Stem Cell Therapy + Exoskeleton/Virtual Reality for Spinal Cord Injury
(SciExVR Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it mentions that if you are on current medical therapy, you should be stable on that treatment.
What data supports the effectiveness of the treatment Stem Cell Therapy + Exoskeleton/Virtual Reality for Spinal Cord Injury?
Is the combination of stem cell therapy and exoskeleton/virtual reality safe for spinal cord injury?
Research on autologous bone marrow-derived stem cells for spinal cord injury shows that it has been tested in humans with a focus on safety, and no major safety concerns were reported. Additionally, preclinical studies on similar stem cell therapies have shown no adverse effects, supporting their safety in humans.678910
How is the treatment of Autologous Bone Marrow Derived Stem Cells with Exoskeleton/Virtual Reality unique for spinal cord injury?
This treatment is unique because it combines the use of a patient's own stem cells with advanced technologies like exoskeletons and virtual reality to potentially enhance recovery. Unlike traditional treatments, this approach aims to repair the spinal cord by integrating stem cells into the injured area and using technology to support and stimulate movement and neural connections.211121314
What is the purpose of this trial?
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/
Research Team
Steven Silberfarb, DO
Principal Investigator
Florida Orthopaedics and Spine Center
Steven Levy, MD
Principal Investigator
MD Stem Cells
Jeffrey Weiss, MD
Principal Investigator
Coral Springs
Eligibility Criteria
Adults over 18 with spinal cord injuries that are stable and unlikely to improve with current treatments can join this trial. They must be medically cleared, able to give consent, and not at significant risk from the procedure. Pregnant women or those planning pregnancy within 3 months post-treatment cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive bilateral paraspinal injections of BMSC at the level of the injury, superior and inferior to that spinal segment, followed by intravenous and intranasal administration. Some participants may also receive exoskeletal movement or virtual reality visualization.
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 1, 3, 6, and 12 months post-procedure.
Extension
Participants may continue to receive exoskeletal stimulation or virtual reality visualization to augment treatment effects.
Treatment Details
Interventions
- Autologous Bone Marrow Derived Stem Cells
- Paraspinal EX
- Paraspinal VR
Find a Clinic Near You
Who Is Running the Clinical Trial?
MD Stem Cells
Lead Sponsor