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A regenerative approach to consider alongside your existing ALS care team, evaluated personally by Dr. Mehta and Kate Sherman, PA-C in Franklin, TN.
5,000
New ALS cases diagnosed each year in the U.S.
31,000
People living with ALS in the U.S. at any given time
2–5 Years
Typical survival range from disease onset
What Is ALS
What Causes ALS?
Amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig’s disease, is a progressive and fatal neurodegenerative disease affecting nerve cells in the brain and spinal cord. This condition destroys motor neurons, which are responsible for controlling voluntary muscle movements.
There are roughly 5,000 new cases of ALS diagnosed yearly in the United States, with a prevalence of approximately 31,000 cases at any time. On average, an ALS patient lives 2 to 5 years from disease onset, although the course can vary significantly between individuals.
The exact cause of ALS is not always known. However, some factors in combination seem to play a role:
● Mutations in specific genes, leading to defects in superoxide dismutase 1 (an antioxidant enzyme), known in about 5 to 10% of patients who have familial ALS
● Exposure to toxins
● Enduring intense physical trauma
● Autoimmunity, or the patient’s immune system attacking proteins on motor neurons
Risk factors include age (most cases of ALS are diagnosed between 40 and 70), gender (men have a higher chance of developing ALS), family history, and military service.
Symptoms
ALS Symptoms
Symptoms can vary from person to person depending on the severity of the disease. However, some common signs include:
- Muscle weakness starting in the hands or feet that can spread to other parts of the body
- Muscle twitching in the arm, shoulder, tongue, or leg muscles
- Difficulty speaking, breathing, or swallowing, which progressively worsens over time
- Muscle cramps and stiffness
- Excessive drooling and saliva production
Progression
Stages of ALS
Universally accepted stages do not exist for ALS in the same way they do for some other conditions. However, ALS can be classified into several different levels of severity based on symptoms, complications, and functionality in daily living.
01
Early Stage
Muscle weakness or stiffness in one area and subtle speech abnormalities. The patient is independent in mobility and daily activities.
02
Early-Middle Stage
More noticeable weakness in affected muscles and muscle atrophy begins. The patient can still walk and perform daily activities independently, though some tasks may be difficult unassisted.
03
Middle Stage
Progressive muscle weakness, difficulty standing and walking, and difficulty with activities involving the hands. The patient may need a walker or other assistance for mobility but still maintains some independence.
04
Late-Middle Stage
Severe weakness and wasting in legs and dependence on a wheelchair for mobility. The patient needs help with most activities of daily living but can still eat, speak, and use the bathroom independently.
05
Late Stage
Significant loss of function in legs and arms and difficulty maintaining an upright posture. The patient is wheelchair-bound or bedridden and dependent on caregivers for most activities, while still maintaining the ability to communicate and eat.
06
End Stage
Severe difficulty breathing and swallowing. Complete loss of mobility, dependence on caregivers for all care, and requirement of assistance with breathing.
ALS is a diagnosis of exclusion. That means it is typically diagnosed only after ruling out other similar conditions. Diagnosing ALS involves a combination of clinical symptoms, medical history, physical examination, and imaging studies. Each person’s experience with ALS can differ widely, so not everyone will go through all stages or face all potential complications. Early intervention can slow the damage and improve outcomes.
The Science
The Rationale Behind Stem Cell Therapy for ALS
The nerve damage and muscle loss from ALS are lifelong complications with no cure. The standard-of-care treatments may slow down disease progression and manage symptoms but do not reverse the damage done to affected nerves and muscles. Many drugs for ALS also have unpleasant side effects that tend to lower the quality of life. Some patients may not respond well to the available medications or may not be eligible for certain options due to other health conditions.
Stem cells are immature, undifferentiated cells that can grow into various other cell types. In stem cell therapy, these cells are placed in the area of need where they may support repair, modulate inflammation, and contribute to tissue balance.
Stem Cells
Where the Stem Cells Come From
There are two types of stem cells: allogenic and autologous.
Bone marrow and adipose (fat) tissues are the common sites for stem cell harvesting. Adult mesenchymal stem cells are commonly used because they can develop into many important cell types.
Adult Stem Cell Types Used for ALS
Blood Stem Cells (HSCs)
Found in blood and bone marrow, these can turn into all types of blood cells.
Mesenchymal Stem Cells (MSCs)
Found in the blood, bone marrow, and fat tissues, these adult cells can turn into connective tissues, blood vessels, and lymphatic tissues. MSCs may also differentiate into the nerve cell support tissues damaged in ALS.
