Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers
The primary objective is to evaluate the clinical benefit of CureXcell® as adjunct to Standard of Care in the treatment of Chronic Venous Leg Ulcers. CureXcell® is a cell based therapy, containing activated homologous white blood cells prepared from donated healthy whole blood. A total of 252 patients will be randomized to receive either CureXcell® or Placebo.
Chronic Venous Leg Ulcers
Other: Placebo injection
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Phase-3 Prospective, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability and Efficacy of CureXcell® as an Adjunct to Good Ulcer Care Measures in Treating Chronic Venous Leg Ulcers|
- Time to complete closure of Target Ulcer [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]Time to complete closure of Target Ulcer at any time during the 12-week Treatment Phase. Complete closure is confirmed at two consecutive study visits two weeks apart.
- Proportion of complete closure of Target Ulcer [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]Proportion of complete closure of Target Ulcer within the Treatment Phase. Complete closure is confirmed at two consecutive study visits two weeks apart.
- Percentage change from baseline in Target Ulcer surface area [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]Percentage change from baseline in Target Ulcer surface area at the end of the Treatment Phase.
- Proportion of Target Ulcer recurrence [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]Proportion of Target Ulcer recurrence during the 12-week Follow-Up Phase.
- Adverse Events [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]Incidence of adverse events, including overall AEs, AEs related to the CureXcell® and study-ulcer-associated AEs.
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||May 2016 (Final data collection date for primary outcome measure)|
CureXcell® injection will be administered about every 4 weeks for up to 3 treatments, or until ulcer closure, whichever occurs first.
CureXcell® is a cell based therapy obtained from donated whole blood. The blood is collected from healthy young adults, the white blood cells are separated and then activated by hypo-osmotic shock.
Placebo Comparator: Placebo injection
The placebo will be administered by injecting normal saline at each centimeter of the ulcer bed.
Other: Placebo injection
Normal saline injected at each centimeter of ulcer bed
Please refer to this study by its ClinicalTrials.gov identifier: NCT02130310
|Contact: Kush Dhodyemail@example.com|
Show 27 Study Locations
|Principal Investigator:||Robert Kirsner, MD, PhD||University of Miami|
|Principal Investigator:||John Lantis, MD||St. Luke's-Roosevelt Hospital Center|
|Principal Investigator:||Robert Snyder, DPM||Barry University Clinical Research|