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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05152381
Recruitment Status : Suspended (Updating Protocol)
First Posted : December 9, 2021
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
The Foundation for Orthopaedics and Regenerative Medicine

Study Description
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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

Condition or disease Intervention/treatment Phase
Osteoporosis Biological: AlloRx Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for the Treatment of Osteoporosis
Estimated Study Start Date : December 8, 2022
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoporosis Safety

Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment Group (AlloRx)
Single intravenous infusion of 100 million cells
 Biological: AlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells


Outcome Measures
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Primary Outcome Measures :
  1. Safety (adverse events) [ Time Frame: Four year follow-up ]
    Clinical monitoring of possible adverse events or complications


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05152381


Locations
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Antigua and Barbuda
Medical Surgical Associates Center
St. John's, Antigua and Barbuda
Sponsors and Collaborators
The Foundation for Orthopaedics and Regenerative Medicine
Investigators
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Principal Investigator: Chadwick Prodromos, MD The Foundation for Orthopaedics and Regenerative Medicine
More Information
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Responsible Party: The Foundation for Orthopaedics and Regenerative Medicine
ClinicalTrials.gov Identifier: NCT05152381    
Other Study ID Numbers: ATG-1-MSC-018
First Posted: December 9, 2021    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by The Foundation for Orthopaedics and Regenerative Medicine:
Osteoporosis
stem cell treatment
Additional relevant MeSH terms:
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Osteoporosis
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Metabolic Diseases