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Neurologic Stem Cell Treatment Study (NEST)

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ClinicalTrials.gov Identifier: NCT02795052
Recruitment Status : Recruiting
First Posted : June 9, 2016
Last Update Posted : August 28, 2019
Sponsor:
Information provided by (Responsible Party):
MD Stem Cells

Tracking Information
First Submitted Date  ICMJE June 6, 2016
First Posted Date  ICMJE June 9, 2016
Last Update Posted Date August 28, 2019
Study Start Date  ICMJE June 2016
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2016)
Activities of Daily Living (ADL) [ Time Frame: 3 to 12 months ]
Activities of Daily Living (ADL) will be assessed at 3,6 and 12 months following the procedure
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02795052 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2016)
Neurologic Functioning [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neurologic Stem Cell Treatment Study
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Neurologic Disorders
  • Nervous System Diseases
  • Neurodegenerative Diseases
  • Neurological Disorders
  • Stroke
  • Traumatic Brain Injury
  • Cadasil
  • Chronic Traumatic Encephalopathy
  • Cerebral Infarction
  • Cerebral Ischemia
  • Cerebral Stroke
  • Cerebral Hemorrhage
  • Parkinson
  • Multi-System Degeneration
  • MSA - Multiple System Atrophy
  • Progressive Supranuclear Palsy
  • ALS
  • Amyotrophic Lateral Sclerosis
  • Neuropathy
  • Diabetic Neuropathies
Intervention  ICMJE
  • Procedure: Intravenous BMSC
    Autologous Bone Marrow Derived Stem Cells provided intravenous.
    Other Name: IV BMSC
  • Procedure: Intranasal BMSC
    Autologous Bone Marrow Derived Stem Cells provided intranasal (lower 1/3 of nasal passages).
    Other Name: IN BMSC
Study Arms  ICMJE
  • Active Comparator: Arm 1 - Intravenous BMSC
    Intervention- Autologous bone marrow aspiration and separation of Bone Marrow Derived Stem Cell (BMSC) fraction then provided intravenously.
    Intervention: Procedure: Intravenous 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).
    Interventions:
    • Procedure: Intravenous BMSC
    • Procedure: Intranasal BMSC
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 8, 2016)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2021
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Steven Levy, MD 203-423-9494 stevenlevy@mdstemcells.com
Contact: Steven Levy, MD 954-417-3355 stevenlevy@mdstemcells.com
Listed Location Countries  ICMJE United States
Removed Location Countries United Arab Emirates
 
Administrative Information
NCT Number  ICMJE NCT02795052
Other Study ID Numbers  ICMJE MDSC-NEST
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party MD Stem Cells
Study Sponsor  ICMJE MD Stem Cells
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Steven Levy, MD MD Stem Cells
Principal Investigator: Jeffrey Weiss, MD The Healing Institute
PRS Account MD Stem Cells
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP