Is It Safe Safety Of Commercial Stem Cell Clinic Work
Safety data is also limited, although there have been some publicized lawsuits claiming that these treatments resulted in harm. Stem cell researchers in general question whether cells harvested in such a way contain sufficient amounts of adult-derived stem cells to be meaningful. It is also unclear how this type of procedure would target the stem cells to the correct location. If stem cells are introduced in the nose for example, it is unclear how they would find their way to the basal ganglia and make the correct connection in order to help a person with Parkinsons disease.
In order for the medical community to accept this type of treatment as safe and beneficial, it would need to be shown to work in a placebo-controlled clinical trial for which participants do not pay, are aware of the known risks and benefits, and are carefully monitored throughout the trial. In addition, the trial would need to track adverse events, as well as record and share the outcomes of trial participants as they compare to the group of patients receiving a placebo treatment. So far this has not happened. The FDA is in fact studying mesenchymal stem cells in the laboratory in order to determine the best way to use them to help people, but these studies have not yet led to approved treatments. Most recently, the FDA filed federal complaints against two clinics that are marketing stem cell products without regulatory approval.
Stem Cell Therapy For Parkinson’s Disease
Parkinsonâs disease is one of the most common neurological conditions in the world. It causes the loss and degeneration of neurons in the body, resulting in delays in movement, reaction, and general coordination. The strong anti-inflammatory properties of MSCs have drastic effects on Parkinsonâs symptoms. More recently, long-term clinical trials have shown improvements in common symptoms including facial expression, gait and freezing episodes, and research has also shown improvements in other common behaviors such as tremor and motility.
Stem cell therapy may have the benefit of replacing and repairing damaged dopamine-producing nerve cells within the brain. This has already been found in a study conducted by Neelam K.Venkataramana and colleagues. Seven PD patients aged 22 to 62 years with a mean duration of disease 14.7 ± 7.56 years were enrolled to participate in the prospective, uncontrolled, pilot study of single-dose, Â mesenchymal stem cells . Patients were followed up for 36 months post-transplant, 3 of the 7 patients showed significant improvement in their Unified Parkinson’s Disease Rating Scale of 38%.
Clinical Trials For Parkinsons Disease And What Should We Expect
While transplantations of fetal midbrain material continue to be explored under the TRANSEURO trial, the use of fetal tissues is associated with several ethical and standardization issues that may not be a realistic cell therapy option for PD, especially since cells from approximately 4 fetuses would be required for a single patient . A global consortium, GForce-PD, has also been set up, bringing together major research teams in Europe, USA and Japan to work on developing stem cell-derived neural cell therapies for PD . The EUROPEAN STEM-PD, NYSTEM-PD, CiRA Trial and Summit for PD Trial are four of such planned clinical trials by members of the GForce-PD using either human ESCs or iPSCs as initial cell source . On 1 August 2018, a cell transplantation trial for PD led by Jun Takahashi, Ryosuke Takahashi and colleagues in Kyoto Universitys Center for iPS Cell Research and Application had begun to recruit their first patients. The key features and considerations of these upcoming and ongoing trials are previously reviewed in .
Fig. 1
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When Will Stem Cell Therapy Be Available As A Parkinson’s Treatment
Whilst there has been considerable progress in stem cell research in the last decade, particularly for the treatment of blood and immune system disorders, scientists are still some way from being able to start clinical trials using stem cell therapy for Parkinsons. No-one can predict how long it is likely to take for stem cell therapy to be a viable treatment for Parkinsons.
Also, even if a therapy is approved, it is unlikely to work for everyone just as no one medication is suitable for everyone.
At this stage, scientists do not know which type of stem cell, if any, may eventually lead to a successful treatment or cure.
The key challenges for scientists at present are:
- to understand the way cells grow and differentiate
- to identify methods to differentiate the stem cells into the cell types needed in the brains of people with Parkinsons
- to establish the best ways of getting stems cells into the right part of the brain.
What Are Stem Cells And How Are They Of Value In Medicine
The potency of these cells to differentiate into all types of cells make them useful in treating diseases affecting almost any tissue and organ.
