Endogenous Progenitors Cell Therapy for Diabetic Foot Ulcers

• Status: Withdrawn
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborators: Genzyme, a Sanofi Company; National Institutes of Health (NIH)
• Treatments: Becaplermin; JM 3100; Platelet-derived growth factor BB; Plerixafor

Criteria

Inclusion Criteria:

1. Insulin-dependant type 2 diabetic patients

2. Age between 35 and 60 years-old

3. HbA1C between 6 and 12%

4. Full-thickness diabetic neuropathic foot ulcers

5. ≥ 2 weeks duration

6. Following standard of care débridement, ulcer size must be between 1 and 6 cm2

7. Adequate perfusion, defined as either transcutaneous oxygen measurements on the dorsum of the foot >30 mmHg or ankle brachial indexes 0.7>30 mmHg.

Exclusion Criteria:

1. Clinical infection at the studied ulcer site (bacterial and fungal)

2. Clinically significant lower-extremity ischemia (as defined by an ankle/brachial index of <0.65)

3. Active Charcot's foot as determined by clinical and radiographic examination

4. Ulcer of a non-diabetic pathophysiology (e.g., rheumatoid, radiation-related, and vasculitis-related ulcers, and especially venous stasis ulcer)

5. Significant medical conditions that would impair wound healing will also be excluded from the study. These conditions include liver disease, aplastic anemia, scleroderma and malignancy, treatment with immunosuppressive agents or steroids, myocardial infarcts, stroke, major surgery within 6 months of the study, usage of tobacco

6. Subjects with cancerous or pre-cancerous lesions in the area to be treated

7. Body weight > 160 kg (because of Plerixafor's pharmacokinetic limitation)

8. Severe renal dysfunction (creatinine clearance < 50 ml/min)

9. Severe non-proliferative or proliferative diabetic retinopathy

10. Capillary blood glucose >350