TWB-103 for Adult Patients With Split-Thickness Skin Graft Donor Site Wounds

• ClinicalTrials.gov Identifier: NCT02737748
• Recruitment Status: Completed
• First Posted: April 14, 2016
• Last Update Posted: October 6, 2021
• Sponsor: Transwell Biotech Co., Ltd.
• Collaborator: A2 Healthcare Taiwan Corporation
• Information provided by (Responsible Party): Transwell Biotech Co., Ltd.

Study Description

Brief Summary:

Primary objective:

1. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW) for Phase I in terms of Incidence of treatment-related AEs and SAEs (including infections and bleeding)
2. To evaluate the efficacy for Phase I+II of TWB-103 in split-thickness skin graft donor site wounds (DSW) in terms of The healing time from DSW creation to 100% re-epithelialization

Secondary objective:

1. To evaluate the efficacy of TWB-103 in split-thickness skin graft donor site wounds (DSW) in secondary efficacy endpoints
2. To evaluate the safety of TWB-103 in split-thickness skin graft donor site wounds (DSW) in secondary safety endpoints

Condition or disease	Intervention/treatment	Phase
Donor Site Complication	Drug: TWB-103 add-on Tegaderm; Drug: Placebo+Tegaderm	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 48 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Phase I/II Study to Evaluate the Safety and Efficacy of TWB-103 in Adult Patients With Split-Thickness Skin Graft Donor Site Wounds (DSW)
• Actual Study Start Date: July 6, 2017
• Actual Primary Completion Date: May 7, 2021
• Actual Study Completion Date: May 7, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Treatment Group; TWB-103 add-on Tegaderm	Drug: TWB-103 add-on Tegaderm; TWB-103 is the primary therapeutics with the use of Tegaderm as a wound-site protection
Placebo Comparator: Control Group; Placebo+Tegaderm	Drug: Placebo+Tegaderm; Placebo to TWB-103 with the use of Tegaderm as a wound-site protection

Outcome Measures

Primary Outcome Measures :

1. Incidence of treatment-related AEs and SAEs (including infections and bleeding) [ Time Frame: Day 0~Day 28 ]
   The incidence of treatment-related AEs and SAEs (including infections and bleeding) will be observed for the 6 patients in Phase I
2. The healing time from DSW creation to the first 100% re-epithelialization with confirmation for at least 10 days apart assessed by the investigator [ Time Frame: Days 42 or earlier ]
   The healing time from DSW creation to the first 100% re-epithelialization with confirmation for at least 10 days apart assessed by the investigator for all patients in Phase I and II

Secondary Outcome Measures :

1. The healing time from DSW creation to the first 100% re-epithelialization with confirmation for at least 10 days apart, assessed by the first additional evaluator [ Time Frame: Days 42 or earlier ]
   The healing time from DSW creation to the first 100% re-epithelialization with confirmation for at least 10 days apart, assessed by the first additional evaluator for all patients in Phase I and II
2. The healing rates (complete wound closure) of patients at Day 7, 10 and 14 after DSW creation [ Time Frame: Day 7, 10 and 14 ]
   Complete wound closure is defined as skin 100% re-epithelialization without drainage or dressing requirements. This endpoint will be in all patients in Phase I and II.
3. The healing percentage of wounds (ratio of healing area and original area) at Days 7, 10 and 14 after DSW creation [ Time Frame: Day 7, 10 and 14 ]
   The healing percentage of wounds will be calculated based on the healing area measured on Day 7, 10 and 14, comparing to the original area measured on Day 0 for all patients in Phase I and II.
4. The pain change from baseline to post-wound creation visits based on short-form McGill pain questionnaire score [ Time Frame: Days 3, 7, 10, 14, 28, 42, Day 90/180/270/360 from Day 28 or 42 ]
   All patients in Phase I and II will evaluate the pain based on Short-form McGill pain questionnaire at each visit.
5. Incidence of AEs and SAEs [ Time Frame: Screening~ Day 360 from Day 28 or 42 ]
   All incidence of AEs and SAEs will be analyzed for all patients in Phase I and II.
6. Changes in post-treatment physical examination, vital signs, and general laboratory assessment compared to baseline [ Time Frame: Days 3, 7, 10, 14, 28, 42 ]
   Will be analyzed for all patients in Phase I and II.
7. Incidence of treatment-related AEs and SAEs (including infections and bleeding) [ Time Frame: Screening~ Day 360 from Day 28 or 42 ]
   The incidence of treatment-related AEs and SAEs (including infections and bleeding) will be observed for all patients in Phase I and II

