Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study

NCT03225625 | Enrolling By Invitation DMC

• 1 other identifier: SciExVR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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/

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

Keywords

spinal cord injury; spinal cord compression; spinal cord ischemia; spinal cord diseases; spinal paralysis; paraplegia; paraparesis; SCI

Outcome Measures

Primary Outcomes (1)

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

  AIS is based on the Frankel scale which is used to classify the degree or completeness of spinal cord injury (SCI) by assessing motor and sensory function. Patients will have AIS assessment prior to procedure and post-procedure for comparison and identification of any improvements in motor or sensory function.

  Pre-procedure, 1,3,6 and 12 months post-procedure

Secondary Outcomes (2)

• Autonomic Nervous System (ANS) Function

  1,3,6 and 12 months post-procedure

• General Well-Being

  1,3,6,12 months post-procedure

Study Arms (3)

Paraspinal

EXPERIMENTAL

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.

Procedure: Paraspinal

Paraspinal EX

EXPERIMENTAL

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.

Procedure: Paraspinal; Procedure: Paraspinal EX

Paraspinal VR

EXPERIMENTAL

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.

Procedure: Paraspinal; Procedure: Paraspinal VR

Interventions

Paraspinal PROCEDURE

BMSC provided by paraspinal injection, intravenous and intranasal

Also known as: Arm 1

Paraspinal; Paraspinal EX; Paraspinal VR

Paraspinal EX PROCEDURE

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

Also known as: Arm 2

Paraspinal EX

Paraspinal VR PROCEDURE

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

Also known as: Arm 3

Paraspinal VR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MD Stem Cells: lead

Study Sites (1)

MD Stem Cells

Coral Springs, Florida, 33063, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Spinal Cord Compression; Spinal Cord Ischemia; Spinal Cord Diseases; Paraplegia; Paraparesis

Interventions

DMAC2L protein, human

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Spinal Cord Vascular Diseases; Vascular Diseases; Cardiovascular Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Paresis

Study Officials

• Steven Levy, MD

  MD Stem Cells

  STUDY CHAIR

• Jeffrey Weiss, MD

  Coral Springs

  PRINCIPAL INVESTIGATOR

• Steven Silberfarb, DO

  Florida Orthopaedics and Spine Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There will be 3 Arms: Arm 1: BMSC Paraspinal, IV, Intranasal . Arm 2: BMSC Paraspinal,IV,Intranasal + exoskeleton or equivalent . Arm 3: BMSC Paraspinal, IV, Intranasal + virtual reality or equivalent .

Study Record Dates

• First Submitted: July 17, 2017
• First Posted: July 21, 2017
• Study Start: July 1, 2017
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 16, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)