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Regenerative Medicine for Trigeminal Neuralgia Pain
Free Download: Stem Cell Therapy for Trigeminal Neuralgia Pain
Disclaimer:
The information provided by R3 Stem Cell is for educational purposes and is not a substitute for professional medical advice, diagnosis, or treatment. Individual results may vary and are not guaranteed. The FDA considers stem cell therapy experimental at this point.
Any claims made on this website refer to procedures performed OUTSIDE of the USA. R3 Stem Cell has clinics in Mexico, Philippines, South Africa, Turkey, India, Pakistan.
Every day, R3 Stem Cell receives inquiries worldwide from individuals asking if stem cell therapy can help with Trigeminal Neuralgia. Spoiler alert: It can help a lot! In this guide, we’ll go through the basics of how stem cells and exosomes work, the latest research, and what to expect with a regenerative procedure.
Chronic orofacial pain is prevalent in the United States and impacts approximately 20% of the population. Chronic orofacial pain (CP) is a persistent and debilitating condition that affects the face, mouth, and jaw and can have a significant impact on an individual’s quality of life by posing problems to eat, speak, and perform everyday activities.
Trigeminal neuralgia is one of the types of CP. Others include TMJ, myofascial pain and headaches originating from the face, head or neck. Trigeminal neuralgia (TN), also known as tic douloureux, is sometimes described as the most excruciating pain known to humanity. The pain typically involves the lower face and jaw, although sometimes it affects the area around the nose and above the eye. This intense, stabbing, electric shocklike pain is caused by irritation of the trigeminal nerve, which sends branches to the forehead, cheek and lower jaw. It usually is limited to one side of the face.
Over 150,000 individuals per year are newly diagnosed with TN, with women being twice as likely to have it. Managing chronic orofacial pain may require a comprehensive and multidisciplinary approach to address the underlying mechanisms contributing to its persistence.
Neuropathic pain responds poorly to opioid and over-the-counter analgesics. First-line antineuropathic medication utilizes tricyclic antidepressants and anticonvulsants administered to approximately 40% of people with facial neuropathies. However, pain relief experienced with these treatments is only moderate. On average, a minimum of three peripheral and central chronic pain patients need to be treated before one patient will experience a 50% improvement in pain symptoms.
The current front-line drugs for the treatment of neuropathic pain exhibit minimal efficacy. For example, gabapentin is one of the most favorable drugs on the market. At its maximum dose (3,600 mg), it provides pain relief to less than 60% of patients, with an NNT (numbers needed to treat) value of four.
In addition, approximately 25% of people with facial neuropathies receive no treatment at all. Compliance with antineuropathic medication can be problematic for patients with potential side effects of weight gain, drowsiness, dry mouth, negative mood changes, and increased suicide risk.
There are two types of TN — primary and secondary. The exact cause of TN is still unknown, but the pain associated with it represents an irritation of the nerve. Primary trigeminal neuralgia has been linked to the compression of the nerve, typically in the base of the head where the brain meets the spinal cord. This is usually due to contact between a healthy artery or vein and the trigeminal nerve at the base of the brain. This places pressure on the nerve as it enters the brain and causes the nerve to misfire.
Secondary TN is caused by pressure on the nerve from a tumor, MS, a cyst, facial injury or another medical condition that damages the myelin sheaths. The prevalence of TN due to damage to peripheral branches of the trigeminal nerve after implants, orthognathic surgery, third molar extractions, mid-face ruptures, or root canal surgery reaches approximately 3%-5%.
There is an increased incidence of anxiety, depression, and insomnia in patients affected by TN. When severe, individuals with TN suffer during speaking, chewing, and swallowing, and it’s described as the most excruciating pain known to humanity. The main medication side effects of concern were drowsiness, affecting work performance and social activities, and weight gain, affecting personal esteem.
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The use of mesenchymal stem cells (MSCs) in the treatment of neuropathic pain is a rapidly expanding field due to a few core properties of these cells. MSCs have been reported to exert an anti-inflammatory effect through cytokine release that may combat the increased inflammation involved in neuropathic pain and have been shown to play an important role in nerve healing and regeneration.
This hypothesis has been tested in animal models of trigeminal neuropathic pain, diabetic neuropathy, and hind paw neuropathic pain, all of which showed promising results, with a significant reduction in neuropathic pain symptoms.
The immunosuppressive and immunomodulatory properties of stem cells have been shown to contribute to this pain relief. Additionally, the secretome of stem cells (e.g. exosomes) are also sufficient to produce these effects, suggesting that paracrine (cell to cell) release of cytokines and other factors are necessary.
These observations provide evidence of MSCs producing behavioral pain relief associated with orofacial injury and indicate suppression of trigeminal neuronal hyperexcitability. Stamatoski and Fidoski [2017] investigated PRP administration in a clinical pilot study conducted with Twentynine patients with TN. PRP was applied around the trigeminal region (either through the facial or intraoral route). PRP application was carried out five times, at seven-day intervals, in either male or female patients.
Clinical Pilot Study: PRP for Trigeminal Neuralgia
Patients were assessed before each PRP injection and subjected to the visual analogue scale for pain, which was also applied in the second and sixth follow-up months. The outcomes were extremely positive since the magnitude of pain had significantly decreased over seven examinations and fully disappeared at the third follow-up month.
Australian Study: MSC Therapy for Chronic Trigeminal Neuralgia
A 2014 study out of Australia evaluated the use of mesenchymal stem cells for ten female subjects with a diagnosis of chronic trigeminal neuralgia. Each patient received between 40 million and 160 million MSC’s with local injections around the trigeminal nerve.
Safety of Stem Cell Injections
No subject showed any side effects of the treatment. There was no evidence of unusual localized swellings or lesions at any of the injection sites nor evidence of general or medical health issues at any follow-up stage (to 6 months).
Outcomes
The primary treatment outcome to be measured was change in pain intensity and the secondary outcome measure was any reduction in the daily consumption of anti-neuropathic medication. Subjects were reviewed for safety evaluation for any clinical sign of trigeminal nerve deficit (paresthesia, dysesthesia), facial nerve paresis, infection, and unusual swellings or lesions at the injection sites.
The results showed a reduction in pain intensity scores from the stem cell treatment in 7/9 patients (one patient was lost to follow-up). Five of the most positive responders also reduced their need for gabapentin medication. The majority of subjects, however, reported a positive effect from stem cell therapy with pain reduction in addition to lowering anti-neuropathic medication dose to enable an improved quality of life with fewer drug side effects.
There were no visible deleterious changes at any of the injection sites. In addition, there were no changes to normal nerve physiology of the involved cranial nerves where stem cells were administered; specifically, no numb¬ness, tingling, dysesthesia on the lower lip, chin, lateral border of the tongue or face (trigeminal nerve branches V2 and V3), and no report of motor nerve dysfunction to the face (C7, facial nerve) or jaw (motor branch of the trigeminal nerve). In addition, no infection of the environment was observed where the stem cells were injected.
Challenges of Traditional Neuropathic Pain Treatment
Neuropathic pain is recognized as a difficult and challenging pain state to obtain meaningful and prolonged pain reduction. Prior to the trial, the subjects were undergoing pain management for months to years on appropriate anti-neuropathic medication at therapeutic dose ranges. Despite utilizing proven pharmacotherapy, the mean pain intensity of 7.5 still revealed a major deficiency in treating chronic neuropathic pain to achieve an acceptable quality of life. This trial showed a good response to a single dose of MSCs.
The majority of the subjects in the study were on a slow but escalating dose of medication, with the likelihood of increased medication requirements for the next 30– 40 years of their life, assuming normal life expectancy. The current front-line drugs for the treatment of neuropathic pain exhibit minimal efficacy. For example, gabapentin is one of the most favorable drugs on the market. At its maximum dose (3,600 mg), it provides pain relief to less than 60% of patients, with an NNT (numbers needed to treat) value of four. In our study, the near-significant reduction in gabapentin use and minor reduction in amitriptyline suggested that stem cells may exhibit biological priority in recovering myelinated fibers over unmyelinated fibers.
Colombian Study: PRP for Peripheral Neuropathic Pain
A Colombian study in 2018 evaluated 45 patients with neuropathic pain treated with simply platelet rich plasma therapy. 45 patients with shooting, burning, electric, or lancinating pain and allodynia, with refractory multimodal approach to pharmacologic management for more than 3 months were included in the study.
Causes of the peripheral NP included; 23 patients with post-herpetic neuralgia (PHN) affecting: the brachial plexus (9 patients), the occipital nerve (2 patients) or the intercostal nerve (12 patients); 14 patients with peripheral nerve injury following trauma, and 8 patients with chronic post-surgical pain (CPSP) following abdominal surgery but with clear clinical involvement of the ilioinguinal nerve. So none actually had trigeminal neuralgia in this study.
Prior to inclusion in the PRP study, all patients had been receiving pharmacologic management for more than 3 months, including tricyclic antidepressants, pregabalin or carbamazepine, and opioids (tramadol, hydrocodone, or oxycodone), in a multimodal regimen, with poor pain relief (EVA pain scale > 7) but with burdensome adverse effects associated to the pharmacological regime.
None of the included patients specifically had trigeminal neuralgia. Patients with involvement of peripheral nerves were managed with an ultrasound approach for the nerve injections, and a volume of 10 ml PRP was injected.
