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

The Foundation for Orthopaedics and Regenerative Medicine

Status and phase: Withdrawn; Phase 1

Conditions: Osteoporosis

Treatments: Biological: AlloRx

Study type: Interventional

Funder types: Other

Identifiers

NCT05152381

ATG-1-MSC-018

Details and patient eligibility

About

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

Full 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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Treatment Group (AlloRx)

Experimental group

Description:

Single intravenous infusion of 100 million cells

Treatment:

Biological: AlloRx