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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02619877
Recruitment Status : Completed
First Posted : December 2, 2015
Last Update Posted : September 1, 2017
Sponsor:
Information provided by (Responsible Party):
Anterogen Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Biological: ALLO-ASC-DFU Other: Standard therapy Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : October 2015
Actual Primary Completion Date : September 2016
Actual Study Completion Date : October 2016

Resource links provided by the National Library of Medicine


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 Name: 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




Primary Outcome Measures :
  1. Proportion of re-epithelialization [ Time Frame: During 8 weeks ]

Secondary Outcome Measures :
  1. Proportion of re-epithelialization [ Time Frame: During 12 weeks ]
  2. Time to re-epithelialization [ Time Frame: During 12 weeks ]
  3. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Follow up to 12 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619877


Locations
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Korea, Republic of
Korea University Guro Hospital
Guro-gu, Seoul, Korea, Republic of, 08308
Eulji General Hospital
Nowon-Gu, Seoul, Korea, Republic of, 01830
Severance Hospital
Seodaemun-Gu, Seoul, Korea, Republic of, 03722
Asan medical center
Songpa-Gu, Seoul, Korea, Republic of, 05505
Sponsors and Collaborators
Anterogen Co., Ltd.
Investigators
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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 automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Anterogen Co., Ltd.
ClinicalTrials.gov Identifier: NCT02619877    
Other Study ID Numbers: ALLO-ASC-DFU-201
First Posted: December 2, 2015    Key Record Dates
Last Update Posted: September 1, 2017
Last Verified: November 2015
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Diabetic Foot
Foot Ulcer
Ulcer
Pathologic Processes
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies
Foot Diseases