Outcomes: Pain and Function Improvement Post-PRP
The treatment improved pain and function in 39 out of the 45 patients after the first therapeutic injection of platelet rich plasma. On VAS scale, pain was reduced by 50 % one month following PRP injection and 70 % at the end of three months, scaling down from 9/10 to 2/10. Half of the patients (20 patients) reported complete resolution of symptoms and were able to discontinue the use of all pain medication, and opioid use was also withdrawn in another 15 patients, in whom pain control was possible with paracetamol and pregabalin alone.
As a consequence of the reduction of pain intensity, patients were able to reduce doses of pain medication, thereby reducing the side effects of the drugs and thus improving their quality of life. In our opinion, the basic and important concept in understanding of the cause of neuropathic pain and the subsequent treatment proposals that may arise is the consideration that all types of central and peripheral neural lesions, whether ischemic, traumatic, infectious, metabolic, malignant, toxic or immune-mediated, are associated to an inflammatory reaction, with increased activity of neutrophils and macrophages that rapidly invade the injured axons and dorsal root ganglion.
Most of the time, such inflammation has neurotrophic and neuroprotective effects but this inflammatory activity can also result in neuronal damage that could contribute to the persistence of neuropathic pain. According to the authors, their evidence-based hypothesis was, alike to lidocaine, that PRP could effectively control neuroinflammation and could contribute to the relief of neuropathic pain, similar to lidocaine or even better, not only by blocking noxious inputs and avoiding the subsequent neural tissue damage but through its anti-inflammatory effect and its important role in nerve healing and regeneration.
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R3 used to perform autologous therapies, where a patient’s own bone marrow or adipose stem cells were used. However, a lot of stem cells in one’s body are as old as that person is, and hence not very active. Their ability to successfully increase sufficient blood flow and allow for tissue regeneration is inferior to umbilical cord stem cells, which are young, potent and extremely active.
Specifically, the therapeutic potential of autologous bone marrow or adipose stem cells in the treatment of older patients is impaired by a number of age related factors such as oxidative stress, telomere length, DNA damage, disease, and long-term use of some medications.
This is in stark contrast to the youthful genotype and phenotype of neonatal tissue-derived stem cells, such as from the umbilical cord. They are better at facilitating repair and regeneration of tissue damage, creating new blood flow with superior anti-inflammatory and immunomodulatory efficacy compared to mature stem cells from one’s adipose or bone marrow.
As a result of the inferiority of autologous stem cells due to the reasons above and better results being seen with umbilical cord stem cells, R3 only uses the donor stem cells today.
Stem cells and exosomes act in the body through several mechanisms. They do NOT become part of a patient’s DNA, which means they do not engraft into the person’s existing cells. The predominant method of action is thought to be through paracrine mechanisms, which means “cell to cell” interaction.
They act through:
Stem Cells can also release a huge variety of molecules into the extracellular environment. These molecules, which include extracellular vesicles, lipids, free nucleic acids, and soluble proteins, exert crucial roles in repairing damaged tissue.
Along with offering MSCs for treatment of Trigeminal Neuralgias, R3 Stem Cell includes stem cell exosomes, which are a type of extracellular vesicle participating in extensive cell to cell communication for new blood flow creation. And according to the research discussed above, platelet rich plasma is very effective for TN as well. So R3 actually includes all three biologics, which are referred to as the TRIFECTA!
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R3 Stem Cell’s regenerative biologics originate from umbilical cord tissue that has been donated after a scheduled c-section. No baby (or mother) is harmed during the c-section procedure. The umbilical cord tissue is normally discarded, but if the mother passes screening tests then the umbilical cord is immediately sent to the lab. The screening tests are extremely rigorous, and mandated by the USA FDA.
The lab carefully processes the umbilical cord to generate large amounts of stem cells and exosomes that are of the highest quality possible. The lab team consists of multiple PhD’s working in ISO Certified, cGMP compliant clean rooms to ensure quality assurance that exceeds USA FDA standards. The proprietary production process combines the highest potency, safety and affordability for providers to confidently offer exosome procedures.
Millions of dollars have been invested into the pharmaceutical-grade production of the biologics including first rate clean rooms, bioreactors, nano-particle tracking analyzers, cytometers, PCR, tangential flow machines and real time environmental monitoring. The quality assurance testing complies with screening and testing standards consistent with the American Association of Tissue Banks, cGMP standards, FDA regulations and the highest level of any regulatory agency globally,
R3 Stem Cell’s Centers of Excellence globally include umbilical cord stem cell derived exosomes with umbilical cord stem cells to provide enhanced results. Exosomes are lipid bound vesicles (acellular) produced by cells which contain a plethora of growth factors, cytokines, mRNA and other proteins.
