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Recruiting NCT06141811

A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-302 Clinical Trial

— Observational Diabetic Foot Ulcer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ALLO-ASC-DFU, Vehicle sheet.
Who it may be relevant to
Registry conditions: Diabetic Foot Ulcer. Basic parameters: 19 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

This is a follow-up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-302) for 24 months

Detailed description

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 3 clinical trial (ALLO-ASC-DFU-302) for 24 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.

Interventions

  • Biological ALLO-ASC-DFU
    Application of ALLO-ASC-DFU sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.
  • Procedure Vehicle sheet
    Application of Vehicle sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.

Primary outcome measures

  • Evaluation of systemic tolerance through incidence of abnormal laboratory test results [Time frame: Up to 9 months]
  • Evaluation of incidence of clinically significant change in physical examination and vital signs [Time frame: Up to 18 months]
  • Evaluation of localized tolerance through incidence of clinically significant change about treatment area [Time frame: Up to 24 months]
  • Evaluation of incidence of adverse events [Time frame: Up to 24 months]

Eligibility criteria

Inclusion criteria

  • Subjects who are treated with ALLO-ASC-DFU sheet or Vehicle sheet in phase 3 clinical trial of ALLO-ASC-DFU-302.
  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-control

Study locations

South Korea · 4 centers
  • Soonchunhyang University Hospital — Bucheon-si
  • Bucheon ST. Mary's Hospital — Bucheon-si
  • Asan Medical Center — Seoul
  • Borame Medical Center — Seoul

Identifiers

NCT: NCT06141811 · ALLO-ASC-DFU-304

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