Neurologic Stem Cell Treatment Study

Stroke Clinical Trial

— NEST  

Official title:

Neurologic Bone Marrow Derived Stem Cell Treatment Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02795052
• Other study ID #: MDSC-NEST
• Status: Recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: July 31, 2026

Study information

• Verified date: April 2024
• Source: MD Stem Cells
• Contact: Steven Levy, MD
• Phone: 203-423-9494
• Email: stevenlevy[@]mdstemcells.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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/

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.

The NEST Study provides a treatment Arm 1 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 31, 2026
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• ALS
• Alzheimer Disease
• Amyotrophic Lateral Sclerosis
• Aphasia, Primary Progressive
• Brain Diseases
• Brain Injuries
• Brain Injuries, Traumatic
• Brain Ischemia
• CADASIL
• Cerebral Hemorrhage
• Cerebral Infarction
• Cerebral Ischemia
• Cerebral Stroke
• Chronic Traumatic Encephalopathy
• Cognitive Dysfunction
• Cognitive Impairment
• Dementia
• Diabetic Neuropathies
• Frontotemporal Dementia
• Hemorrhage
• Ischemia
• Lewy Body Disease
• Lewy Body Variant of Alzheimer Disease
• Motor Neuron Disease
• MSA - Multiple System Atrophy
• Multi-System Degeneration
• Multiple System Atrophy
• Nervous System Diseases
• Neurodegenerative Diseases
• Neurologic Disorders
• Neurological Disorders
• Neuropathy
• Parkinson
• Peripheral Nervous System Diseases
• Pick Disease of the Brain
• Progressive Supranuclear Palsy
• Sclerosis
• Shy-Drager Syndrome
• Stroke
• Supranuclear Palsy, Progressive
• Traumatic Brain Injury

Intervention

Procedure:
• Intravenous and Intranasal BMSC
Autologous Bone Marrow Derived Stem Cells provided intravenous and intranasal (lower 1/3 of nose)

Locations

Country	Name	City	State
United Arab Emirates	Medcare Orthopaedics & Spine Hospital	Dubai
United States	MD Stem Cells	Coral Springs	Florida
United States	MD Stem Cells	Westport	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
MD Stem Cells

Countries where clinical trial is conducted

United States,  United Arab Emirates, 

References & Publications (10)

Anbari F, Khalili MA, Bahrami AR, Khoradmehr A, Sadeghian F, Fesahat F, Nabi A. Intravenous transplantation of bone marrow mesenchymal stem cells promotes neural regeneration after traumatic brain injury. Neural Regen Res. 2014 May 1;9(9):919-23. doi: 10.4103/1673-5374.133133. — View Citation

Bhasin A, Srivastava M, Bhatia R, Mohanty S, Kumaran S, Bose S. Autologous intravenous mononuclear stem cell therapy in chronic ischemic stroke. J Stem Cells Regen Med. 2012 Nov 26;8(3):181-9. doi: 10.46582/jsrm.0803011. eCollection 2012. — View Citation

Cella D, Lai JS, Nowinski CJ, Victorson D, Peterman A, Miller D, Bethoux F, Heinemann A, Rubin S, Cavazos JE, Reder AT, Sufit R, Simuni T, Holmes GL, Siderowf A, Wojna V, Bode R, McKinney N, Podrabsky T, Wortman K, Choi S, Gershon R, Rothrock N, Moy C. Neuro-QOL: brief measures of health-related quality of life for clinical research in neurology. Neurology. 2012 Jun 5;78(23):1860-7. doi: 10.1212/WNL.0b013e318258f744. Epub 2012 May 9. — View Citation

Cella D, Nowinski C, Peterman A, Victorson D, Miller D, Lai JS, Moy C. The neurology quality-of-life measurement initiative. Arch Phys Med Rehabil. 2011 Oct;92(10 Suppl):S28-36. doi: 10.1016/j.apmr.2011.01.025. — View Citation

Chapman CD, Frey WH 2nd, Craft S, Danielyan L, Hallschmid M, Schioth HB, Benedict C. Intranasal treatment of central nervous system dysfunction in humans. Pharm Res. 2013 Oct;30(10):2475-84. doi: 10.1007/s11095-012-0915-1. Epub 2012 Nov 8. — View Citation

Jiang Y, Zhu J, Xu G, Liu X. Intranasal delivery of stem cells to the brain. Expert Opin Drug Deliv. 2011 May;8(5):623-32. doi: 10.1517/17425247.2011.566267. Epub 2011 Mar 19. — View Citation

Laroni A, de Rosbo NK, Uccelli A. Mesenchymal stem cells for the treatment of neurological diseases: Immunoregulation beyond neuroprotection. Immunol Lett. 2015 Dec;168(2):183-90. doi: 10.1016/j.imlet.2015.08.007. Epub 2015 Aug 18. — View Citation

Lescaudron L, Naveilhan P, Neveu I. The use of stem cells in regenerative medicine for Parkinson's and Huntington's Diseases. Curr Med Chem. 2012;19(35):6018-35. — View Citation

Teixeira FG, Carvalho MM, Sousa N, Salgado AJ. Mesenchymal stem cells secretome: a new paradigm for central nervous system regeneration? Cell Mol Life Sci. 2013 Oct;70(20):3871-82. doi: 10.1007/s00018-013-1290-8. Epub 2013 Mar 1. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Neurologic Function	Neurologic function from prior to treatment (0 month) and the change in neurologic function at 1,3,6 and 12 months post treatment will be compared to pretreatment using the Neuro-QOL (Neurology Quality of Life) questionnaire. The scales of the Neuro-QOL assess the following Outcome Measures: Communication, Social Roles and Activities ,Anxiety , Depression, Emotional and Behavioral Dyscontrol, Lower Extremity Function (Mobility), Positive Affect and Well-Being, Sleep Disturbance, Upper Extremity Function ( Fine Motor, ADL/Activities of Daily Living) , Stigma , Satisfaction with Social roles and Activities, Cognitive Function. The scale for each question ranges from 1 to 5 with 1 being the most impairment and 5 being no impairment; higher numbers are better. The scale can range from 5 indicating no impairment to 45 for significant impairment. Each scale will be recorded and presented as separate Outcome Measurements.	0,1,3,6 and 12 months