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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

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Procedure: Autologous Incubated Macrophages (cell therapy) Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : September 2003

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Improvement of ASIA grade

Secondary Outcome Measures :
  1. Sensory scores
  2. Motor scores
  3. Bladder and bowel function

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00073853

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United States, Colorado
Craig Hospital
Englewood, Colorado, United States, 80110
United States, Georgia
Shepherd Center
Atlanta, Georgia, United States, 30309
United States, New Jersey
Newark, New Jersey, United States, 07103
Kessler Medical Rehabilitation Research and Education Corporation
West Orange, New Jersey, United States, 07052
United States, New York
Mount Sinai Spinal Cord Injury Model System
New York, New York, United States, 10029
United States, Pennsylvania
Shriners Hospital for Children
Philadelphia, Pennsylvania, United States, 19140
Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Proneuron Biotechnologies
The Marcus Foundation
B.I.R.D. (Israel-U.S. Binational Industrial Research and Development)
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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
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00073853    
Other Study ID Numbers: 22-P-01
First Posted: December 11, 2003    Key Record Dates
Last Update Posted: August 28, 2009
Last Verified: March 2006
Keywords provided by Proneuron Biotechnologies:
nerve regeneration
Acute, Complete SCI
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System