Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers

Diabetic Foot Ulcer Clinical Trial

Official title:

Phase 2 Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers: A Randomized, Comparator-controlled, Single-blind, Parallel-group, Multi-center Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02619877
• Other study ID #: ALLO-ASC-DFU-201
• Status: Completed
• Phase: Phase 2
• First received: November 30, 2015
• Last updated: August 30, 2017
• Start date: October 2015
• Est. completion date: October 2016

Study information

• Verified date: November 2015
• Source: Anterogen Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase II single-blinded study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to standard therapy.

Description:

ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Diabetic Foot Ulcer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: October 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Subject is between 18 years and 80 years of age.

2. Subject is diagnosed with Type I or Type II diabetes, and had defined as diabetic foot ulcers presence of wound for more than 4 weeks at the screening visit.

3. Ulcer located the foot, and ulcer size is between 1 cm^2 and 25 cm^2.

4. Ulcer extends into the dermis, subcutaneous tissue, tendon or joint capsule (Wagner grade 1 or 2).

5. Ulcer is free of necrotic debris.

6. Subjects had adequate circulation to ulcer as documented by one of the methods below:

• Palpation of pulses around ulcer using Doppler exam

• Ankle Brachial index (ABI) values ranging between 0.7 and 1.3, or

• Transcutaneous Oxygen Pressure (TcPO2) > 30 mmHg.

7. Subject is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1. Ulcer is of non-diabetic pathophysiology.

2. The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.

3. Subject is Human Immunodeficiency Virus (HIV) positive.

4. Subjects with severe hepatic deficiencies.

5. Subjects with a glycated hemoglobin A1c (HbA1c) level of > 15%.

6. Subject who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue.

7. Subjects requiring intravenous (IV) antibiotics to treat the index wound infection.

8. Subjects with severe renal deficiencies that is uncontrolled by dialysis

9. Subjects who are pregnant or breast-feeding.

10. Subjects who are unwilling to use an "effective" method of contraception during the study.

11. Current evidence of severe infection including pus drainage from the wound site.

12. Subjects who have a clinically relevant history of alcohol or drugs abuse.

13. Subject's blood sugar is > 450 mg/dL at postprandial.

14. Subjects who are not able to understand the objective of this study or to comply with the study requirements.

15. Subjects who are considered to have a significant disease which can impact the study by the investigator.

16. Subjects who are considered not suitable for the study by the investigator.

17. Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma in situ).

18. Subjects who are currently or were enrolled in another clinical study within 60 days of screening.

19. Subjects who have undergone wound treatments with cell therapy, dermal substitutes, or other biological therapies within the last 30 days.

20. Subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents to unstable dosage.

Related Conditions & MeSH terms

• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Ulcer

Intervention

Biological:
• ALLO-ASC-DFU
Application of ALLO-ASC-DFU sheet to diabetic foot ulcer

Other:
• Standard therapy
Standard therapy conducted for patients with diabetic foot ulcer

Locations

Country	Name	City	State
Korea, Republic of	Korea University Guro Hospital	Guro-gu	Seoul
Korea, Republic of	Eulji General Hospital	Nowon-Gu	Seoul
Korea, Republic of	Severance Hospital	Seodaemun-Gu	Seoul
Korea, Republic of	Asan medical center	Songpa-Gu	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Anterogen Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of re-epithelialization		During 8 weeks
Secondary	Proportion of re-epithelialization		During 12 weeks
Secondary	Time to re-epithelialization		During 12 weeks
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		Follow up to 12 weeks