Skin Ulcer
Conditions
Keywords
Skin Ulcer, stem cell treatment
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
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.
Interventions
BIOLOGICALAlloRx
cultured allogeneic adult umbilical cord derived mesenchymal stem cells
Sponsors
The Foundation for Orthopaedics and Regenerative Medicine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety (adverse events) | Four year follow-up | Clinical monitoring of possible adverse events or complications |
Countries
Antigua and Barbuda
Outcome results
None listed