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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 Multiple Sclerosis (MS). Spoiler alert: It can help a lot! In this guide, we’ll go through the basics of how stem cells and exosomes work for MS, the latest research, and what to expect with a regenerative procedure.
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Multiple sclerosis (MS) is an immune-mediated inflammatory disease in which the immune system progressively destroys its own myelinated axons in the central nervous system, in episodes lasting from a few months to many years in duration.
It is induced by the attack of autoreactive lymphocytes on the myelin sheath and endogenous remyelination failure, eventually leading to the accumulation of neurological disability. As a consequence, neuronal impulses are not adequately transmitted and patients develop neurological symptoms. It is one of the main causes of disability in young adults and its incidence is increasing. It is classified as an autoimmune disease.
MS is characterized by demyelination, progressive neurological dysfunction, and remission and relapse. The eventual demyelination and axonal degeneration can cause serious and debilitating motor, sensory, balance and cognitive problems, disability, serious complications, and negatively impact quality of life.
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MS affects approximately 2.5 million people worldwide and is thought to be the most commonly acquired neurological disease of young adults. Women are typically affected twice as frequently as men, and most patients are diagnosed between 20 and 40 years of age.
Multiple sclerosis is more common in Europe and the US, with a prevalence rate of 100 to 200 per 100,000 individuals. Asia is a low-incidence area.
Multiple sclerosis cannot be completely cured. As the disease develops, dysfunction is gradually progressive, resulting in disability. The main principle of treatment is immunosuppression and immunomodulation, but these still cannot prevent recurrence. The proportion of patients with disease progression and the incidence of long-term disability do not reduce. Therefore, effective treatment methods with few side effects are urgently needed.
Although an interplay of genetic and environmental factors are likely to be contributory, the precise cause of MS remains unresolved. Its pathological hallmarks include multi-focal inflammation, primary demyelination (where axons pathologically lose their investing myelin sheaths), acute and chronic axonal damage and astrogliosis.
In MS, a dysregulated immune response, possibly triggered by environmental factors such as a microbial trigger, occurs in genetically susceptible individuals. In this scenario, autoimmunity prone T cells are activated in the periphery by a pathogen, possibly due to an inefficient control by regulatory systems, such as regulatory T cells, and, as a consequence, upregulate adhesion molecules necessary to cross the brain endothelium.
Upon migration into the CNS, autoreactive T cells are further activated by local antigen-presenting cells (APCs), such as microglia, and initiate a complex attack against myelin antigens through the recruitment of several other immune cells, including B cells, overall leading to myelin disintegration and impairment of nerve conduction.
An uncontrolled autoimmune response is likely to sustain recruitment of other pathogenic cells from the periphery leading, at later stages, to the compartmentalization of the pathogenic attack inside the CNS. Chronic aggression against the myelin sheath will eventually lead to axonal sufferance and subsequent loss of neurons and oligodendrocytes, the biological basis of irreversible disability. The ideal treatment for MS should therefore target the autoimmune attack and support tissue repair or at least tissue protection. Indeed, tissue repair without the arrest of the cause of tissue damage would be ineffective.
The majority of patients experience two disease phases; relapsing-remitting (RR) followed by a secondary progressive (SP) course. The former is pathologically characterised by inflammatory activity while SPMS is dominated by neurodegeneration and variable remyelination. Major recent advances in antiinflammatory disease modifying treatments (DMTs) have transformed the outlook of newly diagnosed RRMS patients.
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Currently, there is no cure for MS. During the past decades, therapies for MS are either immunomodulatory or immunosuppressive. Immunomodulatory and anti-inflammatory agents are effective in the relapsing–remitting stage by reducing the frequency of relapses, and decreasing the formation of inflammatory lesions, but they do not influence the course of progressive MS and therefore are not sufficient enough to cure chronic neurological disability.
The permanent neuronal loss that starts early and characterizes the progressive stage of MS remains untreatable. Therapeutic options such as Mitoxantrone for PPMS patients are limited to symptomatic treatments and the long-term prognosis is generally poor. Future therapeutic strategies are aimed to achieve neuroprotection, remyelination and regeneration of new oligodendrocytes and neurons.
Treatments available include steroids for temporary flare-ups, disease-modifying drugs, and drugs targeting specific symptoms. While these may reduce the frequency of exacerbations and slow disease progression, none have myelin or nerve regenerative capability to restore the cumulative damage already in place.
