Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • CADASIL
  • ALS
  • Parkinson
  • Amyotrophic Lateral Sclerosis
  • Nervous System Diseases
  • Progressive Supranuclear Palsy
  • Neuropathy
  • Cerebral Hemorrhage
  • Cerebral Infarction
  • Traumatic Brain Injury
  • Stroke
  • Cerebral Ischemia
  • Cerebral Stroke
  • Chronic Traumatic Encephalopathy
  • Neurodegenerative Diseases
  • Diabetic Neuropathies
  • Neurologic Disorders
  • Neurological Disorders
  • MSA - Multiple System Atrophy
  • Multi-System Degeneration
Type
Interventional
Phase
Not Applicable
Design
Allocation: Non-RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Various clinical studies have registered with the National Institutes of Health (NIH) to study neurologic diseases and damage. There have also been a number of journal reports of the benefits of treatment with BMSC for diseases and damage to nervous tissue. The investigators hope to add to the volum...

Various clinical studies have registered with the National Institutes of Health (NIH) to study neurologic diseases and damage. There have also been a number of journal reports of the benefits of treatment with BMSC for diseases and damage to nervous tissue. The investigators hope to add to the volume of literature regarding the use of BMSC in those neurologic diseases and conditions identified as likely to respond to this treatment. Intravenous administration of BMSC is a well-established approach to neurologic disease and injury with much support for its effectiveness in the pre-clinical and clinical literature. BMSC and the associated bone marrow fraction are posited to have a number of different mechanisms by which they may potentially improve neurologic function. In regards their ability to penetrate the blood-brain barrier for potential neuronal transdifferentiation and direct impact on the neurons and glial tissue within the brain, it should be remembered that within the diencephalon there are specific circumventricular organs which lie in the wall of the third ventricle. These are noteworthy for a significantly diminished blood-brain barrier and glial limitans which facilitates their function of coordinating homeostatic mechanisms of the endocrine and nervous systems. Therefore the investigators believe entry of BMSC may be facilitated in this area of the brain. In addition to Arm 1 providing intravenous BMSC, the NEST Study provides a treatment Arm 2 which combines intravenous BMSC with topical application of BMSC to the lower 1/3 of the nasal passages as a means of introducing BMSC to the Central Nervous System (CNS). This is applied bilaterally to the inferior nasal conchas and meatuses. The Trigeminal Nerve or 5th Cranial Nerve is a paired, large sensory and motor nerve with multiple branches. It provides sensation to the surface and interior structures of the face including the nasal mucosa that lines the nose. The nerves of the Trigeminal Nerve providing sensation to this area converge and enter the brain at the level of the pons. There is documentation in the scientific literature that intranasal delivery of BMSC allows the BMSC to follow the pathways of the trigeminal nerve, facilitating entry into the parenchyma and cerebral spinal fluid (CSF) for effects on the CNS.

Tracking Information

NCT #
NCT02795052
Collaborators
Not Provided
Investigators
Study Chair: Steven Levy, MD MD Stem Cells Principal Investigator: Jeffrey Weiss, MD Coral Springs