Neurologic Stem Cell Treatment Study | Clinical Trial

Key information

Conditions

Neurologic Disorders ALS Alzheimer Disease Amyotrophic Lateral Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Autonomic Nervous System Diseases Basal Ganglia Diseases Brain Damage, Chronic Brain Diseases Brain Infarction Brain Injuries Brain Injuries, Traumatic Brain Injury, Chronic Brain Ischemia CADASIL Cardiovascular Diseases Central Nervous System Diseases Cerebral Arterial Diseases Cerebral Hemorrhage Cerebral Infarction Cerebral Ischemia Cerebral Small Vessel Diseases Cerebral Stroke Cerebrovascular Disorders Chronic Disease Chronic Traumatic Encephalopathy Cognition Disorders Cognitive Dysfunction Cognitive Impairment Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cranial Nerve Diseases Craniocerebral Trauma Dementia Dementia, Vascular Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Diabetes Complications Diabetes Mellitus Diabetic Neuropathies Disease Attributes Endocrine System Diseases Eye Diseases Frontotemporal Dementia Frontotemporal Lobar Degeneration Genetic Diseases, Inborn Hemorrhage Hypotension Immune System Diseases Infarction Intracranial Arterial Diseases Intracranial Hemorrhages Ischemia Lewy Body Disease Lewy Body Variant of Alzheimer Disease MSA - Multiple System Atrophy Mental Disorders Metabolic Diseases Motor Neuron Disease Movement Disorders Multi-System Degeneration Multiple Sclerosis Multiple System Atrophy Necrosis Nerve Degeneration Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Neurological Disorders Neuromuscular Diseases Neuropathy Nutritional and Metabolic Diseases Ocular Motility Disorders Ophthalmoplegia Paralysis Parkinson Parkinson Disease Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Primary Dysautonomias Progressive Supranuclear Palsy Proteostasis Deficiencies Shy-Drager Syndrome Signs and Symptoms Spinal Cord Diseases Stroke Supranuclear Palsy, Progressive Synucleinopathies TDP-43 Proteinopathies Tauopathies Trauma, Nervous System Traumatic Brain Injury Vascular Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Saudi-German Hospital, Dubai, United Arab Emirates

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Have documented functional damage to the central or peripheral nervous system unlikely to improve with present standard of care.
Be at least 6 months post-onset of the disease.
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 neurologic functional damage as a result of the ongoing pharmacologic or surgical treatment.
In the estimation of Dr. Weiss and the neurologists 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 with the sub-investigators or their own neurologists as outlined in the protocol.
Patients must be capable of providing informed consent.
In the estimation of Dr. Weiss 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.

Treatment and study plan

Intravenous and Intranasal BMSC

Procedure

Autologous Bone Marrow Derived Stem Cells provided intravenous and intranasal (lower 1/3 of nose)

Other names: IV and IN BMSC

Primary outcomes

Change in Neurologic Function

Time frame: 0,1,3,6 and 12 months

Neurologic function from prior to treatment (0 month) and the change in neurologic function at 1,3,6 and 12 months post treatment will be compared to pretreatment using the Neuro-QOL (Neurology Quality of Life) questionnaire. The scales of the Neuro-QOL assess the following Outcome Measures: Communication, Social Roles and Activities ,Anxiety , Depression, Emotional and Behavioral Dyscontrol, Lower Extremity Function (Mobility), Positive Affect and Well-Being, Sleep Disturbance, Upper Extremity Function ( Fine Motor, ADL/Activities of Daily Living) , Stigma , Satisfaction with Social roles and Activities, Cognitive Function. The scale for each question ranges from 1 to 5 with 1 being the most impairment and 5 being no impairment; higher numbers are better. The scale can range from 5 indicating no impairment to 45 for significant impairment. Each scale will be recorded and presented as separate Outcome Measurements.

Study contacts

Contact information is provided by the study sponsor or research team.

Steven Levy, MD

CONTACT

[email protected]

203-423-9494

Sponsors and collaborators

Lead sponsor

MD Stem Cells

Industry

Registry information

Official study title

Neurologic Bone Marrow Derived Stem Cell Treatment Study

Acronym: NEST

Important dates

Study start: 2016
Primary completion: 2027
Study completion: 2028
First posted: Jun 9, 2016
Registry last updated: Jun 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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