Currently, there isn’t an effective therapeutic conventional treatment model for MS disease. Current medications are costly and are focused on lessening the symptoms and chronic inflammation but not curing the disease or repairing the damaged myelin. Furthermore, the symptoms were recurrent or became aggravated after drug withdrawal.
Adding to this is the unfortunate reality that medicines with immunomodulatory and immunosuppressant properties provide partial efficacy to ameliorate autoimmune reactions. This is the reason why disease progression can lead to approximately 50% of affected patients developing chronic progressive disease with a poor prognosis. Recent evidence has suggested that an appropriate treatment should be centered on the modulation or suppression of aggressive immune response, protection of neurons and axons against degenerative processes, as well as improvement of repair or remyelination.
Although immunomodulatory therapies are proving to be increasingly effective in controlling the initial relapsing-remitting phase of MS, the secondary progressive phase, in which there is continual atrophy of demyelinated axons, remains largely untreatable. Indeed, axon degeneration occurs despite immunomodulatory therapies, suggesting that axon integrity and protection may occur through mechanisms independent of inflammation.
Several lines of evidence suggest that the basis of axon atrophy in chronically demyelinated lesions is due, in part, to the absence of myelin-associated trophic signals that are critical for maintaining axon integrity. None of the available traditional medications act on axon integrity, protection or remyelination.
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There are 2 principal components in treating MS: 1) the prevention of damage, usually involving an immunomodulatory approach; and 2) the repair of damage, involving the regeneration of new myelin sheaths (remyelination).
Protection of neurons and their axons, the loss of which is the principal anatomical correlate of progressive clinical deterioration, might be considered a third component. Indeed, the overarching goal of all MS therapy is to identify strategies to prevent axonal loss. Axon protection can be achieved directly as a result of intervention in the mechanisms by which axons are injured or degenerate. However, axon protection can also be achieved as a consequence of immunomodulatory therapies and by the promotion of remyelination. The human central nervous system does possess some capacity for variable degrees of remyelination, which can even be extensive in some cases.
Although remyelination results in thinner and shorter myelin sheath “internodes” than would be expected for a given diameter of axon, its potential as a reparative strategy is clearly demonstrated by experimental association with resolution of function deficits in animal models. Unfortunately, however, remyelination ultimately fails to keep pace with disease progression and neurological deficit accumulates. Understanding why endogenous remyelination appears to fail in some patients and is variable across different lesions in the same individual is critical to guiding therapeutic strategy.
Indeed in MS post-mortem tissue, axon preservation is seen in remyelinated lesions; again reinforcing the concept of a supportive role for myelin in axon protection. Such studies raise the hypothesis that there are oligodendroglia-derived factors that protect axons; indeed insulin like growth factor 1 (IgF1) and glial derived neurotrophic
factor (GDNF) have been shown to be produced by oligodendrocytes in cell culture where they do exert axon-protective effects.
Despite classic dogma from early neuroanatomists, the adult mammalian CNS does indeed contain populations of resident, proliferating and multipotent neural stem cells. These adult stem cells are diffusely distributed throughout the neuraxis in the form of oligodendrocyte precursor cells (OPCs). The OPC may well have the potential to behave as a neural stem cell in the context of injury, representing a new approach to brain repair. An increasing body of evidence suggests that remyelinating oligodendrocytes arise from adult OPCs.
This means there are neural stem cells and OPCs throughout the Central Nervous System, ready to be “activated” and create new myelin on demand. One of the main beneficial functions seen with mesenchymal stem cells being applied into the central nervous system is exactly this activation!
The properties of MSCs that have been shown to be of potential therapeutic value for MS are as follows:
Stem cells can also be isolated from non-neural tissues (e.g., mesenchymal stem cells isolated from umbilical cord tissue). Although these cell populations do not reliably generate functional neural derivatives, their therapeutic potential arises from their biological properties through either the direct constitutive actions of the cells in question, such as immunomodulatory, or through their use as a vehicle following ex-vivo manipulation to secrete growth factors as mentioned above.
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Currently, R3 Stem Cell centers offer umbilical cord mesenchymal stem cell therapy along with a couple centers offering autologous adipose derived stem cell treatment. Amongst the research studies described below, it is important to understand the term EDSS. The Expanded Disability Status Scale (EDSS) is a method of quantifying disability in multiple sclerosis and monitoring changes in the level of disability over time. It is widely used in clinical trials and in the assessment of people with MS.
