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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
Be over the age of 18 and capable of providing informed consent.
Have documented functional damage to the spinal cord unlikely to improve with present standard of care.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1,3,6,12 months post-procedure
Awards & highlights

SciExVR Trial 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.Check my eligibility
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.See study design
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.

SciExVR Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 18 and can give my consent.
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My spinal cord injury is not expected to get better with current treatments.
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My current treatment for spinal cord damage is stable and not expected to reverse the damage.
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My spinal cord injury is not expected to get better with current treatments.
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Dr. Weiss and Dr. Silberfarb believe BMSC treatment could help me with minimal risk.
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My spinal cord injury is not expected to improve with current treatments.
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I am over 18 and can give my consent.
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My doctor agrees I can safely undergo a medical procedure.

SciExVR Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
American Spinal Injury Association (ASIA) Impairment Scale (AIS)
Secondary outcome measures
Autonomic Nervous System (ANS) Function
General Well-Being

SciExVR 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
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 Location

Who is running the clinical trial?

MD Stem CellsLead Sponsor
4 Previous Clinical Trials
1,400 Total Patients Enrolled
Jeffrey Weiss, MDPrincipal InvestigatorCoral Springs
4 Previous Clinical Trials
1,400 Total Patients Enrolled
Steven Silberfarb, DOPrincipal InvestigatorFlorida Orthopaedics and Spine Center

Media Library

Autologous Bone Marrow Derived Stem Cells (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03225625 — N/A
Spinal Cord Injury Research Study Groups: Paraspinal, Paraspinal EX, Paraspinal VR
Spinal Cord Injury Clinical Trial 2023: Autologous Bone Marrow Derived Stem Cells Highlights & Side Effects. Trial Name: NCT03225625 — N/A
Autologous Bone Marrow Derived Stem Cells (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03225625 — N/A
Spinal Cord Injury Patient Testimony for trial: Trial Name: NCT03225625 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment opportunities available for this experiment?

"The information hosted on clinicaltrials.gov indicates that this particular research is no longer recruiting patients; the trial was posted in July 2017 and last updated August 2022. Nonetheless, there are an additional 1,405 medical studies currently seeking study participants."

Answered by AI

Who else is applying?

What state do they live in?
Ohio
Oklahoma
Florida
How old are they?
18 - 65
What site did they apply to?
Fakeeh University Hospital
MD Stem Cells
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

To find help or relief that have not been available to me since my injury.
PatientReceived no prior treatments
I've been looking for stem cell research trial that I could get into for a while now. I believe this trial could really help me and promote more movement. I think I would be a good fit.
PatientReceived no prior treatments
I have been following this research for sometime now and i have confidence in its effectiveness..i would like to try it and help millions of people suffering from this condition to be able to regain function if it succeeds.
PatientReceived 2+ prior treatments
After reviewing most treatments I feel this is the best option. I have a bullet lodged in my T5 &6 received on 4/9/2023 4 months into my recovery still pretty limber, and would like to get some of my body functions back if possible.
PatientReceived no prior treatments
After my sci I have come a long way, but still lack. I believe with a medical trial I can overcome and be a success in a trail. I am able to do more than what you expect a spinal cord injury survivor could do and I am willing to try new things. I have good movement of my leg, but I don’t have feeling from the knees down or control of my ankles. I can do more activities than most paraplegics.
PatientReceived 2+ prior treatments

What questions have other patients asked about this trial?

Lol.. when can we start? How do the visits take? Would there be an issue since I can do more than most paraplegics?
PatientReceived 2+ prior treatments

How responsive is this trial?

Most responsive sites:
  1. MD Stem Cells: < 24 hours
Typically responds via
Email
Average response time
  • < 1 Day
~1 spots leftby Jul 2024