Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries
- Conditions
- Spinal Cord Injury
- Registration Number
- NCT00073853
- Lead Sponsor
- Proneuron Biotechnologies
- 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
Not available
Recruitment & Eligibility
- Status
- SUSPENDED
- Sex
- All
- Target Recruitment
- 61
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Improvement of ASIA grade
- Secondary Outcome Measures
Name Time Method Sensory scores Motor scores Bladder and bowel function
Trial Locations
- Locations (7)
Shepherd Center
🇺🇸Atlanta, Georgia, United States
UMDNJ
🇺🇸Newark, New Jersey, United States
Shriners Hospital for Children
🇺🇸Philadelphia, Pennsylvania, United States
Kessler Medical Rehabilitation Research and Education Corporation
🇺🇸West Orange, New Jersey, United States
Mount Sinai Spinal Cord Injury Model System
🇺🇸New York, New York, United States
Chaim Sheba Medical Center
🇮🇱Tel Hashomer, Israel
Craig Hospital
🇺🇸Englewood, Colorado, United States