Researchers at the University of California (UC) San Diego School of Medicine reported promising results of the phase I of the clinical trial, where Stem Cells were transplanted into four chronic Spinal Cord Injury patients, with conditions ranging from injuries at a T2 to T12 thoracic level. Each received a total of six injections of 1.2 million stem cells and yielded encouraging improvements.
This clinical research is the first trial on human. Considered an advancement in the field of Regenerative Medicine, it is performed subsequently to the previous successful transplantation of Stem Cells in rats with Spinal Cord Injuries, which resulted in improvement in the rodents’ mobility, functioning, as well as neuronal regeneration.
“The primary purpose of this first trial was to assess safety. And no procedure-related complications were observed in any of the patients,” said Joseph Ciacci, MD, the principal investigator and a neurosurgeon at UC San Diego Health. Instead, three of the four patients who underwent the clinical trial saw improvements in their motor and sensory functions and experienced no serious side effects.
“Our results suggest the approach can be performed safely. These early signs of potential efficacy [of the stem cells], combined with the promising results of earlier animal studies, argue for pressing ahead with new trials and greater doses to see if we can further accelerate repair and recovery,” he continued.
Fueled by the encouraging results, researchers at University of California San Diego prepares for the development of the second clinical trial, whose focus will be on cervical level injuries.
Mesenchymal Stem Cells and Its Benefit in Stem Cell Therapy
The U.S Food & Drug Administration (FDA) had been developing methods that would help them discover how manufactured or isolated Mesenchymal Stem Cells (MSCs) behave in patients. MSCs are discovered to have the ability to protect, restore, or repair tissues in the body, becoming an important part of Regenerative Medicine. Therefore, the ability to predict specific functions of different preparations of MSCs in the lab could be a big leap toward creating safe and effective FDA-approved treatments for patients.
MSCs, also called a multipotent tissue or adult stem cell, can produce more than one type of specialized cell of the body but not all types of cells. Their skills are limited to specialized cells that are found in skeletal tissues including cartilage cells, bone cells, and fat cells. MSCs may also help the body control inflammation by suppressing immune cell functions, also called immunosuppression.
The Problem with MSCs
According to FDA’s research, MSCs are found to be responsive to their environment. However, in a lab-based manufacturing process, MSCs are not tested on the body, and therefore could react in unexpected ways when it is put into a patient. For example, they might not suppress inflammation well, might form wrong tissues in a place where it is not needed, and even form tumors, according to U.S Food & Drug Administration’s article.
Morphological Profiling to Predict Outcomes in MSCs
In an effort to prevent MSCs yielding undesirable effects, FDA had researched ways to predict cells’ behavior or whether stimulated MSCs are going to differentiate into specific cells that can do specific tasks. This approach is called functionally-relevant morphological profiling, which monitors and analyzes the changes in the size and shape of thousands of cells through imaging technology.
Human MSCs undergo morphological changes after being stimulated by growth factors, making the identification of these cells’ size and shape especially crucial. This is because FDA scientists have demonstrated that these morphological changes can predict the ability of the cells to develop specialized properties that might support their use in Regenerative Medicine clinical trials.
Although MSC-based therapies have not been made available yet, the ability to predict specific functions of MSCs in the lab is a significant advancement towards finally developing safe and effective treatment for patients. Until then, researchers must be certain that MSCs do not act independently, but ensure that they will work together to perform the same specific and predictable function.
A Stem Cell Treatment may help strokerecovery in patients with the method involving a single dose of millions of adult, bone-marrow-derived stem cells, a method which is observed to be safe and well-tolerated by the patients. The multicenter trial monitors stroke recovery even though it may not significantly improve their condition within the first three months, according to a research from Medical College of Georgia at Augusta University, reported by Science Daily.
The American Heart Association defines stroke as a leading cause of long-term disability and the
leading preventable cause of disability.
