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Neurologic Stem Cell Treatment Study (NEST)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by MD Stem Cells
Sponsor:
Collaborator:
The Healing Institute
Information provided by (Responsible Party):
MD Stem Cells
ClinicalTrials.gov Identifier:
NCT02795052
First received: June 6, 2016
Last updated: April 10, 2017
Last verified: April 2017
  Purpose
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.

Condition Intervention
Neurologic Disorders Nervous System Diseases Neurodegenerative Diseases Neurological Disorders Procedure: Intravenous BMSC Procedure: Intranasal BMSC

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Neurologic Bone Marrow Derived Stem Cell Treatment Study

Further study details as provided by MD Stem Cells:

Primary Outcome Measures:
  • 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:
  • 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.


Estimated Enrollment: 300
Study Start Date: June 2016
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: June 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02795052

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

Locations
United States, Florida
The Healing Institute Recruiting
Margate, Florida, United States, 33063
Contact: Steven Levy, MD    203-423-9494    stevenlevy@mdstemcells.com   
Principal Investigator: Jeffrey N Weiss, MD         
United Arab Emirates
Al Zahra Hospital Not yet recruiting
Dubai, United Arab Emirates
Contact: Steven Levy, MD    203-423-9494    stevenlevy@mdstemcells.com   
Sponsors and Collaborators
MD Stem Cells
The Healing Institute
Investigators
Study Director: Steven Levy, MD MD Stem Cells
Principal Investigator: Jeffrey Weiss, MD The Healing Institute
  More Information

Publications:

Responsible Party: MD Stem Cells
ClinicalTrials.gov Identifier: NCT02795052     History of Changes
Other Study ID Numbers: MDSC-NEST
Study First Received: June 6, 2016
Last Updated: April 10, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Disease
Nervous System Diseases
Neurodegenerative Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on September 21, 2017