Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study

Part of paid clinical trials in Coral Springs, Florida.

Sponsor
MD Stem Cells
Study ID
NCT03225625
Status
Enrolling By Invitation

Conditions

  • Paraplegia
  • Paraplegia, Spinal
  • Paraplegia/Paraparesis
  • Paraplegia; Traumatic
  • SCI - Spinal Cord Injury
  • Spinal Cord Compression
  • Spinal Cord Diseases
  • Spinal Cord Injuries
  • Spinal Cord Ischemia
  • Spinal Paralysis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Paraspinal — PROCEDURE
    BMSC provided by paraspinal injection, intravenous and intranasal
  • Paraspinal EX — PROCEDURE
    BMSC provided by paraspinal injections, intravenous and intranasal followed by exoskeleton or equivalent stimulation
  • Paraspinal VR — PROCEDURE
    BMSC provided by paraspinal injections, intravenous and intranasal followed by virtual reality or equivalent visualization

Study Details

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/

Key Dates

Start date
Jul 1, 2017
Status verified
Apr 2024
Primary completion
Jul 31, 2025
Completion
Jul 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Paraspinal
    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.
  • Experimental: Paraspinal EX
    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. Exoskeleton or equivalent stimulation following this treatment.
  • Experimental: Paraspinal VR
    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. Virtual Reality or equivalent visualization following this treatment.

Primary Outcome Measure

American Spinal Injury Association (ASIA) Impairment Scale (AIS) [ Time Frame: Pre-procedure, 1,3,6 and 12 months post-procedure ]

Locations (1)

FacilityCityStateZIPSite coordinators
MD Stem CellsCoral SpringsFlorida33063-

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By research site
MD Stem Cells· Coral Springs, FL

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