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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Macrocure Ltd.
ClinicalTrials.gov Identifier:
NCT01038986
First received: December 23, 2009
Last updated: January 30, 2013
Last verified: January 2013
  Purpose

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 Intervention
Wounds
Biological: CureXcell

Study Type: Observational
Study Design: 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

Further study details as provided by Macrocure Ltd.:

Primary Outcome Measures:
  • Incidence and frequency of adverse experiences [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percent of complete healing following CureXcell™ treatments [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: December 2009
Study Completion Date: October 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Genders Eligible for Study:   Both
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

Criteria

Inclusion Criteria:

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

INCLUSION CRITERIA FOR THE BLINDING GUESSING TEST

  • 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
  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: NCT01038986

Locations
Israel
Rambam Health Care Campus
Haifa, Israel, 9602
Rabin Medical Center
Petah Tiqva, Israel
Sheba Medical Center
Tel Hashomer, Israel
Sponsors and Collaborators
Macrocure Ltd.
Investigators
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
  More Information

Publications:
Responsible Party: Macrocure Ltd.
ClinicalTrials.gov Identifier: NCT01038986     History of Changes
Other Study ID Numbers: MC101-IL-01
Study First Received: December 23, 2009
Last Updated: January 30, 2013
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on November 27, 2014