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Stem Cell Therapy

Stem Cell Therapy + Exoskeleton/Virtual Reality for Spinal Cord Injury (SciExVR Trial)

N/A

Waitlist Available

Led By Jeffrey Weiss, MD

Research Sponsored by MD Stem Cells

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have documented functional damage to the spinal cord unlikely to improve with present standard of care.

Have documented functional damage to the spinal cord unlikely to improve with present standard of care

Must not have

Patients must be capable of providing informed consent.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1,3,6,12 months post-procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating whether autologous bone marrow derived stem cells can help improve motor or sensory function in people with spinal cord injury. The treatment involves injections of the cells around the area of the injury, as well as an intravenous injection and intranasal placement. Patients may also be assigned to use exoskeletal movement or virtual reality visualization to help improve function.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include discomfort at injection sites, infection risk from injections, allergic reactions to stem cells, and potential unknown risks associated with stem cell therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My spinal cord injury is not expected to get better with current treatments.

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My spinal cord injury is not expected to improve with current treatments.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am able to understand and agree to the study's procedures and risks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1,3,6,12 months post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1,3,6,12 months post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1,3,6,12 months post-procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

American Spinal Injury Association (ASIA) Impairment Scale (AIS)

Secondary study objectives

Autonomic Nervous System (ANS) Function

General Well-Being

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

0 / 3Eligibility criteria met