Mechanisms
How Stem Cell Therapy May Help with ALS
Research has identified the following contributing dysfunctions in the nervous system in ALS: abnormal RNA metabolism and protein function, abnormal transport of materials inside cells, impaired DNA repair, mitochondrial dysfunction and oxidative stress, impaired transport of neurotransmitters, inflammation, abnormal functions of insulating cells that help speed up nerve signals (oligodendrocytes), and oxidative stress.
Stem cell therapy is studied for its potential to address several of these dysfunctions through multiple mechanisms:
Modulating Inflammation
Excess inflammation in ALS can perpetuate existing damage and delay the healing process. Mesenchymal stem cells may help by decreasing pro-inflammatory markers like IL-6, IL-23, and TNF-a; increasing anti-inflammatory markers IL-10 and TGF-B; increasing the activity of M2 macrophages (anti-inflammatory immune cells); and reducing the recruitment of neutrophils (inflammatory immune cells).
Secreting Neuronal Self-Repair Signals
These signals may stimulate damaged neurons and support self-repair processes.
Promoting Blood Vessel Formation
Angiogenesis and vascular repair may allow for improved blood flow to undamaged neural and muscle tissue.
Donating Mitochondria
ALS reduces mitochondrial numbers and energy production, causing ineffective energy production and nerve cell deaths. MSCs may donate healthy mitochondria to nerves, allowing them to produce energy, reduce oxidative damage, and support survival. For most neurodegenerative diseases, supporting mitochondrial health is associated with improved outcomes.
How It Works
How Stem Cell Therapy for ALS Works at Vita Nova
Once harvested, the stem cell suspension may be administered intravenously or through the spine. The route of administration depends on the type of stem cells used and the stage and severity of the disease.
Step 1: Consultation
Dr. Mehta and Kate Sherman review your diagnosis, current symptoms, ALSFRS-R score where available, medications, and the rest of your care team. Not every ALS patient is a candidate for regenerative therapy. The team says that clearly in the first conversation, before any financial commitment.
Step 2: Cell Harvest (If Using Autologous)
Stem cells are collected from your bone marrow or adipose tissue in a minimally invasive, in-office procedure.
Step 3: Processing (If Using Autologous)
Your cells are processed under direct clinical supervision before administration.
Step 4: Cell Count & Quality Verification
Your cells are tested for count and viability before your procedure begins. This internal quality control step ensures that what is being administered meets the clinical standard your care plan requires.
Step 5: Administration
Dr. Mehta administers the stem cell preparation using the route appropriate for your case, which may include intravenous infusion or injection into the spine.
Step 6: Follow-Up & Coordination
Kate Sherman and the clinical team monitor your progress, communicate with your neurology and pulmonology teams, and adjust the plan based on response. For ALS patients, this coordination is built into how Vita Nova works.
Research
What the Research Shows
2003
First clinical trial using adult stem cells in ALS patients began
36
ALS participants received their own adult stem cells in a 2019 randomized trial
13 of 20
Patients showed at least a 25% reduction in disease progression (ALSFRS-R)
The first clinical trial using adult stem cells in ALS patients started in 2003. Researchers have since explored the potential of stem cells to slow disease progression.
In a 2019 randomized clinical trial, 12 ALS participants received a placebo, while 36 ALS participants received their own adult stem cells either through their spine or muscles. The stem cells were pre-stimulated with a nerve growth stimulant before injection. In 21 rapidly progressing ALS patients who received the stem cells, the rate of disease progression was significantly lowered within six months after the procedure. The patients also had higher markers of nerve growth and lower inflammation than the placebo group.
In another randomized clinical trial, 20 patients with ALS received four injections of their own adult stem cells over six months. Over this time, 13 out of 20 patients experienced at least a 25% reduction in disease progression, measured using the Amyotrophic Lateral Sclerosis Functional Rating Scale Revised (ALSFRS-R) score. Seven patients in the study showed clinical improvement on the ALSFRS-R measures used. Improvement rates were dependent on how frequently injections were given, pointing to the need for repeated stem cell administration to address ALS disease progression.
A review of eight clinical trials demonstrated that stem cell therapy using the ALS patient’s own adult stem cells is safe and well-tolerated, with no serious side effects reported. Reported outcomes in some trials included reduced inflammation markers and other secondary measures.
There is growing interest in this area of research and the potential for stem cells to play a role in the care of ALS. However, individuals with ALS should consult with their physician and carefully consider the potential risks and benefits of stem cell therapy before any decision.
