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A regenerative approach to manage symptoms of systemic lupus
Free Download: Stem Cell Therapy for Systemic Lupus Erythematosus
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 Lupus Erythematosus (SLE). Spoiler alert: It can help a lot! In this guide, we’ll go through the basics of how stem cells and exosomes work for autoimmune diseases, the latest research, and what to expect with a regenerative procedure.
Conventional treatments for SLE are not able to regenerate and repair joint tissue significantly. They are very limited and mostly “band aids.” For example, steroid injections do not repair joint tissue at all, and actually contribute to more joint degeneration.
Stem cell therapy for SLE is turning out to be an excellent opportunity for individuals to achieve pain relief, improved function and to potentially achieve long lasting remission. Let’s dig in!
Struggling with SLE symptoms? Speak with our team at (844) GET-STEM.
Lupus is a lifelong disease that can cause pain, redness, and swelling in any part of the body. The Lupus Foundation of America estimates that 1.5 million Americans, and at least five million people worldwide, have a form of lupus. Anyone can develop lupus, but 90% of lupus diagnoses are in women aged 15-44 years.
Some people call lupus an “invisible illness” because it is often not recognizable to others. The mechanisms underlying the cause of SLE remain unclear.
Systemic lupus erythematosus (SLE) is a life-threatening autoimmune inflammatory disease involving a variety of autoantibodies, which are produced by overactivated B cells and circulate in peripheral blood or deposit in organs. Deposition of autoantibodies triggers the formation of immune complexes and then leads to tissue inflammation in multiple organs, including blood vessels, joints, kidneys, and skin.
Renal involvement, termed lupus nephritis (LN), occurs in approximately 50–60% of the patients and remains one of the most serious visceral complications in SLE. Men with SLE tend to have more aggressive disease with higher rates of renal and cardiovascular involvements and are more likely to develop kidney failure than women.
The patients with SLE may present with various systemic manifestations. The general symptoms include: fever, malaise, arthralgias, myalgias, headache, and loss of appetite and weight. Nonspecific fatigue, fever, arthralgia, and weight changes are the most common symptoms in new cases or recurrent active SLE flares.
SLE affects the immune system, thus reducing the body’s ability to prevent and fight infection. In addition, many of the drugs used to treat SLE also suppress the function of the immune system, thereby further depressing the ability to fight infection. The most common infections involve the respiratory tract, urinary tract, and skin. Other opportunistic infections, particularly Salmonella, herpes zoster, and Candida infections, are more common in patients with SLE because of altered immune status.
Joint pain is one of the most common reasons for the initial clinical presentation in patients with SLE. Arthralgia, arthritis, osteonecrosis (avascular necrosis of bone), and myopathy are the principal manifestations. Arthritis and arthralgias have been noted in up to 95 percent of patients with SLE.
Cutaneous manifestations of SLE comprise four diagnostic criteria and multiple other clues to a potential diagnosis of lupus. The first is malar rash, which is characterized by an erythematous rash over the cheeks and nasal bridge. It lasts from days to weeks and is occasionally painful or pruritic.
The second feature is photosensitivity, which may be elicited from patients who are asked if they have any unusual rash or symptom exacerbation after sun exposure. The third feature may be discoid rash. Discoid lesions often also develop in sun-exposed areas but are plaque like in character, with follicular plugging and scarring. They may be part of systemic lupus or may represent discoid lupus without organ involvement, which is a separate diagnostic entity.
Alopecia is the fourth and often less-specific cutaneous feature of SLE. It often affects the temporal regions or creates a patch like pattern of hair loss.
The kidney is the most commonly involved visceral organ in SLE. Although only approximately 50% of patients with SLE develop clinically evident renal disease, biopsy studies demonstrate some degree of renal involvement in almost all patients. Renal failure and sepsis are two main causes of death in patients with SLE.
Common manifestations may include arthralgias and arthritis, malar and other skin rashes, pleuritis or pericarditis, renal or CNS involvement, and hematologic cytopenias. Disease severity is wide ranging, SLE can present major challenges because of accrued organ damage, coagulation defects. SLE is characterized by an autoantibody response to nuclear and cytoplasmic antigens. It is potentially fatal depending on organ involvement.
Have lupus-related joint or kidney issues? Talk with R3 today at (844) GET-STEM.
Currently, the classic methods for SLE treatment are corticosteroids and immunosuppressors, which chronically prolong the disease course and mostly exhibit chronic remission relapse, whereas a few patients achieve long-term remission.
Importantly, immunosuppressive therapies fail to prevent disease relapse in more than half of the patients, and high-dose treatment may even increase the risk of severe infection and death. Additionally, most patients exhibit damage to the kidneys or other organs, partly limiting the application of immunosuppressive therapy.
In the past 60 years, belimumab has been the only biological agent approved by the US FDA for SLE treatment; however, this agent utilizes a single target and cannot inhibit plasma cells and switched memory B cells. Also, other biological agents, such as tabalumab, do not significantly improve the disease conditions and even have adverse side effects in patients with SLE.
