drugset / Trial / NCT01353937
Endogenous Progenitors Cell Therapy for Diabetic Foot Ulcers
Phase 1
Withdrawn
NYU Langone Health
Genzyme, a Sanofi Company · collabNational Institutes of Health (NIH) · collab
RandomizedParallel-groupSingle-blindTreatment
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.
Timeline
- Start
- 2014-04
- Primary completion
- 2016-03
- Completion
- 2016-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | AMD3100 | Small molecule | 240 ug/kg | Subcutaneous |
| Comparator | Becaplermin | Protein / enzyme biologic | — | Topical |