Results show that giving the Stem Cell Therapy early to patients within the first 36 hours after stroke symptoms appear may enhance physical recovery, reduce destructive inflammation as well as the risk for serious infections.
“There is solid evidence from our basic science work and now some indicators from this phase 2 patient trial that giving these stem cells can safely help dial back the body’s immune response to stroke injury that can ultimately further damage the brain and body,” said Dr. David C. Hess, stroke specialist and chairman of the Department of Neurology at the Medical College of Georgia at Augusta University.
The study was conducted at 33 centers in the United States and the United Kingdom from October 2011 to December 2015. It included 129 adult patients with moderately severe strokes. Some were given a dose of 400 million cells, then increased to 1,200 million cells for the majority of patients, whilst the remainder of the patients received placebo. The two groups, however, also underwent standard stroke therapies, including the clot-buster tPA and/or and endovascular procedure to retrieve the clot.
The trial was done within a timeframe of 36 hours and patients were followed for 90 days to a full year to study long term results. The result shows that a group that received Stem Cell Therapy and whose results are observed in a longer-term, rather than those under placebos, is more likely to see reduced disability and fewer infections.
The multipotent cells used in the treatment, called MultiStem, were developed by the international biotechnology company Athersys Inc., that funded the clinical trial. Doses were the largest ever given in a human cell therapy trial.
Dr. Hess said, “The cells are ‘off the shelf’ and ready to go. One donor of these cells provides hundreds of thousands of doses to patients.”
Dr. Hess explained that the cells work by modulating the body’s immune response which helps the brain heal
and remove debris from dead or damaged tissue. The researchers also found patients receiving cell therapy had lower blood levels of inflammatory signals, which prevent natural healing tendencies of the body.
Stroke also causes the spleen to shrink in size within the first hours after symptoms of stroke arise.
“Shrinkage that follows a stroke prompts it to quickly dump activated immune cells that can go to the brain and worsen inflammation and damage there,” Hess said. The spleen is an organ about four inches long located to the left of the stomach and is an important immune system regulator that filters blood and stores immune cells. Although, in the trial, the spleen was not examined, animal trials proved that there is a spleen shrinkage reduction with cell therapy and researchers hope to look more into this in future studies.
Regenerative Medicine Goes to The Root Causes of Diseases
Regenerative Medicine is a type of stem cell treatment that attacks the root cause of diseases rather than just the symptom. The process involves taking a cell from a donor and putting them into a patient to treat a disease or injury. It can replace lost cells or organs or fix a problematic gene. However, as reported by Medical News Today, Regenerative Medicine needs to develop itself into mainstream medicine through better science and regulation as well as integrating with innovative manufacturing methods to make treatments affordable to the mass.
The Difference Between Regenerative Medicine and Traditional Drugs for Treatment
Regenerative Medicine aims to replace or repair human cells, or regenerate tissue or organs to restore normal function. It makes use of cells, biomaterials, and molecules to fix structures in the body that is malfunctioning. For example, if a person with type 1 diabetes wants to start producing insulin, the traditional way to treat a person with type 1 diabetes would be injecting insulin daily to keep blood sugar levels normal. With Regenerative Medicine, a patient can regenerate their own insulin-producing tissue called the islets of Langerhans, which eliminates the need for routine insulin rejection. While this treatment for type 1 diabetes is not yet possible, there are some areas of Regenerative Medicine that is used in medical practice today.
Methods of Regenerative Medicine
Cell therapy originated from the method of transfusion of the blood which is a common practice in clinics around the world. There was also the method of transplanting the bone marrow where patients with radiation damage or blood cancers can regenerate healthy blood cells using the donor’s bone marrow stem cells. Cell therapy using a patient’s own cells is also used for severe burn and injuries. Medical News Today also reported on a chip technology that can change one cell type into another and heal entire organs and another method of spray painting biomaterials onto damaged hearts using surgery.
