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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2019-05-28

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.

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Detailed Description

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Conditions

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Diabetes Diabetic Foot Ulcer Non-healing Wound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ExpressGraft-C9T1 Skin Tissue

Enrolled participants receive one application of ExpressGraft-C9T1 skin tissue

Group Type EXPERIMENTAL

ExpressGraft-C9T1 Skin Tissue

Intervention Type BIOLOGICAL

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

Interventions

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ExpressGraft-C9T1 Skin Tissue

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Exclusion Criteria

MEDICAL HISTORY/CURRENT MEDICAL CONDITION

1. Pregnant or nursing women
2. Prisoners
3. Abnormal laboratory value(s) for routine blood work that the Clinical Investigator deems would not be in the subject's best interest to participate
4. Osteomyelitis in the study ulcer foot in the last 30 days
5. Grade 3 or 4 lower extremity edema
6. Unable to tolerate off-loading
7. Active Charcot's foot
8. History of malignancy in previous 5 years, except for basal cell carcinoma that has been treated with local excision and is no longer present
9. Patients with unstable chronic renal disease or requiring dialysis
10. Gangrene in any part of study ulcer foot
11. 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.
12. Patients with history of poor compliance
13. Patients with baseline panel reactive antibody (PRA) of ≥ 20%

MEDICATIONS/THERAPIES
14. Oral or parenteral corticosteroids, immunosuppressants, radiation therapy or chemotherapy within 30 days prior to study enrollment
15. Use of an investigational product within the preceding 60 days

STUDY ULCER
16. Signs and symptoms of clinical infection at study ulcer site
17. Study ulcer requiring antimicrobial therapy at Screening Visit or Study Treatment Day 0 due to clinical suspicion of infection
18. Treatment of study ulcer with Regranex® or hyperbaric oxygen within preceding 30 days
19. Previous treatment of study ulcer with any cell and/or tissue product (CTP) therapy
20. Change in wound size (increase/decrease) greater than 25% from Screening Visit to Study Treatment Day 0
21. Other ulcers within 3 cm of study ulcer
22. Ulcers with tendon, muscle, joint capsule, or bone exposure

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No