Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries

August 27, 2009 updated by: Proneuron Biotechnologies

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

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Tel Hashomer, Israel, 52621
        • Chaim Sheba Medical Center
  • United States
    • Colorado
      • Englewood, Colorado, United States, 80110
        • Craig Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Shepherd Center
    • New Jersey
      • Newark, New Jersey, United States, 07103
        • UMDNJ
      • West Orange, New Jersey, United States, 07052
        • Kessler Medical Rehabilitation Research and Education Corporation
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Spinal Cord Injury Model System
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Shriners Hospital for Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Improvement of ASIA grade

Secondary Outcome Measures

Outcome Measure
Sensory scores
Motor scores
Bladder and bowel function

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Proneuron Biotechnologies

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2003

Study Registration Dates

First Submitted

December 10, 2003

First Submitted That Met QC Criteria

December 10, 2003

First Posted (Estimate)

December 11, 2003

Study Record Updates

Last Update Posted (Estimate)

August 28, 2009

Last Update Submitted That Met QC Criteria

August 27, 2009

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-P-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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