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Free Download: Stem Cell Therapy for Systemic Sclerosis (Scleroderma)
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.
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Every day, R3 Stem Cell receives inquiries worldwide from individuals asking if stem cell therapy can help with systemic sclerosis. Spoiler alert: It can help a lot! In this guide, we’ll go through the basics of how stem cells and exosomes work for Systemic Sclerosis, the latest research, and what to expect with a regenerative procedure.
Conventional treatments for Systemic Sclerosis are often not able to stop the disease progression and control the topical plaques and joint erosion. For those who desire reduced pain along with improved skin appearance, failure with conventional treatments is disappointing and occurs all too often.
Stem cell therapy for Systemic Sclerosis is turning out to be an excellent opportunity for individuals to achieve meaningful long-term results. Let’s dig in!
Call now to ask about regenerative care for scleroderma — (844) GET-STEM.
Systemic Sclerosis (SSc) is a rare autoimmune disease, which affects most frequently middle age patients with a prevalence ranging from 100 to 300 per million depending on the country. Scleroderma makes your body produce too much collagen, a protein that you need for healthy skin and tissue. It’s an autoimmune condition, which means your immune system attacks your body instead of protecting it.
The disease is characterized by vascular damage and diffuse fibrosis, which mainly affects skin and lung tissues but heart and digestive tract could also be involved. One of the earliest and most frequent symptoms is the Raynaud’s Phenomenon but vasculopathy is also responsible for other clinical signs such as digital ulcers, pulmonary arterial hypertension, and telangiectasia.
All of these symptoms are responsible for increased morbidity and lead to functional disability (reduced mouth opening and loss of hand function, for example), pain, and psychological consequences.
In at least half of the cases, patients will die from SSc-related disorders and the other half from higher incidence of malignancies and cardiovascular diseases compared to the general population.
What are the reasons Systemic Sclerosis occurs?
The cause of Systemic Sclerosis is a complex interplay of genetic and environmental factors, leading to fibroblast activation and endothelial impairment. The role of endogenous and/or exogenous oxidative stress in Systemic Sclerosis is crucial, as shown by the link between environmental exposure to oxidants and professional disease.
The cause of scleroderma is unknown. However, researchers think that the immune system overreacts and causes inflammation and injury to the cells that line blood vessels. This triggers connective tissue cells, especially a cell type called fibroblasts, to make too much collagen and other proteins.
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There is no treatment that can cure or stop the overproduction of collagen that is characteristic of scleroderma. But a variety of treatments can help control symptoms and prevent complications.
To date, treatment of Systemic Sclerosis patients is mostly palliative, based on symptomatic drugs alleviating Raynaud’s phenomenon, gastro-esophageal reflux, pain, and immunosuppressants (methotrexate, mycophenolate mofetil, and cyclophosphamide), or organ transplantation in case of severe cardio-pulmonary involvement. Although new drugs have been developed for the treatment, SSc general prognosis and mortality have not changed in the last 40 years.
Table 1: Summary of clinical trials and preclinical studies of MSC for autoimmune-related fibrotic skin diseases
Considering the immunomodulatory, angiogenic and antifibrotic capabilities of mesenchymal stem cells (MSC), MSC-based therapy could represent a complete breakthrough in this severe life-threatening disease with unmet medical need.
The first patient who received MSCs in the treatment of progressive diffuse SSc has been reported in 2008. A young female patient had a severe disease, refractory to all immunosuppressive drugs. At the time of implantation, she presented with six painful ulcerations and received 60 million intravenous administrations of allogeneic donor MSCs.
No adverse events were reported and 3 months after treatment, a significant decrease in the patient’s painful ulcerations was measured. Vascular improvement in the blood circulation of hands and fingers was noticed. In 2011, the same team reported four supplementary cases of allogeneic BM-MSC systemic injection. Here again, improvement of vasculopathy and skin fibrosis was observed.
It has become increasingly evident that MSCs and MSCEVs are advantageous in treating autoimmune-related fibrotic skin diseases (SSc and ScI-GVHD). These therapies have shown particular promise in three main areas:
Rebalancing immune and inflammatory disorders
Enhancing antioxidant defenses, and
Inhibiting overactivated fibrosis.
