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Rebuilding Gut Health in IBD with Cell-Based Care
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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 for inflammatory bowel diseases, such as Ulcerative Colitis and Crohn’s Disease. Spoiler alert: It can help a lot! In this guide, we’ll go through the basics of how stem cells and exosomes work for IBD relief, the latest research, and what to expect with a regenerative procedure.
Conventional treatments for Inflammatory Bowel Diseases (IBD) have improved dramatically over the past decade. Despite the efforts being made to optimize the use of the existing drugs, the current situation is far from ideal. Up to half of all IBD patients stop responding to conventional medications, and continue to suffer complications that may end up with surgery, fistulas and hospitalizations.
Stem cell therapy for IBD is turning out to be an excellent opportunity for individuals to potentially achieve remission, improve function and to avoid the need for potentially risky surgery. Let’s dig in!
Speak with our doctor about IBD care options at (844) GET-STEM.
Inflammatory bowel diseases (IBDs) represent a group of chronic inflammatory disorders of the gastrointestinal (GI) tract including ulcerative colitis (UC), Crohn’s disease (CD), and unclassified IBDs.
According to epidemiology, the prevalence of IBDs in Western countries is significantly higher than that in Eastern countries, but it is also rapidly increasing in Asian countries.
Both male and female are affected equally, specially adults aged 30–40 years. The incidence of Ulcerative Colitis (UC) has been increasing around the world. The highest annual incidence reported was 24.3 per 100,000 person-years in Europe, 6.3 per 100,000 person-years in Asia and the Middle East, and 19.2 per 100,000 person-years in North America.
Furthermore, in the last few decades there has been an increase in the disease in low-incidence zones as South Korea, China, India, Iran, Lebanon, Thailand, the French West Indies, North Africa and Japan. IBD poses an important health problem, since its worldwide incidence is increasing.
The condition affects young people and persists for life – exerting a strong impact upon quality of life, in the professional setting, and in patients’ personal relations. Furthermore, IBD is associated with considerable healthcare costs.
At present, IBD is regarded as the result of an abnormal host immune response to intraluminal antigens occurring in a genetically predisposed individual, with the production of chronic inflammation of the gastrointestinal tract, accompanied by tissue destruction. IBD is an autoimmune disorder, meaning the body’s immune system attacks healthy tissues. It is not yet known what triggers these attacks and why IBD develops in some people and not in others.
The cause of IBDs is very complicated and has not yet been completely understood. IBD is the consequence of complex interaction among genetic, environmental and microbial factors, producing sustained inflammation at intestinal level, favored by alteration of the mucosal barrier and immune system defects. Among the environmental factors, smoking, drug use, diet habits, mental stress, and many other external factors are related to the occurrence of IBDs.
In particular, smoking increases the risk of CD and is related with an increase in the recurrence rate. Air pollution can also increase the risk of CD and UC disease. At the same time, Bitton et al. also proposed that people with less stress would have less chance of developing IBDs.
In addition, IBDs has a strong genetic tendency, especially in the first-degree relatives of patients who are at higher risk for IBDs. Compared with fraternal twins, identical twins have a higher prevalence rate of IBDs. Genetic studies have reached a consistent conclusion: genetic factors play an important but non-decisive role in the occurrence of IBDs.
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The clinical signs and symptoms of the IBDs mainly include enteritis, diarrhea, recurrent hemorrhage, abdominal pain, reduced appetite, and weight loss. Currently, there is still no cure for IBDs.
People may experience ulcers and inflammation of the inner lining of the colon, that may also lead to rectal bleeding.
Common IBD symptoms include:
If inflammation is not controlled, over time IBD can damage the intestines, causing
In some people with IBD, the inflammation can affect areas of the body outside the intestines:
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Medications are key to treating IBD. The goal is easing symptoms, halting inflammation and reducing flare-ups.
Conventional medication options include:
If medications do not calm the inflammation, over time the intestines can become damaged, making symptoms worse and increasing the need for surgery. About half of people with IBD may need surgery at some point in their lives to:
The majority of ulcerative colitis (UC) patients would be subject to medications including antiinflammatory agents such as 5-aminosalicylic acids (5-ASA), systemic corticosteroids, and topical corticosteroids, as well as immunomodulators like azathioprine, 6-mercaptopurine (6-MP), cyclosporine, and methotrexate.
Unfortunately, 74% of UC patients experience at least one relapse during 5-year observation in a prospective population-based cohort study. A metaanalysis conducted by Ford et al. has shown that 887 (60.3%) of 1470 UC patients fell short of achieving remission in randomized to receive 5-ASA, indicating that more than half of UC patients may not be able to have a positive response to traditional medications.
What is more, taking these drugs could lead to the occurrence of various adverse effects. The use of corticosteroids is confirmed to be associated with cutaneous effects, weight gain, hyperglycemia, osteoporosis, adrenal insufficiency, and cataracts. Moreover, corticosteroid therapy is capable of increasing risk of opportunistic infections, especially when administered in combination with other immunosuppressive drugs. The intolerance or potential occurrence of myelotoxicity and hepatotoxicity generated by immunomodulators could make nearly one fourth of patients discontinue the treatments.
Among the recently available therapies, anti-tumor necrosis factor α (anti-TNFα) agents are the most notable predecessors (infliximab, adalimumab, etc.), resulting in improved health outcomes and decreased need for surgical intervention. However, treatment failure is observed in many patients treated with anti-TNFα agents, including primary and secondary nonresponders. Additionally, anti-TNF-α agents are associated with rare but serious adverse effects, including serious infection, paradoxical autoimmune reactions, and a small but increased risk of malignancy.
Two types of stem cell therapy are currently used for the treatment of inflammatory bowel disease
| Type of Therapy | Mechanisms of Action |
|---|---|
|
Hematopoietic stem cells |
- Autologous transplant: Elimination of reactive T lymphocytes (lymphoablation, new reconstitution of the immune system of the patient with more tolerogenic naïve lymphocytes). |
|
Mesenchymal stem cells (autologous or allogenic) |
Systemic and local administration: Immune-modulating and trophic action. |
The effects of systemic administration of autologous or allogeneic MSCs have been evaluated in clinical trials., indicating that the systemic administration of mesenchymal stem cells significantly improved the clinical outcome and prognosis for IBDs.
Stem Cells have been found to inhibit intestinal inflammation, promote long-term intestinal mucosal healing, and significantly improve patient quality of life, making them a valuable alternative IBD treatment.
R3 Stem Cell does not use Hematopoietic Stem Cell Therapy (HSCT). This treatment actually has an unfortunate name, because hematopoietic stem cells are a component of umbilical cord blood. R3 uses cord blood internationally in some locations for treatments, but not HSCT. Let me explain.
HSCT is a treatment where a patient receives a myeloablation. This involves administering a chemotherapy regimen to knock out a person’s immune system, and then applying a person’s own bone marrow for replenishing the immune system. It’s basically a cancer style treatment with an autologous bone marrow transplant.
While there are some very good published results, there are significant risks associated with HSCT. One may experience opportunistic infection, anemia, and death in rare circumstances. So R3 Stem Cell does not perform HSCT, rather, mesenchymal stem cell therapies are performed that do not involve knocking out a person’s immune system.
Wang et al published a meta-analysis in 2021 where they evaluated 18 human studies on IBD, including 360 patients. In the studies that looked at remission rates with mesenchymal stem cells, rates at 1, 3, 5, 12, 24, and 36 months after stem cell therapy were 43%, 68%, 73%, 54%, 52%, and 46%, respectively, thus both high and stable.
In 2006, Onken et al published an abstract on mesenchymal stem cells used to treat 10 patients with active Crohn’s Disease (CDAI >220, C-reactive protein ≥ 5 mg/L) refractory to treatment with corticosteroids, immune modulators and infliximab.
The patients were randomized to two groups, both of which received two intravenous doses of MSCs, spaced one week apart. One group received high-dose MSCs (8 million MSCs/kg), while the other group received low dose MSCs (2 million MSCs/kg). The primary endpoint was percentage clinical response, defined as a reduction in the CDAI score of ≥ 100 points.
All subjects presented a mean reduction in CDAI score of 105 points on day 28. The CDAI scores decreased to a greater extent in the high-dose group.
In 2014, Forbes et al published a study looking at donor mesenchymal stem cells in patients with luminal Crohn’s Disease who were nonresponders to traditional therapies. Sixteen patients were given intravenous infusions of allogeneic MSCs (2 million stem cells/kg body weight) weekly for 4 weeks.
Among the 15 patients who completed the study, the mean CDAI score was reduced from 370 to 203 at day 42 (P < .0001). That’s a decrease of 46%!
The mean CDAI scores decreased after each MSC infusion (370 before administration, 269 on day 7, 240 on day 14, 209 on day 21, 182 on day 28, and 203 on day 42). Twelve patients had a clinical response, 8 had clinical remission.
In 2018, Zhang et al published the BEST study to date on umbilical cord MSC’s for Crohn’s Disease. The study sought to investigate the efficacy and safety of UC-MSCs for the treatment of Crohn’s Disease.
Eighty-two patients who had been diagnosed with CD and had received steroid maintenance therapy for more than 6 months were included in this study. Forty-one patients were randomly selected to receive a total of four peripheral intravenous infusions of 1 million umbilical cord stem cells/kg, with one infusion per week. Patients were followed up for 12 months.
The Crohn’s disease activity index (CDAI), HarveyBradshaw index (HBI), and corticosteroid dosage were assessed. Twelve months after treatment, the CDAI, HBI, and corticosteroid dosage had decreased by 62.5, 3.4, and 4.2 mg/day, respectively, in the UC-MSC group.
In the control group, the CDAI, HBI, and corticosteroid dosage had decreased by 23.6, 1.2 and 1.2mg/day, respectively.
The superiority of umbilical cord mesenchymal stem cells was statistically significant, and patients were able to avoid the side effects of chronic steroid use! No serious adverse events were observed. The conclusion was that umbilical cord mesenchymal stem cells were effective in the treatment of Crohn’s Disease and produced mild side effects.
Below you will see before and after endoscopic results of two patients in the study who received the mesenchymal stem cells. Complete colon healing!
Below is a table of several clinical trials showing the dose of stem cells used, number of patients, follow up duration and the outcome. The results are extremely impressive!
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How do Stem Cells Work in the Body?
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 treatment of IBD, R3 Stem Cell includes stem cell exosomes, which are a type of extracellular vesicle participating in extensive cell to cell communication for cartilage tissue repair and regeneration.
The stem cells administered by R3 are not the ones that become a patient’s new mucosal cell. The administered mesenchymal stem cells are not specifically designed to replace damaged and lost cells in the intestines, but rather coordinate and enhance this repair response by one’s own mechanisms.
How do Stem Cells Work in the Body?
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 IBD, R3 Stem Cell includes stem cell exosomes, which are a type of extracellular vesicle participating in extensive cell to cell communication for cartilage tissue repair and regeneration.
The stem cells administered by R3 are not the ones that become a patient’s new mucosal cell. The administered mesenchymal stem cells are not specifically designed to replace damaged and lost cells in the intestines, but rather coordinate and enhance this repair response by one’s own mechanisms.
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, cytokines, growth factors and proteins to the recipient cells, in this way, allowing cell-to-cell communication and transporting molecules among both close and distant cells.
As IBD involves significant intestinal inflammation, the exosomes will travel there and be ingested by cells. Then they will release their “payload” and facilitate mucosal repair.
Exosomes are most likely the mediators of most stem cell-associated therapeutic activities. Therefore, adding them along with the mesenchymal stem cells during the therapy acts as a “1-2 punch” for patient outcomes.
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 at our clinics. 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 potentials. In fact, they have been shown to be anti-tumor forming.
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Protocol
For the past decade, R3 has been successfully treating IBD patients with stem cell and exosome infusion therapy. The cells and exosomes are attracted to inflammation, which is a large component of inflammatory bowel diseases.
R3’s providers use between one to three million stem cells per kilogram (depends on severity of IBD). R3 Stem Cell’s IBD treatment protocol includes intravenous mesenchymal stem cells and exosomes along with a multivitamin. Safety is paramount with the biologics products being rigorously tested prior to use, and expert providers managing each treatment as if you are a family member!
Book a FREE consultation by calling (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!
What are the Outcomes?
Similar to the research mentioned above, R3 Stem Cell’s outcomes for IBD patients have been exceptional! The patient satisfaction rate is 85% year over year. Patients typically see exceptional pain relief, less bleeding, less urgency and long term complications (e.g. fistulas).
It may take six to twelve 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 IBD, and may need to be repeated every one to two years.
Affordability
Because stem cell therapy for IBD is not a “one and done” cure, it’s important to make it affordable. Repeat therapies every few years can help people achieve continued pain relief and functional improvements. So a lot of IBD patients seek additional treatments at R3 Stem Cell every one to two years.
Unfortunately, stem cell clinics in Colombia, China and Panama charge over $20,000 USD for IBD treatment. Because the one treatment cost 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 exosomes 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. Over a thousand have been for IBD. 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 your IBD pain relief. 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: 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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