Brief Title
Neurologic Stem Cell Treatment Study
Official Title
Neurologic Bone Marrow Derived Stem Cell Treatment Study
Brief 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.
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.
Study Type
Interventional
Primary Outcome
Activities of Daily Living (ADL)
Secondary Outcome
Neurologic Functioning
Condition
Neurologic Disorders
Intervention
Intravenous BMSC
Study Arms / Comparison Groups
Arm 1 - Intravenous BMSC
Description: Intervention- Autologous bone marrow aspiration and separation of Bone Marrow Derived Stem Cell (BMSC) fraction then provided intravenously.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
300
Start Date
June 2016
Completion Date
June 2023
Primary Completion Date
June 2022
Eligibility Criteria
Inclusion Criteria:
1. Have documented functional damage to the central or peripheral nervous system unlikely
to improve with present standard of care.
2. Be at least 6 months post-onset of the disease.
3. 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.
4. 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.
5. Be over the age of 18 and capable of providing informed consent.
6. 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:
1. 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.
2. 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.
3. Patients must be capable of providing informed consent.
4. 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. .
5. Patients who are not medically stable or who may be at significant risk to their
health undergoing the procedure will not be eligible.
6. Women of childbearing age must not be pregnant at the time of treatment and should
refrain from becoming pregnant for 3 months post treatment.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Steven Levy, MD, 203-423-9494, [email protected]
Location Countries
United Arab Emirates
Location Countries
United Arab Emirates
Administrative Informations
NCT ID
NCT02795052
Organization ID
MDSC-NEST
Responsible Party
Sponsor
Study Sponsor
MD Stem Cells
Study Sponsor
Steven Levy, MD, Study Chair, MD Stem Cells
Verification Date
September 2021