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

(SciExVR Trial)

Recruiting at 1 trial location

Overseen By Steven Levy, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MD Stem Cells

Disqualifiers: Unstable health, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 1 day

40 Participants Needed

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{2 11 12 13 14}

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

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.

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.

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

Group I: Paraspinal VR Experimental Treatment 2 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 EX Experimental Treatment 2 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: Paraspinal Experimental Treatment 1 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.

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

1. United States pubmed.ncbi.nlm.nih.gov

A Phase III Clinical Trial Showing Limited Efficacy of Autologous Mesenchymal Stem Cell Therapy for Spinal Cord Injury. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Marrow stromal cells form guiding strands in the injured spinal cord and promote recovery. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Electroacupuncture-enhanced differentiation of bone marrow stromal cells into neuronal cells. [2019]

4. China pubmed.ncbi.nlm.nih.gov

[Status and application prospect in repair of spinal cord injury by stem cells]. [2010]

5. United States pubmed.ncbi.nlm.nih.gov

Case control series of intrathecal autologous bone marrow mesenchymal stem cell therapy for chronic spinal cord injury. [2022]

6. France pubmed.ncbi.nlm.nih.gov

Efficacy and safety of neural stem cell therapy for spinal cord injury: A systematic literature review. [2021]

7. Turkey pubmed.ncbi.nlm.nih.gov

Autologous bone marrow derived mononuclear cell therapy for spinal cord injury: A phase I/II clinical safety and primary efficacy data. [2012]

8. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Human Embryonic Stem Cell-Derived Oligodendrocyte Progenitor Cells: Preclinical Efficacy and Safety in Cervical Spinal Cord Injury. [2020]

10. England pubmed.ncbi.nlm.nih.gov

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]

11. England pubmed.ncbi.nlm.nih.gov

Using primate neural stem cells cultured in self-assembling peptide nanofiber scaffolds to repair injured spinal cords in rats. [2018]

12. United States pubmed.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 States pubmed.ncbi.nlm.nih.gov

Functional recovery following traumatic spinal cord injury mediated by a unique polymer scaffold seeded with neural stem cells. [2018]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Integration of donor mesenchymal stem cell-derived neuron-like cells into host neural network after rat spinal cord transection. [2022]