ExpressGraft-C9T1 Skin Tissue as a Treatment of Diabetic Foot Ulcers

Study Overview
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Brief Summary
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This study is designed as a prospective, open-label trial focused on assessing the safety and tolerability of ExpressGraft-C9T1 skin tissue in the treatment of diabetic foot ulcers (DFU). Because the focus is on safety rather than efficacy, a standard of care comparator is not included in this first-in-human study. Targeted enrollment for this study is up to 6 subjects with a confirmed diagnosis of diabetes and who have foot ulcers. Subjects will each receive a single application of ExpressGraft-C9T1 skin tissue on a single identified study DFU following a 10-14 day run-in period. Any subjects requiring additional treatment will receive protocol-defined dressings through Study Treatment Week 12 as necessary. Enrollment will occur with a minimum of one week between each subject.

Official Title
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An Open-Label, Prospective, Safety, and Tolerability Study of ExpressGraft-C9T1 Skin Tissue in the Treatment of Diabetic Foot Ulcers

Conditions
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Diabetes, Diabetic Foot Ulcer, Non-healing Wound

Intervention / Treatment
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* Biological: ExpressGraft-C9T1 Skin Tissue


Participation Criteria
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Eligibility Criteria
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SUBJECT-SPECIFIC CRITERIA Men and women 18 - 80 years of age, inclusive Female subjects of childbearing potential must agree to practice birth control for the duration of the study Documented Type 1 or Type 2 Diabetes Mellitus HgbA1C ≤ 10.0% Ankle:brachial blood pressure index (ABI) of 0.7 to 1.3 If ABI is > 1.3 (i.e., non-compressible ankle vessels) or cannot be measured, then Toe brachial index (TBI) of ≥ 0.5, or Doppler arterial waveforms that are triphasic or biphasic at the ankle of affected leg If ABI and TBI cannot be measured, then Transcutaneous pressure (TcpO2) of ≥ 40 around ulcer site, or Skin perfusion pressure > 30 if neither ABI, TBI, nor TcpO2 can be measured near ulcer Stable medications for 2 weeks prior to Study Treatment Day 0 Sliding scale insulin permitted Select antimicrobial therapies can be used as needed Capable and willing to attend the scheduled visits and comply with study procedures Signed informed consent form (ICF) for study enrollment WOUND-SPECIFIC CRITERIA Full-thickness ulcer on the foot of 1.0 cm^2 - 5.0 cm^2 at Screening Visit after debridement with no clinical signs and symptoms of infection. Full thickness is defined as penetrating the dermis, but not extending beyond the subcutaneous tissue. Study ulcer has been present for at least 4 weeks but not more than 1 year Exclusion criteria: MEDICAL HISTORY/CURRENT MEDICAL CONDITION Pregnant or nursing women Prisoners Abnormal laboratory value(s) for routine blood work that the Clinical Investigator deems would not be in the subject's best interest to participate Osteomyelitis in the study ulcer foot in the last 30 days Grade 3 or 4 lower extremity edema Unable to tolerate off-loading Active Charcot's foot History of malignancy in previous 5 years, except for basal cell carcinoma that has been treated with local excision and is no longer present Patients with unstable chronic renal disease or requiring dialysis Gangrene in any part of study ulcer foot Patients with a history of above- or below-knee amputation in the contralateral leg related to underlying chronic disease. History of toe amputation in either leg would not be exclusionary. Patients with history of poor compliance Patients with baseline panel reactive antibody (PRA) of ≥ 20% MEDICATIONS/THERAPIES Oral or parenteral corticosteroids, immunosuppressants, radiation therapy or chemotherapy within 30 days prior to study enrollment Use of an investigational product within the preceding 60 days STUDY ULCER Signs and symptoms of clinical infection at study ulcer site Study ulcer requiring antimicrobial therapy at Screening Visit or Study Treatment Day 0 due to clinical suspicion of infection Treatment of study ulcer with Regranex® or hyperbaric oxygen within preceding 30 days Previous treatment of study ulcer with any cell and/or tissue product (CTP) therapy Change in wound size (increase/decrease) greater than 25% from Screening Visit to Study Treatment Day 0 Other ulcers within 3 cm of study ulcer Ulcers with tendon, muscle, joint capsule, or bone exposure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ExpressGraft-C9T1 Skin Tissue<br>Enrolled participants receive one application of ExpressGraft-C9T1 skin tissue | Biological: ExpressGraft-C9T1 Skin Tissue<br>* ExpressGraft-C9T1 skin tissue is provided as a suturable, biologically-active, circular skin tissue with a fully-stratified epithelial compartment comprised of human keratinocytes (NIKSC9T1) and a dermal compartment containing fibroblasts<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events through study completion | Clinically significant vital signs, infection, blood chemistry, hematology and immunological evaluations are recorded as adverse events during the study. The safety of ExpressGraft-C9T1 skin tissue will be evaluated by adverse events through the 12 month study session. | Through study completion, at approximately 12 months |