ACTIVATED MACROPHAGES (ACUTE INJURY)

Dr. Michal Schwartz and colleagues (Rehovot, Israel) founded Proneuron, a SCI-focused biotechnology company whose mission is to develop immunological approaches that minimize post-injury neurological damage. Inspired by Hippocrates’ ancient wisdom that “natural forces within us are the true healers of disease,” Schwartz uses the body’s inherent healing mechanisms to develop therapeutic approaches that proactively augment naturally occurring autoimmune processes.

Specifically, the investigators use activated macrophages (a white blood cell) isolated from patient’s blood to reduce neurological damage after acute SCI. Although healing immune cells are scarce in the “immune-privileged” central nervous system, Schwartz and her colleagues haves circumvented this limitation by incubating the patient’s macrophage-containing blood with skin tissue. The isolated macrophages are then surgically implanted into the spinal cord within 14 days of injury. By mediating protective immune responses, these activated macrophages theoretically promote functional recovery.

Phase 1 clinical trials showed no adverse treatment effects. Functional improvement was measured using ASIA assessment standards (see appendix 1). Of the eight patients treated (2 cervical and 8 thoracic injuries), three improved from ASIA A to C (complete injury to partial motor and sensory recovery). Of the remaining ASIA A patients, three showed improvements in sensory scores and nerve conduction.

Proneuron  initiated a much larger phase II clinical trial intending to recruit 61 patients at several treatment sites: Sheba Hospital (Israel), Craig Hospital (Colorado), Mt. Sinai (New York), Kessler Rehabilitation (New Jersey), Shepherd Center (Georgia), and Shriners Hospital for Children (Pennsylvania). In 2006, apparently due to financial problems, Proneuron suspended the trial.