Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Skin Ulcer
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 |
---|---|---|
|
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
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
- Safety (adverse events) [Four year follow-up]
Clinical monitoring of possible adverse events or complications
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosis of Skin Ulcer
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Understanding and willingness to sign a written informed consent document
Exclusion Criteria:
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Active infection
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Active cancer
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Chronic multisystem organ failure
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Pregnancy
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Clinically significant Abnormalities on pre-treatment laboratory evaluation
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Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
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Continued drug abuse
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Pre-menopausal women not using contraception
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Previous organ transplant
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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.- ATG-2-MSC-015