Are you ready to unleash the power of regenerative medicine? Sharlin Health and Neurology is offering a revolutionary approach to promoting health and wellness beyond traditional treatments. Our Regenerate pillar, combining stem cell therapy with world-class expertise, is designed to address all aspects of your overall health. From chronic illnesses and neurological disorders to general vitality, our team at Sharlin Health strives to provide comprehensive medical solutions tailored for individuals seeking advanced healthcare options.
The Age of Cellular Therapy
The regenerate pillar focuses on our proprietary stem cell approach using medicinal signaling cells (mesenchymal stem cells).
It’s important to understand that we are in the age of cellular therapy. Cellular therapy (or biological therapy) is used throughout neurology, rheumatology, and cancer treatments. Sometimes these approaches involve manipulation of the immune system to attack cancer by focusing on your immune cells and their behavior to go after cancer rather than kill it.
Sometimes it focuses on treatment with a variety of antibodies. Antibodies are proteins that act like a key to unlock a lock. They can be designed to target specific areas of a protein. This might, for example, treat Alzheimer’s disease or shut down migraines from where they’re starting.
Finally, we can use cells that are already in the body, and that’s where stem cell treatment comes in.
Medicinal Signaling Cells
What is a stem cell?
Stem cells are normally found in places like the bone marrow and fat tissue in the body. When there is injury and inflammation, this is our first line of defense. The cells come out, they are anti-inflammatory, and they participate in tissue repair.
A stem cell is a type of cell that is not yet specialized. This means that it can become any other type of cell in the body. They have the ability to renew themselves, which means they can make more stem cells. They’re able to change into different types of cells depending on the conditions.
There are two types of stem cells: embryonic and non-embryonic. Our focus is on non-embryonic stem cells. But first, a few definitions.
- Autologous: Stem cells and autologous transplants come from the person who will actually get the transplant. In other words, the patient himself is the donor.
- Allogeneic: the stem cells in allogeneic transplants come from a person or an animal other than the patient, who is either matched or could also be an unrelated donor at Sharlin Health and Regeneration Center.
- The Institutional Review Board (Research Review Board): is an independent ethics committee. They are an ethical review board responsible for reviewing the methods proposed for a research study to ensure they are ethical. You might see the phrase “IRB-approved” on websites or from companies that sell stem cell treatments. This does not mean that the FDA has approved the treatment. It only means that an institutional review board has looked at the study to make sure it is ethical and follows proper protocols.
- IND stands for “Investigative New Drug. This refers to a drug or a biological compound that’s been approved for use in a clinical trial to investigate its safety and/or efficacy. So when we hear “IND status,” it means it’s been approved for use in specific clinical trials. Moreover, if you have IND status for a study of a compound you’re investigating, you can’t use it in a completely unrelated study.
Phases of a Clinical Trial
Clinical trials, ultimately, are about getting products out to the market to you. In the United States, healthcare companies are allowed to advertise their products on TV. This is because the drugs have been approved by the FDA, which means they have gone through all of the necessary steps.
- Preclinical phase: the drug is being studied in animal or cell models in the laboratory in Petri dishes, fruit flies, mice, and so forth. There is still ongoing animal research, although of course some of it has been limited in recent years by animal rights advocates.
- Phase One Studies: Phase One studies are not efficacy studies at all. The people who take part in phase one of a drug study are mostly men who are 18 to 25 years old and who are very healthy. Why only men? And why that age?
It is because they will be receiving a drug. We don’t want to give the drug at this stage to anyone who could become pregnant or who has other health problems. The only purpose of a phase one study is to get some early safety data and to study what happens when we give the drug to people. For example, how quickly does it get into the bloodstream? How quickly does it reach the target tissue? These are called pharmacokinetic and pharmacodynamic studies. They have nothing to do with the effectiveness of the drug to treat a given condition.
- Phase two studies – is kind of a test study. There is an element of efficacy now, so we are treating the target population. We’re still going to get safety data, as we always do. Usually, they’re what are called primary outcome measures—the main thing that needs to be studied. Then there are secondary measures that are added on.
