First human implantation of a bioresorbable polymer scaffold for acute traumatic spinal cord injury: A clinical pilot study for safety and feasibility

Nicholas Theodore, Randall Hlubek, Jill Danielson, Kristin Neff, Lou Vaickus, Thomas R. Ulich, Alexander E. Ropper

Research output: Contribution to journalArticle

Abstract

BACKGROUND AND IMPORTANCE: 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). CLINICAL PRESENTATION: 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. CONCLUSION: 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.

Original languageEnglish (US)
Pages (from-to)E305-E312
JournalNeurosurgery
Volume79
Issue number2
DOIs
StatePublished - Aug 1 2016
Externally publishedYes

Fingerprint

Spinal Cord Injuries
Polymers
Safety
Spinal Cord
Contusions
Surgical Decompression
Spinal Nerve Roots
Neurologic Examination
Accidents
Cysts
Animal Models
Clinical Trials
Pressure
Clinical Studies
Wounds and Injuries

Keywords

  • Myelotomy
  • Scaffold
  • Spinal cord injury
  • Spinal cord rehabilitation

ASJC Scopus subject areas

  • Clinical Neurology
  • Surgery

Cite this

First human implantation of a bioresorbable polymer scaffold for acute traumatic spinal cord injury : A clinical pilot study for safety and feasibility. / Theodore, Nicholas; Hlubek, Randall; Danielson, Jill; Neff, Kristin; Vaickus, Lou; Ulich, Thomas R.; Ropper, Alexander E.

In: Neurosurgery, Vol. 79, No. 2, 01.08.2016, p. E305-E312.

Research output: Contribution to journalArticle

Theodore, Nicholas ; Hlubek, Randall ; Danielson, Jill ; Neff, Kristin ; Vaickus, Lou ; Ulich, Thomas R. ; Ropper, Alexander E. / First human implantation of a bioresorbable polymer scaffold for acute traumatic spinal cord injury : A clinical pilot study for safety and feasibility. In: Neurosurgery. 2016 ; Vol. 79, No. 2. pp. E305-E312.
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