Neurologic Stem Cell Treatment Study (NEST)
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| ClinicalTrials.gov Identifier: NCT02795052 |
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Recruitment Status :
Recruiting
First Posted : June 9, 2016
Last Update Posted : August 28, 2019
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| 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 |
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 (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 |
|---|---|
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Active Comparator: Arm 1 - Intravenous BMSC
Intervention- Autologous bone marrow aspiration and separation of Bone Marrow Derived Stem Cell (BMSC) fraction then provided intravenously.
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Procedure: Intravenous BMSC
Autologous Bone Marrow Derived Stem Cells provided intravenous.
Other Name: IV BMSC |
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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).
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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 |
- 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
- 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 |
Inclusion Criteria:
- Have documented functional damage to the central or peripheral nervous system unlikely to improve with present standard of care.
- Be at least 6 months post-onset of the disease.
- 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.
- 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.
- Be over the age of 18 and capable of providing informed consent.
- 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:
- 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.
- 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.
- Patients must be capable of providing informed consent.
- 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. .
- Patients who are not medically stable or who may be at significant risk to their health undergoing the procedure will not be eligible.
- Women of childbearing age must not be pregnant at the time of treatment and should refrain from becoming pregnant for 3 months post treatment.
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
| Contact: Steven Levy, MD | 203-423-9494 | stevenlevy@mdstemcells.com | |
| Contact: Steven Levy, MD | 954-417-3355 | stevenlevy@mdstemcells.com |
| 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 | |
| Study Director: | Steven Levy, MD | MD Stem Cells | |
| Principal Investigator: | Jeffrey Weiss, MD | The Healing Institute |
Study Data/Documents: Clinical Study Report
Publications:
| 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: | August 28, 2019 |
| Last Verified: | August 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
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Neurologic Disease Cerebral Vascular Accident Stroke Traumatic Brain Injury Multiple Sclerosis |
Parkinsons Disease Neuropathy Neurodegeneration Diabetic Neuropathy Cerebral Ischemia |
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Stroke Brain Injuries Peripheral Nervous System Diseases Brain Injuries, Traumatic Motor Neuron Disease Amyotrophic Lateral Sclerosis Brain Diseases Diabetic Neuropathies Cerebral Infarction Neurodegenerative Diseases Multiple System Atrophy Shy-Drager Syndrome Supranuclear Palsy, Progressive Brain Ischemia Cerebral Hemorrhage |
CADASIL Chronic Traumatic Encephalopathy Disease Sclerosis Hemorrhage Ischemia Nervous System Diseases Pathologic Processes Cerebrovascular Disorders Central Nervous System Diseases Vascular Diseases Cardiovascular Diseases Basal Ganglia Diseases Movement Disorders Craniocerebral Trauma |