This trial is active, not recruiting.

Condition chronic venous leg ulcers
Treatments curexcell®, placebo injection
Phase phase 3
Sponsor Macrocure Ltd.
Start date May 2014
End date May 2016
Trial size 252 participants
Trial identifier NCT02130310, MC-105


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
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)
The placebo will be administered by injecting normal saline at each centimeter of the ulcer bed.
placebo injection
Normal saline injected at each centimeter of ulcer bed

Primary Outcomes

Time to complete closure of Target Ulcer
time frame: up to 16 weeks

Secondary Outcomes

Proportion of complete closure of Target Ulcer
time frame: up to 16 weeks
Percentage change from baseline in Target Ulcer surface area
time frame: up to 12 weeks
Proportion of Target Ulcer recurrence
time frame: up to 24 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator Robert Kirsner, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by Macrocure Ltd..