Back to results

Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers

Primary Purpose

Diabetic Foot Ulcer

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

ALLO-ASC-DFU

Standard therapy

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:

Subject is between 18 years and 80 years of age.
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.
Ulcer located the foot, and ulcer size is between 1 cm^2 and 25 cm^2.
Ulcer extends into the dermis, subcutaneous tissue, tendon or joint capsule (Wagner grade 1 or 2).
Ulcer is free of necrotic debris.
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.
Subject 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% or more during one week after the screening visit.
Subject is Human Immunodeficiency Virus (HIV) positive.
Subjects with severe hepatic deficiencies.
Subjects with a glycated hemoglobin A1c (HbA1c) level of > 15%.
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 with severe renal deficiencies that is uncontrolled by 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 severe infection including pus drainage from the wound site.
Subjects who have a clinically relevant history of alcohol or drugs abuse.
Subject's blood sugar is > 450 mg/dL at postprandial.
Subjects who are not able to understand the objective of this study or to comply with the study requirements.
Subjects who are considered to have a significant disease which can impact the study by the investigator.
Subjects who are considered not suitable for the study by the investigator.
Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma in situ).
Subjects who are currently or were enrolled in another clinical study within 60 days of screening.
Subjects who have undergone wound treatments with cell therapy, dermal substitutes, or other biological therapies within the last 30 days.
Subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents to unstable dosage.

Sites / Locations

Korea University Guro Hospital
Eulji General Hospital
Severance Hospital
Asan medical center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ALLO-ASC-DFU

Standard therapy

Arm Description

Allogeneic mesenchymal stem cells

Standard therapy for patients with diabetic foot ulcer

Outcomes

Primary Outcome Measures

Proportion of re-epithelialization

Secondary Outcome Measures

Proportion of re-epithelialization

Time to re-epithelialization

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

Full Information

NCT ID

NCT02619877

First Posted

November 30, 2015

Last Updated

August 30, 2017

Sponsor

Anterogen Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02619877

Brief Title

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

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Completed

Study Start Date

October 2015 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

October 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Anterogen Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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

Participant

Allocation

Randomized

Enrollment

59 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ALLO-ASC-DFU

Arm Type

Experimental

Arm Description

Allogeneic mesenchymal stem cells

Arm Title

Standard therapy

Arm Type

Active Comparator

Arm Description

Standard therapy for patients with diabetic foot ulcer

Intervention Type

Biological

Intervention Name(s)

ALLO-ASC-DFU

Other Intervention Name(s)

Allogeneic mesenchymal stem cells

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Standard therapy

Intervention Description

Standard therapy conducted for patients with diabetic foot ulcer

Primary Outcome Measure Information:

Title

Proportion of re-epithelialization

Time Frame

During 8 weeks

Secondary Outcome Measure Information:

Title

Proportion of re-epithelialization

Time Frame

During 12 weeks

Title

Time to re-epithelialization

Time Frame

During 12 weeks

Title

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

Time Frame

Follow up to 12 weeks

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: Subject is between 18 years and 80 years of age. 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. Ulcer located the foot, and ulcer size is between 1 cm^2 and 25 cm^2. Ulcer extends into the dermis, subcutaneous tissue, tendon or joint capsule (Wagner grade 1 or 2). Ulcer is free of necrotic debris. 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. Subject 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% or more during one week after the screening visit. Subject is Human Immunodeficiency Virus (HIV) positive. Subjects with severe hepatic deficiencies. Subjects with a glycated hemoglobin A1c (HbA1c) level of > 15%. 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 with severe renal deficiencies that is uncontrolled by 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 severe infection including pus drainage from the wound site. Subjects who have a clinically relevant history of alcohol or drugs abuse. Subject's blood sugar is > 450 mg/dL at postprandial. Subjects who are not able to understand the objective of this study or to comply with the study requirements. Subjects who are considered to have a significant disease which can impact the study by the investigator. Subjects who are considered not suitable for the study by the investigator. Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma in situ). Subjects who are currently or were enrolled in another clinical study within 60 days of screening. Subjects who have undergone wound treatments with cell therapy, dermal substitutes, or other biological therapies within the last 30 days. Subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents to unstable dosage.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Seung-Kyu Han, MD. PhD.

Organizational Affiliation

Korea University Guro Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ki-Won Young, MD. PhD.

Organizational Affiliation

Eulji General Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hyun-suk Suh, MD. PhD.

Organizational Affiliation

Asan Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jin Woo Lee, MD. PhD.

Organizational Affiliation

Severance Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Korea University Guro Hospital

City

Guro-gu

State/Province

Seoul

ZIP/Postal Code

08308

Country

Korea, Republic of

Facility Name

Eulji General Hospital

City

Nowon-Gu

State/Province

Seoul

ZIP/Postal Code

01830

Country

Korea, Republic of

Facility Name

Severance Hospital

City

Seodaemun-Gu

State/Province

Seoul

ZIP/Postal Code

03722

Country

Korea, Republic of

Facility Name

Asan medical center

City

Songpa-Gu

State/Province

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

30679183

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.

Results Reference

derived

Learn more about this trial

Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers

We'll reach out to this number within 24 hrs