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

NCT02737748 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 16-FDF-C001
• Study Type: interventional
• Target: 48
• Locations: 2 countries
• Sites: 3

Brief Summary

Primary objective:

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

Conditions

Donor Site Complication

Keywords

Donor Site Wounds

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Treatment-related AEs and SAEs (Including Infections and Bleeding)

  The number of participants with treatment-related AEs and SAEs (including infections and bleeding) will be observed for the 7 patients in Phase I

  Day 0~Day 28

• The Healing Time From DSW Creation to the First 100% Re-epithelialization With Confirmation for at Least 10 Days Apart Assessed by the Investigator

  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.

  Days 42 or earlier

• Number of Participants Reached Confirmed Healing Within 28 Days.

  The number of participants in Phase I and II reached confirmed healing by the investigator within 28 days.

  Days 42 or earlier

Secondary Outcomes (26)

• 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

  Days 42 or earlier

• Number of Participants With Complete Wound Closure at Day 7, 10 and 14 After DSW Creation.

  Day 7, 10 and 14

• The Healing Percentage of Wounds (Ratio of Healing Area and Original Area) at Days 7, 10 and 14 After DSW Creation

  Day 7, 10 and 14

• The Pain Change From Baseline to Post-wound Creation Visits Based on Short-form McGill Pain Questionnaire Score

  Days 3, 7, 10, 14, 28, 42, Day 90/180/270/360 from Day 28 or 42

• Number of Participants With AEs and SAEs

  Screening~ Day 360 from Day 28 or 42

Study Arms (2)

TWB-103 Group

EXPERIMENTAL

Subjects will receive TWB-103 2 to 3 times till 100% re-epithelialization or up to 10 days (around once every 3 days).

Drug: TWB-103 Group

Placebo Group

PLACEBO COMPARATOR

Subjects will receive placebo 2 to 3 times till 100% re-epithelialization or up to 10 days (around once every 3 days).

Drug: Placebo Group

Interventions

TWB-103 Group DRUG

Each subject received TWB-103+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.

Also known as: TWB-103+Tegaderm

TWB-103 Group

Placebo Group DRUG

Each subject received Placebo+Tegaderm for up to 10 days or to the day of 100% re-epithelialization, whichever comes first, followed by Tegaderm alone application from Day 10 to 14 if failing to achieve 100% re-epithelialization by Day 10.

Also known as: Placebo+Tegaderm

Placebo Group

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female/male patients, aged 20-65 years old
• 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.
• 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%.
• 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
• Both male and female patients must agree to use highly effective contraceptives from signing informed consent to 30 days after the last dose administration.
• Willing to comply with the study protocol and to sign the Informed Consent Form

You may not qualify if:

• 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.
• 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).
• Patients who are currently receiving or have received the following treatments within 4 weeks prior to study entry are excluded from the study:
• systemic or inhaled corticosteroids or immunosuppressant agents; or
• 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.
• Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
• Hematologic disease, malignancy or hypo-immunity.
• History of HIV or congenital immunodeficiency.
• History of alcoholism or drug abuse.
• Have used any tobacco product within 1 week prior to Day 0.
• Patients previously treated with any cell-based product, including autologous tissue at the treatment site.
• Received an investigational drug, device or biological/bioactive treatment within 30 days prior to Screening Visit.
• Any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the trial treatment.
• History of sensitivity to bovine or porcine origin materials, or human serum albumin.
• DSWs located in the face, over joints, lower legs or the buttocks

Sponsors & Collaborators

• Transwell Biotech Co., Ltd.: lead
• A2 Healthcare Taiwan Corporation: collaborator

Study Sites (3)

Nippon Medical School

Tokyo, 113-8603, Japan

Location

Tokyo Medical University

Tokyo, 160-0023, Japan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

Limitations and Caveats

Some cases that healing observed by 1st evaluator could not be confirmed due to the lack of following visits. These are considered as flaws of protocol design.

Results Point of Contact

• Title: Dr. Bin-Ru She
• Organization: Transwell Biotech Co., Ltd.

binru.she@tw-bio.com

+886-3-5670399

Study Officials

• Niann-Tzyy Dai, MD, PhD.

  Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2016
• First Posted: April 14, 2016
• Study Start: July 6, 2017
• Primary Completion: May 7, 2021
• Study Completion: May 7, 2021
• Last Updated: July 28, 2023
• Results First Posted: July 28, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1); JP (2)