Neurologic Stem Cell Treatment Study

NCT02795052 | Recruiting DMC

• 1 other identifier: MDSC-NEST
• Study Type: interventional
• Target: 500
• Locations: 2 countries
• Sites: 3

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/

Conditions

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; Alzheimer Disease; Dementia; Frontotemporal Dementia; Lewy Body Disease; Cognitive Impairment; Lewy Body Variant of Alzheimer Disease

Keywords

Neurologic Disease; Cerebral Vascular Accident; Stroke; Traumatic Brain Injury; Multiple Sclerosis; Parkinsons Disease; Neuropathy; Diabetic Neuropathy; Cerebral Ischemia; Cognitive Impairment; Dementia; Neurodegeneration

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Arm 1- Intravenous and Intranasal BMSC

OTHER

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 and Intranasal BMSC

Interventions

Intravenous and Intranasal BMSC PROCEDURE

Autologous Bone Marrow Derived Stem Cells provided intravenous and intranasal (lower 1/3 of nose)

Also known as: IV and IN BMSC

Arm 1- Intravenous and Intranasal BMSC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MD Stem Cells: lead

Study Sites (3)

MD Stem Cells

Westport, Connecticut, 06880, United States

RECRUITING

MD Stem Cells

Coral Springs, Florida, 33065, United States

RECRUITING

The Saudi-German Hospital

Dubai, 337-1500, United Arab Emirates

RECRUITING

Related Publications (10)

• 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.

  PMID: 23135822 BACKGROUND

• 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.

  PMID: 21417782 BACKGROUND

• 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.

  PMID: 24693196 BACKGROUND

• 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.

  PMID: 23456256 BACKGROUND

• 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.

  PMID: 22963567 BACKGROUND

• 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.

  PMID: 26296458 BACKGROUND

• 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.

  PMID: 25206912 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 22573626 BACKGROUND

• 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.

  PMID: 21958920 BACKGROUND

MeSH Terms

Conditions

Nervous System Diseases; Neurodegenerative Diseases; Stroke; Brain Injuries, Traumatic; CADASIL; Chronic Traumatic Encephalopathy; Cerebral Infarction; Brain Ischemia; Cerebral Hemorrhage; Shy-Drager Syndrome; Supranuclear Palsy, Progressive; Amyotrophic Lateral Sclerosis; Diabetic Neuropathies; Alzheimer Disease; Dementia; Frontotemporal Dementia; Lewy Body Disease; Cognitive Dysfunction; Lewy Body Variant of Alzheimer Disease; Multiple Sclerosis; Parkinson Disease; Nerve Degeneration

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Injuries; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Infarction; Cerebral Small Vessel Diseases; Dementia, Vascular; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Brain Injury, Chronic; Brain Damage, Chronic; Chronic Disease; Disease Attributes; Intracranial Hemorrhages; Hemorrhage; Multiple System Atrophy; Primary Dysautonomias; Autonomic Nervous System Diseases; Basal Ganglia Diseases; Movement Disorders; Hypotension; Ophthalmoplegia; Ocular Motility Disorders; Cranial Nerve Diseases; Tauopathies; Paralysis; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Spinal Cord Diseases; Motor Neuron Disease; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Peripheral Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Neurocognitive Disorders; Mental Disorders; Frontotemporal Lobar Degeneration; Parkinsonian Disorders; Synucleinopathies; Cognition Disorders; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Steven Levy, MD

  MD Stem Cells

  STUDY CHAIR

• Jeffrey Weiss, MD

  Coral Springs, Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Levy, MD

CONTACT

203-423-9494; stevenlevy@mdstemcells.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Intravenous and intranasal bone marrow derived stem cells.

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 9, 2016
• Study Start: June 1, 2016
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AE (1); US (2)