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

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ClinicalTrials.gov Identifier: NCT03754465
Recruitment Status : Recruiting
First Posted : November 27, 2018
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
Anterogen Co., Ltd.

Tracking Information
First Submitted Date  ICMJE November 20, 2018
First Posted Date  ICMJE November 27, 2018
Last Update Posted Date November 27, 2018
Estimated Study Start Date  ICMJE November 2018
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2018)
Proportions of subjects who achieved complete wound closure [ Time Frame: During 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2018)
  • Time to initial complete wound closure between the two groups [ Time Frame: During 12 weeks ]
  • Changes in wound size compared to baseline between the two groups [ Time Frame: During 12 weeks ]
    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 [ Time Frame: During 12 weeks(at every visit during treatment period) ]
  • Durability of complete wound closure [ Time Frame: Follow up to 24 weeks from the initial complete wound closure. ]
    Wound size is measured by using eKare 3D Wound Measurement system(Mobile Devices)
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 of ALLO-ASC-SHEET in Subjects With Diabetic Foot Ulcers
Official Title  ICMJE A Phase 2 Clinical Study to Evaluate the Efficacy and Safety of ALLO-ASC-SHEET in Subjects With Diabetic Foot Ulcers
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
  1. Active Group: ALLO-ASC-SHEET
  2. Control Group: Hydrogel SHEET (vehicle control)
  3. Study Type: Interventional
  4. Study Design: Randomized, Comparator-controlled, Double-blind, multi-center study.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description:
Double-Blind
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: Hydrogel SHEET(Vehicle control)
    Application of Hydrogel SHEET to diabetic foot ulcer
    Other Name: Hydrogel sheet without Allogenic Mesenchymal Stem Cells
Study Arms  ICMJE
  • Experimental: ALLO-ASC-DFU
    Experimental: ALLO-ASC-DFU Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells
    Intervention: Biological: ALLO-ASC-DFU
  • Placebo Comparator: Hydrogel SHEET(Vehicle control)
    Placebo Comparator: Vehicle Control Hydrogel sheet without allogenic adipose-derived mesenchymal stem cells
    Intervention: Procedure: Hydrogel SHEET(Vehicle control)
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 25, 2018)
44
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female subjects between 18 and 80 years of age.
  2. 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 located in the instep, border or sole of the foot, with ulcer size between 1 cm2 and 15 cm2.
  4. Ulcer graded I by Wagner grade, and extended to skin, subcutaneous tissue, but without exposure of muscle, tendon, bone or joint capsule.
  5. Ulcer is free of necrotic debris, exhibits no signs of clinical infection.
  6. 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.
  7. 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% during the week after the Screening Visit.
  3. Is Human Immunodeficiency Virus (HIV) positive?
  4. Have severe hepatic deficiencies.
  5. Have a glycated hemoglobin A1c (HbA1c) level of > 10%.
  6. Have allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue.
  7. Require intravenous (IV) antibiotics to treat the target wound infection.
  8. Have severe renal failure including subject on renal dialysis.
  9. Pregnant or breast-feeding.
  10. Is unwilling to use an "effective" method of contraception during the study.
  11. Have evidence of current infection including pus drainage from the wound site.
  12. Have a clinically relevant history of alcohol or drugs abuse.
  13. Have postprandial blood sugar > 350 mg/dl.
  14. Is not able to understand the objective of this study or to comply with the study requirements.
  15. Is considered by the investigator to have a significant disease which might have impacted the study.
  16. Is considered not suitable for the study by investigator.
  17. Have a history of malignancy within the last five years (except basal cell carcinoam in situ).
  18. Is currently or were enrolled in another clinical study within 60 days of screening.
  19. Have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days.
  20. Is receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening.
  21. Cannot maintain off-loading process
  22. Panel reactive antibody (PRA) levels ≥ 20%
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: David G. Armstrong, MD.Ph D. (+1)5203059393 armstrong@usa.net
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03754465
Other Study ID Numbers  ICMJE ALLO-ASC-SHEET-102
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
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: David G. Armstrong, MD.Ph D. University of Southern California
Principal Investigator: Alexander M. Reyzelman, DPM Center for Clinical Research
Principal Investigator: Young Nathan, DPM Martinsville Research Institute
PRS Account Anterogen Co., Ltd.
Verification Date November 2018

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