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

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ClinicalTrials.gov Identifier: NCT03370874
Recruitment Status : Active, not recruiting
First Posted : December 13, 2017
Last Update Posted : January 22, 2021
Sponsor:
Information provided by (Responsible Party):
Anterogen Co., Ltd.

Tracking Information
First Submitted Date  ICMJE November 28, 2017
First Posted Date  ICMJE December 13, 2017
Last Update Posted Date January 22, 2021
Actual Study Start Date  ICMJE July 4, 2018
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
Proportions of subjects who achieved complete wound closure [ Time Frame: During 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2017)
  • Time taken to complete wound closure between the two groups [ Time Frame: During 12 weeks ]
  • Proportions of subjects who achieved complete wound closure [ Time Frame: Follow up to 12 weeks ]
  • Proportions of subjects who achieved complete wound closure by the classification of Wagner Grade between the two groups [ Time Frame: Follow up to 12 weeks ]
  • Change rates in wound size and depth compared to baseline between the two groups [ Time Frame: During 12 weeks ]
    cm^2
  • Proportions of subjects who achieved complete wound closure at every visit by the classification of ulcer locations [ Time Frame: Follow up to 12 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers.
Official Title  ICMJE Phase 3 Clinical Study to Evaluate Efficacy and Safety of ALLO-ASC-DFU in Patients With Diabetic Foot Ulcers: A Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center Study
Brief Summary This is a phase III double-blind study to evaluate the efficacy and safety of ALLO-ASC-DFU in patients with Diabetic Foot Ulcer, compared to placebo therapy.
Detailed Description Experimental: ALLO-ASC-DFU, Placebo Comparator: Vehicle Sheet, Study type: Interventional, Study design: Randomized, Placebo-controlled, Double-blind, Parallel-group, Multi-center Study
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetic Foot Ulcer
Intervention  ICMJE
  • Biological: ALLO-ASC-DFU
    Application of ALLO-ASC-DFU sheet to diabetic foot ulcer
    Other Name: Hydrogel sheet containing allogenic mesenchymal stem cells
  • Procedure: Vehicle sheet
    Application of Vehicle sheet to diabetic foot ulcer
    Other Name: Hydrogel sheet without Allogenic mesenchymal stem cell
Study Arms  ICMJE
  • Experimental: ALLO-ASC-DFU
    Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells
    Intervention: Biological: ALLO-ASC-DFU
  • Placebo Comparator: Vehicle Sheet
    Hydrogel sheet without Allogenic mesenchymal stem cell
    Intervention: Procedure: Vehicle sheet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: December 7, 2017)
164
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subject is between 18 and 75 years of age.
  2. Subject is diagnosed with Type I or Type II diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit.
  3. Foot ulcer size is between 1 cm2 and 15 cm2
  4. Ulcer graded I or II by Wagner grade, and extended to skin, tendon, and subcutaneous tissue.
  5. Free of necrotic debris at target ulcer
  6. Around ulcer area blood circulation should be secured to meet one of below criteria;

    • Blood vessels around the ulcer detected by Doppler Test
    • 0.7 < Ankle Brachial Index(ABI) < 1.3
    • Transcutaneous Oxygen Pressure, TcPO2 higher than 30 mmHg
  7. Subject is able to give written informed consent prior to study start and to comply with the study requirements during study.

Exclusion Criteria:

  1. Non-diabetic pathophysiologic ulcer.
  2. The ulcer has increased or decreased in size by 30% or more during one week after the screening visit.
  3. Subjects requiring intravenous (IV) antibiotics to treat infection.
  4. Current evidence of infection including pus drainage from the wound site.
  5. Subject has a glycated hemoglobin A1c (HbA1c) level of > 15%
  6. Subject's blood sugar is > 450 mg/dl at postprandial.
  7. Subjects with severe renal failure that cannot be managed by renal dialysis.
  8. Subjects with severe hepatic deficiencies.
  9. Subject is Human Immunodeficiency Virus (HIV) positive.
  10. Subject who has allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
  11. Subject who is pregnant or breast-feeding.
  12. Subjects who are unwilling to use an "effective" method of contraception during the study.
  13. Subjects who have a clinically relevant history of alcohol or drugs abuse.
  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 investigator.
  16. Subjects who are considered not suitable for the study by investigator.
  17. Subjects who had had a history of surgery for malignant tumor within the last five years (except carcinoma in situ).
  18. Subjects who are currently or are enrolled in another clinical study within 60 days of screening.
  19. Subjects who have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
  20. Subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
  21. Subjects not comply with off-loading procedure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03370874
Other Study ID Numbers  ICMJE ALLO-ASC-DFU-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Anterogen Co., Ltd.
Study Sponsor  ICMJE Anterogen Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Seung-Kyu Han, MD. Ph D. Korea University Guro Hospital
Principal Investigator: Ki-Won Young, MD. Ph D. Eulji General Hospital
Principal Investigator: Junpyo Hong, MD. Ph D. Asan Medical Center
Principal Investigator: Donghyeok Shin, MD. Ph D. Konkuk University Medical Center
Principal Investigator: Junhyeong Kim, MD. Ph D. Keimyung University Dongsan Medical Center
Principal Investigator: Kang Chan, MD. Ph D. Chungnam National University Hospital
Principal Investigator: Hyungmin Hahn, MD. Ph D. Ajou University Medical Center
Principal Investigator: Changsik Park, MD. Ph D. Seoul National University Bundang Hospital
Principal Investigator: Youngkoo Lee, MD. Ph D. Soonchunhyang University Hospital
PRS Account Anterogen Co., Ltd.
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP