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Trial record 1 of 2 for:    proneuron
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Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries

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: NCT00073853
Recruitment Status : Suspended
First Posted : December 11, 2003
Last Update Posted : August 28, 2009
The Marcus Foundation
B.I.R.D. (Israel-U.S. Binational Industrial Research and Development)
Information provided by:
Proneuron Biotechnologies

Tracking Information
First Submitted Date  ICMJE December 10, 2003
First Posted Date  ICMJE December 11, 2003
Last Update Posted Date August 28, 2009
Study Start Date  ICMJE September 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
Improvement of ASIA grade
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 23, 2005)
  • Sensory scores
  • Motor scores
  • Bladder and bowel function
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries
Official Title  ICMJE A Phase II Multicenter, Randomized-Controlled Study to Evaluate the Safety and Efficacy of Autologous Incubated Macrophages for the Treatment of Patients With Complete Spinal Cord Injuries
Brief Summary

Autologous Incubated Macrophages (ProCord) is being developed as a therapy for acute, complete spinal cord injury (SCI). The therapy is intended to reverse the loss of motor and sensory function.

Following non-CNS tissue injury, macrophages quickly arrive on the scene, where they clean up cell debris, secrete different molecules thus promoting a controlled inflammatory reaction that forms the first phase of the wound healing process. While this process occurs in most tissues, including peripheral nerves, it does not occur in the CNS, where macrophages and other immune cells are relatively rare, and their activities curtailed by a biochemical mechanism known as "immune privilege."

In animal studies, it appears that incubated macrophages circumvent the immune privilege, thus supporting the regrowth of axons through the injury site and enabling the recovery of neurological function. The concept derives from the pioneering research of Prof. Michal Schwartz at the Weizmann Institute of Science.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Spinal Cord Injury
Intervention  ICMJE Procedure: Autologous Incubated Macrophages (cell therapy)
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Suspended
Enrollment  ICMJE
 (submitted: June 23, 2005)
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE Not Provided
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Traumatic SCI during last 14 days
  • Age 16 to 65 years
  • Complete spinal cord injury (ASIA A)
  • Neurological level : C5 to T11
  • MRI showing lesion

Exclusion Criteria:

  • Women who are pregnant or breastfeeding
  • Coma or other severe injury or disease
  • Penetrating injury
  • Ongoing mechanical ventilation
  • Unsuitable based on MRI or other factor
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT00073853
Other Study ID Numbers  ICMJE 22-P-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Proneuron Biotechnologies
Collaborators  ICMJE
  • The Marcus Foundation
  • B.I.R.D. (Israel-U.S. Binational Industrial Research and Development)
Investigators  ICMJE
Study Director: Daniel Lammertse, M.D. Craig Hospital
Study Director: Nachshon Knoller, M.D. Chaim Sheba Medical Center
Study Director: Marca Sipski, M.D. University of Miami
Study Director: Edward Benzel, M.D. The Cleveland Clinic
PRS Account Proneuron Biotechnologies
Verification Date March 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP