Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study (SciExVR)
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ClinicalTrials.gov Identifier: NCT03225625 |
Recruitment Status :
Enrolling by invitation
First Posted : July 21, 2017
Last Update Posted : August 2, 2022
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Condition or disease | Intervention/treatment | Phase |
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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 | Procedure: Paraspinal Procedure: Paraspinal EX Procedure: Paraspinal VR | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | 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 . |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study |
Actual Study Start Date : | July 1, 2017 |
Estimated Primary Completion Date : | July 2023 |
Estimated Study Completion Date : | July 2024 |

Arm | Intervention/treatment |
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Experimental: Paraspinal
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.
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Procedure: Paraspinal
BMSC provided by paraspinal injection, intravenous and intranasal
Other Name: Arm 1 |
Experimental: Paraspinal EX
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
BMSC provided by paraspinal injection, intravenous and intranasal
Other Name: Arm 1 Procedure: Paraspinal EX BMSC provided by paraspinal injections, intravenous and intranasal followed by exoskeleton or equivalent stimulation
Other Name: Arm 2 |
Experimental: 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. Virtual Reality or equivalent visualization following this treatment. |
Procedure: Paraspinal
BMSC provided by paraspinal injection, intravenous and intranasal
Other Name: Arm 1 Procedure: Paraspinal VR BMSC provided by paraspinal injections, intravenous and intranasal followed by virtual reality or equivalent visualization
Other Name: Arm 3 |
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) [ Time Frame: 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.
- Autonomic Nervous System (ANS) Function [ Time Frame: 1,3,6 and 12 months post-procedure ]The autonomic nervous system (ANS) through the sympathetic and parasympathetic divisions is responsible for many functions of the body including bladder and bowel control and sweating. Patients will self-report changes in ANS function and their abilities to perform ANS functions following the procedure.
- General Well-Being [ Time Frame: 1,3,6,12 months post-procedure ]General Well-Being is a term that may encompass mood, sense of well-being, family relationships, ability to do daily tasks and other practical or emotional practices that vary from person to person. Patients will self-report changes in their Quality of Life

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03225625
United States, Florida | |
MD Stem Cells | |
Coral Springs, Florida, United States, 33063 |
Study Chair: | Steven Levy, MD | MD Stem Cells | |
Principal Investigator: | Jeffrey Weiss, MD | Coral Springs | |
Principal Investigator: | Steven Silberfarb, DO | Florida Orthopaedics and Spine Center |
Responsible Party: | MD Stem Cells |
ClinicalTrials.gov Identifier: | NCT03225625 |
Other Study ID Numbers: |
SciExVR |
First Posted: | July 21, 2017 Key Record Dates |
Last Update Posted: | August 2, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
spinal cord injury spinal cord compression spinal cord ischemia spinal cord diseases |
spinal paralysis paraplegia paraparesis SCI |
Spinal Cord Injuries Paralysis Paraplegia Spinal Cord Compression Spinal Cord Diseases Paraparesis Spinal Cord Ischemia Ischemia Wounds and Injuries |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Pathologic Processes Neurologic Manifestations Paresis Spinal Cord Vascular Diseases Vascular Diseases Cardiovascular Diseases |