An interventional study of Intravenous and Intranasal BMSC in Neurologic Disorders, Nervous System Diseases and Neurodegenerative Diseases, sponsored by MD Stem Cells. Recruiting at 3 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by MD Stem Cells · Not applicable, Interventional, and Treatment
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/
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.
757 studies on the registry are indexed under Nervous System Diseases; 218 are open to participants now.
This study's planned enrollment of 500 is above the median of 55 across 495 interventional studies indexed under Nervous System Diseases.
Browse Nervous System Diseases studies →MD Stem Cells is the lead sponsor of 6 studies on the registry; 5 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention- Autologous bone marrow aspiration and separation of Bone Marrow Derived Stem Cell (BMSC) fraction then provided intravenously and intranasally (lower 1/3 of nasal passages).
Procedure: Intravenous and Intranasal BMSC
Autologous Bone Marrow Derived Stem Cells provided intravenous and intranasal (lower 1/3 of nose)
Also known as: IV and IN BMSC
Change in Neurologic Function
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.
Time frame: 0,1,3,6 and 12 months
Plan to share: No
Started Jun 2016 (actual). Primary completion is estimated for Jul 2027, 133 months after the start.
Of 193 interventional studies with no phase under Nervous System Diseases, half reached primary completion within 30 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 57. This study's planned 133 months is above that.
Nervous System Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.
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