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Stem Cell Therapy

Becaplermin (Regranex Gel) for Foot Ulcer (AMD3100 Trial)

Phase 1
Waitlist Available
Led By Stephen Warren, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
All Individual Drugs Already Approved
Approved for 5 Other Conditions
No Placebo-Only Group

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.

Eligible Conditions
  • Foot Ulcer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Quality of Life
Rate of Wound Closure
Secondary study objectives
Ankle-brachial index (ABI, Prestige sphygmomanometer and Summit doppler probe)
Glycosylated hemoglobin (HbA1C)
Transcutaneous oxygen tension measurements on wound and 1 cm-radius periphery (Radiometer adult sensor)
+8 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 5 Other Conditions
This treatment demonstrated efficacy for 5 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: Becaplermin (Regranex Gel)Active Control1 Intervention
Topical application
Group II: Novel Combination TherapyActive Control1 Intervention
AMD3100 (Plerixafor) injection with Regranex Gel topical application
Group III: Standard of CareActive Control1 Intervention
All patients will be receiving the Standard of Care treatments regardless of whether or not they are receiving study drug.

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,807 Previous Clinical Trials
8,153,590 Total Patients Enrolled
4 Trials studying Foot Ulcer
209 Patients Enrolled for Foot Ulcer
NYU Langone HealthLead Sponsor
1,405 Previous Clinical Trials
855,676 Total Patients Enrolled
1 Trials studying Foot Ulcer
1,609 Patients Enrolled for Foot Ulcer
Genzyme, a Sanofi CompanyIndustry Sponsor
526 Previous Clinical Trials
185,720 Total Patients Enrolled
~0 spots leftby Nov 2025