A Post-marketing Observational Study of Cell Therapy for Chronic Wounds

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01038986
Recruitment Status : Completed
First Posted : December 24, 2009
Last Update Posted : January 31, 2013
Information provided by (Responsible Party):
Macrocure Ltd.

Brief Summary:
A post-marketing multi-center observational study to provide data describing the safety and effectiveness of CUREXCELL™ as it is applied in a real-life setting for treatment in patients with chronic and/or refractory wounds.

Condition or disease Intervention/treatment
Wounds Biological: CureXcell

Detailed Description:

Chronic wounds can be categorized into two main groups: (a) chronic ulcers, such as diabetic foot ulcers, venous leg ulcers and pressure (decubitus) ulcers (b) post-operative or traumatic, difficult-to-heal wounds, some of which may be infected such as sternal wound infections following cardiac surgery or wounds following abdominal or orthopedic surgery. Age, peripheral vascular disease, infection, diabetes mellitus, auto-immune dis., obesity, cardiac disease, cardiac failure, malnutrition, immunological deficiencies, steroid treatment, bed confinement and prolonged operation time are among the causes of wound repair delay or failure and often results in considerable morbidity and mortality. In addition, these wounds lengthen hospital stays, significantly increase the cost of care, and negatively impact the quality of life of both the patients and care giversCurrently available wound care products include various dressings, ointments, gels, antiseptic agents and devices. These products are intended to supply a suitable environment for wound healing (e.g. moist environment, particular factors required for the healing process), but they do not provide an adequate solution for this growing problem of chronic wounds.

Macrocure has developed an advanced cellular therapy for wound healing named Curexcell™. Curexcell™ not only provides the natural environment for wound healing, but also ensures that the appropriate cell activities and factor secretions are maintained as required during each of the stages of wound healing. The product contains primed/activated Monocytes, Neutrophils and Lymphocytes derived from whole blood unit, which are key role players in the normal natural wound healing process. The cells are injected locally into the wound bed.

The proposed study is a post-marketing observational study (PMOS) in which the decision to use Curexcell™ for treatment of patients with chronic and/or refractory wounds are made by local physicians. Curexcell™ will be administered to the patient in accordance with the Instructions for Use.

In this PMOS, there is no control by the investigator with respect to patients, duration and frequency of follow-up and the method by which patients are managed in general. This design truly reflects real-life circumstances.

Study Type : Observational
Actual Enrollment : 70 participants
Time Perspective: Prospective
Official Title: A Post-marketing Multi-center Observational Study to Provide Data Describing the Safety and Effectiveness of CUREXCELL™ as it is Applied in a Real-life Setting for Treatment in Patients With Chronic and/or Refractory Wounds
Study Start Date : December 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
CureXcell treated
Patients with chronic and/or refractory wounds for at least 4 weeks with no improvement that have been referred by their physician for CureXcell treatment
Biological: CureXcell
The CureXcell™ dosage form consists of an aseptically-processed activated cell suspension that has been isolated, activated and purified from the peripheral blood of healthy allogeneic donors, by hypo-osmotic shock, using the MacroCure custom closed bag system.

Primary Outcome Measures :
  1. Incidence and frequency of adverse experiences [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. Percent of complete healing following CureXcell™ treatments [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with chronic and/or refractory wounds that have been referred by their physician for CureXcell treatment

Inclusion Criteria:

  • Patients with chronic and/or refractory wounds that have been referred by their physician for CUREXCELLTM treatment
  • Signed consent form


  • Patients with chronic lower extremity ulcers (on malleoli and below) and diabetes mellitus
  • Signed the blinding guessing test section of the consent form
  • Were not treated in the past by CureXcell

Exclusion Criteria:

  • Patients with known or suspected present malignancy (except for successfully treated basal cell carcinoma) within the past 3 years.
  • Patients with gangrene
  • Patients for whom amputation or a complete resection of the infection site is planned component of treatment
  • Patients simultaneously participating in any interventional clinical trial
  • Patients with any other known or suspected condition that may jeopardize adherence to registry protocol requirements

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01038986

Rambam Health Care Campus
Haifa, Israel, 9602
Rabin Medical Center
Petah Tiqva, Israel
Sheba Medical Center
Tel Hashomer, Israel
Sponsors and Collaborators
Macrocure Ltd.
Principal Investigator: Itzchak Zivner, MD Sheba Medical Center
Principal Investigator: Eli Peled, M.D. Rambam Health Care Campus, Israel
Principal Investigator: Dean David Ad-El, M.D. Rabin-Schnider Medical Center

Responsible Party: Macrocure Ltd. Identifier: NCT01038986     History of Changes
Other Study ID Numbers: MC101-IL-01
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013

Keywords provided by Macrocure Ltd.:
chronic wound
refractory wound
activated cell suspension

Additional relevant MeSH terms:
Wounds and Injuries