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New Option for Multiple Sclerosis treatment

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New Option for Multiple Sclerosis treatment

September 10
18:21 2019

Multiple Sclerosis (MS) remains a difficult and typically progressive disease, despite medications that are now available.  Dr. Steven Levy, CEO of MD Stem Cells and Study Director of the Neurologic Stem Cell Treatment (NEST) study, describes the study and how their research group sees the procedure fitting into the limited treatments available for MS patients.

“NEST offers a specific stem cell procedure that can be called a ‘Middle Option’ for MS patients,” explains Dr. Levy. “It is a ‘softer’ procedure for patients who would like to do more than medication, are interested in newer approaches, but do not want the stresses and potential risks of another approach under study called HSCT or Hematopoietic Stem Cell Transplantation.“

What is NEST?

NEST is the Neurologic Stem Cell Treatment study uses the patient’s own (autologous) bone marrow stem cells (BMSC) given intravenously and intranasally.  The entire procedure is done as an outpatient in a fully licensed surgical center under anesthesia and takes less than an hour.  No hospitalization is required.  Continued use of any MS medication or alternative medicines is permitted.  Dr. Levy was instrumental in developing the NEST study and directs the study.  

Why is NEST a ‘Middle Option’ for MS? 

Patients with MS who are not benefitting from medication, have side effects from medication, or may be concerned about progression may be good candidates for NEST. NEST can offer a stem cell intervention which may potentially benefit their disease but is much simpler and much less difficult for patients to undergo than HSCT (described below). “The goal in any progressive disease is to do what is necessary for the patient to potentially benefit but no more,” opines Dr. Levy. “We see NEST as an approach that splits the choice between medication alone and HSCT.” 

How safe is NEST?

NEST is supervised by an Institutional Review Board- which reports to the National Institutes of Health (NIH) and is periodically assessed by FDA. NEST is registered with the NIH on clinicaltrials.gov.  NEST is a regulated, clinical study reviewed annually. MD Stem Cells has been conducting clinical studies using bone marrow derived stem cells since 2012.  

No adverse events or complications have occurred for patients treated in NEST.  Patients do not receive any preparatory drugs or chemotherapy.  No immune suppression is needed or used.  NEST is a one-day outpatient procedure- there is no hospitalization.  The body’s own stem cells are used so there is no risk of transmissible infection.  There is no special preparation needed; the stem cells are harvested, separated and transferred back to the patient in the same operating room. 

How is NEST thought to potentially help MS?

Preclinical research suggests that Bone Marrow Stem Cells (BMSC) may help neurologic disease in at least 3 ways: 

Exosome / Microvesicle Production:

The BMSC can release proteins and nucleic acids in small packets that can potentially help make neural cells stronger and more resilient  – this is called neuroprotection.  Nerve Growth Factor, Neurotrophic Factors, miRNA can help neural cells work better and survive stress.  BMSC can also transfer parts of themselves to damaged cells.  

Neuronal Transdifferentiation:

BMSC may potentially turn into other cells including neurons.  

Immune Modulation:

BMSC can quiet abnormal immune system attacks while preserving normal functions such as fighting infections. 

BMSC circulate intravenously to get to the peripheral nerves and into the brain and spinal cord.  BMSC can reach the brain through the paraventricular organs where there is no blood-brain barrier.  When placed intranasal, they can follow cranial nerves to the brain.  It is hoped that treatment in NEST will help repair damaged neurons and support cells, help them function better and reduce relapses. 

What causes MS?

In MS the person’s own immune system mistakenly attacks the myelin sheaths that help neurons to transmit information. Myelin is the living outer membrane of helper cells that is tightly wrapped, sometimes hundreds of times, around the part of the neuron that carries the signals.  The ‘helpers’ are one type of glial cells- specialized nerve cells that make up about half the nervous system and help neurons to work.  The patient’s immune system begins to attack the myelin sheaths and creates scars that prevent normal transmission of information by the neurons. The exact reason remains unknown, but the process results in many neurologic problems.  MS has recently been reported to kill neurons directly, particularly the projection neurons in the outer layers of the brain.

Search Cambridge University Stem Cell Institute for details: www.stemcells.cam.ac.uk/news

What are the types of MS?

About 85% of MS patients present with the most common Relapsing-Remitting Multiple Sclerosis (RRMS) with symptoms that come and go.  But over time most will develop Secondary Progressive Multiple Sclerosis (SPMS) with further weakness, balance and walking issues.  Progressive means that the disease gets worse over time. Less commonly patients present with Primary Progressive (PPMS) about 10% of the time or Progressive Relapsing (PRMS) about 5% of the time with worsening being part of the early presentation.  

Can you treat MS with medication?

Patients are usually encouraged by their physicians to have medication treatment early in their disease, because research has found that MS may cause more damage during the initial stages.  Early treatment is thought to lower the relapse rate and reduce new damage.  Several drugs are used in RRMS to reduce relapses- others for SPMS, PPMS or PRMS.  Most are thought to suppress the body’s immune cells to help protect the myelin sheath.  All can have side effects- sometimes mild, sometimes more serious. Unfortunately, none have been shown to slow the advance of disability.   

What is HSCT treatment for MS? 

HSCT or Hematopoietic Stem Cell Transplantation is being studied as an approach that seeks to ‘reset’ the immune system and stop inflammation, typically for aggressive forms.  The procedure starts with collecting the stem cells from the person’s own bone marrow or blood.  Then a powerful mix of chemotherapy drugs is given over multiple days to kill or suppress immune cells in the body. The harvested stem cells are given back intravenously.  Hospitalization can be up to 160 days if there are serious side effects. It can take 3-6 months for the immune system to recover.  Several studies have been done with promising results of reduced relapses, however receiving high dose chemotherapy for multiple days to kill most cells in the immune system is a serious undertaking.  

A good source of information on HSCT is  www.nationalmssociety.org – the National Multiple Sclerosis Society website. 

How do I apply for NEST?

As with any clinical study, results cannot be guaranteed, and it is not possible to predict whether an individual patient will improve from treatment or continue to have progression of their MS disease.  The purpose of the study is to potentially benefit patients as well as to gather data to determine whether statistical significance is present for any improvements.

Patients may receive information about the study by emailing the Study Director, Steven Levy MD,  at [email protected]; using the ‘contact us’ page on the website www.mdstemcells.com; calling 954-417-5533 and leave a voice message with their telephone number; alternative number 203-423-9494 (no messaging). The Neurologic Stem Cell Treatment (NEST) study is enrolling patients with different neurologic diseases including Stroke (CVA), Traumatic Brain Injury (TBI), Multiple Sclerosis, Parkinsons, ALS, PSP, MSA, CADASIL, Peripheral Neuropathy and others.  MD Stem Cells has no grant support for NEST and is not a pharmaceutical company; this is a patient sponsored study and the patients pay for both treatment and travel.

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