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NCT05158127 | NOT YET RECRUITING | Skin Ulcer

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

The Foundation for Orthopaedics and Regenerative Medicine

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

Skin Ulcer

Intervention/treatment

AlloRx

Phase

PHASE1

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 Type : INTERVENTIONAL
Estimated Enrollment : 20 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for the Treatment of Skin Ulcer
Actual Study Start Date : 2025-12
Estimated Primary Completion Date : 2028-12
Estimated Study Completion Date : 2028-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study:
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cells for Skin Ulcer

Location Details

NCT05158127

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Antigua and Barbuda,

Medical Surgical Associates Center

St. John's, Antigua and Barbuda,