Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Osteoporosis

NCT05152381 — Phase 1, Withdrawn, The Foundation for Orthopaedics and Regenerative Medicine

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Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Osteoporosis

Registry	NCT05152381
Status	Withdrawn - Difficulty Recruiting Participants
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Sponsor	The Foundation for Orthopaedics and Regenerative Medicine (Other)
Conditions	Osteoporosis
Interventions	AlloRx (Biological)
Dates	start 2022-12-08, primary completion 2025-04-04, completion 2025-04-04, first posted 2021-12-09, last updated 2025-04-08
Locations	1 site in Antigua and Barbuda

-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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Treatment Group (AlloRx)	Experimental	Biological: AlloRx	Single intravenous infusion of 100 million cells

AlloRx (Biological): cultured allogeneic adult umbilical cord derived mesenchymal stem cells

+Outcome measures

Primary outcomes

Safety (adverse events) [Four year follow-up]: Clinical monitoring of possible adverse events or complications

+Eligibility

Sex: All

Inclusion Criteria:

* Diagnosis of Osteoporosis
* 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

+Locations (1)

Facility	City	Country	Status
Medical Surgical Associates Center	St John's	Antigua and Barbuda

+Investigators

Chadwick Prodromos, MD, Principal investigator, The Foundation for Orthopaedics and Regenerative Medicine