Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Macrocure Ltd.
Sponsor:
Information provided by (Responsible Party):
Macrocure Ltd.
ClinicalTrials.gov Identifier:
NCT02130310
First received: May 1, 2014
Last updated: September 3, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Chronic Venous Leg Ulcers
Biological: CureXcell®
Other: Placebo injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Macrocure Ltd.:

Primary Outcome Measures:
  • Time to complete closure of Target Ulcer [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
    Percentage change from baseline in Target Ulcer surface area at the end of the Treatment Phase.

  • Proportion of Target Ulcer recurrence [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    Proportion of Target Ulcer recurrence during the 12-week Follow-Up Phase.


Other Outcome Measures:
  • Adverse Events [ Time Frame: up to 24 weeks ] [ Designated as safety issue: Yes ]
    Incidence of adverse events, including overall AEs, AEs related to the CureXcell® and study-ulcer-associated AEs.


Estimated Enrollment: 252
Study Start Date: May 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02130310

Contacts
Contact: Kush Dhody 301-956-2536 kushd@amarexcro.com

  Show 27 Study Locations
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Macrocure Ltd.
ClinicalTrials.gov Identifier: NCT02130310     History of Changes
Other Study ID Numbers: MC-105
Study First Received: May 1, 2014
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Macrocure Ltd.:
Chronic ulcers
Venous ulcers

Additional relevant MeSH terms:
Ulcer
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014