Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Osteoporosis
- Registration Number
- NCT05152381
- Lead Sponsor
- The Foundation for Orthopaedics and Regenerative Medicine
- 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 Osteoporosis
- Detailed Description
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 Osteoporosis. Patients 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- 20
- Diagnosis of Osteoporosis
- Understanding and willingness to sign a written informed consent document
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Group (AlloRx) AlloRx Single intravenous infusion of 100 million cells
- Primary Outcome Measures
Name Time Method Safety (adverse events) Four year follow-up Clinical monitoring of possible adverse events or complications
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medical Surgical Associates Center
🇦🇬St. John's, Antigua and Barbuda