Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study

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/

Conditions

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

Interventions

PROCEDURE

Paraspinal

BMSC provided by paraspinal injection, intravenous and intranasal

PROCEDURE

Paraspinal EX

BMSC provided by paraspinal injections, intravenous and intranasal followed by exoskeleton or equivalent stimulation

PROCEDURE

Paraspinal VR

BMSC provided by paraspinal injections, intravenous and intranasal followed by virtual reality or equivalent visualization

Sponsors & Collaborators

• MD Stem Cells

  lead INDUSTRY

Principal Investigators

• Steven Levy, MD · MD Stem Cells

• Jeffrey Weiss, MD · Coral Springs

• Steven Silberfarb, DO · Florida Orthopaedics and Spine Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-07-01

Primary Completion

2025-07-31

Completion

2026-07-31

Countries

• United States

Study Locations