A Promising Future: Spinal Cord Injury Clinical Trials and Drug Therapy Update

Interesting innovations in medication therapies, cellular transplantation, spinal cord stimulation, and robotic devices.

Research in spinal cord injury (SCI) has been especially active in the past several decades, as demonstrated by a rise in promising therapies being studied in clinical trials. This article describes SCI therapies planned or currently under study, including innovations in medication therapies, cellular transplantation, spinal cord stimulation, and robotic devices.
Microscopic work station. Microscope, computer monitor with digital fluorescent image and tools.Basic science, animal and human studies are advancing drug therapies and devices, such as robotics to improve outcomes after traumatic spinal cord injury.Medication Innovations for Spinal Cord Injury
The latest advances in drug therapies for SCI are largely categorized as neuroprotective or neuroregenerative treatments.

Neuroprotective treatments

  • Minocycline: A large clinical trial is planned for this drug, which has been shown to protect nerves in animal studies. A study showed a 6-point increase in the American Spinal Injury Association (ASIA) motor score 1 year after administering minocycline for 7 days compared with placebo. (You can read more about ASIA motor scores, sensory scores, and the ASIA Impairment Scale grade in Spinal Cord Injury Classification and Syndromes.)
  • Riluzole: Researchers are enrolling people into a later-stage clinical trial for this therapy, which may prevent cell swelling and death after SCI. A phase I trial showed improved ASIA motor scores 90 days after riluzole treatment in people who had cervical (neck) SCI compared to people who did not take the drug.
  • Basic fibroblast growth factor (bFGF): bFGF has been shown to improve functional recovery in animal tests. Initial trials assessing therapies that are structurally similar to bFGF have ended and are awaiting results.
  • Systemic hypothermia: Hospital-induced hypothermia can safely curb inflammation after SCI. It is also associated with better ASIA Impairment Scale grades. Hypothermia as a neuroprotective therapy is being assessed in a phase II/III clinical trial.

Neuroregenerative treatments

  • Cethrin: Cethrin showed promise in early clinical trials for promoting cell regeneration. With Cethrin, ASIA motor score recovery after 1 year was better than expected recovery rates. A phase II/III clinical trial to further assess the therapy is underway.
  • Anti-Nogo antibody: Researchers believe a protein called Nogo‑A interferes with functional recovery after SCI. Anti-Nogo antibodies have shown promise in helping nerve cells regenerate in early clinical trials. These antibodies are being studied in a phase II trial in Europe.
  • Implantable bioengineered scaffolds or matrices: Biomaterials as an innovation for SCI recovery are designed to mimic lost cells in the spinal cord, and may help regulate cell migration and regrowth. A phase III trial studying patients with thoracic (mid-back) SCI is being conducted to assess safety and effectiveness in improving ASIA Impairment Scale grades, motor scores, and sensory scores.

Cellular Transplantation to Repair the Damaged Spinal Cord
Spinal cord injury causes a significant amount of tissue loss that cannot be saved by the spinal cord’s natural ability to repair itself. Innovations in cell transplantation can help replace lost cells, regulate cell function at the injury site, and improve cell regeneration.

In animal studies, cell transplantation into the damaged spinal cord was shown to promote motor function (walking, paw use, and climbing) and bladder function. A promising aspect of cell transplantation is that cells implanted 1 month after the traumatic injury were effective in animal tests.

Human trials have shown the safety and early effectiveness of cell transplantation after SCI, but larger patient sizes and longer follow-up studies are needed to understand the true safely and effectiveness of this therapy.

Spinal Cord Stimulation and Robotics Improve Outcomes After Spinal Cord Injury
In addition to drug therapies and cell transplantation, spinal cord stimulation and robotic technologies are exciting areas of SCI innovation.

Spinal cord stimulation uses a surgically implanted electrical current in the epidural space to improve functional and walking-related outcomes in patients with chronic SCI (chronic SCI refers to having SCI for more than 1 year).

Robotics are also playing a bigger role in helping people with SCI regain function and independence after their injury. In 2014, the U.S. Food and Drug Administration (FDA) approved the first wearable robotic exoskeleton for people with paraplegia after SCI. The device fits around the legs and back, allowing people to stand, walk, turn, and climb.

As researchers continue to learn more about spinal cord injury, the hope is that the various medical advances—medications, cellular technology, spinal cord stimulation, and robotics—may be used together to improve long-term outcomes for people affected by traumatic SCI.

Suggested Additional Reading
A special issue of the Global Spine Journal set forth guidelines for the Management of Degenerative Myelopathy and Acute Spinal Cord Injury, which is summarized on SpineUniverse in Summary of the Clinical Practice Guidelines for the Management of Degenerative Cervical Myelopathy and Traumatic Spinal Cord Injury.

Updated on: 01/10/18
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News Update: FDA Approves Robotic Exoskeleton to Help People with Spinal Cord Injury Walk

Recently, the FDA allowed ReWalk to be marketed. It is the first motorized device intended to act as an exoskeleton for people with lower body paralysis due to a spinal cord injury.
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