Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers
NCT ID: NCT02130310
Last Updated: 2015-09-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
252 participants
INTERVENTIONAL
2014-05-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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CureXcell®
CureXcell® injection will be administered about every 4 weeks for up to 3 treatments, or until ulcer closure, whichever occurs first.
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 injection
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
Interventions
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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 injection
Normal saline injected at each centimeter of ulcer bed
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Macrocure Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Kirsner, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
John Lantis, MD
Role: PRINCIPAL_INVESTIGATOR
St. Luke's-Roosevelt Hospital Center
Robert Snyder, DPM
Role: PRINCIPAL_INVESTIGATOR
Barry University Clinical Research
Locations
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Mesa, Arizona, United States
Phoenix, Arizona, United States
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
Hialeah, Florida, United States
Miami, Florida, United States
South Miami, Florida, United States
Chicago, Illinois, United States
Oak Park, Illinois, United States
Indianapolis, Indiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Las Vegas, Nevada, United States
Emerson, New Jersey, United States
Summit, New Jersey, United States
Toms River, New Jersey, United States
New York, New York, United States
Chapel Hill, North Carolina, United States
Willoughby, Ohio, United States
Wyomissing, Pennsylvania, United States
Dallas, Texas, United States
Lewisville, Texas, United States
McAllen, Texas, United States
Countries
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Other Identifiers
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MC-105
Identifier Type: -
Identifier Source: org_study_id
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