Examples of stem cells include; embryonic stem cells, derived from early embryonic cells, adult stem cells, derived from the bone marrow, cord stem cells, derived from umbilical cord blood, and amniotic fluid stem cells, which are derived from the fluid within the uterus during pregnancy.
Autologous stem cell therapy is the safest form, as it has the advantage of 100 percent compatibility and doesnât induce advserse effects such as transplant rejection. The most common adverse effects seen with autologous stem cell therapy is pain or mild swelling at the site of puncture and this can be treated with over-the-counter analgesics.
The first step in stem cell therapy is signaling and activating the stem cells to make them functional. This is achieved using vitamins, coenzymes, diverse cytokines, growth hormones and/or growth factors that stimulate the process. Although these substances are normally produced by the body, synthetic versions with the same chemical composition can be made in laboratories for this purpose.
In our practice, we have successfully treated several diseases with bone marrow stem cells without complications.
These diseases include:
- Kidney failure
- Spinal disorders
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What Are The Current Treatments For Parkinsons Disease
Drug therapy is the primary way that doctors manage the symptoms of Parkinsons disease. While these medications can help control the symptoms and slow the progression of the disease, many patients experience the onset of side effects including diarrhea, nausea and vomiting, loss of appetite, lightheadedness and low blood pressure, confusion, fatigue, involuntary movements, changes in behaviors, and difficulty urinating. Parkinsons drugs also become less effective over time and require higher doses. As a result, not all individuals can tolerate these conventional treatments and others see an incomplete response.
So What Are Stem Cells
Stem cells are cells that have not yet specialized in the body, meaning they have not grown to a particular type of cell with a specific function . A stem cell can become many different cell types in the human body. The process of stem cells become new types of cells is called differentiation. This process is the most important aspect of stem cell therapies, as the cells become the type of cells required for your body to heal. Stem cells are also self-replicating. This allows them to multiply into identical copies of the stem cells that have already gone through differentiation in the body. For example, if stem cells were used to treat a neurological injury, cells administered during treatment could become nerve cells, and then replicate to create exponentially more nerve cells on their own. This drastically increases the effectiveness of stem cell treatments over time.
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Is There Any Guarantee That A Stem Cell
There is no therapy, be it an experimental or established treatment, for which your treating physician can promise or even guarantee a therapeutic success. In the case of innovative and experimental therapies such as stem cell therapy, doctors must perform a benefit-to-risk-analysis for each individual case and ensure that the therapy is beneficial to the patient and these benefits outweigh the risks. Only when this is the case, your doctor will suggest treatment with stem cells.
They Have Alzheimers Brains But No Symptoms A New Wave Of Drug Developers Wants To Know Why
Lopezs dopamine high and the feeling that his brain and body were their pre-Parkinsons selves lasted two days. Then he was back to baseline: no worse, but no better. Still, he said, what we did was stop the deterioration. They gave me another shot at life. Without the cell implants, Lopez said, I think I would be dead now.
At the insistence of the FDA, the procedure at Cornell shot cells into only the left side of Lopezs brain: The agency said that if things went south, it would be twice as bad if Lopez had cell implants on both sides of his brain. I disagreed, Lopez said. I should have had both sides done at once. By requiring two surgeries, he said, the FDA doubled the risk and the cost.
But the first procedure didnt seem to cause harm: no infection, no tumors, no hemorrhaging, no worsening of symptoms. On March 6, 2018, another batch of dopamine cells made from Lopezs skin cells underwent a 20-minute journey from Dana-Farber, not to Manhattan but to Mass. General, which was now equipped to do the surgery. Schweitzer transplanted them into the right side of Lopezs putamen.
This time, Lopez didnt have a Lourdesian experience. No one is quite sure why, but it might be that fresher cells dont give the brain a quick dopamine hit. But they might form enduring synapses. Eventually.
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I Am Willing To Fund The Work
Apart from offers of penis enlargers, this was the most obvious spam hed ever seen, Kwang-Soo Kim thought as he scrolled through his inbox on May 2, 2013. A name hed never heard of was atop an email that was effusive in its praise, calling Kims research at McLean, on stem-cell therapy for Parkinsons disease, the most promising hed ever come across.
