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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 : October 29, 2019
Sponsor:
Information provided by (Responsible Party):
MD Stem Cells

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/

Condition or disease Intervention/treatment Phase
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 Procedure: Intravenous BMSC Procedure: Intranasal BMSC Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2021


Arm Intervention/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 Name: 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 Name: IV BMSC

Procedure: Intranasal BMSC
Autologous Bone Marrow Derived Stem Cells provided intranasal (lower 1/3 of nasal passages).
Other Name: IN BMSC




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795052


Contacts
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Contact: Steven Levy, MD 203-423-9494 stevenlevy@mdstemcells.com
Contact: Steven Levy, MD 954-417-3355 stevenlevy@mdstemcells.com

Locations
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United States, Connecticut
MD Stem Cells Recruiting
Westport, Connecticut, United States, 06880
Contact: Steven Levy, MD    203-423-9494    stevenlevy@mdstemcells.com   
Contact    954-417-3355      
United States, Florida
MD Stem Cells Recruiting
Coral Springs, Florida, United States, 33065
Contact: Steven Levy, MD    203-423-9494    stevenlevy@mdstemcells.com   
Contact    954-417-5533      
Sub-Investigator: Steven Levy, MD         
Principal Investigator: Jeffrey Weiss, MD         
Sponsors and Collaborators
MD Stem Cells
Investigators
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Study Director: Steven Levy, MD MD Stem Cells
Principal Investigator: Jeffrey Weiss, MD Coral Springs

Study Data/Documents: Clinical Study Report  This link exits the ClinicalTrials.gov site
http://mdstemcells.com/nest/

Publications:
Weiss JN, Levy S. Neurologic Stem Cell Treatment Study (NEST) using bone marrow derived stem cells for the treatment of neurological disorders and injuries: study protocol for a nonrandomized efficacy trial. Clin Trials Degener Dis. 2016 [cited 2019 Jun 18];1:176-80.

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Responsible Party: MD Stem Cells
ClinicalTrials.gov Identifier: NCT02795052     History of Changes
Other Study ID Numbers: MDSC-NEST
First Posted: June 9, 2016    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by MD Stem Cells:
Neurologic Disease
Cerebral Vascular Accident
Stroke
Traumatic Brain Injury
Multiple Sclerosis
Parkinsons Disease
Neuropathy
Neurodegeneration
Diabetic Neuropathy
Cerebral Ischemia
Additional relevant MeSH terms:
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Amyotrophic Lateral Sclerosis
Multiple System Atrophy
Sclerosis
Pathologic Processes
Stroke
Brain Injuries
Peripheral Nervous System Diseases
Brain Injuries, Traumatic
Motor Neuron Disease
Brain Diseases
Diabetic Neuropathies
Cerebral Infarction
Neurodegenerative Diseases
Shy-Drager Syndrome
Supranuclear Palsy, Progressive
Brain Ischemia
Cerebral Hemorrhage
CADASIL
Chronic Traumatic Encephalopathy
Disease
Hemorrhage
Ischemia
Nervous System Diseases
Cerebrovascular Disorders
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Basal Ganglia Diseases
Movement Disorders
Craniocerebral Trauma