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Stem Cell Therapy
Endogenous Progenitors Cell Therapy for Diabetic Foot Ulcers (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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
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 moreAwards & 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
2,830 Previous Clinical Trials
8,169,994 Total Patients Enrolled
4 Trials studying Foot Ulcer
192 Patients Enrolled for Foot Ulcer
NYU Langone HealthLead Sponsor
1,415 Previous Clinical Trials
856,082 Total Patients Enrolled
1 Trials studying Foot Ulcer
1,609 Patients Enrolled for Foot Ulcer
Genzyme, a Sanofi CompanyIndustry Sponsor
527 Previous Clinical Trials
185,736 Total Patients Enrolled
Stephen Warren, MDPrincipal InvestigatorNYU Langone Health