Autologous Incubated Macrophages for Patients With Complete Spinal Cord Injuries

Paused · Phase 2

Conditions studied: Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT00073853

Run by

Proneuron Biotechnologies

People needed

61

Starts

2003-09-01

Last updated by the study team

2009-08-28

Who can join

Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Craig Hospital — Englewood, Colorado, United States
• Shepherd Center — Atlanta, Georgia, United States
• UMDNJ — Newark, New Jersey, 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
• Shriners Hospital for Children — Philadelphia, Pennsylvania, United States
• Chaim Sheba Medical Center — Tel Litwinsky, Israel

Full record on ClinicalTrials.gov

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