Although there are many studies into Regenerative Medicine, the Food and Drug Administration (FDA) only approves 15 entries for cellular and gene therapy products
The Future of Regenerative Medicine
Although there are many breakthrough researches for Regenerative Medicine, medical treatment through this process is still scarce and a panel of FDA commissioners noted that there is a lack of progress in the field, with only a handful of breakthroughs have made it to patients. Despite the success of Regenerative Medicine studies, only a small number of diseases can be treated through this method. Prof. Giulio Cossu from the Division of Cell and Matrix Biology & Regenerative Medicine at the University of Manchester in the United Kingdom, said that complex diseases such as diabetes or heart will require more advanced approaches than what is available today.
Doctors found a major breakthrough in Stem Cell treatment for Multiple Sclerosis (MS), according to Telegraph.MS is a disease where the immune system stops functioning and instead, attacks nerve cells in the brain and spinal cord. Patients often cannot move, have blurred visions, and lose the sense of balance and the ability to talk.
The Stem Cell treatment is used in chemotherapy in which the immune system is deactivated for a short period of time and then resets again, as described by Telegraph. Patients were given a drug which would move stem cell from the bone marrow into the bloodstream, where they were removed from the body. A high dosage of chemotherapy was then used to kill all immune cells, before the patient’s stem cells were put back into the body to reset the immune system. A studyconducted by Imperial College London discovered that 46 percent of patients who had been treated with stem cell transplantation were able to freeze the disease progression for as long as five years.
This treatment was also tested internationally with 100 patients from hospitals in Chicago, Sheffield, Stockholm, and Sao Paolo, according to BBC.They were either being treated with Stem Cell Treatment or the Conventional Drugs. According to the test results, there was only one relapse among 52 patients who had the stem cell treatment and 3 failed transplant treatment. In contrary, those who were given conventional drug treatment showed poorer results with 39 of 50 patients having a relapse within a year. Over three years, the treatment failed for 30 of them.
Besides slowing down disease progression, the Stem Cell treatment also reduces disability for people with MS. Louise Willmetts, 36, from Rotherham said to BBC that she was free from symptoms of MS since she was diagnosed in 2010 and described the experience as a miracle.
However, the researchers said that AHSCT comes with some risks. Since the chemotherapy deactivates the immune system for a short period of time, it can shut down disease fending mechanism during the time. Those who were treated also had relapsing-remitting MS (RRMS), which is common in people with multiple sclerosis (MS). There are many symptoms during RRMS which includes numbness and a tingling pain that runs down the spine when bending the neck.
Despite possible risks and relapses, the treatment gives hope to patients who are currently affected by multiple sclerosis (MS), considering there is no cure at the moment. Prof John Snowden, Director of blood and bone marrow transplantation at Sheffield’s Royal Hallamshire Hospital, told the BBC: “We are thrilled with the results – they are a game changer for patients with drug resistant and disabling multiple sclerosis.”
The US Food and Drug Administration (FDA) planned to speed up the process to regulate Stem Cell Therapy so that it would be both safe and effective for patients. Months ago, the FDA led a crack down on stem cell clinics, however it announced later on that it will support innovation in Stem Cell treatment, according to CNN.
FDA announced that there needs to be a balance between safety and innovation when it comes to the possibilities of using stem cells in medicine. This evaluation was based on a paper written by Dr. Scott Gottlieb, the FDA commissioner, and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
FDA’s aim is to adjust its traditional tools used for regulation of Stem Cell Therapy so that it could meet modern challenges and opportunities created by innovative products used as stem cell Regenerative Medicine Treatment. Gottlieb and Marks also remarked that despite the widespread application of stem cells as Regenerative Medicine, the clinical benefits still have not yet been clearly proven.
Paul Knoepfler, professor of cell biology and human anatomy at the University of California, Davis School of Medicine, who wrote a blog post about the paper said to CNN, “The FDA seems to be saying they want to find a sweet spot of stem cell oversight where they encourage innovation by good citizens and yet also carefully regulate this sphere as well as encouraging those interested in transplanting stem cells into patients to work with the FDA.”
