Last updated on August 2018

Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study

Brief description of study

The SciExVR study will evaluate the potential benefit of autologous bone marrow derived stem cells (BMSC) in the treatment of spinal cord injury with evidence of impaired motor or sensory function. The treatment consists of bilateral paraspinal injections of the BMSC at the level of the injury as well as superior and inferior to that spinal segment followed by an intravenous injection and intranasal placement. Patients undergoing BMSC treatment may also be assigned to use of exoskeletal movement (or equivalent) or virtual reality visualization (or equivalent) to augment upper motor neuron firing and/or receptivity of the sensory neurons.

Detailed Study Description

The Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality (SciExVR) study is based on the progress that researchers have made treating spinal cord injury (SCI) with bone marrow derived stem cells (BMSC). While major improvements have remained elusive with other approaches, modest benefits have been achieved.

The use of subarachnoid BMSC provided via intrathecal injection has resulted in improvements for certain sensory and bladder functions. Exoskeleton treatment has shown certain benefits in sensory, bowel and bladder function.

Intravenous (IV) BMSC have benefited stroke and other central nervous system damage. In the sponsor's concomitant Neurologic Stem Cell Treatment (NEST) study for general neurologic disease, benefit has been shown by combining IV with intranasal BMSC.

The SciExVR study uses paraspinal injections- meaning the BMSC are placed adjacent to the spinal nerves which enter the spinal canal through the intervertebral foramen of the vertebral bodies. The BMSC will be placed at the level of the injury on both sides of the spine as well as approximately two segments above and two segments below. The investigators believe this will allow entry into the spinal tissue at the injury site as well as to the injured upper motor neuron pathways; lower motor neurons which may be injured; sensory pathways; dorsal root ganglia at and below the site and autonomic ganglia. Placement in the paraspinal tissue may extend the time that BMSC have to proliferate at, above and below the vicinity of the spinal cord injury and interact with damaged cells in the spinal cord, spinal roots, spinal nerves and paravertebral ganglion. Potential benefits of these interactions include BMSC mitochondrial transfer to target cells, secretion of mRNA increasing target cell activity, secretion of nerve growth factor and other neurotrophic factors beneficial to nerve regrowth. Increased proliferation and contact time may increase neuronal transdifferentiation of BMSC to neurons and/or neuroglia. Following paraspinal injections the patient receives the remaining BMSC intravenously (IV) and also topically intranasally. BMSC given IV may enter the central nervous system through the paraventricular organs in the brain to potentially reach the ascending and descending pathways, thalamus, sensory cortex, motor cortex and circulate through the cerebral spinal fluid (CSF). Intranasal provides access through the axons of the Trigeminal (V) cranial nerves and entry into the brain at the level of the pons with similar opportunity to move through the tissues.

BMSC are separated from bone marrow obtained from the posterior iliac crest with a single aspiration on each side. The procedure is performed under general or MAC anesthesia at the fully licensed surgical center so there is no discomfort in performing the procedure. The BMSC are separated from the aspirate using an FDA cleared class II device.

After BMSC treatment patients who are in Arm 1 simply follow up with their own neurologists at 1,3,6 and 12 months.

Those in Arm 2 require similar follow up and pursue treatment at centers that can provide exoskeletal stimulation or physical therapy equivalent. Exoskeleton devices move the limbs of the patient to provide stimulation to the muscles in a self directed fashion but similar to physical therapy that is often performed for SCI. The investigators believe that Arm 2 may provide stimulation of the upper and lower motor neurons and sensory receptors such as exteroceptors and proprioceptors which may, in the presence of BMSC, assist in regeneration or reactivation of the spinal cord pathways.

Patients in Arm 3 require similar follow up and may use Virtual Reality headsets or equivalent to increase visualization of movement of the lower extremities and/or sensory feedback. This may also help stimulate the upper and lower motor neurons and sensory receptors.

Clinical Study Identifier: NCT03225625

Contact Investigators or Research Sites near you

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Steven Levy, MD

The Healing Institute
Margate, FL United States
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