Introduction: In preclinical models, Neuro-Spinal Scaffold (NSS) implantation following SCI promotes neural sparing and regeneration through internal decompression and tissue remodeling. Rather than typical post-injury cyst formation, the NSS acts through appositional healing to form neuro-permissive remodeled tissue. A pilot study of the NSS enrolled 5 patients with complete thoracic SCI; three converted to incomplete. Neurologic recovery in 2 patients was either sustained (beyond 12 months) or delayed by 6 months. Post-injury MRI scans and clinical time course suggest that reduced cyst formation and ongoing neural regeneration may contribute to these observations.
Methods: Scaffolds were implanted 7-81 hours after injury within the intraspinal lesion. ISNCSCI exams and MRIs were performed before implantation and through 6-month follow-up.
Results: There were no NSS-related serious safety events. On screening MRI, patients typically exhibited spinal cord compression and edema. 3 of 5 patients had intraspinal hemorrhage. Based upon central neuroradiology review of pre and postoperative MRI scans through 6 months, none of the patients had definite cyst formation defined by T2 and T1 changes. By 6 months, 3/5 patients had converted from AIS A to AIS B(2) or C(1). One patient gained 10 points of hip and knee function by 6 months, with additional improvement and new ankle function at 12 months (increased motor score of 8). One patient converted from AIS A to B at 6 months, a late-occurring conversion that is extremely rare.
Conclusions: This study represents the first use of the intraspinal NSS in patients with complete thoracic SCI. By 6 months, the low incidence of cyst formation with preservation of some intra-lesion internal architecture is consistent with preclinical results in which the resorbable NSS was replaced by a matrix of axon-containing remodeled tissue. The possibility of ongoing neural regeneration may contribute to the high incidence of AIS conversion and sustained period of neurologic recovery.
Patient Care: By possibly offering a new therapy to be considered in the treatment of patients with acute spinal cord injury
Learning Objectives: By the conclusion of this session, participants should be able to: 1. Describe the concept of implantable scaffold devices following acute spinal cord injury. 2. Describe the time course of recovery for patients with AIS conversion associated with the NSS. 3. Discuss changes in SCI lesion in patients implanted with Neuro-Spinal Scaffold following acute thoracic complete spinal cord injury.