NCT00073853

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.

Trial Health

45
At Risk

Trial Health Score

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

Trial recruitment is currently suspended
Enrollment
61

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
2 countries

7 active sites

Status
suspended

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

September 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2003

Completed
Last Updated

August 28, 2009

Status Verified

March 1, 2006

First QC Date

December 10, 2003

Last Update Submit

August 27, 2009

Conditions

Spinal Cord Injury

Keywords

paraplegiaquadraplegiatetraplegiaparalysisnerve regenerationAcute, Complete SCI

Outcome Measures

Primary Outcomes (1)

  • Improvement of ASIA grade

Secondary Outcomes (3)

  • Sensory scores

  • Motor scores

  • Bladder and bowel function

Interventions

Autologous Incubated Macrophages (cell therapy)PROCEDURE

Eligibility Criteria

Age16 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Craig Hospital

Englewood, Colorado, 80110, United States

Location

Shepherd Center

Atlanta, Georgia, 30309, United States

Location

UMDNJ

Newark, New Jersey, 07103, United States

Location

Kessler Medical Rehabilitation Research and Education Corporation

West Orange, New Jersey, 07052, United States

Location

Mount Sinai Spinal Cord Injury Model System

New York, New York, 10029, United States

Location

Shriners Hospital for Children

Philadelphia, Pennsylvania, 19140, United States

Location

Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Related Publications (4)

  • 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. doi: 10.3171/spi.2005.3.3.0173.

    PMID: 16235699BACKGROUND

  • 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. doi: 10.1016/s0165-5728(03)00260-1.

    PMID: 14512160BACKGROUND

  • 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. doi: 10.1038/nm0798-814.

    PMID: 9662373BACKGROUND

  • 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.

    PMID: 22525310DERIVED

MeSH Terms

Conditions

Spinal Cord InjuriesParaplegiaQuadriplegiaParalysis

Interventions

Cell- and Tissue-Based Therapy

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological TherapyTherapeutics

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 10, 2003

First Posted

December 11, 2003

Study Start

September 1, 2003

Last Updated

August 28, 2009

Record last verified: 2006-03

Locations

IL(1)US(6)