Autologous macrophage therapy in patients with complete spinal cord injuries: Phase I experience

Irit Shefer, Gustavo Auerbach, Nachshon Knoller, Moshe Hadani, Jacques Brotchi, Valentin Fulga, Gabriel Zeilig, Josef Attias, David Snyder, Ronit Bakimer, Michal Schwartz 

Open-label, non-randomized trials were conducted to assess the safety of autologous macrophages in 16 patients with acute, complete spinal cord injury. The macrophages were prepared from monocytes isolated from patient blood and co-incubated with autologous skin tissue. The cells were then injected into the spinal cord parenchyma within 14 days of injury. Patients were monitored for safety parameters, neurological status (according to ASIA standards), electrophysiology, and bladder and bowel function.

All patients were classified ASIA A (complete spinal cord injury) at baseline. Fourteen patients were followed for 12 months: one became ASIA B (motor complete, sensory incomplete), three became ASIA C (motor and sensory incomplete), one with recovered voluntary bladder control. Of two patients still in the first year of follow-up, one has already recovered to ASIA B. Of the patients who remained ASIA A, three showed some increase in sensory scores and some regained electrophysiological activity, suggesting restored nerve conduction.  These outcomes are considered significantly better than expected for patients with similar injuries. 

No adverse events were attributed to the autologous macrophage implantation.

We conclude that administration of autologous macrophages has a favourable benefit to risk ratio for the treatment of patients with acute, complete spinal cord injury.