Proving Effectiveness of Stem Cell Treatment Through Multipotent Stromal Cells
FDA have acknowledged the many benefits of Stem Cell Therapy. Currently, Stem Cell technology has the ability to regenerate all types of complex tissue which gives the potential for stem cells the ability to treat diseases. Stem cell therapies can treat illnesses infecting the blood, including acute myeloid leukemia and HIV infections. One of the ways Stem Cell Treatment is used is through Regenerative Treatment which involves the process of destroying the diseased immune system and transplanting healthy hematopoietic stem cells, instead. Hematopoietic cells play a role in replenishing the lost immune cells without restoring the disease. Besides treating illnesses, stem cells also has the ability to repair visual impairment or slow down the aging process.
Despite research that Stem Cell Therapy could help treat diseases, there are limited ways to prove its effectiveness. Currently, stem cell- based products are tested by the FDA using a small number of cell surface markers and by measuring cell product activity.
One of the ways FDA is trying to create a high standard in Stem Cell therapy is through studying multipotent stromal cells. FDA’s Multipotent Stromal Cell Consortium, a team of scientists studying these cells are hoping that it could help in standardizing and developing stem cell therapy practices. Multipotent stromal cells differentiate into a variety of cell types and could contribute to tissue repair or help replace, restore or regenerate other parts of the body.
Steven Bauer, chief of the cellular and tissues therapy branch in the Center for Biologics Evaluation and Research, gave a presentation that focused on how multipotent stromal cells can ensure predictability in its result in therapies. He concluded that using the information from the studies of the cells could help generate standards of Stem Cell Therapy that could help further develop regenerative medicine and products.
Regenerative Medicine witnessed a giant leap towards the future when the U.S. Food and Drug Administration (FDA) has finally granted the permission for the production of automated stem cells in large quantities. Stem Cells, which are the basic building blocks of the human body, have the ability to regenerate and replicate to become any specialised type of cells. They are known to have the potential to promote tissue repair and healing of several tissues, including bone, heart, and brain.
With the exponential increase of the quantities of stem cells, this initiative by FDA will pave ways for significant medical advancement. First, it could rise as the solution for cells insufficiency. The current Stem Cell production has long been a time-consuming and a labor-intensive process, in which researchers must carefully cultivate hundreds of flasks only to produce enough stem cells for a few patients. The surplus of the supplies now means Stem Cell treatment for a wide-range of conditions is made available for patients even on a short notice.
Stem Cells possess the ability of regenerating and developing into any cell, organ or tissue of specific function. It is also one of the most practical and effective way to repair cell damage and treat fatal injuries or cell degeneration in different body parts. Stem Cell Treatment with Verita Neuro has shown potential in treating many degenerative conditions. Please contact us for more information about the treatments and supportive therapies.
The researchers found that stem cells can mature into sensory interneurons, which can help in the recovery of spine damages. Interneurons are involved with reflex functions in the brain, like moving your hand away from a hot iron. They also process, react, or pass the information to the brain for analysis.
However, to be able to use this discovery in a medical treatment, researchers must find a way to differentiate stem cells into sensory interneurons, which is a new challenge for scientists who had already found ways to differentiate stem cell neurons.
“Directing stem cells into spinal motor neurons was developed a while ago,” said Samantha Butler, a professor of neurobiology and senior author of the research to Daily Bruin, “But how to differentiate stem cells into sensory interneurons was really an open question – a protocol needed to be developed.”
Young stem cells can differentiate or mature into specific cell types, like blood cells or neurons, according to the National Institutes of Health. To replace old or damaged tissues with young and healthy cells, it is crucial to learn how to differentiate stem cells into specific neuron types.
