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PHASE 1, OPEN-LABEL SAFETY STUDY OF UMBILICAL CORD LINING MESENCHYMAL STEM CELLS (CORLICYTE®) TO HEAL CHRONIC DIABETIC FOOT ULCERS

NCT04104451 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2024-01-29

No results posted yet for this study

Summary

Study Objective:

The objective of this Phase 1 open-label study is to establish the safety and tolerability of Corlicyte mesenchymal stem cells (MSCs) in the treatment of patients with chronic diabetic foot ulcers (DFUs).

Conditions

  • Diabetic Foot Ulcer

Interventions

DRUG

Corlicyte

expanded umbilical cord lining mesenchymal stem cells

Sponsors & Collaborators

  • University of Colorado, Denver

    lead OTHER

Principal Investigators

  • Cecilia Low Wang, MD · University of Colorado, Denver

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-12
Primary Completion
2023-08-01
Completion
2023-08-01
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 NCT04104451 on ClinicalTrials.gov