First Human Implantation of a Bioresorbable Polymer Scaffold for Acute Traumatic Spinal Cord Injury: A Clinical Pilot Study for Safety and Feasibility.

  title={First Human Implantation of a Bioresorbable Polymer Scaffold for Acute Traumatic Spinal Cord Injury: A Clinical Pilot Study for Safety and Feasibility.},
  author={Nicholas Theodore and Randall J. Hlubek and Jill Danielson and Kristin M. Neff and Lou Vaickus and Thomas R. Ulich and Alexander E. Ropper},
  volume={79 2},
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 ( Identifier: NCT02138110). CLINICAL… 

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Spinal cord injury

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Collagen scaffold combined with human umbilical cord-mesenchymal stem cells transplantation for acute complete spinal cord injury

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Functional recovery following traumatic spinal cord injury mediated by a unique polymer scaffold seeded with neural stem cells

  • Y. TengE. Lavik E. Snyder
  • Biology
    Proceedings of the National Academy of Sciences of the United States of America
  • 2002
Implantation of the scaffold–neural stem cells unit into an adult rat hemisection model of SCI promoted long-term improvement in function relative to a lesion-control group, suggesting a possible regeneration component.


In order to arrive at an adequate concept as to the amount of impact a spinal cord could receive and yet recover its function, I designed an instrument whereby a given weight could be placed on the cord.

Neurologic Improvement After Thoracic, Thoracolumbar, and Lumbar Spinal Cord (Conus Medullaris) Injuries

Study Design. Retrospective. Objective. With approximately 10,000 new spinal cord injury (SCI) patients in the United States each year, predicting public health outcomes is an important public health

Characterization of neurological recovery following traumatic sensorimotor complete thoracic spinal cord injury

The data suggest that a sustained deterioration of three or more thoracic sensory levels or loss of upper extremity motor function are rare events and may be useful for tracking the safety of a therapeutic intervention in early phase acute SCI clinical trials, if a significant proportion of study subjects exhibit such an ascent.

Evaluation of clinical experience using cell-based therapies in patients with spinal cord injury: a systematic review.

The quality of the literature was very low, with 3 Grade III levels of evidence and 9 Grade IV studies, and several different cellular-mediated strategies for adult SCI have been reported to be relatively safe with varying degrees of neurological recovery.

Cerebrospinal fluid drainage and induced hypertension improve spinal cord perfusion after acute spinal cord injury in pigs.

The combination of MAP elevation and CSFD significantly and sustainably improved spinal cord blood flow and spinal cord perfusion pressure.

Myelotomy reduces spinal cord edema and inhibits aquaporin-4 and aquaporin-9 expression in rats with spinal cord injury

Myelotomy improves locomotor function, reduces edema in rats with SCI and is associated with decreased expression of AQP4 and AQP9.

Translational potential of preclinical trials of neuroprotection through pharmacotherapy for spinal cord injury.

There are major deficiencies in the effort that has been extended to coordinate and conduct preclinical neuroprotection/pharmacotherapy trials in the SCI field and a recommendation is made for the development and validation of a preclinical scoring system involving worldwide experts in preclinical and clinical SCI.