Clinical Study of ALLO-ASC-SHEET in Subjects with Diabetic Foot Ulcers

NCT03754465 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: ALLO-ASC-SHEET-102
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Foot Ulcers, compared to placebo therapy.

Conditions

Diabetic Foot Ulcer

Outcome Measures

Primary Outcomes (1)

• Proportions of subjects who achieved complete wound closure

  Proportions of subjects who achieved complete wound closure

  During 12 weeks

Secondary Outcomes (4)

• Time to initial complete wound closure between the two groups

  During 12 weeks

• Changes in wound size compared to baseline between the two groups

  During 12 weeks

• Proportions of subjects who achieved complete wound closure by the classification of location of diabetic foot ulcer, Plantar and the other location between the two groups

  During 12 weeks(at every visit during treatment period)

• Durability of complete wound closure

  Follow up to 24 weeks from the initial complete wound closure.

Study Arms (2)

ALLO-ASC-DFU

EXPERIMENTAL

Experimental: ALLO-ASC-DFU Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells

Biological: ALLO-ASC-DFU

Hydrogel SHEET(Vehicle control)

PLACEBO COMPARATOR

Placebo Comparator: Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells

Procedure: Hydrogel SHEET(Vehicle control)

Interventions

ALLO-ASC-DFU BIOLOGICAL

Application of ALLO-ASC-DFU Sheet to diabetic foot ulcer

Also known as: Hydrogel sheet containing Allogenic Mesenchymal Stem Cells

ALLO-ASC-DFU

Hydrogel SHEET(Vehicle control) PROCEDURE

Application of Hydrogel SHEET to diabetic foot ulcer

Also known as: Hydrogel sheet without Allogenic Mesenchymal Stem Cells

Hydrogel SHEET(Vehicle control)

Eligibility Criteria

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

You may qualify if:

• Male or female subjects between 18 and 80 years of age.
• Diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
• Foot ulcer located in the instep, border or sole of the foot, with ulcer size between 1 cm2 and 15 cm2.
• Ulcer graded I by Wagner grade, and extended to skin, subcutaneous tissue, but without exposure of muscle, tendon, bone or joint capsule.
• Ulcer is free of necrotic debris, exhibits no signs of clinical infection.
• Ulcer area blood circulation meets one of the following criteria
• A. Blood vessels around the ulcer detected by Doppler Test
• B. range of Ankle Brachial Index(ABI) was \> 0.7 to \< 1.3
• C. Transcutaneous oxygen pressure, (TcPO2) \> 30 mmHg.
• 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.
• The ulcer has increased or decreased in size by ≥ 30% during the week after the Screening Visit.
• Is Human Immunodeficiency Virus (HIV) positive?
• Have severe hepatic deficiencies.
• Have a glycated hemoglobin A1c (HbA1c) level of \> 10%.
• Have allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
• Require intravenous (IV) antibiotics to treat the target wound infection.
• Have severe renal failure including subject on renal dialysis.
• Pregnant or breast-feeding.
• Is unwilling to use an "effective" method of contraception during the study.
• Have evidence of current infection including pus drainage from the wound site.
• Have a clinically relevant history of alcohol or drugs abuse.
• Have postprandial blood sugar \> 350 mg/dl.
• Is not able to understand the objective of this study or to comply with the study requirements.
• Is considered by the investigator to have a significant disease which might have impacted the study.

Sponsors & Collaborators

• Anterogen Co., Ltd.: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

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

• David G. Armstrong, MD.Ph D.

  University of Southern California

  PRINCIPAL INVESTIGATOR

• Alexander M. Reyzelman, DPM

  Center for Clinical Research

  PRINCIPAL INVESTIGATOR

• Young Nathan, DPM

  Martinsville Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2018
• First Posted: November 27, 2018
• Study Start: January 2, 2019
• Primary Completion: October 23, 2023
• Study Completion: October 23, 2023
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)