Overview

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

Status:
Recruiting
Trial end date:
2022-12-30
Target enrollment:
0
Participant gender:
All
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
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Transwell Biotech Co., Ltd.
Criteria
Inclusion Criteria:

1. Adults at least 20 years of age.

2. 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).

3. 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).

4. 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.

5. The study wound is not prone to infection.

6. The wound should allow complete sealing of the wound by TegadermTM film.

7. 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.

8. 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.

9. When the subject has more than one wound which met the inclusion criteria, only one
wound is selected as the study wound. The other wounds will be treated by standard
cares.

10. 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.

11. A negative pregnancy test at Screening. This applies to any female subject with
childbearing potential.

12. 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:

1. Established use of oral, injected or implanted hormonal methods of contraception

2. Placement of an intrauterine device (IUD) or intrauterine system (IUS)

3. Barrier methods of contraception: condom or occlusive cap (diaphragm or
cervical/vault caps)

13. Able to follow the Investigator's instruction on wound care.

14. With signed informed consent form.

Exclusion Criteria:

1. Being pregnant or nursing.

2. With autoimmune disease other than diabetes, e.g. lupus erythematosus, multiple
sclerosis.

3. With current malignancy or hypo-immunity.

4. 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.

5. With serum chemistry abnormalities below

1. AST or ALT > 5 × ULN,

2. Serum albumin < 2.0 g/dL,

6. With history of HIV infection

7. With history of alcoholism or drug abuse.

8. Received any cell-based product at the study wound.

9. Received an investigational drug, device or biological/bioactive treatment within 30
days prior to Screening Visit.

10. With any clinical condition or significant concurrent disease judged by the
investigator to complicate the evaluation of the trial treatment.

11. With history of sensitivity to materials of bovine, porcine origin, or human serum
albumin.

12. With active infection or active osteomyelitis in the study wound.