Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study (SciExVR)
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| ClinicalTrials.gov Identifier: NCT03225625 |
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Recruitment Status :
Recruiting
First Posted : July 21, 2017
Last Update Posted : November 28, 2018
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Sponsor:
MD Stem Cells
Collaborator:
The Healing Institute
Information provided by (Responsible Party):
MD Stem Cells
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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/
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Spinal Cord Injuries Spinal Cord Compression Spinal Cord Ischemia Spinal Cord Diseases Spinal Paralysis Paraplegia Paraplegia, Spinal Paraplegia/Paraparesis Paraplegia; Traumatic | Procedure: Paraspinal Procedure: Paraspinal EX Procedure: Paraspinal VR | Not Applicable |
Show Detailed Description
| 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 1, 2021 |
| Estimated Study Completion Date : | July 1, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Spinal Cord Injuries
| 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 |
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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 |
Primary Outcome Measures :
- 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.
Secondary Outcome Measures :
- 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
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Information from the National Library of Medicine
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
Contacts
| Contact: Steven Levy, MD | 203-423-9494 | stevenlevy@mdstemcells.com |
Locations
| United States, Florida | |
| The Healing Institute | Recruiting |
| Margate, Florida, United States, 33063 | |
| Contact: Steven Levy, MD 203-423-9494 stevenlevy@mdstemcells.com | |
Sponsors and Collaborators
MD Stem Cells
The Healing Institute
Investigators
| Study Director: | Steven Levy, MD | MD Stem Cells | |
| Principal Investigator: | Jeffrey Weiss, MD | The Healing Institute | |
| Principal Investigator: | Steven Silberfarb, DO | Florida Orthopaedics and Spine Center |
Additional Information:
| Responsible Party: | MD Stem Cells |
| ClinicalTrials.gov Identifier: | NCT03225625 History of Changes |
| Other Study ID Numbers: |
SciExVR |
| First Posted: | July 21, 2017 Key Record Dates |
| Last Update Posted: | November 28, 2018 |
| Last Verified: | November 2018 |
| 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 | |
Keywords provided by MD Stem Cells:
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spinal cord injury spinal cord compression spinal cord ischemia spinal cord diseases |
spinal paralysis paraplegia paraparesis |
Additional relevant MeSH terms:
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Wounds and Injuries Ischemia Spinal Cord Injuries Paralysis Paraplegia Spinal Cord Compression Spinal Cord Diseases Paraparesis Spinal Cord Ischemia Pathologic Processes |
Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System Neurologic Manifestations Signs and Symptoms Paresis Spinal Cord Vascular Diseases Vascular Diseases Cardiovascular Diseases |