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

August 30, 2017 updated by: Anterogen Co., Ltd.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Seoul
      • Guro-gu, Seoul, Korea, Republic of, 08308
        • Korea University Guro Hospital
      • Nowon-Gu, Seoul, Korea, Republic of, 01830
        • Eulji General Hospital
      • Seodaemun-Gu, Seoul, Korea, Republic of, 03722
        • Severance Hospital
      • Songpa-Gu, Seoul, Korea, Republic of, 05505
        • Asan Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Subject is between 18 years and 80 years of age.
  2. 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.
  3. Ulcer located the foot, and ulcer size is between 1 cm^2 and 25 cm^2.
  4. Ulcer extends into the dermis, subcutaneous tissue, tendon or joint capsule (Wagner grade 1 or 2).
  5. Ulcer is free of necrotic debris.

  6. 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.
  7. Subject is able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

  1. Ulcer is of non-diabetic pathophysiology.
  2. The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
  3. Subject is Human Immunodeficiency Virus (HIV) positive.
  4. Subjects with severe hepatic deficiencies.
  5. Subjects with a glycated hemoglobin A1c (HbA1c) level of > 15%.
  6. Subject who are allergic or have a hypersensitive reaction to bovine-derived proteins or fibrin glue.
  7. Subjects requiring intravenous (IV) antibiotics to treat the index wound infection.
  8. Subjects with severe renal deficiencies that is uncontrolled by dialysis
  9. Subjects who are pregnant or breast-feeding.
  10. Subjects who are unwilling to use an "effective" method of contraception during the study.
  11. Current evidence of severe infection including pus drainage from the wound site.
  12. Subjects who have a clinically relevant history of alcohol or drugs abuse.
  13. Subject's blood sugar is > 450 mg/dL at postprandial.
  14. Subjects who are not able to understand the objective of this study or to comply with the study requirements.
  15. Subjects who are considered to have a significant disease which can impact the study by the investigator.
  16. Subjects who are considered not suitable for the study by the investigator.
  17. Subjects who have a history of surgery for malignant tumor within the last five years (except carcinoma in situ).
  18. Subjects who are currently or were enrolled in another clinical study within 60 days of screening.
  19. Subjects who have undergone wound treatments with cell therapy, dermal substitutes, or other biological therapies within the last 30 days.
  20. Subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents to unstable dosage.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ALLO-ASC-DFU
Allogeneic mesenchymal stem cells
Biological: ALLO-ASC-DFU
Application of ALLO-ASC-DFU sheet to diabetic foot ulcer
Other Names:
  • Allogeneic mesenchymal stem cells
Active Comparator: Standard therapy
Standard therapy for patients with diabetic foot ulcer
Other: Standard therapy
Standard therapy conducted for patients with diabetic foot ulcer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of re-epithelialization
Time Frame: During 8 weeks
During 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of re-epithelialization
Time Frame: During 12 weeks
During 12 weeks
Time to re-epithelialization
Time Frame: During 12 weeks
During 12 weeks
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: Follow up to 12 weeks
Follow up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anterogen Co., Ltd.

Investigators

  • Principal Investigator: Seung-Kyu Han, MD. PhD., Korea University Guro Hospital
  • Principal Investigator: Ki-Won Young, MD. PhD., Eulji General Hospital
  • Principal Investigator: Hyun-suk Suh, MD. PhD., Asan Medical Center
  • Principal Investigator: Jin Woo Lee, MD. PhD., Severance Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2015

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

December 1, 2015

First Posted (Estimate)

December 2, 2015

Study Record Updates

Last Update Posted (Actual)

September 1, 2017

Last Update Submitted That Met QC Criteria

August 30, 2017

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALLO-ASC-DFU-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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