NEST: Neurologic Stem Cell Treatment Study

Sponsor
MD Stem Cells (Industry)
Overall Status
Recruiting
CT.gov ID
NCT02795052
Collaborator
(none)
300
Enrollment
3
Locations
2
Arms
96
Duration (Months)
100
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Neurologic Bone Marrow Derived Stem Cell Treatment Study
Study Start Date :
Jun 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

ArmIntervention/Treatment
Active Comparator: Arm 1 - Intravenous BMSC

Intervention- Autologous bone marrow aspiration and separation of Bone Marrow Derived Stem Cell (BMSC) fraction then provided intravenously.

Procedure: Intravenous BMSC
Autologous Bone Marrow Derived Stem Cells provided intravenous.
Other Names:
  • IV BMSC
  • Active Comparator: Arm 2- Intravenous and Intranasal BMSC

    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 BMSC
    Autologous Bone Marrow Derived Stem Cells provided intravenous.
    Other Names:
  • IV BMSC
  • Procedure: Intranasal BMSC
    Autologous Bone Marrow Derived Stem Cells provided intranasal (lower 1/3 of nasal passages).
    Other Names:
  • IN BMSC
  • Outcome Measures

    Primary Outcome Measures

    1. Activities of Daily Living (ADL) [3 to 12 months]

      Activities of Daily Living (ADL) will be assessed at 3,6 and 12 months following the procedure

    Secondary Outcome Measures

    1. Neurologic Functioning [3 to 12 months]

      Deficits of neurologic function identified by the patient as impaired prior to treatment will be assessed. As examples, neurologic functions may include speech, balance, hearing, gait, strength, pain, parasthesias, etc.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1MD Stem CellsWestportConnecticutUnited States06880
    2MD Stem CellsCoral SpringsFloridaUnited States33065
    3Medcare Orthopaedics & Spine HospitalDubaiUnited Arab Emirates

    Sponsors and Collaborators

    • MD Stem Cells

    Investigators

    • Study Chair: Steven Levy, MD, MD Stem Cells
    • Principal Investigator: Jeffrey Weiss, MD, Coral Springs

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    MD Stem Cells
    ClinicalTrials.gov Identifier:
    NCT02795052
    Other Study ID Numbers:
    • MDSC-NEST
    First Posted:
    Jun 9, 2016
    Last Update Posted:
    Apr 6, 2022
    Last Verified:
    Apr 1, 2022

    Study Results

    No Results Posted as of Apr 6, 2022