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

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Venous Leg Ulcers
• Intervention / Treatment: Biological: CureXcell®; Other: Placebo injection

• Study Type: Interventional
• Enrollment (Anticipated): 252
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Mesa, Arizona, United States
    • Phoenix, Arizona, United States
  • California
    • Carlsbad, California, United States
    • Castro Valley, California, United States
    • Fresno, California, United States
    • Laguna Hills, California, United States
    • Los Angeles, California, United States
    • San Francisco, California, United States
    • Sylmar, California, United States
  • Florida
    • Hialeah, Florida, United States
    • Miami, Florida, United States
    • South Miami, Florida, United States
  • Illinois
    • Chicago, Illinois, United States
    • Oak Park, Illinois, United States
  • Indiana
    • Indianapolis, Indiana, United States
  • Maryland
    • Baltimore, Maryland, United States
  • Massachusetts
    • Boston, Massachusetts, United States
  • Nevada
    • Las Vegas, Nevada, United States
  • New Jersey
    • Emerson, New Jersey, United States
    • Summit, New Jersey, United States
    • Tom's River, New Jersey, United States
  • New York
    • New York, New York, United States
  • North Carolina
    • Chapel Hill, North Carolina, United States
  • Ohio
    • Willoughby, Ohio, United States
  • Pennsylvania
    • Wyomissing, Pennsylvania, United States
  • Texas
    • Dallas, Texas, United States
    • Lewisville, Texas, United States
    • McAllen, Texas, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CureXcell®; CureXcell® injection will be administered about every 4 weeks for up to 3 treatments, or until ulcer closure, whichever occurs first.	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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to complete closure of Target Ulcer	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.	up to 16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of complete closure of Target Ulcer	Proportion of complete closure of Target Ulcer within the Treatment Phase. Complete closure is confirmed at two consecutive study visits two weeks apart.	up to 16 weeks
Percentage change from baseline in Target Ulcer surface area	Percentage change from baseline in Target Ulcer surface area at the end of the Treatment Phase.	up to 12 weeks
Proportion of Target Ulcer recurrence	Proportion of Target Ulcer recurrence during the 12-week Follow-Up Phase.	up to 24 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Incidence of adverse events, including overall AEs, AEs related to the CureXcell® and study-ulcer-associated AEs.	up to 24 weeks

Collaborators and Investigators

• Sponsor: Macrocure Ltd.
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): June 1, 2016

Study Registration Dates

• First Submitted: May 1, 2014
• First Submitted That Met QC Criteria: May 1, 2014
• First Posted (Estimate): May 5, 2014

Study Record Updates

• Last Update Posted (Estimate): September 23, 2015
• Last Update Submitted That Met QC Criteria: September 22, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Chronic ulcers; Venous ulcers
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Skin Ulcer; Varicose Veins; Ulcer; Leg Ulcer; Varicose Ulcer
• Other Study ID Numbers: MC-105