The EDSS scale ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability. Scoring is based on an examination by a neurologist.
In a 2009 Panama study of 20 patients with MS (relapsing-remitting, primary or secondary progressive), patients received intravenous infusions of umbilical cord mesenchymal stem cells.
Enrolled subjects received 140 million umbilical cord mesenchymal stem cells (UCMSC) intravenously over the course of seven visits (20 million stem cells each) separated by 1–4 days. In our case, the statistically significant (p < 0.03) change in EDSS mean scores from baseline to 1 month reflects a change in disability category, which could translate into an improved ability to walk and work a full day with minimal, if any, assistance. The intravenous infusion of UCMSC over several days is safe in subjects with MS.
Additionally, UCMSC infusions may hold benefits, since this small study group saw improvement in bladder, bowel, and sexual dysfunction, walking, upper extremity physical function, energy and fatigue, general perspective of a positive health change and improved quality of life, and MRI lesions. Most subjects (83.3%) showed no disease progression or new lesions in their MRIs.
In 2022, a case report was published of an MS patient treated for 11 years, with multiple infusions of MSCs derived from either his bone marrow (BM), pooled human umbilical cords (UC), or from his own child umbilical cord. The mesenchymal stem cell (MSC) treatment was well tolerated with no significant side effects.
A 27-year-old male started treatment in 2008, who was diagnosed as relapsing remitting MS From 2008 to January 2010, he received 3 intravenously as well as 3 intrathecal infusion of BM-MSCs. As the patient stabilized, UC-MSCs were subsequently used for the transplantation. From August 2009 to December 2018, he received a total of 12 intravenous infusions of UC-MSCs, in the absence of any other disease-modifying therapy (DMT).
They looked at the long term effect of multiple MSCs infusions in an MS patients to a period of some 11 years. It is noteworthy that following the MSC treatment, the patient with a progressive MS, showed a significant improvement in his EDSS score over time and this was in the absence of any disease-modifying therapy (eg, glucocorticoid pulse). The treatment which consisted of 16 MSCs infusions, administrated over more than a decade period, was overall well tolerated and led to an apparent clinical and radiological disease recovery. Indeed, the MRI examinations performed from 2008 until 2018, confirmed the absence of subclinical disease activity, a finding in agreement with other MSCs transplantation studies in MS.
Of particular note is the continuous improvement we witnessed over the 10 years of treatment both clinically and pathologically. The table below details his EDSS score improvements.
A 2018 study published out of China evaluated two patients with multiple sclerosis, who received several mesenchymal stem cell infusions over a two year period.
Intravenous transfusions were performed with 1 to 2 million stem cells/kg at 3-month intervals for 7 times.
Patients in the treatment group received seven times of UCMSCs treatments. During that period of time, they didn’t undergo other drug treatments. The patients in the control group (2 additional patients) continued those medications they had already been taking, including methylprednisolone, glucocorticoid hormones, interferon, human immunoglobulin,
neurotrophic factor, and traditional Chinese medicines. However, their conditions were still progressively aggravated.
In this study, UCMSC transplantation was used to treat two patients with multiple sclerosis for a total of seven times of treatments. No obvious adverse reactions or residual pathological syndromes appeared during transplantation. The physiological examination and MRI results revealed normal indexes. Toxic reactions of the UCMSCs were not detected during the 8-year follow-up. Clinical signs and symptoms were mitigated in the two patients after transplantation.
The onset frequency was compared within the same time after transplantation, and the average annual onset frequency in the transplant patients were remarkably less than before transplantation. The EDSS scores demonstrated that the clinical symptoms were mitigated in Patient 1. At the time of this writing, his symptom was stable and not progressive.
After the first and second transplantations, the symptoms of Patient 2 were progressive. Therefore, we shortened the time interval and administered cell therapy. His condition was stable at the time of this writing. The MRI findings showed that the number of foci was obviously reduced after transplantation, suggesting that UCMSC transplantation promoted remyelination.
The researchers wrote, “In summary, UCMSCs play an important role in immune regulation and neural protection. UCMSCs can regulate pathological immune responses and antibody attacks in the body. The neuroprotective effect is strongly associated with the mechanism of promoting remyelination. Our findings confirm that UCMSCs have functions of immune regulation and nerve protection, indicating the feasibility of UCMSC transplantation for multiple sclerosis.
