Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Aging Frailty
Study Details
Study Description
Brief Summary
This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Aging Frailty
Condition or Disease | Intervention/Treatment | Phase |
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Phase 1 |
Detailed Description
Studies have shown that stem cell treatment is safe and efficacious for the treatment of Aging Frailty. This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Frailty. Patients with Frailty will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Treatment Group Single intravenous infusion of 100 million cells |
Biological: AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
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Outcome Measures
Primary Outcome Measures
- Safety (adverse events) [Four year follow-up]
Clinical monitoring of possible adverse events or complications
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of Aging Frailty
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Understanding and willingness to sign a written informed consent document
Exclusion Criteria:
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Active infection
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Active cancer
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Chronic multisystem organ failure
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Pregnancy
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Clinically significant abnormalities on pre-treatment laboratory evaluation
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Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
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Continued drug abuse
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Pre-menopausal women not using contraception
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Previous organ transplant
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Hypersensitivity to sulfur
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Medical Surgical Associates Center | St. John's | Antigua and Barbuda |
Sponsors and Collaborators
- The Foundation for Orthopaedics and Regenerative Medicine
Investigators
- Principal Investigator: Chadwick Prodromos, MD, The Foundation for Orthopaedics and Regenerative Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
- Golpanian S, DiFede DL, Khan A, Schulman IH, Landin AM, Tompkins BA, Heldman AW, Miki R, Goldstein BJ, Mushtaq M, Levis-Dusseau S, Byrnes JJ, Lowery M, Natsumeda M, Delgado C, Saltzman R, Vidro-Casiano M, Pujol MV, Da Fonseca M, Oliva AA Jr, Green G, Premer C, Medina A, Valasaki K, Florea V, Anderson E, El-Khorazaty J, Mendizabal A, Goldschmidt-Clermont PJ, Hare JM. Allogeneic Human Mesenchymal Stem Cell Infusions for Aging Frailty. J Gerontol A Biol Sci Med Sci. 2017 Oct 12;72(11):1505-1512. doi: 10.1093/gerona/glx056.
- Tompkins BA, DiFede DL, Khan A, Landin AM, Schulman IH, Pujol MV, Heldman AW, Miki R, Goldschmidt-Clermont PJ, Goldstein BJ, Mushtaq M, Levis-Dusseau S, Byrnes JJ, Lowery M, Natsumeda M, Delgado C, Saltzman R, Vidro-Casiano M, Da Fonseca M, Golpanian S, Premer C, Medina A, Valasaki K, Florea V, Anderson E, El-Khorazaty J, Mendizabal A, Green G, Oliva AA, Hare JM. Allogeneic Mesenchymal Stem Cells Ameliorate Aging Frailty: A Phase II Randomized, Double-Blind, Placebo-Controlled Clinical Trial. J Gerontol A Biol Sci Med Sci. 2017 Oct 12;72(11):1513-1522. doi: 10.1093/gerona/glx137.
- SC-11-ATG-12-01