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Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries

NCT00073853 · Status: SUSPENDED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2009-08-28

No results posted yet for this study

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.

Conditions

  • Spinal Cord Injury

Interventions

PROCEDURE

Autologous Incubated Macrophages (cell therapy)

Sponsors & Collaborators

  • The Marcus Foundation

    collaborator OTHER

  • B.I.R.D. (Israel-U.S. Binational Industrial Research and Development)

    collaborator UNKNOWN

  • Proneuron Biotechnologies

    lead INDUSTRY

Principal Investigators

  • Daniel Lammertse, M.D. · Craig Hospital

  • Nachshon Knoller, M.D. · Chaim Sheba Medical Center

  • Marca Sipski, M.D. · University of Miami

  • Edward Benzel, M.D. · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
16 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30

Countries

  • United States
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00073853 on ClinicalTrials.gov