Diabetic Foot Ulcer
Conditions
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 diabetic foot ulcers (DFUs).
Interventions
DRUGCorlicyte
expanded umbilical cord lining mesenchymal stem cells
Sponsors
University of Colorado, Denver
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria: 1. Males or non-pregnant, non-lactating females. 2. Age 18 or greater at the time of informed consent. 3. Able and willing to provide written informed consent. 4. Type 1 or Type 2 diabetes. 5. Chronic DFU as the index ulcer meeting all of the following criteria: 1. present for at least 4 weeks at the time of Screening Visit 1 2. located below the malleoli of the foot 3. extends to the dermis or subcutaneous tissue, surrounded by healthy skin, without evidence of exposed muscle, tendon, bone, or joint capsule 4. area measures 1 to 10 cm2 inclusive, at Screening Visit 1, and 5. non-healing (defined as ≤50% reduction in ulcer size by the Baseline Visit, as compared to Screening Visit 1). 6. 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. 7. For an index ulcer on the plantar surface of the foot, willingness to offload the foot per study protocol. 8. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SAE | throughout study completion, an average of 4 months per subject | Number and percent of subjects in each dosing cohort and overall with a serious adverse reaction to Corlicyte®. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibodies to HLA Class I - Time To Development | throughout study completion, an average of 4 months per subject | 2\. Time to development of high titer of antibodies to HLA Class I molecules expressed on Corlicyte® |
| Increase Ulcer Size | throughout study completion, an average of 4 months per subject | 3\. Number and percent of subjects with an increase in ulcer size by the end of the Treatment Phase as reviewed by the Wound Core Laboratory (WCL). |
| Adverse Reaction | throughout study completion, an average of 4 months per subject | 4\. Number and percent of subjects with an adverse reaction to Corlicyte® in each cohort and overall. |
| Antibodies to HLA Class I - number and percent | throughout study completion, an average of 4 months per subject | 1\. Number and percent of subjects who develop a high titer of antibodies to human leukocyte antigen (HLA) Class I molecules expressed on Corlicyte® |
| Suspected Serious Adverse Reaction | throughout study completion, an average of 4 months per subject | 6\. Number and percent of subjects with a suspected serious adverse reaction to Corlicyte® in each cohort and overall. |
| Change in A1c | throughout study completion, an average of 4 months per subject | 7\. Change in hemoglobin A1c from Screening to End-of-Study/Early Termination |
| Suspected Adverse Reaction | throughout study completion, an average of 4 months per subject | 5\. Number and percent of subjects with a suspected adverse reaction to Corlicyte® in each cohort and overall. |
Countries
United States
Outcome results
None listed