Title
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
Phase
Phase 3Lead Sponsor
MacroCure Ltd.Study Type
InterventionalStatus
Unknown statusIndication/Condition
Chronic Venous Leg UlcersIntervention/Treatment
leukocytes ...Study Participants
252The 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.
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.
Normal saline injected at each centimeter of ulcer bed
CureXcell® injection will be administered about every 4 weeks for up to 3 treatments, or until ulcer closure, whichever occurs first.
The placebo will be administered by injecting normal saline at each centimeter of the ulcer bed.
Inclusion Criteria: Ankle Brachial Pressure Index (ABI) ≥ 0.80 Venous insufficiency confirmed by duplex Doppler ultrasound Presence of a venous leg ulcer, unresponsive to Standard of Care treatment for at least 4 weeks and between ≥ 1 cm2 and ≤ 17.1 cm2 at screening; and between ≥ 1 cm2 and ≤ 12cm2 at the Baseline Visit Exclusion Criteria: Target Ulcer has decreased >30% in size from Screening to Baseline Documented history of osteomyelitis at the Target Ulcer location within 6 months preceding the Baseline Visit. Patients who are unable to tolerate multi-layer compression therapy. Ulcer, which in the opinion of the Investigator is suspicious for cancer. Any malignancy within the past 5 years, excluding successfully treated basal cell carcinoma or squamous cell carcinoma without evidence of metastases. History of radiation at the Target Ulcer site in previous 12 months prior to Baseline Visit. Patients with clinically significant claudication Current sepsis Patients with known history of significantly compromised immunity for any reason including radiation therapy, chemotherapy or HIV