A newly published study (2024) titled “Human Umbilical Cord–Derived Mesenchymal Stem Cells in the Treatment of Multiple Sclerosis Patients: Phase I/ II Dose-Finding Clinical Study” looked at umbilical cord mesenchymal stem cell therapy in two different dosings.
Patients were divided into two groups: Group A comprised 20 MS patients who received two doses, each with a total of 150 million UC-MSCs divided into two injections, 50 million administered through the IV route, and 100 million administered through the intrathecal (IT) route. A month later, another similar dose was administered. At 3 months, 8 to 10 ml of UC-MSCs Conditioned Media was delivered IT.
On the other hand, Group B comprised 15 MS patients who received one dose of 150 million UC-MSCs divided into 50 million administered through the IV route and 100 million administered through IT route. At 3 months, 8 to 10 ml UC-MSCs Conditioned Media was delivered IT. Prior to each IT treatment, the same volume injected was withdrawn as CSF to maintain the CNS pressure and decrease the potential post-IT injection headache.
So Group A received TWO treatments (a month apart) and Group B received just one. Both received conditioned media IT at 3 months.
Although the intravenous (IV) administration of stem cells is the most common, a combined route of UC-MSCs injection could be an important efficacy element, as tracking studies have shown that MSCs injected intrathecally (IT) migrate to the site of injury in the white matter of the brain. The migration of allogenic MSCs injected IT was found to be through the cerebrospinal fluid (CSF), reaching different locations of the CNS where they would persist without the need for immune suppressants.
The results indicated that both stem cell treatment protocols halted the overall progressive deterioration in the EDSS during the 12-month follow-up period. An improvement at all time points for both groups, except for the 3 months for Group A, was observed. The walking and balance results are in line with the EDSS outcomes in Group B, while a gradual deterioration was noted in Group A.
In summary, this study demonstrated the safety and efficacy of both treatment protocols with comprehensive assessment tools, using an allogenic stem cell source originating from a single umbilical cord donor and expanded in vitro. The various aspects studied point to halting and reversing MS symptoms using stem cell therapy with parallel effects on the cellular and gene expression levels.
There is an advantage of administering two doses compared to one, which warrants more extensive studies on larger numbers of MS patients. Examining the addition of more doses and a more extended followup period is recommended for future studies.
The findings of this study emphasize the critical role of regenerative medicine in managing MS. Optimizing the dose of treatment is an essential milestone for the standardization of protocols to attain a safe cellular treatment of MS symptoms. The many aspects studied detected a reversal of some MS symptoms and stabilization of others. The clear advantage of administering two doses of UC-MSCs instead of one in this study, in addition to one dose of CM, is encouraging.
Of the several types of MSCs, UCMSCs are the best option for MS treatment for several reasons. These cells can do a faster self renewal than other MSCs, can differentiate into three germ layers, and can accumulate in damaged tissue or inflamed areas. They also have their own advantages that makes them the choice of MS therapy. First, the separation of the cells from the UC is easy, painless, and without ethical issues. Second, the amount of stem cells produced per unit area is high. Third, the cost of stem cell transfusion from the UC is not expensive.
Fourth, these cells are very safe to use. Based on the studies presented in the section about UCMSCs, these cells would be considered as a safe and alternative option for treatment of the neurological parameters of MS, through results confirmed by EDSS, the ninehole peg test, the expanded EDSS rating neurologic impairment, and the 25-foot walking time.
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If a new technology such as mesenchymal stem cell and exosome therapy could provide excellent MS benefits with improved quality of life and lower overall healthcare costs for an individual, it would and should become a preemptive therapy. Stopping disease progression and receiving potentially some regression of the disease are highly desirable, with the adage being, “Health is Wealth”.
MSC-based therapy reduces inflammation, modulates the immune system and involves improving local microenvironmental, immunoregulation and anti-inflammatory biological activities through the secretion of exosomes, growth factors, cytokines, anti-inflammatory factors and other bioactive molecules.
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.
They act through:
Stem Cells can also release a huge variety of molecules into the extracellular environment. These molecules, which include extracellular vesicles (exosomes), lipids, free nucleic acids, and soluble proteins, exert crucial roles in repairing damaged tissue. Along with offering stem cells for MS, R3 Stem Cell includes stem cell exosomes, which are a type of extracellular vesicle participating in extensive cell to cell communication for tissue repair and regeneration.
