Neurologic Stem Cell Treatment Study

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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