Skin Ulcer Clinical Trial
Official title:
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Skin Ulcer
| Verified date | November 2021 |
| Source | The Foundation for Orthopaedics and Regenerative Medicine |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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
| Status | Suspended |
| Enrollment | 20 |
| Est. completion date | January 2026 |
| Est. primary completion date | January 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Antigua and Barbuda | Medical Surgical Associates Center | St. John's |
| Lead Sponsor | Collaborator |
|---|---|
| The Foundation for Orthopaedics and Regenerative Medicine |
Antigua and Barbuda,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety (adverse events) | Clinical monitoring of possible adverse events or complications | Four year follow-up |
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