Clinical trial NCT01038986: A Post-marketing Observational Study of Cell Therapy for Chronic Wounds
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Wounds
Keywords: chronic wound
refractory wound
CureXcell
activated cell suspension
Lead sponsor: Macrocure Ltd.
Sponsor class: INDUSTRY
First posted: 2009-12-24
Enrollment: 70
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with chronic and/or refractory wounds that have been referred by their physician for CureXcell treatment

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.

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 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

Primary outcomes:
measure: Incidence and frequency of adverse experiences
timeFrame: 3 years
Secondary outcomes:
measure: Percent of complete healing following CureXcell™ treatments
timeFrame: 3 years
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Petah Tiqva
country: Israel
facility: Rabin Medical Center
city: Tel Hashomer
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Itzchak Zivner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rambam Health Care Campus, Israel
name: Eli Peled, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rabin-Schnider Medical Center
name: Dean David Ad-El, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Leor J, Rozen L, Zuloff-Shani A, Feinberg MS, Amsalem Y, Barbash IM, Kachel E, Holbova R, Mardor Y, Daniels D, Ocherashvilli A, Orenstein A, Danon D. Ex vivo activated human macrophages improve healing, remodeling, and function of the infarcted heart. Circulation. 2006 Jul 4;114(1 Suppl):I94-100. doi: 10.1161/CIRCULATIONAHA.105.000331.
citation: Orenstein A, Kachel E, Zuloff-Shani A, Paz Y, Sarig O, Haik J, Smolinsky AK, Mohr R, Shinar E, Danon D. Treatment of deep sternal wound infections post-open heart surgery by application of activated macrophage suspension. Wound Repair Regen. 2005 May-Jun;13(3):237-42. doi: 10.1111/j.1067-1927.2005.130304.x.
citation: Zuloff-Shani A, Kachel E, Frenkel O, Orenstein A, Shinar E, Danon D. Macrophage suspensions prepared from a blood unit for treatment of refractory human ulcers. Transfus Apher Sci. 2004 Apr;30(2):163-7. doi: 10.1016/j.transci.2003.11.007.
citation: Frenkel O, Shani E, Ben-Bassat I, Brok-Simoni F, Rozenfeld-Granot G, Kajakaro G, Rechavi G, Amariglio N, Shinar E, Danon D. Activated macrophages for treating skin ulceration: gene expression in human monocytes after hypo-osmotic shock. Clin Exp Immunol. 2002 Apr;128(1):59-66. doi: 10.1046/j.1365-2249.2002.01630.x.
citation: Danon D, Kowatch MA, Roth GS. Promotion of wound repair in old mice by local injection of macrophages. Proc Natl Acad Sci U S A. 1989 Mar;86(6):2018-20. doi: 10.1073/pnas.86.6.2018.