NCT05158127

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
32mo left

Started Dec 2025

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Dec 2025Dec 2028

First Submitted

Initial submission to the registry

December 2, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 15, 2021

Completed
4 years until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

April 17, 2025

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

December 2, 2021

Last Update Submit

April 15, 2025

Conditions

Skin Ulcer

Keywords

Skin Ulcerstem cell treatment

Outcome Measures

Primary Outcomes (1)

  • Safety (adverse events)

    Clinical monitoring of possible adverse events or complications

    Four year follow-up

Study Arms (1)

Treatment Group (AlloRx)

EXPERIMENTAL

intravenous infusion and intralesional injection of 100 million cells

Biological: AlloRx

Interventions

AlloRxBIOLOGICAL

cultured allogeneic adult umbilical cord derived mesenchymal stem cells

Treatment Group (AlloRx)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of Skin Ulcer
  • Understanding and willingness to sign a written informed consent document

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Surgical Associates Center

St John's, Antigua and Barbuda

Location

MeSH Terms

Conditions

Skin Ulcer

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Chadwick Prodromos, MD

    The Foundation for Orthopaedics and Regenerative Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2021

First Posted

December 15, 2021

Study Start

December 1, 2025

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

April 17, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

AN(1)