations | 1 site (Santiago, Las Condes) |
| Trial ID | NCT06431152 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates the safety of small extracellular vesicles (sEVs) derived from allogeneic mesenchymal stromal cells, administered via intra-articular injection in patients with mild to moderate symptomatic knee osteoarthritis. The study is an open-label, dose-escalation pilot trial involving 12 participants, divided into three cohorts receiving increasing doses of the treatment. The sEVs will be produced in a GMP facility, ensuring high-quality standards, and the follow-up period will last up to 12 months to monitor safety and feasibility.
Who should consider this trial
Good fit: Ideal candidates are adults aged 30 to 70 with Kellgren-Lawrence grade II-III knee osteoarthritis and moderate pain levels.
Not a fit: Patients with symptomatic bilateral knee osteoarthritis or those with significant comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a novel, minimally invasive option for alleviating symptoms of knee osteoarthritis.
How similar studies have performed: While the use of MSC-derived therapies is gaining traction, this specific approach using sEVs is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 30 to 70 years. * Kellgren-Lawrence grade II - III knee OA (Rosenberg view x-ray) * VAS for pain ≥ 40 mm, without surgical indication in the affected knee. * In case of bilateral involvement, the most affected knee will be treated. The contralateral knee should be asymptomatic or present a VAS ≤ 20 mm. * Stable knee with normal physical examination. * Signed Informed Consent Exclusion Criteria: * Symptomatic bilateral knee OA * BMI \> 30 kg/m2 * Joint instability at physical examination. * Mechanical meniscal tear on physical examination. * Associated conditions: active local or systemic infection, neoplasia, immunosuppression, pregnancy, anticoagulant therapy, coagulation disorders, inflammatory joint disease (autoimmune, by crystal or other), joint prosthesis, symptomatic spine or hip disease. * Recent use of intra-articular (last 6 months) or oral (last month) steroid therapy. * Recent use of intra-articular hyaluronic acid therapy (last 6 months) * Subchondral bone fracture.
Where this trial is running
Santiago, Las Condes
- Clinica Universidad de los Andes — Santiago, Las Condes, Chile (RECRUITING)
Study contacts
- Study coordinator: Jose Matas, MD
- Email: jmatas@clinicauandes.cl
- Phone: +56 2 26183347
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Osteo Arthritis Knee