Umbilical-cord mesenchymal stem cell infusion and joint injection for osteoarthritis
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Osteoarthritis
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 |
| Enrollment | 92 (estimated) |
| Sex | All |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 2 sites (St John's and 1 other locations) |
| Trial ID | NCT05147675 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Prior small studies of mesenchymal stem cells for osteoarthritis reported acceptable safety and some symptom improvement, but larger randomized trials remain limited.
Eligibility criteria
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 this trial is running
St John's and 1 other locations
- Medical Surgical Associates Center — St John's, Antigua and Barbuda (Recruiting)
- Athens Beverly Hills Medical Group — Glyfada, Athens, Greece (Recruiting)
Study contacts
- Principal investigator: Chadwick Prodromos, MD — The Foundation for Orthopaedics and Regenerative Medicine
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.