Safety of ALLO-ASC-DFU in the Patients With Diabetic Foot Ulcers

NCT02394886 | Completed Phase 1 DMC

• 1 other identifier: ALLO-ASC-DFU-101
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase I open-label study to evaluate the safety of ALLO-ASC-DFU in diabetic foot ulcers patients. 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 an new option in treating a diabetic foot ulcer.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events as a Measure of Safety and Tolerability

  up to 4 weeks

Secondary Outcomes (1)

• Wound size and depth measurement

  baseline and 1, 2, 4 weeks

Study Arms (1)

ALLO-ASC-DFU

EXPERIMENTAL

ALLO-ASC-DFU treatment with conventional care

Biological: ALLO-ASC-DFU

Interventions

ALLO-ASC-DFU BIOLOGICAL

ALLO-ASC-DFU

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is between 18 and 80 years of age.
• Subject is diagnosed with Type I or Type II diabetes.
• Subjects who have a wound defined as diabetic foot ulcer presence for more than 4 weeks, but not present for more than 54 weeks at the screening visit.
• Foot ulcer located below the malleoli on plantar or dorsal surface of the foot and ulcer size is between 1 cm\^2 and 25 cm\^2.
• Ulcer extends into the dermis or subcutaneous tissue without evidence of exposed muscle, tendon, bone, or joint capsule.
• Ulcer is free of necrotic debris, exhibits no signs of clinical infection, and appears to be made of primarily vascularized tissue.
• \< Ankle Brachial Index (ABI) \< 1.3.
• Subject is able to give written informed consent prior to study start and to comply with the study requirements.

You may not qualify if:

• Ulcer is of non-diabetic pathophysiology.
• Gangrene is present on any part of the affected foot.
• Ulcer is over an active Charcot deformity.
• The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
• The longest dimension of the Index Ulcer exceeds 5 cm at the screening visit.
• Subject is Human Immunodeficiency Virus (HIV) positive.
• Subjects with severe hepatic deficiencies.
• Subjects with a glycated hemoglobin A1c (HbA1c) level of \> 12%.
• Subject who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue.
• Subjects requiring intravenous (IV) antibiotics to treat the index wound infection.
• Subjects who are currently receiving dialysis.
• Subjects who are pregnant or breast-feeding.
• Subjects who are unwilling to use an "effective" method of contraception during the study.
• Current evidence of osteomyelitis, cellulitis, or other evidence of infection including pus drainage from the wound site.
• Subjects who have a clinically relevant history of alcohol or drugs abuse.

Sponsors & Collaborators

• Anterogen Co., Ltd.: lead

Study Sites (1)

Asan Medical Center

Seoul, South Korea

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

Study Officials

• Joon Pio Hong, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

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: March 3, 2015
• First Posted: March 20, 2015
• Study Start: November 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 16, 2015

Record last verified: 2015-03

Locations

KR (1)