Umbilical-cord mesenchymal stem cell infusion and joint injection for osteoarthritis
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells for the Treatment of Osteoarthritis
Run by The Foundation for Orthopaedics and Regenerative Medicine · NCT05147675 · Data updated 2026-11-12
This treatment will try giving cultured umbilical‑cord mesenchymal stem cells by intravenous infusion and directly into the affected joint to see if they are safe and help people with osteoarthritis.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Sex | All |
| Enrollment | 92 (estimated) |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 2 sites (Naples, Florida and 1 other locations) |
| Status | Recruiting |
| Started | December 1, 2022 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | October 16, 2026 |
| Trial ID | NCT05147675 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with a diagnosis of osteoarthritis who can provide informed consent and are medically stable without active infection, active cancer, multisystem organ failure, pregnancy, recent organ transplant, or uncontrolled substance abuse are ideal candidates.
✕Probably not a fit
Patients who are pregnant, have active infection or cancer, chronic multisystem organ failure, recent organ transplant, uncontrolled substance abuse, significant pre-treatment lab abnormalities, or who cannot travel to the Athens sites are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1, patient-funded trial gives adults with osteoarthritis a total dose of 100 million cultured allogeneic umbilical cord–derived mesenchymal stem cells delivered by one intravenous infusion and one intraarticular injection. Participants are screened before treatment and excluded for active infection, active cancer, multisystem organ failure, pregnancy, recent organ transplant, uncontrolled substance abuse, or significant laboratory abnormalities. Safety and preliminary efficacy are measured at 1, 6, 12, 24, 36, and 48 months after treatment with clinical assessments and standard laboratory monitoring. The trial is conducted at two sites in Athens, Greece, to establish safety and feasibility for future larger trials.
Why it matters
Potential benefit: If successful, the treatment could reduce joint pain and improve function with an acceptable safety profile.
How similar studies have gone: Prior small studies of mesenchymal stem cells for osteoarthritis reported acceptable safety and some symptom improvement, but larger randomized trials remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Osteoarthritis * Understanding and willingness to sign a written informed consent document Exclusion Criteria: * Active infection * Active cancer * Chronic multisystem organ failure * Pregnancy * Clinically significant Abnormalities on pre-treatment laboratory evaluation * Medical condition that would (based on the opinion of the investigator) compromise patient's safety. * Continued drug abuse * Pre-menopausal women not using contraception * Previous organ transplant * Hypersensitivity to sulfur
Where it's running
-
Prodromos Stem Cell Institute
Naples, Florida, United States Recruiting -
Prodromos Stem Cell Institute
Athens, Greece Recruiting
Study contacts
- Study coordinator: Chadwick Prodromos, MD
- Email: care@thepsci.com
- Phone: 847-699-6810
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.