Infusion of stem cells to treat aging frailty
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Aging Frailty
This study is testing if a single infusion of stem cells from umbilical cords can help older adults with frailty feel better and improve their health over time.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 86 (estimated) |
| Sex | All |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 3 sites (St John's and 2 other locations) |
| Trial ID | NCT05018767 on ClinicalTrials.gov |
What this trial studies
This trial investigates the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for treating Aging Frailty. Participants diagnosed with frailty will receive a single infusion of 100 million UC-MSCs. Evaluations will occur at multiple time points, including one month pre-treatment and at 1, 6, 12, 24, 36, and 48 months post-treatment to assess safety and efficacy. The study is patient-funded and aims to contribute to the understanding of stem cell therapy in geriatric care.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with Aging Frailty who can provide informed consent.
Not a fit: Patients with active infections, cancer, or other significant health issues may not benefit from this treatment.
Why it matters
Potential benefit: If successful, this treatment could improve the quality of life and functional status for patients suffering from aging frailty.
How similar studies have performed: Previous studies have indicated that stem cell treatments can be safe and effective for frailty, suggesting a promising avenue for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of Aging Frailty * 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 2 other locations
- Medical Surgical Associates Center — St John's, Antigua and Barbuda (Recruiting)
- Athens Beverly Hills Medical Group — Glyfada, Athens, Greece (Recruiting)
- Artros — Ljubljana, Slovenia, Slovenia (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.