About Cell Therapy Pharmaceuticals Contact Us

 

Neuralstem Cell Therapy

for Chronic Spinal Cord Injury

  • Product status:
    • U.S.: IND filed August 2010 for Phase I Safety Clinical Trial, pending approval
    • India: IND filing expected in 2012, with company evaluating potential trial centers and collaborators
    • Czech Republic: Clinical protocol design stage at the Czech Institute of Experimental Medicine in Prague
  • Mechanism of Action: Rebuilding neural circuitry across and below the injury site
  • Route of Administration: Direct injections into the spinal cord in and around the injury site

According to the National Spinal Cord Injury Association, three classes of neural tissue damage leading to paralysis have been identified:

  • Nerve cell death within the spinal cord
  • Disruption of nerve pathways
  • Demyelination, or destruction of the protective insulation surrounding axons, which conduct nerve signals

Recent clinical work has indicated that intensive rehabilitation can improve motor function in spinal cord injury patients even several years post injury. Neuralstem’s human spinal cord stem cells (HSSCs) could provide a neuron-rich substrate to the injured spinal cord segments, possibly promoting and supporting repair, regeneration and reorganization.

Neuralstem expects its cells will integrate into a patient’s own neural tissue and possibly create new circuitry to help transmit nerve signals to muscles. Specifically, neurons differentiated from these grafts may serve as a bridge to connect the axons located above the injury site to neurons of segments below the injury. The transplanted cells may also promote reorganization of the spinal cord segmental circuitry over time, possibly leading to improved motor function. In preclinical work, rats with ischemia-induced spinal cord injury recovered a significant amount of motor function after transplantation with Neuralstem cells. View published paper here.

Neuralstem cells also express powerful nerve growth factors that are essential to the healthy function of the central nervous system (CNS). These could protect the patient’s own neurons from further degeneration due to injury.

Planned Neuralstem Chronic Spinal Cord Injury Study

Neuralstem has submitted an Investigational New Drug (IND) application to the FDA to initiate a Phase I safety trial of its human spinal cord stem cells (HSSCs) for chronic spinal cord injury in August 2010. This trial will enroll chronic spinal cord injury patients with an American Spinal Injury Association (ASIA) grade A level of impairment one-to-two years post-injury. ASIA A refers to a patient with no motor or sensory function in the relevant segments and is considered to be complete paralysis.

If approved, the clinical trial will evaluate the safety of Neuralstem cells and proprietary Spinal Cord Delivery Platform and Floating Cannula in up to 16 spinal cord injury patients one-to-two years post injury. The cells will be transplanted directly in and around the injury site. Trial protocol will include extensive physical therapy to guide newly formed nerves to their proper connections and functionality.

In India, the company is evaluating potential trial surgery centers and collaborators for a planned IND filing expected in 2012. In Prague, a cSCI program in clinical protocol design stage is underway at the Czech Institute of Experimental Medicine.

Patient Resources:

For more information on spinal cord injury:

Privacy and Terms ©Neuralstem, Inc. 2012

Spinal cord injury (SCI) is damage to the spinal cord that results in a loss of function such as mobility or feeling, according to the National Spinal Cord Injury Association. There are approximately 840,000 spinal cord injury patients in the U.S., with more than 10,000 new spinal cord injuries in the U.S. each year. Eighty-five percent of SCI patients who survive the first 24 hours are still alive ten years later. Chronic spinal cord injury (cSCI) refers to this group of patients, in whom some level of paralysis persists following injury.

Website by inktank LLC