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

NCT04497805 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2023-08-24

No results posted yet for this study

Summary

This is a phase 2 double-blind clinical study to evaluate the efficacy and Safety of ALLO-ASC-SHEET in subjects with Diabetic Wagner Grade II Foot Ulcers, compared to placebo therapy.

Conditions

  • Diabetic Foot Ulcer

Interventions

BIOLOGICAL

ALLO-ASC-SHEET

Hydrogel sheet containing Allogenic Mesenchymal Stem Cells

Sponsors & Collaborators

  • Anterogen Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yun Jung Choi, PM · Anterogen Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2024-12-31
Completion
2025-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04497805 on ClinicalTrials.gov