NCT02130310

Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: Macrocure Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Chronic Venous Leg Ulcers

Interventions

Type	Name	Description
BIOLOGICAL	CureXcell®	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.
OTHER	Placebo injection	Normal saline injected at each centimeter of ulcer bed

Timeline

• Start date: 2014-05-01
• Primary completion: 2016-05-01
• Completion: 2016-06-01
• First posted: 2014-05-05
• Last updated: 2015-09-23

Locations

28 sites across 1 country: United States