NCT03225625
Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study
UNKNOWN
NAAges 18+InterventionalTreatmentMD Stem Cells
~40 participants
Updated 2024-04-16 on ClinicalTrials.gov
What's tested:ParaspinalParaspinal EXParaspinal VR
At a glance
Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
American Spinal Injury Association (ASIA) Impairment Scale (AIS)
Measured over Pre-procedure, 1,3,6 and 12 months post-procedure
Conditions
Where it's being run
1 sites across 1 statesFlorida1
Study leadership
- Steven Levy, MD · STUDY_CHAIR · MD Stem Cells
- Jeffrey Weiss, MD · PRINCIPAL_INVESTIGATOR · Coral Springs
- Steven Silberfarb, DO · PRINCIPAL_INVESTIGATOR · Florida Orthopaedics and Spine Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
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
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.
What this trial measures
- American Spinal Injury Association (ASIA) Impairment Scale (AIS)Pre-procedure, 1,3,6 and 12 months post-procedure
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.