- The phase three study is the larger version of the phase two study. This is the big study that’s going to be used if the treatment is deemed successful or effective. The company that owns that product is going to submit data to the FDA for approval.
- Phase four studies: these involve post-marketing studies, gathering additional data about the drug or treatment. The drug is already approved and out there in the marketplace.
I have seen situations where people are told they are in a research trial for a new medical treatment, but they are actually being asked to pay for the treatment themselves. This is not supposed to happen very often, and it makes the FDA very suspicious. If you are ever asked to pay for participation in a research trial, you should ask more questions to find out why.
When you look at a website that has a product, you can usually see where that product is in the pipeline. This means you can find out if the product is approved by the IRB and what stage of a clinical trial it is in. If something is in phase one trial, that means it is not being studied to treat a condition yet.
351 Products versus 361 Products
In the United States, cellular therapies are regulated by the FDA’s Office of Cellular Tissue and Gene Therapies within the FDA Center for Biologics Evaluation and Research.
The FDA distinguishes between what they refer to as 351 products and 361 products.
Currently, the only stem cell treatments approved by the Food and Drug Administration are 351 products. They are regulated as drugs or biological therapies. Vaccines, NurOwn, and monoclonal antibodies are examples of these. They have to go through the clinical trial approval pathway mentioned. We have 351 products approved to treat certain cancers and disorders of the blood and immune system.
The FDA has not approved any exosome product, if you’ve heard of that term, for any use whatsoever. If you have a practitioner in the United States offering to give you Exosome, please understand it is a direct violation of the FDA regulations.
In contrast, there are HCTPs (human cells, tissues, and tissue-based products). The FDA regulates HCTPs as 361 products under 21 CFR 127110A. While 361 products must meet specific criteria set by the FDA to be designated as HCTPs, they are not required to go through the clinical trial approval pathway. These criteria are what distinguish HCTPs from drugs and biological therapies.
Mesenchymal Stem Cells
They fall into the 361 category. Mesenchymal stem cells (MSCs) can be isolated from various tissues, such as the umbilical cord end, endometrium (including polyps), menstrual blood, bone marrow, and fat tissue. Mesenchymal stem cells are multipotent, meaning they can differentiate into a variety of different cell types, including bone cells, cartilage cells, muscle cells, and fat cells that give rise to marrow adipose tissue. The reason why mesenchymal stem cells are attractive from a clinical perspective is not because of their differentiation potential.
Dr. Arnold Kaplan is the scientist who was credited with discovering MSCs and is known as the “Father of Mesenchymal Stem Cells.” He proposes that they may be best termed medicinal signaling cells as opposed to mesenchymal stem cells, but if we use the two terms, they are interchangeable.
MSCs provide growth factors that facilitate nerve cell growth, repair, and survival through compounds like VEGF (Vascular Endothelial Growth Factor), nerve growth factor, and brain-derived neurotrophic factor. MSCs help with T and B cells, which are white blood cells. White blood cells help the body fight off viruses, bacteria, and parasites. But sometimes the white blood cells can be too aggressive. This can cause autoimmune diseases.
Your brain has its own immune cells, and sometimes those immune cells are protective and at other times they’re on the attack. We need them to be on attack at the right times, but we don’t want them to be on attack all of the time. These cells can switch back and forth between their two states.
- MSCs increase the protective anti-inflammatory type or form of microglia.
- MSCs increase anti-inflammatory chemical signals called cytokines.
- They deliver microRNA that regulates a wide variety of processes involved in immune modulation and neuroprotection.
- They are anti-apoptotic; they can stop or slow the process of programmed cell death.
Struggling with body and neurological ailments can be daunting, but our approach offers you the chance to finally find relief! Let us show you how we make help possible. We’d be happy to schedule a discovery call with you. During this call, we can discuss your symptoms in more detail and come up with a plan tailored specifically for you.
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DISCLAIMER: The information in this email is not intended nor implied to be a substitute for professional medical advice, diagnosis or treatment. All content is for general informational purposes only and does not replace a consultation with your own doctor/health professional