I am willing to fund the work, the mysterious George Lopez had written, whatever it takes to go twice as fast. I hope to benefit from that work. If not me, mankind will be better.
Lopez, Kim would soon learn, had himself been diagnosed with Parkinsons nearly a decade earlier. One evening, while his wife was bedridden at their southern California home with the breast cancer that would take her life, Lopez told her hed been experiencing a tremor, a staccato shaking when his hands werent otherwise moving.
So? his wife, Diana Kostyra Lopez, asked. I think I have Parkinsons, Lopez said. You dont have Parkinsons, she said dismissively.
The way she said it, it made me feel stupid, Lopez recalled in a long discussion with STAT in 2018. It also made me feel better.
Soon, however, neurologist Carolyn Neff confirmed his dreaded hunch: He had Parkinsons disease.
Its prognosis is bleak. There is no cure and no treatment that can slow down or stop the disease process, Kim said.
I shouldnt have been afflicted with it if there is any fairness in the universe. But of course, there isnt.
How Can Stem Cells Help With Parkinsons
Stem cells are unique in the sense that they can take on so many different roles. When it comes to neurological conditions like Parkinsons, stem cells can help to slow the progress of the disease or stop it altogether.
Parkinsons symptoms are caused largely by a lack of dopamine or damaged dopamine neurons. The idea is that stem cells can be introduced into the host where they can then begin to produce dopamine and replace the missing dopaminergic cells.
This is a process known as neurogenesis: the creation of new brain cells and synapses.
There are lots of different types of stem cells that can be used in stem cell therapy: embryonic, blood, bone, skin, and so on. Scientists are still working to discover which type of stem cells are most effective for treating the symptoms of Parkinsons disease.
The goal is to identify the most effective cell or selection of cells to regenerate damaged or defunct brain tissue. By doing this the brain can return to an optimum level of dopamine production. This would provide a more long-term solution than simply using drugs to cover up the symptoms.
Restoring the brain to a healthy level of dopamine production would lead to an improvement in the majority of Parkinsons symptoms, but not all of them. Dopaminergic symptoms are those related to motor functions and include tics, slow motions, uncoordinated movements, as well as insomnia, and fatigue. Other symptoms like constipation and memory loss may not be influenced by dopamine.
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Can Stem Cells Reduce Deterioration Of Nerve Cells
Neurological conditions encompass a broad range of disorders that affect the brain, spinal cord, and nervous system. These include conditions such as Amyotrophic Lateral Sclerosis , Parkinsonâs disease, stroke, spinal cord injuries, and even Traumatic Brain Injury . Before the advent of stem cell medicine, these conditions were degenerative and only the symptoms were treated using a spectrum of drugs. The damage caused by the disease to the neuron could not be fixed. However, stem cells have shown remarkable healing properties in the body. Studies have now shown that stem cells have the ability to reduce the deterioration of nerve cells, restore cell function, reduce symptom-causing inflammation, and even regrow new neurons.
How Does Our Stem Therapy Treatment For Parkinsons Disease Process Work
All our stem cell treatments in Mexico are reviewed and administered by subject manner specialist in the area trained in US and Mexico, not just general doctors or physicians, to ensure the highest level of precision, understanding of the condition and quality of treatment for our patients. We are 100% clear and honest with our patients, not everyone is a candidate for our stem cell treatments, we turn-down many patients where the our specialist evaluates the current health condition and medical history and deems not a good fit for the treatment, to avoid false promises or expectations when the risks outweigh the benefits. For this reason and to ensure patient safety in all our treatments, all our patients get evaluated by the specialist before being able to schedule their treatment.
Step 1. Specialist Evaluation For Parkinsons Disease patients, our specialist will need to know the patients age and previous medical treatments. In addition, will need to review specific tests you will be asked to bring.
Step 2. Specialist Phone Consultation Once the specialist has reviewed the medical records and approved your case, we will present options and pricing, at which point we will also offer a free phone consultation to discuss questions and concerns.
Step 5. Treatment Follow-up Our follow up specialist will check in with you according to our follow up calendar for your specific treatment to ensure you have all the tools at your disposal for maximum benefits.
