40 Participants Needed

Stem Cell Therapy + Exoskeleton/Virtual Reality for Spinal Cord Injury

(SciExVR Trial)

Recruiting at 1 trial location
SL
Overseen BySteven Levy, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: MD Stem Cells
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Some studies suggest that stem cells from bone marrow can help improve movement and daily activities in a few patients with spinal cord injuries. Additionally, animal studies have shown that these cells can help repair the spinal cord and improve walking ability.12345

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

SS

Steven Silberfarb, DO

Principal Investigator

Florida Orthopaedics and Spine Center

SL

Steven Levy, MD

Principal Investigator

MD Stem Cells

JW

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

My spinal cord injury is not expected to get better with current treatments.
My current treatment for spinal cord damage is stable and not expected to reverse the damage.
Doctors think that you can get better with the treatment and that the treatment won't be risky for you.
See 5 more

Exclusion Criteria

I am able to understand and agree to the study's procedures and risks.
I can participate fully in a neurological exam.
I am willing and able to attend follow-up neurological exams as required.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits at 1, 3, 6, and 12 months post-procedure.

12 months
4 visits (in-person)

Extension

Participants may continue to receive exoskeletal stimulation or virtual reality visualization to augment treatment effects.

Ongoing

Treatment Details

Interventions

  • Autologous Bone Marrow Derived Stem Cells
  • Paraspinal EX
  • Paraspinal VR
Trial Overview The study tests bone marrow stem cells injected near the injury site, followed by intravenous and intranasal placement. Participants may also use an exoskeleton or virtual reality to potentially enhance nerve function.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: Paraspinal VRExperimental Treatment2 Interventions
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.
Group II: Paraspinal EXExperimental Treatment2 Interventions
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.
Group III: ParaspinalExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

MD Stem Cells

Lead Sponsor

Trials
6
Recruited
1,500+

Findings from Research

Only 30% of the 40 reviewed clinical trials on acute spinal cord injury provided satisfactory reporting of adverse events, indicating a significant gap in safety information that is crucial for assessing risk and designing future studies.
A staggering 82.5% of trials failed to report laboratory-defined toxicity satisfactorily, highlighting the need for improved standards in safety reporting to ensure comprehensive understanding of treatment risks.
A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations.Aspinall, P., Harrison, L., Scheuren, P., et al.[2023]

References

A Phase III Clinical Trial Showing Limited Efficacy of Autologous Mesenchymal Stem Cell Therapy for Spinal Cord Injury. [2018]
Marrow stromal cells form guiding strands in the injured spinal cord and promote recovery. [2022]
Electroacupuncture-enhanced differentiation of bone marrow stromal cells into neuronal cells. [2019]
[Status and application prospect in repair of spinal cord injury by stem cells]. [2010]
Case control series of intrathecal autologous bone marrow mesenchymal stem cell therapy for chronic spinal cord injury. [2022]
Efficacy and safety of neural stem cell therapy for spinal cord injury: A systematic literature review. [2021]
Autologous bone marrow derived mononuclear cell therapy for spinal cord injury: A phase I/II clinical safety and primary efficacy data. [2012]
A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. [2023]
Human Embryonic Stem Cell-Derived Oligodendrocyte Progenitor Cells: Preclinical Efficacy and Safety in Cervical Spinal Cord Injury. [2020]
A case report: The first show phenomenon in the treatment of spinal cord injury with Regentime procedure using autologous bone marrow-derived stem cells. [2023]
Using primate neural stem cells cultured in self-assembling peptide nanofiber scaffolds to repair injured spinal cords in rats. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Chitosan channels containing spinal cord-derived stem/progenitor cells for repair of subacute spinal cord injury in the rat. [2015]
13.United Statespubmed.ncbi.nlm.nih.gov
Functional recovery following traumatic spinal cord injury mediated by a unique polymer scaffold seeded with neural stem cells. [2018]
Integration of donor mesenchymal stem cell-derived neuron-like cells into host neural network after rat spinal cord transection. [2022]
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