NCT01038986

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2009

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

December 23, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

January 31, 2013

Status Verified

January 1, 2013

Enrollment Period

2.7 years

First QC Date

December 23, 2009

Last Update Submit

January 30, 2013

Conditions

Wounds

Keywords

chronic woundrefractory woundCureXcellactivated cell suspension

Outcome Measures

Primary Outcomes (1)

  • Incidence and frequency of adverse experiences

    3 years

Secondary Outcomes (1)

  • Percent of complete healing following CureXcell™ treatments

    3 years

Study Arms (1)

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

Interventions

CureXcellBIOLOGICAL

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.

CureXcell treated

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with chronic and/or refractory wounds that have been referred by their physician for CureXcell treatment

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Rambam Health Care Campus

Haifa, 9602, Israel

Location

Rabin Medical Center

Petah Tikva, Israel

Location

Sheba Medical Center

Tel Litwinsky, Israel

Location

Related Publications (5)

  • 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.

    PMID: 16820652BACKGROUND

  • 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.

    PMID: 15953041BACKGROUND

  • 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.

    PMID: 15062757BACKGROUND

  • 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.

    PMID: 11982591BACKGROUND

  • 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.

    PMID: 2928316BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 23, 2009

First Posted

December 24, 2009

Study Start

December 1, 2009

Primary Completion

August 1, 2012

Study Completion

October 1, 2012

Last Updated

January 31, 2013

Record last verified: 2013-01

Locations

IL(3)