According to the article, Spinal Cord Injuries cost $40 billion in health care annually in the United States. Current therapies are only enough to protect patients from further spinal cord damage, however Stem Cell therapies may reverse and repair damage by replacing damaged cells with new ones.
Motor Neurone Disease Awareness Month takes place in June of every year. Its purpose is to help raise awareness of Motor Neurone Disease (MND), which is a group of diseases that affect the nerve cells, especially motor neurons in the brain and spinal cord. These neurons that control movement gradually fail to reach the muscles responsible for speaking, swallowing, and breathing, causing the muscles to gradually weaken, stiffen, and eventually stop function. MND usually affects people, and not limited to, over 50 years old and above. Although, life expectancy of MND patients is between two and five years, Stephen Hawking is one of the famous people diagnosed with MND, but lived until he was 76.
One of the most commonly known example of Motor Neurone Disease is Amyotrophic Lateral Sclerosis (ALS), or Lou Gehrig’s Disease, which is named after a baseball player who died from this disease in 1941.
MND Campaign #MyEyesSay Collage
The theme for MND Awareness this year is a continuation from last year’s motto: “But With Motor Neurone Disease, My Eyes Could Be All I Can Move.” As a part of the activities to raise awareness, patients and supporters are encouraged to share their experiences of themselves of their families affected with MND by sharing a message and taking a selfie of their eyes with the hashtag #MyEyesSay. Photos that have been selected will be placed on a big collage on #MyEyesSay website. Several ways to create a selfie can be found on the Awareness Day UK website.
Moreover, on June 21 every year, the International Alliance of ALS/MND Association has also been celebrating Global Day for MND patients,. The association not only aims to raise awareness of the disease by organizing various activities, but to find the underlying causes and treatment for this chronic disease.
About Verita Neuro
To help patients with Motor Neurone Disease, globalstemcells.com and Verita Neuro provide access to a progressive and responsible treatment, which is aimed to increase our patients’ quality of lives. We partner with leading-edge, next generation treatment providers, unique products and services that are integrative, safe and effective. Verita Neuro is not a treatment provider.
Multiple Sclerosis (MS) is a long lasting disease that affects the brain, spinal cord, and the optic nerves in the eyes. It happens when the immune system attacks a fatty material called myelin which wraps around the nerve fibers in order to protect them. Without this outer shell, the nerves become damaged.
Symptoms of Multiple Sclerosis
The damage slows down messages between the brain and body and the nerves stop working as they generally should to help to move and feel. This results in symptoms of MS such as trouble walking, feeling tired, muscle weakness, blurred or double vision, numbness, thinking and memory problems, sexual problems, poor bladder or bowel control, balance control, pain, depression and other basic body functions.
The effects vary from person to person having the disease. Symptoms vary from being mild to severe with some of the people even having trouble getting around and doing daily routine tasks. Louise Willett was suffering from Multiple Sclerosis and it had become very severe 2 years ago. Some of the symptoms of Multiple Sclerosis made her dependent on the wheelchair and caused difficulty in reading. She had lost all hopes of having additions to her family or achieving her career goals.
Stem Cell Treatment
A very new and groundbreaking treatment changed Louise’s future. A high dosage of Chemotherapy, originally used to treat cancer patients, was used to kill her faulty immune system and healthy stem cells were infused back into the bloodstream to revive her immune system. She’s been doing well since she received the treatment two years back. Even the MRI scan showed no trace of active disease in her brain. The treatment helped her regain her life back and after that was also able to give birth to a baby.
Scientists believe that the Stem Cell Treatment, which costs huge sums of money, could be a game changer. Stem Cells are the types of cells that differentiate into many different specialised cells within the body. Stem cells are found in both embryos as well as adults. Moreover, these cells are being explored for their potential benefits for treating Multiple Sclerosis. Results of clinical trials will possibly help to determine what the optimal cells, delivery methods, safety and actual effectiveness of such therapies might offer for people with MS.
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