A Phase III Multinational, Multicenter, Randomized, Double-Blind, Parallel-Group, Sham-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CureXcell™ as an Adjunct to Good Wound Care Measures in Treating Lower Extremity Chronic Ulcers in Adults With Diabetes Mellitus
Chronic foot ulcers are particularly prevalent in patients with underlying diabetes
mellitus. The prevalence of diabetes mellitus is growing at epidemic rates in Europe, United
States and in general worldwide. Foot ulceration is a serious complication of diabetes
mellitus associated with increased risk of infection, gangrene and amputation. These ulcers
are reported to be the leading cause of hospitalization among people with diabetes. Despite
existing ulcer therapies and technologies, there continues to be a great necessity for new
wound healing technologies that will further improve healing rates for these chronic ulcers
that remain a major source of morbidity, concern, and cost. This Phase III multinational,
multicenter, randomized, double-blind, controlled study is designed to evaluate CureXcell™
in treating lower extremity chronic ulcers in adults with Diabetes Mellitus.
CureXcell™ is a cell based therapy obtained from donated whole blood. The blood are
collected from healthy, young adult (age 18-40), the cells separated and then activated by
hypo-osmotic shock.
A total of 375 patients, in approximately 25 sites in the US, Canada and Israel, will be
randomized to receive either CureXcell™ or control.
The primary objective of the study is to evaluate the clinical benefit of CureXcell™ (study
biologic) compared to control, as adjunct to GUC. Additional objectives are to demonstrate
safety, tolerability and durability of CureXcell™ compared to control.
The study has two phases: a core double-blind phase followed by an open-label phase. Both
phases consist of treatment and follow up periods.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Proportion of patients with complete healing/closure of their target ulcer at any time during the 16-week double-blind core treatment period with sustained complete closure for 4 additional weeks of follow-up
up to 20 weeks
No
Richard Galperin, DPM
Principal Investigator
South Hampton Community Hospital
United States: Food and Drug Administration
MC-102
NCT01421966
August 2011
November 2015
Name | Location |
---|---|
Tufts Medical Center | Boston, Massachusetts 02111 |
University of Miami | Miami, Florida 33136 |
Southern Arizona VA Healthcare System | Tucson, Arizona 85723 |
Boston University Medical Center | Boston, Massachusetts 02118 |
Hope Research Institute | Phoenix, Arizona |
Phoenix VA Medical Center | Phoenix, Arizona 85012 |
Southern Arizona Limb Salvage Alliance | Tucson, Arizona 85723 |
Center for Clinical Research Inc. | San Fransisco, California 94115 |
Barry University School of Podiatric Medicine | Hialeah, Florida 33013 |
University Hospital Center - Cancer Center Clinical Research Office | Newark, New Jersey 07101 |
St. Lukes - Roosevelt Hospital Center | New York, New York 10025 |
Ohio State University Comprehensive Wound Center | Columbus, Ohio 43212 |
Temple University School of Podiatric Medicine | Philadelphia, Pennsylvania 19107 |
Vascular Health Alliance | Greenville, South Carolina 29615 |
South Hampton Community Hospital | Dallas, Texas 75224 |