A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-101 Clinical Trial

NCT03183726 — Completed, 4 participants, Anterogen Co., Ltd.
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A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 1 Clinical Trial of ALLO-ASC-DFU-101

RegistryNCT03183726
StatusCompleted
Study typeObservational
Enrollment4 (Actual)
SponsorAnterogen Co., Ltd. (Industry)
ConditionsDiabetic Foot Ulcer
InterventionsALLO-ASC-DFU (Biological)
Datesstart 2016-01-11, primary completion 2017-06-30, completion 2017-07-31, first posted 2017-06-12, last updated 2018-01-10

Related Papers Related Patents Related Grants Related Experts
All trials for Diabetic Foot Ulcer All trials of ALLO-ASC-DFU

-Summary

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial (ALLO-ASC-DFU-101) for 23 months.

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+Detailed description

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 1 clinical trial (ALLO-ASC-DFU-101) for 23 months.

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.

+Arms and interventions

ArmTypeInterventionsDescription
ALLO-ASC-DFU treatmentBiological: ALLO-ASC-DFUSubjects with ALLO-ASC-DFU treatment in phase 1 clinical trial of ALLO-ASC-DFU-101
  • ALLO-ASC-DFU (Biological), also known as Allogenic adipose-derived mesenchymal stem cells: 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 an new option in treating a diabetic foot ulcer. This study is a follow-up study without intervention.

+Outcome measures

Primary outcomes

  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [up to 24 months]: Evaluation of AE

Secondary outcomes

  • Wound size and depth measurement [6, 12, 24 months]: Evaluation of the improvement of wound measured by size and depth, and examines the change for 23 months period

+Eligibility

Sex: All, ages: 18 Years to 80 Years

Inclusion Criteria:

1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 1 clinical trial of ALLO-ASC-DFU-101.
2. Subjects who are able to give written informed consent prior to study start and to comply with the study requirements.

Exclusion Criteria:

1\. Subjects who are considered not suitable for the study by the principal investigator (For example, Subjects requiring surgical procedure on target site).

+Investigators