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
Data Collection
Central Nervous System Diseases+3
+ Nervous System Diseases
+ Spinal Cord Diseases
Treatment Study
Summary
Study start date: September 1, 2003
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.61 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 16 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 7 locations
Shepherd Center
Atlanta, United StatesUMDNJ
Newark, United StatesKessler Medical Rehabilitation Research and Education Corporation
West Orange, United States