Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study (SciExVR)
Spinal Cord Injuries, Spinal Cord Compression, Spinal Cord Ischemia
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring spinal cord injury, spinal cord compression, spinal cord ischemia, spinal cord diseases, spinal paralysis, paraplegia, paraparesis, SCI
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.
Sites / Locations
- MD Stem Cells
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Paraspinal
Paraspinal EX
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.
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.
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.