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We Have Great Medications For Parkinsons Disease
Even though Parkinsons is a progressive, degenerative condition, we do have awesome medications for it. See, we know that loss of dopamine is the biggest issue. And physicians have actually been treating that symptom of PD for over forty years in a couple of different ways.
Dopamine Agonists
These are sort of the expendable crewmen of Parkinsons treatment. Dopamine agonists have some of the same effects as dopamine and can control the early stages of Parkinsons symptoms. And there are so many of them that Im not going to bother listing any.
Long story short: dopamine agonists comprise the first line of Parkinsons defense and can work well in the early stages after initial diagnosis.
L-Dopa
Yall know your brain runs your whole body, right? So your body has several ways of protecting it, one of which is the blood-brain barrier. This intricate biological system guards the brain, much like the kind of security youd expect to see in important government buildings. Only things that really need to be in the brain get through.
So if we want to put dopamine in the brain to treat Parkinsons, we have to find a way to get it past the blood-brain barrier. Because the brain thinks dopamine comes from the brain, so it doesnt have a natural mechanism for allowing it past the barrier.
This is usually the point at which patients begin looking at more aggressive treatment options, including the addition of some of the prescriptions below.
Others
What Are Stem Cell Lines
A stem cell line is a family of constantly dividing cells, the product of a single parent group of stem cells. They are obtained from human or animal tissues and have been manipulated in a laboratory so that they have the ability to divide almost indefinitely, creating the line.
Because stem cell lines produce so many copies of themselves , this means that scientists have a large bank of cells for their research and are less likely to need to take cells from an embryo repeatedly. Of course, it is important that researchers are also able to stop such cell lines dividing at some point so that they can generate tissue specific cells, such as for the brain in the case of Parkinsons treatment. The challenge for researchers is to discover how they can control the process which causes stem cells to differentiate.
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Clinical Trials For Parkinsons Disease
A search of the worlds larest clinical trial database, ClinicalTrials.gov, reveals there are at least 16 clinical trials worldwide using different types of stem cells in an attempt to find a treatment for Parkinsons disease.
Additionally, researchers from Kyoto University in Japan are conducting the a groundbreaking study for Parkinsons disease, in which the first patient has been treated with a dose of 2.4 million cells.
Conventional Parkinson Disease Therapies Vs Stem Cell Therapy
Parkinsons Disease is a chronic neurodegenerative disorder caused by selective and gradual loss of dopamine-producing neurons. These neurons are spread throughout the brain, however, the most effected region is the substantia nigra. The symptoms of Parkinson’s Disease are mainly tremor and rigor. At later stages the illness is characterized by more severe symptoms like speech disorder, depression or even dementia. Currently, there is no cure for Parkinsons disease. Nevertheless, there are few hormone replacement-based therapies which tackle the symptoms only. These pharmacological treatments are effective to control the symptoms of PD to a certain degree, with side effects, but are unable to stop neural degeneration, let alone replace dead dopaminergic cells.
Degeneration of dopaminergic neurons in Parkinson’s DiseaseANOVA IRM Germany, © DOI: 10.3389/fnins.2018.00080
Stem cell research has allowed ANOVA, a German Stem Cell Clinic in the heart of Europe near Frankfurt/Main airport, to offer a novel treatment with a new therapeutical approach: The ANOVA Stem Cell Secretome is a cell free and promising treatment option for AD. , whether you wish to apply for a treatment, or simply receive more information.
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How Does Stem Cell Therapy Work
Stem cell therapy leverages the power of master cells to replace the missing cells in the body. Nerves, as stated, are not a naturally renewing resource, and they need replenishment by outside means in order to cure the disease. Heres a brief overview of how the process works:
Therapy Workflow For Early To Mid Parkinson’s Disaease
The precise workflow is described in detail on the stem cell- specific pages of BMC, Secretome/Exosomes and PRP . All therapies are divided into phases such as evaluation of the medical history , initial counseling and evaluation of potential, patient-individual benefit of a stem cell therapy , preliminary examinations, diagnostics, consultation on all therapy options, preparation of an individual treatment plan including cost estimate, harvesting of tissue, production of the stem cell product, quality control of the product and application.
