Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries - Tabular View

Tracking Information

First Received Date ^ICMJE

December 10, 2003

Last Updated Date

August 27, 2009

Start Date ^ICMJE

September 2003

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Improvement of ASIA grade

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00073853 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sensory scores
Motor scores
Bladder and bowel function

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

Spinal Cord Injury

Intervention ^ICMJE

Procedure: Autologous Incubated Macrophages (cell therapy)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

16 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Israel

Administrative Information

NCT ID ^ICMJE

NCT00073853

Responsible Party

Study ID Numbers ^ICMJE

22-P-01

Study Sponsor ^ICMJE

Proneuron Biotechnologies

Collaborators ^ICMJE

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

Investigators ^ICMJE

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.	Cleveland Clinic

Information Provided By

Proneuron Biotechnologies

Verification Date

March 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP