Lecture to APS (American Paraplegia Society) – 7-9/09/2004 in Las Vegas, Nevada

Long-term follow-up of spinal cord injury patients treated with ProCord (Autologous Macrophages)

Linda Jones, Nachshon Knoller, Moshe Hadani, Jacques Brotchi, Gustavo Auerbach, Daniel P Lammertse

Background: The objective of this study was to evaluate the long-term outcomes after complete spinal cord injury (SCI) and subsequent treatment with Procord, a cell therapy consisting of autologous incubated macrophages that have been pre-incubated with autologous skin and injected into the lesion site. Characterization of the incubated macrophages is presented in a separate abstract.

Design: Open label, non-randomized clinical trials at Sheba Medical Center, Israel and Erasmus Hospital, Brussels, Belgium.

Methods: Fourteen SCI patients (C5-T11) diagnosed as ASIA A (American Spinal Injury Association) at baseline were treated with Procord 9 to 15 days after injury. Patients were followed for a least a year by periodic neurological examination according to ASIA standards and questionnaires (Functional Independence Measure, Craig Handicap Assessment and Reporting Technique , Satisfaction with Life Scale, bowel and bladder assessments). Changes in the neurological and functional status and subjective quality of life data were compared to matched control data extracted from the Model Systems Database.

Results: Three patients recovered motor and sensory neurological function, improving from ASIA A to ASIA C. An additional patient recovered sensory function with no motor recovery (ASIA B). Other patients showed improvements in neurological sensory scores but remained ASIA A. The greatest gains occurred during the first year, although one patient showed remarkable neurological and functional gains more than 2 years after the treatment.  

Conclusion:  Despite the small study size (14 patients), recovery of clinically significant neurological function has been observed in several subjects after Procord treatment, whereas untreated patients with complete SCI rarely recover significant function. Thus, Procord appears to be a potentially valuable therapy in the acute stage for improving outcomes after SCI.  

Funding:  Supported by Proneuron Biotechnologies