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Evaluation of CureXcell® in Treating Chronic Venous Leg Ulcers

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Macrocure Ltd. Identifier:
First received: May 1, 2014
Last updated: September 22, 2015
Last verified: September 2015
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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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 ]
    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 ]
    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 ]
    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 ]
    Proportion of Target Ulcer recurrence during the 12-week Follow-Up Phase.

Other Outcome Measures:
  • Adverse Events [ Time Frame: up to 24 weeks ]
    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


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT02130310

  Show 28 Study Locations
Sponsors and Collaborators
Macrocure Ltd.
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

Responsible Party: Macrocure Ltd. Identifier: NCT02130310     History of Changes
Other Study ID Numbers: MC-105
Study First Received: May 1, 2014
Last Updated: September 22, 2015

Keywords provided by Macrocure Ltd.:
Chronic ulcers
Venous ulcers

Additional relevant MeSH terms:
Leg Ulcer
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases processed this record on April 25, 2017