In the past 60 years, belimumab has been the only biological agent approved by the US FDA for SLE treatment; however, this agent utilizes a single target and cannot inhibit plasma cells and switched memory B cells. Also, other biological agents, such as tabalumab, do not significantly improve the disease conditions and even have adverse side effects in patients with SLE.
Corticosteroids and cyclophosphamide (CTX) and mycophenolate mofetil (MMF) are the most classically and widely administered medications, which have led to a signifi¬cant improvement in survival over the last few decades and decreased the progression to end-stage multi-organ failure.
In addition to conventional immunosuppressive therapies, several new strategies have been developed to target specif¬ic activation pathways relevant to SLE pathogenesis,[1] such as rituximab (B-cell depleting therapy), epratuzumab (B-cell modulating therapy), belimumab (inhibition of B-cell survival), abatacept and toralizumab (inhibition of T-cell function), to-cilizumab (IL-6 inhibition), and sifalimumab and rontalizumab (type I interferon inhibitors). Although these drugs have led to a markedly improved outcome in SLE, disease control remains unsatisfactory in a subset of patients. Moreover, use of these agents often leads to serious adverse effects or re¬lapses after discontinuation.
Aside from the poor efficacy, long-term usage of nonspecific immunosuppressive regimens may increase the risk of serious infection and secondary malignant tumors; besides, because of its high cost, the use of biological agents is also limited.
If a new technology such as mesenchymal stem cell and exosome therapy could improve the quality of life for SLE patients, achieve remission and avoid the secondary complications and risky side effects, it would and should become first line therapy.
Here is a rundown of research outcomes worldwide regarding stem cell therapy for SLE.
Guo et al performed a meta-analysis in 2018 to see if stem cell therapy worked well for SLE. A metaanalysis involves compiling available research studies and combining them for statistical evaluation. Eight studies involving 213 patients were included and three of the studies were randomized controlled trials with 66 patients involved.
The MSC group showed that the SLE disease activity index decreased significantly [standard mean difference (SMD)=-1.76, 95% confidence interval (CI):-2.00 to -1.51, P<0.001), the 24 h urine protein decreased significantly (SMD=-1.74, 95%CI:-2.46 to -1.03, P<0.001), as well as the complement C3 increased significantly (SMD=1.28, 95%CI: 0.93 to 1.62, P<0.001).
The conclusion was the current evidences showed that mesenchymal stem cells could improve the disease activity, proteinuria and hypocomplementemia in SLE patients.
A 2014 study from China by Wang et al looked at forty patients with active SLE were recruited from four clinical centers. Donor umbilical cord mesenchymal stem cells were infused intravenously on days 0 and 7. The primary endpoints were safety profiles.
The secondary endpoints included major clinical response (MCR), partial clinical response (PCR) and relapse. Clinical indices, including the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score and renal functional indices, were also taken into account.
The stem cells were well tolerated, and no transplantation-related adverse events were observed. Thirteen and eleven patients achieved MCR (13 of 40, 32.5%) and PCR (11 of 40, 27.5%), respectively, during 12 months of follow-up. Three and four patients experienced disease relapse at 9 months (12.5%) and 12 months (16.7%) of follow-up, respectively, after a prior clinical response. SLEDAI scores significantly decreased at 3, 6, 9 and 12 months follow-up.
Among those patients with lupus nephritis, 24-hour proteinuria declined after transplantation, with statistically differences at 9 and 12 months. Serum creatinine and urea nitrogen decreased to the lowest level at 6 months, but these values slightly increased at 9 and 12 months in seven relapse cases.
In addition, serum levels of albumin and complement 3 increased after MSCT, peaked at 6 months and then slightly declined by the 9- and 12-month followup examinations. Serum antinuclear antibody and anti-double-stranded DNA antibody decreased after MSCT, with statistically significant differences at 3-month follow-up examinations.
The authors noted in conclusion that umbilical cord mesenchymal stem cell therapy resulted in satisfactory clinical response in SLE patients. However, they had several patients experience disease relapse after 6 months, indicating the potential necessity to repeat mesenchymal stem cell therapy after 6 months.
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In another 2014 study out of China, 81 patients with active and refractory lupus nephritis (LN) were enrolled. Umbilical cord-derived mesenchymal stem cells (MSCs) were administered intravenously at the dose of 1 million cells per kilogram of body weight.
During the 12-month follow-up, 60.5 % (49/81) of the patients achieved renal remission. Eleven of 49 (22.4 %) patients experienced renal flare by the end of 12 months after a previous remission.
Glomerular filtration rate (GFR) improved significantly 12 months after MSCT (mean ± SD, from 58.55 ± 19.16 to 69.51 ± 27.93 mL/min). Total disease activity evaluated by Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) scores also decreased after treatment (mean ± SD, from 13.11 ± 4.20 at baseline to 5.48 ± 2.77 at 12 months).
