Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study

Status unconfirmed · Not applicable

Conditions studied: 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

In brief

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 facts

Study ID

NCT03225625

Run by

MD Stem Cells

People needed

40

Starts

2017-07-01

Expected to finish

2026-07-01

Last updated by the study team

2024-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• MD Stem Cells — Coral Springs, Florida, United States

Full record on ClinicalTrials.gov

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