Status:
COMPLETED
PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE®) TO HEAL CHRONIC DIABETIC FOOT ULCERS
Lead Sponsor:
University of Colorado, Denver
Conditions:
Diabetic Foot Ulcer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Study Objective: The objective of this Phase 1 open-label study is to establish the safety and tolerability of Corlicyte mesenchymal stem cells (MSCs) in the treatment of patients with chronic diabet...
Eligibility Criteria
Inclusion
- Males or non-pregnant, non-lactating females.
- Age 18 or greater at the time of informed consent.
- Able and willing to provide written informed consent.
- Type 1 or Type 2 diabetes.
- Chronic DFU as the index ulcer meeting all of the following criteria:
- present for at least 4 weeks at the time of Screening Visit 1
- located below the malleoli of the foot
- extends to the dermis or subcutaneous tissue, surrounded by healthy skin, without evidence of exposed muscle, tendon, bone, or joint capsule
- area measures 1 to 10 cm2 inclusive, at Screening Visit 1, and
- non-healing (defined as ≤50% reduction in ulcer size by the Baseline Visit, as compared to Screening Visit 1).
- Negative for antibodies to HLA Class I molecules expressed on Corlicyte MSCs, as measured by Luminex HLA single antigen beads, within 3 months prior to start of Treatment Phase without interval sensitizing events.
- For an index ulcer on the plantar surface of the foot, willingness to offload the foot per study protocol.
- In women of childbearing potential, willingness to use effective means of birth control during the course of the study; if using systemic birth control, this must have been used for 6 months or longer prior to Screening Visit 1.
Exclusion
Key Trial Info
Start Date :
November 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2023
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04104451
Start Date
November 12 2019
End Date
August 1 2023
Last Update
January 29 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045