NCT02795052

Neurologic Stem Cell Treatment Study

Neurologic Bone Marrow Derived Stem Cell Treatment Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: MD Stem Cells · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1/3 of the nasal passages in order to determine if such a treatment will provide improvement in neurologic function for patients with certain neurologic conditions. http://mdstemcells.com/nest/

Detailed 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 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. The NEST Study provides a treatment Arm 1 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.

Conditions

• Neurologic Disorders
• Nervous System Diseases
• Neurodegenerative Diseases
• Neurological Disorders
• Stroke
• Traumatic Brain Injury
• Cadasil
• Chronic Traumatic Encephalopathy
• Cerebral Infarction
• Cerebral Ischemia
• Cerebral Stroke
• Cerebral Hemorrhage
• Parkinson
• Multi-System Degeneration
• MSA - Multiple System Atrophy
• Progressive Supranuclear Palsy
• ALS
• Amyotrophic Lateral Sclerosis
• Neuropathy
• Diabetic Neuropathies
• Alzheimer Disease
• Dementia
• Frontotemporal Dementia
• Lewy Body Disease
• Cognitive Impairment
• Lewy Body Variant of Alzheimer Disease

Interventions

Type	Name	Description
PROCEDURE	Intravenous and Intranasal BMSC	Autologous Bone Marrow Derived Stem Cells provided intravenous and intranasal (lower 1/3 of nose)

Timeline

• Start date: 2016-06-01
• Primary completion: 2026-07-31
• Completion: 2027-07-31
• First posted: 2016-06-09
• Last updated: 2025-06-06

Locations

3 sites across 2 countries: United States, United Arab Emirates