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Endogenous Progenitors Cell Therapy for Diabetic Foot Ulcers

NCT01353937 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2016-03-04

No results posted yet for this study

Summary

Diabetic foot ulcers, a complication of diabetes leading to 80.000 lower limb amputations annually in the US, are a significant burden to our health system, costing more than a billion dollars annually. Here, we propose a novel combination of two drugs (Mozobil® and Regranex®Gel) to mobilize a specific sub-type of stem cells (endothelial progenitor cells) from the bone marrow and traffic them toward the wound, increasing the blood supply that subsequently improves wound healing. Because we are using the human body's own resources to regenerate itself by targeting and correcting the underlying pathophysiology, we believe that this novel therapy yields great promise in the treatment of diabetic foot ulcers.

Conditions

  • Diabetic Ulcer

Interventions

DRUG

AMD3100 injection + rhPDGF-BB topical

drug therapy to be given for the first 2 week duration given on a daily basis initiated during the first visit (Day 0).

Sponsors & Collaborators

  • National Institutes of Health (NIH)

    collaborator NIH

  • Genzyme, a Sanofi Company

    collaborator INDUSTRY

  • NYU Langone Health

    lead OTHER

Principal Investigators

  • Stephen Warren, MD · NYU Langone Health

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-03-31
Completion
2016-09-30

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT01353937 on ClinicalTrials.gov