They are exceptionally helpful in cell to cell communication, and very effective for reducing inflammation when they become ingested by their recipient cell. They act as shuttles to send nucleic acids and proteins to other cells, in this way, allowing cell-to-cell communication and transporting molecules among both close and distant cells. In general, these released proteins are important regulators of intracellular information.
Exosomes could be the mediators of many stem cell-associated therapeutic activities. We have seen them to be “faster acting” than stem cells, so R3 frequently uses them in conjunction to provide a “1-2 punch” for patient outcomes.
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After a decade of performing over 25,000 stem cell procedures worldwide, R3 knows that regenerative procedures are safe. The quality control employed during stem cell production is second to none, and the side effects R3 sees are usually mild to moderate and temporary.
They may include itching, dizziness, lightheadedness, low-grade fever, chills, and nausea. These are typically temporary. If a patient has an allergic reaction to the multivitamin or a preservative, all of R3’s Centers have the medications to resolve it quickly.
One of the questions we get asked a lot is, “Will the stem cells get rejected?” The answer is NO.
MSCs do not express major histocompatibility complex (MHC) antigens of the class II subtype and contain low levels of MHC molecules of the class I subtype. MSCs also lack the co-stimulatory molecules essential for immune detection, including CD40, CD80, and CD86.
Therefore, MSCs generally have low immunogenicity and can avoid immune rejection by the recipient, which serves as the foundation for their successful application without needing to match the donor to the recipient. Scientists call this being “immunologically privileged”.
Another question often asked is “Is there a chance of a tumor forming?” Current research has concluded that the answer is NO. The mesenchymal stem cells and exosomes used during treatment have never been shown to have tumor-forming potentials. In fact, they have been shown to be anti-tumor forming.
For the past decade, R3 has been successfully treating Trigeminal Neuralgia with stem cell and exosome procedures. As mentioned earlier, R3 also includes PRP derived from the patient’s own blood. The three biologics together are referred to as the TRIFECTA! The regenerative biologics are applied directly around the trigeminal nerve and surrounding tissues with direct injections, and also infused through an IV. Depending on each patient’s unique history, R3’s providers may also incorporate an intra-nasal or intrathecal application.
R3’s providers use one to two million stem cells per kilogram, to make sure that patients achieve the absolute best outcome possible. Between 50 and 100 billion exosomes are included with each procedure.
Similar to the research mentioned above, R3 Stem Cell’s outcomes for Trigeminal Neuralgia have been exceptional! The patient satisfaction rate is 85% year over year. Patients typically experience less pain with less severity and a reduced need for medications. Keep in mind results cannot be guaranteed and will vary between individuals.
Because stem cell therapy for Trigeminal Neuralgia is not typically a permanent cure, it’s important to make it affordable. Repeat therapies can help maintenance and/or achieve additional improvements for pain relief. So a lot of patients seek additional treatments at R3 Stem Cell every twelve to eighteen months.
R3 Stem Cell’s fees are less than half what comparable (and reputable) regenerative clinics charge. Be wary of clinics trying to pass off PRP as a stem cell therapy. If they mention only taking your blood for the treatment, it is NOT a stem cell treatment!
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For the past decade, R3 Stem Cell’s Centers globally have performed over 25,000 regenerative procedures in six countries. Patient satisfaction across all conditions treated is 85%!
R3 combines safety, effectiveness and affordability for the therapies. Internationally, the Intellicell is used, which is culturing the most active mesenchymal stem cells to create the “smartest” stem cell in the world!
R3 Stem Cell offers free consultations for individuals to discuss whether regenerative therapy is indicated for their Trigeminal Neuralgia. Simply call +1 (844) GETSTEM or +1 (888) 988-0515 to schedule yours!
Disclaimer: This guide’s education does not constitute medical advice. The USA FDA considers stem cell therapy experimental. Any claims made in this Guide refer to procedures performed outside of the USA.
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References
David Greene, MD, PhD, MBA, Founder/CEO
R3 Stem Cell offers treatments that bring patients hope and options. Hope that surgery can be avoided, and tissue injury can be repaired with patients being able to get back to desired activities.
Founder and CEO David Greene, MD, PhD, MBA writes extensively on regenerative medicine and gives many seminars worldwide on a regular basis. With over forty Centers of Excellence globally, R3 is at the forefront of regenerative therapies.
R3’s Centers have successfully performed over 25,000 regenerative procedures to date. Call today for your free consultation (844) GET-STEM!
No portion of this document may be reproduced without the Express Written Consent of R3 Stem Cell.
Disclaimer: This guide’s education does not constitute medical advice. The USA FDA considers stem cell therapy experimental. Any claims made in the Guide refer to procedures performed outside the USA.
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