Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Skin Ulcer

Sponsor
The Foundation for Orthopaedics and Regenerative Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT05158127
Collaborator
(none)
20
1
1
48
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Study Details

Study Description

Brief Summary

This trial will study the safety and efficacy of intravenous infusion and intralesional injection of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Skin Ulcer

Condition or Disease Intervention/Treatment Phase
  • Biological: AlloRx
Phase 1

Detailed Description

This patient funded trial aims to study the safety and efficacy of intravenous infusion and intralesional injection of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Skin Ulcer. 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

Study Type:
Interventional
Anticipated 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 Cells for the Treatment of Skin Ulcer
Anticipated Study Start Date :
Jan 1, 2022
Anticipated Primary Completion Date :
Jan 1, 2026
Anticipated Study Completion Date :
Jan 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Group (AlloRx)

intravenous infusion and intralesional injection of 100 million cells

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

Outcome Measures

Primary Outcome Measures

  1. Safety (adverse events) [Four year follow-up]

    Clinical monitoring of possible adverse events or complications

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Diagnosis of Skin Ulcer

  • 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

Locations

Site City State Country Postal Code
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

None provided.
Responsible Party:
The Foundation for Orthopaedics and Regenerative Medicine
ClinicalTrials.gov Identifier:
NCT05158127
Other Study ID Numbers:
  • ATG-2-MSC-015
First Posted:
Dec 15, 2021
Last Update Posted:
Jan 5, 2022
Last Verified:
Nov 1, 2021
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 5, 2022