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Not Yet Recruiting
NCT05158127
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells for Skin Ulcer
Conditions: Skin Ulcer
Sex: All
Healthy volunteers: No
Phase: PHASE1
Enrollment: 20
Sponsor: The Foundation for Orthopaedics and Regenerative Medicine
Location: Prodromos Stem Cell Institute Naples Florida
Summary
This trial will study the safety and efficacy of intravenous infusion and intralesional injection of cultured allogeneic adult umbilical cord or placental derived mesenchymal stem cells for the treatment of Skin Ulcer
Eligibility 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
Source: ClinicalTrials.gov (NCT05158127). StuddyBuddy aggregates publicly available trial information.
