Infusion of stem cells to treat aging frailty
Official title: Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Aging Frailty
Run by The Foundation for Orthopaedics and Regenerative Medicine · NCT05018767 · Data updated 2026-11-12
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 |
| Sex | All |
| Enrollment | 86 (estimated) |
| Sponsor | The Foundation for Orthopaedics and Regenerative Medicine Academic / other |
| Locations | 2 sites (Naples, Florida and 1 other locations) |
| Status | Recruiting |
| Started | January 22, 2022 |
| Main results expected | December 1, 2027 |
| Study ends | December 1, 2027 |
| Registry record updated | October 20, 2026 |
| Trial ID | NCT05018767 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals diagnosed with Aging Frailty who can provide informed consent.
✕Probably not a fit
Patients with active infections, cancer, or other significant health issues may not benefit from this treatment.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have indicated that stem cell treatments can be safe and effective for frailty, suggesting a promising avenue for this approach.
Who can join: the full rules
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 it's running
-
Prodromos Stem Cell Institute
Naples, Florida, United States Recruiting -
Prodromos Stem Cell Institute
Athens, Greece Recruiting
Study contacts
- Principal investigator: Chadwick Prodromos, MD — The Foundation for Orthopaedics and Regenerative Medicine
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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.