Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries

This study has suspended participant recruitment.
Sponsor:
Collaborators:
Marcus Foundation
B.I.R.D. (Israel-U.S. Binational Industrial Research and Development)
Information provided by:
Proneuron Biotechnologies
ClinicalTrials.gov Identifier:
NCT00073853
First received: December 10, 2003
Last updated: August 27, 2009
Last verified: March 2006
  Purpose

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 Intervention Phase
Spinal Cord Injury
Procedure: Autologous Incubated Macrophages (cell therapy)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Proneuron Biotechnologies:

Primary Outcome Measures:
  • Improvement of ASIA grade

Secondary Outcome Measures:
  • Sensory scores
  • Motor scores
  • Bladder and bowel function

Estimated Enrollment: 61
Study Start Date: September 2003
  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00073853

Locations
United States, Colorado
Craig Hospital
Englewood, Colorado, United States, 80110
United States, Georgia
Shepherd Center
Atlanta, Georgia, United States, 30309
United States, New Jersey
UMDNJ
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
Israel
Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Proneuron Biotechnologies
Marcus Foundation
B.I.R.D. (Israel-U.S. Binational Industrial Research and Development)
Investigators
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
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00073853     History of Changes
Other Study ID Numbers: 22-P-01
Study First Received: December 10, 2003
Last Updated: August 27, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Proneuron Biotechnologies:
paraplegia
quadraplegia
tetraplegia
paralysis
nerve regeneration
Acute, Complete SCI

Additional relevant MeSH terms:
Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System

ClinicalTrials.gov processed this record on April 17, 2014