Clinical trial NCT02619877: Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Foot Ulcer
Lead sponsor: Anterogen Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2015-12-02
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of re-epithelialization
timeFrame: During 8 weeks
Secondary outcomes:
measure: Proportion of re-epithelialization
timeFrame: During 12 weeks
measure: Time to re-epithelialization
timeFrame: During 12 weeks
measure: Number of Participants with Adverse Events as a Measure of Safety and Tolerability
timeFrame: Follow up to 12 weeks
Other outcomes:
Locations:
city: Guro-gu
country: Korea, Republic of
facility: Korea University Guro Hospital
state: Seoul
city: Nowon-Gu
country: Korea, Republic of
facility: Eulji General Hospital
state: Seoul
city: Seodaemun-Gu
country: Korea, Republic of
facility: Severance Hospital
state: Seoul
city: Songpa-Gu
country: Korea, Republic of
facility: Asan medical center
state: Seoul
Study officials:
affiliation: Korea University Guro Hospital
name: Seung-Kyu Han, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Eulji General Hospital
name: Ki-Won Young, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Asan Medical Center
name: Hyun-suk Suh, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
affiliation: Severance Hospital
name: Jin Woo Lee, MD. PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moon KC, Suh HS, Kim KB, Han SK, Young KW, Lee JW, Kim MH. Potential of Allogeneic Adipose-Derived Stem Cell-Hydrogel Complex for Treating Diabetic Foot Ulcers. Diabetes. 2019 Apr;68(4):837-846. doi: 10.2337/db18-0699. Epub 2019 Jan 24.