A Follow-up Study to Evaluate the Safety of ALLO-ASC-DFU in ALLO-ASC-DFU-201 Clinical Trial

Overview

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-DFU-201) for 23 months.

Full Title of Study: “A Follow-up Study to Evaluate the Safety for the Patients With ALLO-ASC-DFU Treatment in Phase 2 Clinical Trial of ALLO-ASC-DFU-201″

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: August 17, 2018

Detailed Description

This is an open-label follow up study to evaluate the safety for the subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial (ALLO-ASC-DFU-201) 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.

Interventions

  • Biological: ALLO-ASC-DFU
    • Application of ALLO-ASC-DFU sheet to diabetic foot ulcer. This study is a follow-up study without intervention.
  • Other: Standard therapy
    • Standard therapy conducted for patients with diabetic foot ulcer. This study is a follow-up study without intervention.

Arms, Groups and Cohorts

  • ALLO-ASC-DFU
    • Subjects with ALLO-ASC-DFU treatment in phase 2 clinical trial of ALLO-ASC-DFU-201
  • Standard therapy
    • Subjects with Standard therapy in phase 2 clinical trial of ALLO-ASC-DFU-201

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

Inclusion Criteria

1. Subjects who are treated with ALLO-ASC-DFU sheet in phase 2 clinical trial of ALLO-ASC-DFU-201.

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Anterogen Co., Ltd.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Seung-Kyu Han, MD. Ph D., Principal Investigator, Korea University Guro Hospital
    • Ki-Won Young, MD. Ph D., Principal Investigator, Eulji General Hospital
    • Hyun-suk Suh, MD. Ph D., Principal Investigator, Asan Medical Center
    • Jin Woo Lee, MD. Ph D., Principal Investigator, Severance Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.