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

A patient is eligible for the study if all of the following apply:

1. Female/male patients, aged 20-65 years old
2. Presenting a split-thickness skin graft donor site wound with a minimum size of 15 cm2 but no more than 100 cm2, with a minimum width of 3 cm and with an approximate thickness of 0.010~0.012 inches. The graft cannot be harvested from a site from which a skin graft was previously obtained.
3. If the primary wound is a result of a thermal or chemical burn, the total body surface area of the said wound must be less than 15%.
4. Females of childbearing potential must have a documented negative serum pregnancy test done at the screening visit, which is within 2 weeks prior the DSW creation and the treatment
5. Both male and female patients must agree to use highly effective contraceptives from signing informed consent to 30 days after the last dose administration.
6. Willing to comply with the study protocol and to sign the Informed Consent Form

Any patient meeting any of the exclusion criteria will be excluded from study participation.

1. Female patients who are pregnant or lactating or planning a pregnancy and any male patient whose partner (wife) planning a pregnancy from signing informed consent to 30 days after the last dose administration.
2. Clinically significant disease or condition that may compromise graft take and/or donor site healing (e.g. the presence of a bleeding disorder, capillary fragility, venous or arterial disorder directly affecting the donor site to be treated, known or suspected systemic malignancies, human immunodeficiency virus infection, renal or liver disease, uncontrolled diabetes mellitus, thrombocytopenia, vasculitis, poor nutritional status).

3. Patients who are currently receiving or have received the following treatments within 4 weeks prior to study entry are excluded from the study:

   1. systemic or inhaled corticosteroids or immunosuppressant agents; or
   2. therapeutic doses of anticoagulants (e.g. Coumadin, Heparin, low molecular weight Heparin) for pre-existing medical conditions, for whom a dose interruption from Screening through the end of the study period is contraindicated.
4. Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
5. Hematologic disease, malignancy or hypo-immunity.
6. History of HIV or congenital immunodeficiency.
7. History of alcoholism or drug abuse.
8. Have used any tobacco product within 1 week prior to Day 0.
9. Patients previously treated with any cell-based product, including autologous tissue at the treatment site.
10. Received an investigational drug, device or biological/bioactive treatment within 30 days prior to Screening Visit.
11. Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the trial treatment.
12. History of sensitivity to bovine or porcine origin materials, or human serum albumin.
13. DSWs located in the face, over joints, lower legs or the buttocks
14. Any of the following hematologic abnormalities: (Hemoglobin < 10.0 g/dL, ANC < 1,500/μL, platelets < 75,000 /μL)
15. Any of the following serum chemistry abnormalities: (Total bilirubin > 1.5 × ULN, AST or ALT > 3 × ULN, gamma-GT > 2.5 x ULN, Alk-P > 2.5 x ULN, serum albumin < 2.7 g/dL, creatinine >1.5 x ULN, any other ≥ Grade 2 laboratory abnormality (based on CTCAE) at baseline (other than those listed above)
16. DSWs in area with active skin infection or with skin condition that is considered highly susceptible to infection judged by the investigator

Contacts and Locations

Locations

Japan

Nippon Medical School

Tokyo, Japan, 113-8603

Tokyo Medical University

Tokyo, Japan, 160-0023

Taiwan

Tri-Service General Hospital

Taipei, Taiwan, 114

Sponsors and Collaborators

Transwell Biotech Co., Ltd.

A2 Healthcare Taiwan Corporation

Investigators

• Principal Investigator: Niann-Tzyy Dai, MD, PhD.; Tri-Service General Hospital

More Information

• Responsible Party: Transwell Biotech Co., Ltd.
• ClinicalTrials.gov Identifier: NCT02737748
• Other Study ID Numbers: 16-FDF-C001
• First Posted: April 14, 2016
• Last Update Posted: October 6, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Transwell Biotech Co., Ltd.:

Donor Site Wounds