The safety of MSC-based therapy in clinics has been proved, and it is considered as a potentially effective option for treating Systemic Sclerosis. The table above summarizes clinical trials that have been performed for systemic Sclerosis. In the Main results column, notice how prominent the beneficial outcomes have been!
Speak with a specialist at R3 Stem Cell: (844) GET-STEM.
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.
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:
Angiogenesis
provokes the formation of new blood vessels.
Reduce inflammation
Systemic Sclerosis is associated with significant inflammation, and the regenerative biologics reduce it nicely.
Immune system modulation
the stem cells and exosomes modulate the immune system very differently than steroids. Instead of blankety suppressing the immune system, the regenerative biologics tamp down the harmful processes while amping up the beneficial ones. This includes ramping up production of several helpful growth factors and cytokines, while tamping down harmful ones.
Cellular signaling
the biologics are able to perform "cell to cell" communication. This promotes recipient cells to proliferate their growth factor production, protein production and regenerate nerve tissues that are damaged.
Prevent cell death
most cells have a timed death, where they are only allowed to live a certain length of time. This is called apoptosis. The regenerative biologics allow normally functioning cells (i.e. neuron cells) to live longer, and spare them from the pre-programmed death.
Preventing scar tissue
Once that scar tissue forms, it becomes nonfunctional. Stem Cells and exosomes are great at preventing scar tissue (anti-fibrosis).
Table 1: Proteins involved in the therapeutic mechanism of MSCs.
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 the treatment of Systemic Sclerosis, R3 Stem Cell includes stem cell exosomes, which are a type of extracellular vesicle participating in extensive cell to cell communication for ovarian tissue repair and regeneration.
The stem cells administered by R3 are not the ones that become part of a patient’s DNA. The administered mesenchymal stem cells are not specifically designed to replace damaged and lost epithelial cells, but rather coordinate immune system modulation.
Speak directly with our clinic today: (844) GET-STEM.
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 exposure 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.
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 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. 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.
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, 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 treating patients with stem cell and exosome therapies with injection, infusion, intranasal, intrathecal and nebulizer procedures.
For Systemic Sclerosis, R3’s providers use between one and two million stem cells per kilogram (depending on patient weight). In addition, billions of stem cell exosomes and platelet-rich plasma therapy (PRP) are included at no cost.
R3 Stem Cells Systemic Sclerosis treatment protocol includes an IV therapy combining mesenchymal stem cells and exosomes, along with a multivitamin IV as well. R3 has developed a proprietary injection protocol for the legs combining the biologics along with platelet rich plasma therapy to increase the effectiveness of the therapy. 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!
Talk to the team at R3 Stem Cell — call (844) GET-STEM.
Why does R3 Stem Cell use donor tissue for its stem cells?
Although 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!
Stem cell therapy for Systemic Sclerosis may be the key step to completely changing a person's quality of life, and we want to make it affordable for as many individuals as possible. Our global volume has allowed us to keep our patient cost as low as possible.
Unfortunately, stem cell clinics in Colombia, China and Panama charge over $20,000 USD for Systemic Sclerosis treatment. How are individuals supposed to budget for that?? R3 Stem Cell's fees are typically less than half that for full treatment, which also includes free exosomes, PRP and a multivitamin infusion!
For the past decade, R3 Stem Cell’s Centers globally have performed over 24,000 regenerative procedures in six countries. Patient satisfaction across all conditions treated is very high, at 85%. R3 has treated hundreds of patients with varying types of peripheral neuropathy, and over a thousand patients with diabetes.
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 your Systemic Sclerosis. 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 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.
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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The information provided by R3 Stem Cell is not a substitute for professional medical advice, diagnosis, or treatment. Individual results may vary and only your medical professional can explain all the risks and potential benefits of any therapy based on your circumstances. R3 Stem Cell does not recommend or endorse any specific tests, products, procedures, opinions, or other information that may be mentioned on this website. Reliance on any information provided by R3 Stem Cell, its employees, others appearing on this website at the invitation of R3 Stem Cell, or other visitors to the website is solely at your own risk. R3 Stem Cell is not responsible for the outcome of your procedure. The FDA considers stem cell therapy experimental at this point.
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