Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study

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Brief Title

Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study

Official Title

Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study

Brief Summary

      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. http://mdstemcells.com/sciexvr/
    

Detailed 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.
    


Study Type

Interventional


Primary Outcome

American Spinal Injury Association (ASIA) Impairment Scale (AIS)

Secondary Outcome

 Autonomic Nervous System (ANS) Function

Condition

Spinal Cord Injuries

Intervention

Paraspinal

Study Arms / Comparison Groups

 Paraspinal
Description:  Bilateral paraspinal injection of bone marrow derived stem cells (BMSC) at spinal cord injury level, superior to injury level and inferior to injury level. Following paraspinal injection remaining BMSC provided intravenous and intranasal.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

40

Start Date

July 1, 2017

Completion Date

July 1, 2023

Primary Completion Date

July 1, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  Have documented functional damage to the spinal cord unlikely to improve with present
             standard of care.

          -  If under current medical therapy (pharmacologic or surgical treatment) for the
             condition be considered stable on that treatment and unlikely to have reversal of the
             associated spinal cord damage as a result of the ongoing pharmacologic or surgical
             treatment.

          -  In the estimation of Dr. Weiss and Dr. Silberfarb have the potential for improvement
             with BMSC treatment and be at minimal risk of any potential harm from the procedure.

          -  Be over the age of 18 and capable of providing informed consent.

          -  Be medically stable and able to be medically cleared by their primary care physician
             or a licensed primary care practitioner for the procedure. Medical clearance means
             that in the estimation of the primary care practitioner, the patient can reasonably be
             expected to undergo the procedure without significant medical risk to health.

        Exclusion Criteria:

          -  All patients must be capable of an adequate neurologic examination and evaluation to
             document the pathology. This will include the ability to cooperate with the exam.

          -  Patients must be capable and willing to undergo follow up neurologic exams as outlined
             in the protocol.

          -  Patients must be capable of providing informed consent.

          -  In the estimation of Dr. Weiss and Dr. Silberfarb the BMSC collection and treatment
             will not present a significant risk of harm to the patient's general health or to
             their neurologic function. .

          -  Patients who are not medically stable or who may be at significant risk to their
             health undergoing the procedure will not be eligible.

          -  Women of childbearing age must not be pregnant at the time of treatment and should
             refrain from becoming pregnant for 3 months post treatment.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Steven Levy, MD, 203-423-9494, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03225625

Organization ID

SciExVR


Responsible Party

Sponsor

Study Sponsor

MD Stem Cells


Study Sponsor

Steven Levy, MD, Study Chair, MD Stem Cells


Verification Date

September 2021