Clinical Study of ALLO-ASC-SHEET in Subjects With Diabetic Wagner Grade II Foot Ulcers

NCT04497805 | Unknown Phase 2 FDA Drug

• 1 other identifier: ALLO-ASC-SHEET
• Study Type: interventional
• Target: 64
• 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 Wagner Grade II 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 the 12 weeks.

  During 12 weeks

Secondary Outcomes (5)

• Time to initial complete wound closure between the 2 groups.

  During 12 weeks

• Changes in wound size compared to baseline between the 2 groups.

  During 12 weeks

• Proportions of subjects who achieved complete wound closure between the 2 groups by the classification of wound size.

  During 12 weeks

• Proportions of subjects who achieved complete wound closure between the 2 groups by the classification of location of diabetic foot ulcer.

  During 12 weeks

• Durability of complete wound closure for the additional 24 weeks.

  During 36 weeks

Study Arms (2)

ALLO-ASC-SHEET

EXPERIMENTAL

ALLO-ASC-SHEET Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells

Biological: ALLO-ASC-SHEET

Hydrogel SHEET(Vehicle control)

PLACEBO COMPARATOR

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

Biological: ALLO-ASC-SHEET

Interventions

ALLO-ASC-SHEET BIOLOGICAL

Hydrogel sheet containing Allogenic Mesenchymal Stem Cells

Also known as: Hydrogel sheet containing Allogenic Mesenchymal Stem Cells

ALLO-ASC-SHEET; 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 between 18 and 80 years of age.
• Diagnosed with Type I or Type II diabetes and has Wagner Grade II diabetic foot ulcers for longer than 4 weeks at the time of screening.
• Foot ulcer located in the plantar or dorsal, with ulcer size between1.5 cm2 and 15 cm2.
• Ulcer, Graded II by Wagner grade, and extended to muscle periosteum, muscle, tendon, or joint capsule, but not to bone.
• Ulcer is free of necrotic debris,exhibits no signs of clinical infection.
• Ulcer area blood circulation meets 1 of the following criteria:
• A. Blood vessels around the ulcer detected by Doppler Test to have biphasic or triphasic flow B. Range of Ankle Brachial Index(ABI) is\>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 2 weeks screening period.
• Patient is currently on higher dose antibiotic therapy as defined by increased dose or change in therapy from the initial treatment regimen at screening to treat index wound infection or patient is on suppressive antibiotic therapy for diabetic foot wound infection.
• The longest dimension of the index wound exceeds 15 cm at the baseline visit.
• Patient with skin lesion confirmed by biopsy (when Investigator deems suspicious) and then judged by Investigator to be an etiology other than diabetic foot ulcer (i.e.,example skin cancer in situ, pyoderma).
• Current evidence of active charcot, osteomyelitis, cellulitis, or evidence of other infection including fever or purulentdrainage from wound site.
• Is Human Immunodeficiency Virus (HIV) positive
• Havesevere hepatic deficiencies.
• Have a glycated hemoglobin A1c (HbA1c) level of \>10%.
• Have an allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
• Have severe renal function insufficiency documented with creatinine greater than 3.0 mg/dL.
• Pregnant or breast-feeding.
• Is unwilling to use an "effective" method of contraception during the study.
• Have evidence of current infection including purulent drainage from the wound site.
• Have a clinically relevant history of alcohol or drugs abuse.

Sponsors & Collaborators

• Anterogen Co., Ltd.: lead

Study Sites (1)

University of Southern California

Los Angeles, California, 90033, United States

RECRUITING

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

• Yun Jung Choi, PM

  Anterogen Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Yun Jung Choi, PM

CONTACT

82 10 9199 0164; yunjungchoi@anterogen.com

Jessi Choi, PM

CONTACT

82 10 9199 0164

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2020
• First Posted: August 4, 2020
• Study Start: September 8, 2020
• Primary Completion: December 1, 2024
• Study Completion: June 1, 2025
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)