Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries

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

Study Description

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

Study Design

• 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

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Improvement of ASIA grade

Secondary Outcome Measures :

1. Sensory scores
2. Motor scores
3. Bladder and bowel function

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

The 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

Publications:

Knoller N, Auerbach G, Fulga V, Zelig G, Attias J, Bakimer R, Marder JB, Yoles E, Belkin M, Schwartz M, Hadani M. Clinical experience using incubated autologous macrophages as a treatment for complete spinal cord injury: phase I study results. J Neurosurg Spine. 2005 Sep;3(3):173-81.

Bomstein Y, Marder JB, Vitner K, Smirnov I, Lisaey G, Butovsky O, Fulga V, Yoles E. Features of skin-coincubated macrophages that promote recovery from spinal cord injury. J Neuroimmunol. 2003 Sep;142(1-2):10-6.

Rapalino O, Lazarov-Spiegler O, Agranov E, Velan GJ, Yoles E, Fraidakis M, Solomon A, Gepstein R, Katz A, Belkin M, Hadani M, Schwartz M. Implantation of stimulated homologous macrophages results in partial recovery of paraplegic rats. Nat Med. 1998 Jul;4(7):814-21.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lammertse DP, Jones LA, Charlifue SB, Kirshblum SC, Apple DF, Ragnarsson KT, Falci SP, Heary RF, Choudhri TF, Jenkins AL, Betz RR, Poonian D, Cuthbert JP, Jha A, Snyder DA, Knoller N. Autologous incubated macrophage therapy in acute, complete spinal cord injury: results of the phase 2 randomized controlled multicenter trial. Spinal Cord. 2012 Sep;50(9):661-71. doi: 10.1038/sc.2012.39. Epub 2012 Apr 24.

• ClinicalTrials.gov Identifier: NCT00073853 History of Changes
• Other Study ID Numbers: 22-P-01
• First Posted: December 11, 2003
• Last Update Posted: August 28, 2009
• Last Verified: March 2006

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