First Human Implantation of a Bioresorbable Polymer Scaffold for Acute Traumatic Spinal Cord Injury: A Clinical Pilot Study for Safety and Feasibility.
A porous bioresorbable polymer scaffold has previously been tested in preclinical animal models of spinal cord contusion injury to promote appositional healing, spare white matter, decrease posttraumatic cysts, and normalize intraparenchymal tissue pressure. This is the first report of its human implantation in a spinal cord injury patient during a pilot study testing the safety and feasibility of this technique (ClinicalTrials.gov Identifier: NCT02138110).



A 25-year-old man had a T11-12 fracture dislocation sustained in a motocross accident that resulted in a T11 American Spinal Injury Association Impairment Scale (AIS) grade A traumatic spinal cord injury. He was treated with acute surgical decompression and spinal fixation with fusion, and enrolled in the spinal scaffold study. A 2 × 10 mm bioresorbable scaffold was placed in the spinal cord parenchyma at T12. The scaffold was implanted directly into the traumatic cavity within the spinal cord through a dorsal root entry zone myelotomy at the caudal extent of the contused area. By 3 months, his neurological examination improved to an L1 AIS grade C incomplete injury. At 6-month postoperative follow-up, there were no procedural complications or apparent safety issues related to the scaffold implantation.



Although longer-term follow-up and investigation are required, this case demonstrates that a polymer scaffold can be safely implanted into an acutely contused spinal cord. This is the first human surgical implantation, and future outcomes of other patients in this clinical trial will better elucidate the safety and possible efficacy profile of the scaffold.



AIS, American Spinal Injury Association Impairment ScaleSCI, spinal cord injurytSCI, traumatic spinal cord injury.
*Division of Neurological Surgery, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center, Phoenix, Arizona; ‡InVivo Therapeutics Corporation, Cambridge, Massachusetts; §akta Pharmaceutical Development, LLC, Boston, Massachusetts.
Nicholas
N
Theodore
Randall
R
Hlubek
Jill
J
Danielson
Kristin
K
Neff
Lou
L
Vaickus
Thomas R
TR
Ulich
Alexander E
AE
Ropper
D020341:Absorbable Implants; D000328:Adult; D019299:Decompression, Surgical; D005240:Feasibility Studies; D006801:Humans; D008297:Male; D009460:Neurologic Examination; D010865:Pilot Projects; D011108:Polymers; D013119:Spinal Cord Injuries / Q000601:surgery*; D016103:Spinal Fractures / Q000601:surgery*; D013904:Thoracic Vertebrae / Q000293:injuries*; D054457:Tissue Scaffolds; D016896:Treatment Outcome
D011108:Polymers