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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.

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.

Condition or disease Intervention/treatment Phase
Diabetic Foot Ulcer Biological: ALLO-ASC-DFU Procedure: Hydrogel SHEET(Vehicle control) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double-Blind
Primary Purpose: Treatment
Official Title: A Phase 2 Clinical Study to Evaluate the Efficacy and Safety of ALLO-ASC-SHEET in Subjects With Diabetic Foot Ulcers
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ALLO-ASC-DFU
Experimental: ALLO-ASC-DFU Hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells
Biological: ALLO-ASC-DFU
Application of ALLO-ASC-DFU Sheet to diabetic foot ulcer
Other Name: Hydrogel sheet containing Allogenic Mesenchymal Stem Cells

Placebo Comparator: Hydrogel SHEET(Vehicle control)
Placebo Comparator: Vehicle Control Hydrogel sheet without allogenic adipose-derived 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




Primary Outcome Measures :
  1. Proportions of subjects who achieved complete wound closure [ Time Frame: During 12 weeks ]

Secondary Outcome Measures :
  1. Time to initial complete wound closure between the two groups [ Time Frame: During 12 weeks ]
  2. 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)

  3. 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) ]
  4. 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)



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. 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%

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): NCT03754465


Contacts
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Contact: David G. Armstrong, MD.Ph D. (+1)5203059393 armstrong@usa.net

Locations
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United States, California
University of Southern California Recruiting
Los Angeles, California, United States, 90089
Contact: David G. Armstrong, MD.Ph D.         
Sponsors and Collaborators
Anterogen Co., Ltd.
Investigators
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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

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Responsible Party: Anterogen Co., Ltd.
ClinicalTrials.gov Identifier: NCT03754465     History of Changes
Other Study ID Numbers: ALLO-ASC-SHEET-102
First Posted: November 27, 2018    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Ulcer
Diabetic Foot
Foot 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