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

(SciExVR Trial)

Enrolling by invitation 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether stem cell therapy can help people with spinal cord injuries regain movement or feeling. It involves injecting autologous bone marrow-derived stem cells near the injury and using either an exoskeleton (Paraspinal EX) or virtual reality (Paraspinal VR) to stimulate nerves and muscles. The trial seeks participants with spinal cord injuries that have not improved with current treatments and whose health is stable. Those experiencing difficulty with movement or sensation due to a spinal cord injury may find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could lead to new treatment options for spinal cord injuries.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using a person's own bone marrow stem cells has been tested for safety in people with spinal cord injuries. In these studies, fever and headache were the most common side effects, typically resolving on their own within a day or two. This indicates the treatment is generally well-tolerated. Other research also shows that these stem cells are safe and can aid recovery in spinal cord injury cases. Although there is less direct safety data on the exoskeleton and virtual reality components of the treatment, they are non-invasive and generally considered safe. Overall, the evidence supports the safety of this combined treatment approach for spinal cord injury. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about this trial because it explores a novel combination of stem cell therapy with advanced technologies like exoskeletons and virtual reality for spinal cord injuries. Unlike traditional treatments that mainly focus on managing symptoms or preventing further damage, this approach aims to promote healing and functional recovery by using autologous bone marrow-derived stem cells. These stem cells are injected around the spinal injury and delivered intravenously and intranasally, potentially offering a new avenue for repair by regenerating damaged tissues. Additionally, the integration of exoskeletons or virtual reality could enhance rehabilitation by stimulating the nervous system and improving motor function, offering hope for more comprehensive recovery.

What evidence suggests that this trial's treatments could be effective for spinal cord injury?

Studies have shown that using a person's own bone marrow stem cells can aid those with spinal cord injuries. In earlier research, 80% of patients with urinary problems noticed improvements after receiving this stem cell treatment. Animal studies suggest that these stem cells repair spinal cord damage by protecting tissues and promoting nerve regrowth. In this trial, participants will receive one of the following treatments: the Paraspinal treatment with stem cells alone, the Paraspinal EX treatment combining stem cells with exoskeleton stimulation, or the Paraspinal VR treatment combining stem cells with virtual reality. These combinations might further enhance nerve activity and sensory response. Overall, these stem cell therapies have proven safe and promising for people with spinal cord injuries. ^{1 4 5 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3735529/

A clinical trial report of autologous bone marrow-derived ... Of the ten SCI individuals suffering from urinary dysfunction, 80% (8/10) experienced post-stem cell transplantation improvement in urinary function to varying ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01730183

To Study the Safety and Efficacy of Autologous Bone ... Bone marrow derived stem cells have been shown to promote anatomical and functional recovery in animal models of SCI by promoting tissue sparing, axonal ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S146532490870210X

Treatment of chronic spinal cord injured patients with ... All the data showed that BM-derived autologous stem cell therapy is effective and safe for the treatment of chronic SCI. Introduction. Traumatic spinal cord ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12061012/

Therapeutic efficacy of autologous bone marrow ... This study aims to perform a meta-analysis of clinical evidence for the treatment of SCI with autologous BMSCs to assess their safety and efficacy.

5. mayoclinic.org mayoclinic.org/medical-professionals/neurology-neurosurgery/news/study-finds-stem-cell-therapy-is-safe-and-may-benefit-people-with-spinal-cord-injuries/mac-20567444

Study finds stem cell therapy is safe and may benefit ... Seven of 10 participants in the preliminary trial showed improvement after regenerative medicine therapy.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4445989/

Safety and neurological assessments after autologous ... Safety and neurological assessments after autologous transplantation of bone marrow mesenchymal stem cells in subjects with chronic spinal cord injury. Marcus ...

7. clinicaltrials.gov clinicaltrials.gov/show/NCT01186679

Safety and Efficacy of Autologous Bone Marrow Stem Cells ... In our present study, we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells surgically transplanted directly into the lesion ...