Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers

NCT02130310 | Unknown Phase 3 DMC

• 1 other identifier: MC-105
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 28

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.

Conditions

Chronic Venous Leg Ulcers

Keywords

Chronic ulcers; Venous ulcers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Proportion of complete closure of Target Ulcer

  up to 16 weeks

• Percentage change from baseline in Target Ulcer surface area

  up to 12 weeks

• Proportion of Target Ulcer recurrence

  up to 24 weeks

Other Outcomes (1)

• Adverse Events

  up to 24 weeks

Study Arms (2)

CureXcell®

EXPERIMENTAL

CureXcell® injection will be administered about every 4 weeks for up to 3 treatments, or until ulcer closure, whichever occurs first.

Biological: CureXcell®

Placebo injection

PLACEBO COMPARATOR

The placebo will be administered by injecting normal saline at each centimeter of the ulcer bed.

Other: Placebo injection

Interventions

CureXcell® BIOLOGICAL

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.

CureXcell®

Placebo injection OTHER

Normal saline injected at each centimeter of ulcer bed

Placebo injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Macrocure Ltd.: lead

Study Sites (28)

Unknown Facility

Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Carlsbad, California, United States

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Castro Valley, California, United States

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Fresno, California, United States

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Laguna Hills, California, United States

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Los Angeles, California, United States

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San Francisco, California, United States

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Sylmar, California, United States

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Hialeah, Florida, United States

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Miami, Florida, United States

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South Miami, Florida, United States

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Chicago, Illinois, United States

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Oak Park, Illinois, United States

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Indianapolis, Indiana, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Las Vegas, Nevada, United States

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Emerson, New Jersey, United States

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Summit, New Jersey, United States

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Toms River, New Jersey, United States

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New York, New York, United States

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Chapel Hill, North Carolina, United States

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Willoughby, Ohio, United States

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Wyomissing, Pennsylvania, United States

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Dallas, Texas, United States

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Lewisville, Texas, United States

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McAllen, Texas, United States

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MeSH Terms

Conditions

Varicose Ulcer

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 1, 2014
• First Posted: May 5, 2014
• Study Start: May 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: September 23, 2015

Record last verified: 2015-09

Locations

US (28)