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

Primary Purpose

Diabetic Foot Ulcer

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

ALLO-ASC-DFU

Hydrogel SHEET(Vehicle control)

About this trial

This is an interventional treatment trial for Diabetic Foot Ulcer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Is considered not suitable for the study by investigator.
Have a history of malignancy within the last five years (except basal cell carcinoam in situ).
Is currently or were enrolled in another clinical study within 60 days of screening.
Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
Is receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
Cannot maintain off-loading process
Panel reactive antibody (PRA) levels ≥ 20%

Sites / Locations

University of Southern California

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ALLO-ASC-DFU

Hydrogel SHEET(Vehicle control)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Proportions of subjects who achieved complete wound closure

Secondary Outcome Measures

Time to initial complete wound closure between the two groups

Changes in wound size compared to baseline between the two groups

Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices)

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

Proportions of subjects who achieved complete wound closure

Durability of complete wound closure

Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices)

Full Information

NCT ID

NCT03754465

First Posted

November 20, 2018

Last Updated

August 23, 2023

Sponsor

Anterogen Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03754465

Brief Title

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

Official Title

A Phase 2 Clinical Study to Evaluate the Efficacy and Safety of ALLO-ASC-SHEET in Subjects With Diabetic Foot Ulcers

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

May 9, 2019 (Actual)

Primary Completion Date

November 2023 (Anticipated)

Study Completion Date

May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Anterogen Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

Active Group: ALLO-ASC-SHEET Control Group: Hydrogel SHEET (vehicle control) Study Type: Interventional Study Design: Randomized, Comparator-controlled, Double-blind, multi-center study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Foot Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Masking Description

Double-Blind

Allocation

Randomized

Enrollment

56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

ALLO-ASC-DFU

Arm Type

Experimental

Arm Description

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

Arm Title

Hydrogel SHEET(Vehicle control)

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

ALLO-ASC-DFU

Other Intervention Name(s)

Hydrogel sheet containing Allogenic Mesenchymal Stem Cells

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Hydrogel SHEET(Vehicle control)

Other Intervention Name(s)

Hydrogel sheet without Allogenic Mesenchymal Stem Cells

Intervention Description

Application of Hydrogel SHEET to diabetic foot ulcer

Primary Outcome Measure Information:

Title

Proportions of subjects who achieved complete wound closure

Description

Proportions of subjects who achieved complete wound closure

Time Frame

During 12 weeks

Secondary Outcome Measure Information:

Title

Time to initial complete wound closure between the two groups

Description

Time to initial complete wound closure between the two groups

Time Frame

During 12 weeks

Title

Changes in wound size compared to baseline between the two groups

Description

Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices)

Time Frame

During 12 weeks

Title

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

Description

Proportions of subjects who achieved complete wound closure

Time Frame

During 12 weeks(at every visit during treatment period)

Title

Durability of complete wound closure

Description

Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices)

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. Is considered not suitable for the study by investigator. Have a history of malignancy within the last five years (except basal cell carcinoam in situ). Is currently or were enrolled in another clinical study within 60 days of screening. Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days. Is receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening. Cannot maintain off-loading process Panel reactive antibody (PRA) levels ≥ 20%

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David G. Armstrong, MD.Ph D.

Organizational Affiliation

University of Southern California

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Alexander M. Reyzelman, DPM

Organizational Affiliation

Center for Clinical Research

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Young Nathan, DPM

Organizational Affiliation

Martinsville Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Southern California

City

Los Angeles

State/Province

California

ZIP/Postal Code

90089

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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