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Search / Trial NCT03225625

Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study

Launched by MD STEM CELLS · Jul 18, 2017

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

Spinal Cord Injury Spinal Cord Compression Spinal Cord Ischemia Spinal Cord Diseases Spinal Paralysis Paraplegia Paraparesis Sci

ClinConnect Summary

The Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality (SciExVR) study is based on the progress that researchers have made treating spinal cord injury (SCI) with bone marrow derived stem cells (BMSC). While major improvements have remained elusive with other approaches, modest benefits have been achieved.

The use of subarachnoid BMSC provided via intrathecal injection has resulted in improvements for certain sensory and bladder functions. Exoskeleton treatment has shown certain benefits in sensory, bowel and bladder function.

Intravenous (IV) BMSC have benefited stroke and other...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Have documented functional damage to the spinal cord unlikely to improve with present standard of care.
  • If under current medical therapy (pharmacologic or surgical treatment) for the condition be considered stable on that treatment and unlikely to have reversal of the associated spinal cord damage as a result of the ongoing pharmacologic or surgical treatment.
  • In the estimation of Dr. Weiss and Dr. Silberfarb have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.
  • Be over the age of 18 and capable of providing informed consent.
  • Be medically stable and able to be medically cleared by their primary care physician or a licensed primary care practitioner for the procedure. Medical clearance means that in the estimation of the primary care practitioner, the patient can reasonably be expected to undergo the procedure without significant medical risk to health.
  • Exclusion Criteria:
  • All patients must be capable of an adequate neurologic examination and evaluation to document the pathology. This will include the ability to cooperate with the exam.
  • Patients must be capable and willing to undergo follow up neurologic exams as outlined in the protocol.
  • Patients must be capable of providing informed consent.
  • In the estimation of Dr. Weiss and Dr. Silberfarb the BMSC collection and treatment will not present a significant risk of harm to the patient's general health or to their neurologic function. .
  • Patients who are not medically stable or who may be at significant risk to their health undergoing the procedure will not be eligible.
  • Women of childbearing age must not be pregnant at the time of treatment and should refrain from becoming pregnant for 3 months post treatment.

About Md Stem Cells

MD Stem Cells is a leading clinical trial sponsor dedicated to advancing regenerative medicine through innovative stem cell therapies. Committed to rigorous scientific research and ethical practices, the organization focuses on developing groundbreaking treatments for various conditions, leveraging its expertise in cellular biology and patient-centered care. By collaborating with healthcare professionals and institutions, MD Stem Cells aims to translate cutting-edge research into effective clinical applications, ultimately improving patient outcomes and quality of life. Their commitment to safety, efficacy, and transparency underscores their role as a trusted partner in the evolving landscape of medical science.

Locations

Coral Springs, Florida, United States

Patients applied

0 patients applied

Trial Officials

Steven Levy, MD

Study Chair

MD Stem Cells

Jeffrey Weiss, MD

Principal Investigator

Coral Springs

Steven Silberfarb, DO

Principal Investigator

Florida Orthopaedics and Spine Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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