TWB-103 for Treating Lower Limb Ulcers on Patients With DM

NCT03624023 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 18-FDF-C002
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

Primary Objective: To assess the safety profile of TWB-103 administered to subjects with diabetic lower limb ulcers Secondary Objective: To explore the efficacy of TWB-103 administered to subjects with diabetic lower limb ulcers

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Pre-existing abnormalities are considered as AE or SAE only when the conditions escalate. The following events should be discussed specifically: 1. Study wound and its periphery: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling and unexpected surgery. 2. Non-study area and systemic: Infection, pain, pruritus/irritation, skin dysfunction/blister, osteomyelitis, cellulitis, edema/swelling, unexpected surgery, accidental injury, abnormal lab test and general disorders.

  Day 1~ Day 169

Secondary Outcomes (7)

• The Percentage of Subjects With Confirmed Study Wound Closure at Each Week up to 12 Weeks.

  Week 1 ~ Week 12

• Time to Confirmed Wound Closure for Those Subjects Whose Wounds Are Healed During Treatment Period and During the Study Period.

  Week 1 ~ Week 12

• Change of Individual Wound Area for up to 12 Weeks.

  Week 1~ Week 12

• Change of Wound Area at Each Week up to 12 Weeks.

  Week 1 ~ Week 12

• General Granulation Rate.

  Week 1 ~ Week 12

Study Arms (1)

TWB-103

EXPERIMENTAL

(Mixture of TWB-102 cell and TWB-103 hydrogel)

Drug: TWB-103

Interventions

TWB-103 DRUG

TWB-103 will be applied to the target ulcer wound once a week by the investigator, starting from Day 1, until wound closure is confirmed or up to 12 weekly applications

Also known as: Mixture of TWB-102 cell and TWB-103 hydrogel

TWB-103

Eligibility Criteria

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

You may qualify if:

• Adults at least 20 years of age.
• With diagnosed diabetic mellitus (DM), e.g. currently under DM medication treatment, or with HbA1c ≧6.5% but \< 12%, or with fasting plasma glucose ≧126 mg/dL (7.0 mmol/L), or with plasma glucose ≧ 200 mg/dL (11.1 mmol/L) in the two-hour 75-gram oral glucose tolerance test (OGTT).
• With at least one cutaneous ulcer on the foot or the lower legs, and not healing for at least 4 weeks (the ≧2-week standard of care period can be counted as part of the 4-week ulcer history).
• With ankle brachial index (ABI) ≥ 0.4 on the limb with the study ulcer. For subjects with 0.6\>ABI ≧0.4, the investigator will arrange for providing proper treatment to the subject, such as improving circulation by medication or surgical procedures, etc.
• The study wound is not prone to infection.
• The wound should allow complete sealing of the wound by TegadermTM film.
• The study wound size is between 1\~33 cm2. The depth of wound may reach ligament, joint capsule, fascia, or tendon. There should be no sign of osteomyelitis. The wound does not exceed Wagner Grade 27.
• Under the standard care of Investigator for at least 2 weeks, the study wound has not shown significant healing. Significant healing is defined as the following: The area of healed tissue reaches at least 30% of the area of initially presented wound.
• Co-morbidities are under control and non-life threatening as determined by the Investigator based on medical history, physical examination, vital signs, or clinical laboratory tests, etc.
• A negative pregnancy test at Screening. This applies to any female subject with childbearing potential.
• Agrees to use acceptable contraceptive methods while on study (from signing informed consent form to the end of the study). This applies to any female subject with childbearing potential and any male subject whose female partner has childbearing potential.
• Acceptable contraceptive methods include:
• Established use of oral, injected or implanted hormonal methods of contraception
• Placement of an intrauterine device (IUD) or intrauterine system (IUS)
• Barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps)

You may not qualify if:

• Being pregnant or nursing.
• With autoimmune disease other than diabetes, e.g. lupus erythematosus, multiple sclerosis.
• With current malignancy or hypo-immunity.
• With history of recurrent cancer, metastatic cancer, cancer which has high probability of metastasis, or cancer on the limb where the study wound is located.
• With serum chemistry abnormalities below
• AST or ALT \> 5 × ULN,
• Serum albumin \< 2.0 g/dL,
• With history of HIV infection
• With history of alcoholism or drug abuse.
• Received any cell-based product at the study wound.
• Received an investigational drug, device or biological/bioactive treatment within 30 days prior to Screening Visit.
• With any clinical condition or significant concurrent disease judged by the investigator to complicate the evaluation of the trial treatment.
• With history of sensitivity to materials of bovine, porcine origin, or human serum albumin.
• With active infection or active osteomyelitis in the study wound.

Sponsors & Collaborators

• Transwell Biotech Co., Ltd.: lead

Study Sites (2)

National Taiwan University Hospital

Taipei, 10048, Taiwan

Location

Tri-Service General Hospital

Taipei, 114, Taiwan

Location

MeSH Terms

Conditions

Diabetic Foot

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Limitations and Caveats

\[Not Specified\]

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, 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2018
• First Posted: August 9, 2018
• Study Start: December 19, 2019
• Primary Completion: July 9, 2021
• Study Completion: July 9, 2021
• Last Updated: July 12, 2023
• Results First Posted: July 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)