The stem cells administered by R3 are not the ones that become a patient’s new specialty cells. The administered mesenchymal stem cells are not specifically designed to replace damaged and lost cells “themselves”, but rather coordinate and enhance this repair response by one’s own mechanisms.
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Where do the stem cells and exosomes come from?
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 the screening test then the umbilical cord is immediately sent to the lab.
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 in 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 stan¬dards consistent with the American Association of Tissue Banks, cGMP standards, FDA regulations and the highest level of any regulatory agency globally.
Stem Cell Derived Exosomes
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 that 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. Considering they are 100 times smaller than stem cells, they do not have any issues passing through the blood-brain barrier to reach the brain from the bloodstream
So what are the benefits seen with stem cell therapy for MS?
While it’s great to know that the stem cells and exosomes work hard on neuroprotection, reduce neuro-inflammation, promote remyelination and prevent scar tissue, what benefits do patients notice?
Disclaimer: Results will vary and are not guaranteed.
As mentioned in the above research studies, stem cell therapy for MS is typically very successful. However, it is not a cure, and repeat therapies are beneficial for continuing the improvements and preventing disease progression.
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Is stem cell therapy safe?
After a decade of performing over 24,000 stem cell procedures worldwide, R3 knows that the regenerative procedures are safe. The quality control employed during the 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, headache, 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?” Once again the answer is NO. The mesenchymal stem cells and exosomes used during treatment have never been shown to have tumor-forming potential. In fact, they have been shown to be anti-tumor forming.
Treatment Protocol
For the past decade, R3 has been successfully offering stem cell and exosome therapy for multiple sclerosis. We use a combination approach, with the biologics being offered both intravenous along with intrathecal for optimal outcome.
R3’s providers use between one million stem cells per kilogram up to three million stem cells per kilogram. Why such a variable amount? The reason is MS patients are different! Some are in earlier phases than others, patient body weights are different and some patients have comorbidities that need to be addressed.
Others have multiple chronic diseases, drink alcohol, smoke cigarettes, etc. We’re not here to judge, just want to make sure enough cells are provided to obtain the desired effects. So our providers use judgment on the cell quantity needed.
Safety is paramount with the biologics products being rigorously tested prior to use, and expert providers managing each treatment as if you were a family member!
Why does R3 Stem Cell use donor tissue for its stem cells?
lthough autologous (your own) stem cells provide significant advantages, allogeneic (donor) stem cells have more advantages. First of all, autologous MSCs need a long time to culture and expand, which limits its application in treatment, while allogeneic stem cells can be obtained and expanded more quickly, thus avoiding the delay of time window.
Second, age is a factor that affects the physiological characteristics of MSCs. Studies have shown that stem cells from elderly donors have decreased proliferation and differentiation ability. This means they are less in number and less effective!
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What are the Outcomes?
Similar to the research mentioned above, R3 Stem Cell’s outcomes for MS patients have been exceptional! The patient satisfaction rate is 85% year over year. Patients typically see exceptional pain relief, increased range of motion, improved function and mobility, and all of the benefits mentioned above.
It may take four to six weeks for the results to kick in, although we have had patients symptomatically feel much better within the first couple of weeks. It should be noted, again, that stem cell therapy is not a “one and done” procedure, and may need to be repeated every one to two years.
Affordability
Because stem cell therapy is not a “one and done” cure, it’s important to make it affordable. Repeat therapies every year can help people achieve continued improvements. So a lot of patients seek additional MS treatments at R3 Stem Cell repetitively.
Unfortunately, stem cell clinics in Colombia, China and Panama charge over $25,000 USD for MS treatment. Because the one treatment costs so much, how are individuals supposed to budget for that every few years?? R3 Stem Cell’s fees are less than half that for full treatment, which also includes free PRP and a multivitamin infusion!
R3’s Experience
For the past decade, R3 Stem Cell’s Centers globally have performed over 24,000 regenerative procedures in six countries. Hundreds have been for MS. 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!
Our experience with all types of patients has been extensive, and our Success Stories on R3’s YouTube Channel are impressive. You can visit the channel Success Story Playlist HERE.
R3 Stem Cell offers free consultations for individuals to discuss whether regenerative therapy is indicated for you. Simply call (844) GET-STEM to schedule yours!
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 24,000 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: About 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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