Back to resultsEvaluation of CureXcell® in Treating Chronic Venous Leg Ulcers
Primary Purpose
Chronic Venous Leg Ulcers
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CureXcell®
Placebo injection
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Venous Leg Ulcers focused on measuring Chronic ulcers, Venous ulcers
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
CureXcell®
Placebo injection
Arm Description
CureXcell® injection will be administered about every 4 weeks for up to 3 treatments, or until ulcer closure, whichever occurs first.
The placebo will be administered by injecting normal saline at each centimeter of the ulcer bed.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Proportion of Target Ulcer recurrence
Proportion of Target Ulcer recurrence during the 12-week Follow-Up Phase.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02130310
Brief Title
Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
May 2016 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Macrocure Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Venous Leg Ulcers
Keywords
Chronic ulcers, Venous ulcers
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
252 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CureXcell®
Arm Type
Experimental
Arm Description
CureXcell® injection will be administered about every 4 weeks for up to 3 treatments, or until ulcer closure, whichever occurs first.
Arm Title
Placebo injection
Arm Type
Placebo Comparator
Arm Description
The placebo will be administered by injecting normal saline at each centimeter of the ulcer bed.
Intervention Type
Biological
Intervention Name(s)
CureXcell®
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo injection
Intervention Description
Normal saline injected at each centimeter of ulcer bed
Primary Outcome Measure Information:
Title
Time to complete closure of Target Ulcer
Description
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.
Time Frame
up to 16 weeks
Secondary Outcome Measure Information:
Title
Proportion of complete closure of Target Ulcer
Description
Proportion of complete closure of Target Ulcer within the Treatment Phase. Complete closure is confirmed at two consecutive study visits two weeks apart.
Time Frame
up to 16 weeks
Title
Percentage change from baseline in Target Ulcer surface area
Description
Percentage change from baseline in Target Ulcer surface area at the end of the Treatment Phase.
Time Frame
up to 12 weeks
Title
Proportion of Target Ulcer recurrence
Description
Proportion of Target Ulcer recurrence during the 12-week Follow-Up Phase.
Time Frame
up to 24 weeks
Other Pre-specified Outcome Measures:
Title
Adverse Events
Description
Incidence of adverse events, including overall AEs, AEs related to the CureXcell® and study-ulcer-associated AEs.
Time Frame
up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Kirsner, MD, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Lantis, MD
Organizational Affiliation
St. Luke's-Roosevelt Hospital Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Robert Snyder, DPM
Organizational Affiliation
Barry University Clinical Research
Official's Role
Principal Investigator
Facility Information:
City
Mesa
State/Province
Arizona
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Carlsbad
State/Province
California
Country
United States
City
Castro Valley
State/Province
California
Country
United States
City
Fresno
State/Province
California
Country
United States
City
Laguna Hills
State/Province
California
Country
United States
City
Los Angeles
State/Province
California
Country
United States
City
San Francisco
State/Province
California
Country
United States
City
Sylmar
State/Province
California
Country
United States
City
Hialeah
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
South Miami
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Oak Park
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Emerson
State/Province
New Jersey
Country
United States
City
Summit
State/Province
New Jersey
Country
United States
City
Tom's River
State/Province
New Jersey
Country
United States
City
New York
State/Province
New York
Country
United States
City
Chapel Hill
State/Province
North Carolina
Country
United States
City
Willoughby
State/Province
Ohio
Country
United States
City
Wyomissing
State/Province
Pennsylvania
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Lewisville
State/Province
Texas
Country
United States
City
McAllen
State/Province
Texas
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers
We'll reach out to this number within 24 hrs