Candidacy
Which Stage of ALS Is Stem Cell Therapy Appropriate For?
Currently, there are no official guidelines on determining the right candidate for stem cell therapy as research continues to evolve. However, similar to current recommended interventions, considering regenerative options as soon as possible after an ALS diagnosis is generally associated with better preservation of nerve tissue.
Earlier consideration may help:
- Preserve nerve tissue
- Reduce the risk of permanent motor function loss
- Address breathing and swallowing difficulty earlier
- Enhance quality of life
At Vita Nova, we determine candidacy on a case-by-case basis. Dr. Mehta and Kate Sherman review your case alongside your neurologist’s notes during consultation. If a regenerative care plan is not appropriate for your case, they will say so directly.
How Many Sessions Will I Need?
Typically, 1 to 2 administrations, depending on the plan of care. All procedure appointments are in person, but the initial consultation and follow-up can be done by phone. Some patients return for additional sessions over the course of months or years depending on disease stage, response, and care goals.
Standard Care
Current Standard-of-Care Treatments for ALS and Their Shortfalls
Managing ALS usually involves a multifaceted approach that can include lifestyle changes, medication, and symptomatic management.
Medications That Address Underlying Mechanisms
Riluzole reduces the signaling of glutamate, an excitatory neurotransmitter that can lead to nerve damage if stimulated for too long (excitotoxicity). Side effects can include dizziness, stomach upset, liver toxicity, and lung function impairment.
Edaravone acts as a free radical scavenger to reduce oxidative stress and damage to nerves. Side effects include bruising, headache, eczema, and skin inflammation (dermatitis).
Symptomatic Medications
- Baclofen, a muscle relaxant that reduces spasticity and improves muscle tone, may cause drowsiness, weakness, or nausea
- Tizanidine, a skeletal muscle relaxant, has addiction potential and may cause drowsiness, weakness, or flu-like symptoms
- Pain medications (acetaminophen, NSAIDs) for muscle spasms and weakness, with side effects including stomach upset, dizziness, or liver damage with long-term use
- Anti-sialorrhea agents like atropine, which block the effect of acetylcholine on salivary glands
Physical and Occupational Therapy
Physical therapy improves muscle strength, coordination, balance, posture, range of motion, and mobility. Assistive devices including orthotics, braces, walkers, wheelchairs, and communication devices help with mobility, communication, and balance. Occupational therapy helps with activities of daily living and provides adaptations to home or work environments. Speech therapy provides interventions to improve communication.
Other Therapies
- Nutritional therapy, including smoothies or a more liquid diet to offset swallowing difficulties while maintaining caloric intake
- Respiratory care, including use of ventilators in severe cases where diaphragm movement is affected
None of these techniques cure ALS, but they help manage the current state of the disease. While the current standard of care provides benefits for many patients, it has limitations and falls short in certain cases. This is the context that brings patients to a regenerative medicine consultation.
Our Team
Why Vita Nova?
Vita Nova was founded on a specific belief: that the body’s own biology, when properly supported, is the most reliable starting point. Dr. Hemal V. Mehta, MD, founded the practice. Kate Sherman, PA-C, co-founded it and serves as Clinical Director.
Dr. Hemal V. Mehta, MD — Founder
Dr. Mehta is a board-certified Physical Medicine and Rehabilitation physician with fellowship training in interventional spine and pain medicine, and 25 years of clinical experience. He is a member of the American Academy of Physical Medicine & Rehabilitation, American Society of Interventional Pain Physicians, and American Association of Neuromuscular and Electrodiagnostic Medicine.
Kate Sherman, PA-C — Co-Founder & Clinical Director
Kate Sherman brings over 20 years of clinical experience and an extensive background in patient communication and day-to-day clinical leadership. Every ALS patient who comes to Vita Nova is evaluated by Dr. Mehta and Kate Sherman together. There are no assembly-line consultations. There are no standardized protocols applied without review of your specific diagnosis and disease trajectory.
We are committed to honesty in all patient interactions. We will not oversell our services or make promises we cannot keep. If we do not believe regenerative therapy is right for your situation, we will tell you directly.
FAQs
Common Questions About Stem Cell Therapy for ALS
Is stem cell therapy FDA-approved for ALS?
Is this therapy covered by insurance?
Does stem cell therapy involve embryos or fetuses?
How long does it take to see benefits?
What are the potential side effects?
Can I stop taking my ALS medications after stem cell therapy?
How do I know if I am eligible?
Are you ready to get moving again?
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