Unfortunately, we only treat patients in an early to mid stage of PD and according to the risk-benefit ratio, we cannot treat children or pregnant women. In addition, other factors can also be exclusion criteria.
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Fda Grants Fast Track Designation To Stem Cell Therapy For Parkinsons Disease
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The FDA granted fast track designation to DA01, a stem cell-based therapy, for the treatment of advanced Parkinsons disease.
DA01 is an allogeneic, gene-edited pluripotent stem cell-derived dopaminergic neuron therapy that is delivered locally through surgical implantation. Preclinical studies have suggested that dopaminergic neurons can restore motor function and increase dopamine release, according to the manufacturers website.
FDA fast track designation helps to expedite development, review and potential approval of treatments for serious or life-threatening diseases.
Receiving fast track designation from the FDA is an important step will help us further accelerate clinical development of our DA01 cell therapy approach for Parkinsons disease,Joachim Fruebis, PhD, chief development officer with BlueRock, said in a company-issued press release. This is another critical step in the BlueRock mission to create authentic cellular medicines to reverse devastating diseases, with the vision of improving the human condition.
Enrollment is underway for a phase 1 trial of DA01 for older patients with advanced Parkinsons disease.
The study is designed to evaluate the safety and efficacy of DA01 for patients whose current medications are no longer effective and have not received previous neurosurgical treatment for Parkinsons disease.
Cell Replacement Therapy For Parkinsons Disease Hurdles And Solutions
A successful cell transplantation has to be safe, well-tolerated by the recipient, and efficacious in reversing the symptoms of disease. It has been extremely well-established that loss of dopamine in the striatum is responsible for PD. Levodopa, which is a dopamine precursor, has been used to treat PD patients since that replaces the dopamine that is lost . Moreover, numerous animal studies have shown that transplanting dopaminergic neurons improves motor symptoms in PD animals . Even though there was sufficient evidence supporting that dopaminergic cells are clinically relevant for cell therapy in PD, there were aspects relating to their safety and reproducibility. Below, we list some of the hurdles that were eventually overcome so that stem cell derivatives can be used in the clinic.
Hurdle 1 deriving the right neural cell type for transplantation
Hurdle 2 eliminating the risk of tumorigenesis
Hurdle 3 transplanting floorplate progenitor cells, fully differentiated SNpc dopaminergic neurons or an intermediate?
Hurdle 4 source of stem cells: autologous or allogeneic? Fetal, ESC or iPSC-derived?
Hurdle 5 how many cells to transplant? Where to transplant?
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Potency Hypothesis Of Stem Cell Therapies
Stem cells possess the potential to communicate with the immune cells that elicit inflammation and by natural, so far not understood mechanisms may inhibit this immune-over-reaction. Furthermore, stem cells have the ability to stimulate regeneration of tissue thereby counteracting the loss of function.
Stem Cells Have Been Used To Treat Parkinsons Disease
In 2010, this group published a study with follow-up at the three year point for some of their patients. Now, you must pay attention to how they implanted the cells here, because they did it right. This group used the same brain surgery approach I described earlier for those spaghetti noodle implants, but instead of those implants, these guys placed MSCs from the patients bone marrow in the target area.
very important note:
Every time someone uses stem cells, or a drug, or anything to treat anything in the human body. In order for it to work, they must first figure out how to get it where it needs to go.
So when someone says they want to treat Parkinsons Disease, they need to figure out how to get their treatment into the specific area of the brain where we know the cells are dying.
And thats a challenge. Because the blood-brain barrier is legit. It lets very few things pass. Imagine it as Gandalf just constantly yelling YOU SHALL NOT PASS at almost everything. Including stem cells. Stem cells CANNOT pass the blood-brain barrier. Theyre too big.
So when you read about someone using stem cells to treat Parkinsons Disease, you should be looking for an actual brain surgery to get those cells where they need to be.
end very important note
I know this research sounds cool, and Im hopeful that well see some of the MSC based therapies in the regular world within the next ten years. The results thus far are definitely promising.
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