Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers

Phase 3

• Conditions: Chronic Venous Leg Ulcers
• Interventions: Other: Placebo injection; Biological: CureXcell®

• Registration Number: NCT02130310
• Lead Sponsor: Macrocure Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-01
• Study First Submitted QC: 2014-05-01
• Study First Posted: 2014-05-05
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-22
• Last Update Posted: 2015-09-23
• Primary Completion: 2016-05
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 252

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo injection	Placebo injection	The placebo will be administered by injecting normal saline at each centimeter of the ulcer bed.
CureXcell®	CureXcell®	CureXcell® injection will be administered about every 4 weeks for up to 3 treatments, or until ulcer closure, whichever occurs first.

Primary Outcome Measures

Name	Time	Method
Time to complete closure of Target Ulcer	up to 16 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Proportion of complete closure of Target Ulcer	up to 16 weeks	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	up to 12 weeks	Percentage change from baseline in Target Ulcer surface area at the end of the Treatment Phase.
Proportion of Target Ulcer recurrence	up to 24 weeks	Proportion of Target Ulcer recurrence during the 12-week Follow-Up Phase.