Additionally, the doses of concomitant prednisone and immunosuppressive drugs were tapered. No transplantation-related adverse event was observed. Allogeneic MSCT resulted in renal remission for active LN patients within 12-month visit, confirming its use as a potential therapy for refractory LN.
In a 2013 study by Wang et al, eighty-seven patients with persistently active SLE who were refractory to standard treatment or had life-threatening visceral involvement were enrolled. Umbilical cord-derived MSCs were infused intravenously (1 × 10(6) cells/kg of body weight).
During the 4-year follow-up and with a mean follow-up period of 27 months, complete clinical remission rate was 28% at 1 year (23/83), 31% at 2 years (12/39), 42% at 3 years (5/12), and 50% at 4 years (3/6). Rates of relapse were 12% (10/83) at 1 year, 18% (7/39) at 2 years, 17% (2/12) at 3 years, and 17% (1/6) at 4 years.
The overall rate of relapse was 23% (20/87). Disease activity declined as revealed by significant changes in the SLEDAI score, levels of serum autoantibodies, albumin, and complements. No transplantation-related adverse event was observed. Allogeneic MSCT resulted in the induction of clinical remission and improvement in organ dysfunction in drug-resistant SLE patients.
In the diagram below, you can see how mesenchymal stem cells modulate the immune system cells to effectively work against SLE to improve a patient’s energy, vitality, sleep patterns, relieve pain and promote remission.
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
SLE 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 blanketly 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 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. chondrocytes) to live longer, and spare them from the pre-programmed death. This can reduce the rate of cartilage loss in a joint!
Preventing scar tissue
Once that scar tissue forms, it becomes nonfunctional. Stem Cells and exosomes are great at preventing scar tissue (antifibrosis).
It’s important to understand that while stem cells are incredible for improving kidney function, some patients are too far gone. For those whose kidneys have shrunk significantly and the eGFR is below 7, stem cell therapy is most likely not indicated.
However, we have seen plenty of patients do great even while receiving dialysis. Some patients who haven’t urinated in over a year are able to improve to the point of getting off dialysis and urinating just fine! It’s important to note that outcomes will vary and are not guaranteed.
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 treatment of SLE, 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 cartilage cell. The administered mesenchymal stem cells are not specifically designed to replace damaged and lost cartilage, but rather coordinate and enhance this repair response by one’s own mechanisms.
Speak with a regenerative therapy expert today at R3 Stem Cell—call (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 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 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 cellassociated 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 23,000 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, as the stem cells do not have MHC 2 markers. Those are the ones that would cause an immunologic reaction. But they are not there, so the cells are “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 potentials. In fact, they have been shown to be anti-tumor forming.
Call (844) GET-STEM for your free consultation with the R3.
Treatment Protocol
For the past decade, R3 has been successfully treating CKD patients with IV stem cell and exosome therapy. The cells and exosomes are attracted to inflammation, which is a large component of CKD. So they will go predominantly to the kidney, but also, to areas that are experiencing disease as well.
So, for example, if a person has CKD secondary to diabetes, the cells and exosomes will also go to the pancreas to assist with function there too. There are Centers that promote injections directly into the kidney, or renal artery/vein. This is not necessary and entails additional risk!
R3’s providers will calculate the amount of stem cells based on patient weight and CKD severity. It will range from 1 to 3 million stem cells/kg. Depending on the total amount, treatment may need to be broken up into two sessions, three at the most for optimal safety.
R3 Stem Cell’s renal disease protocols are based on the latest research along with Best Practice Protocols developed over the past decade to help patients achieve the best outcomes possible. Safety is paramount with the biologics products being rigorously tested prior to use, and expert providers managing each treatment as if it was a family member!
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!
What are the Outcomes?
Similar to the research mentioned above, R3 Stem Cell’s outcomes for SLE 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 less need for traditional medications. 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 does not eliminate SLE, and may need to be repeated every one to three years.
Affordability
Because stem cell therapy for CKD is not a permanent cure, it’s important to make it affordable. Repeat therapies can help maintenance and/or achieve additional improvements for CKD. So a lot of patients seek additional treatments at R3 Stem Cell every six to eighteen months.
Unfortunately, stem cell clinics in Colombia, China and Panama charge over $20,000 USD for CKD treatment. Because the one treatment cost so much, how are individuals supposed to budget for that every year?? R3 Stem Cell’s fees are less than half that for 100 million high quality stem cells!
R3’s Experience
For the past decade, R3 Stem Cell’s Centers globally have performed over 23,000 regenerative procedures in six countries. Over a thousand have been for CKD. Patient satisfaction across all conditions treated is 85%!
R3 combines safety, effectiveness and affordability for the autism 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 CKD. Simply call (844) GET-STEM or +1 (480) 808-7057 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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