The stem cell industry has scored a major victory in its efforts to keep patient treatments exempt from Food and Drug Administration regulations, brushing aside the regulatory agency’s concerns that the therapies are unproven and could be dangerous.
The FDA made that argument in 2018 when it sought court orders to stop the Beverly Hills and Rancho Mirage offices of the California Stem Cell Treatment Center from administering the treatments. The move was part of a years long FDA crackdown on clinics nationally claiming that stem cells can treat or cure conditions including orthopedic injuries, Alzheimer’s and Parkinson’s diseases, multiple sclerosis, and erectile dysfunction.
Federal Judge Jesus G. Bernal of the U.S. District Court for the Central District of California oversaw a seven-day trial in May 2021 based on the FDA’s lawsuit against CSCTC. More than a year later, on Sept. 1, Bernal issued a ruling siding with CSCTC. Bernal effectively rejected the FDA’s argument that the clinics were selling unapproved drug products in the form of adipose cell mixtures, or connective tissue that is mainly composed of fat cells called adipocytes.
Industry attorneys say the FDA is likely to appeal the ruling by Bernal, who is based in Riverside, California, and was nominated to the federal bench in 2012 by then-President Barack Obama and confirmed by the Senate. But for now, it makes more difficult the agency’s efforts to regulate some stem cell clinics. And it gives a green light to people seeking to use personal stem cells as part of medical treatments.
The FDA’s lawsuits named as defenders CSCTC’s founders, Dr. Elliot Lander and the late Dr. Mark Berman, who died in April. Lander said in a statement that Bernal’s ruling was a vindication of his company’s scientific and medical bona fides.
“We appreciate the Court’s clear and unequivocal ruling, which affirms what we have been saying for 12 years: that our innovative surgical approach to personal cell therapy is safe and legal,” Lander said. “With this victory behind us, we look forward to refocusing our energy on our practice and harnessing life-changing stem cell treatments to support doctors and benefit patients across the country.”
In a request for comment, a spokesperson for the regulatory agency said, “The FDA is reviewing the court’s decision and does not have further comment at this time.”
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Health begins with understanding. And in recent decades, science has come to understand a lot about the human body. Particularly, our genetics. This has unlocked promising options for doctors and patients to treat some of the most debilitating diseases. Scientists are looking for answers where biology, chemistry and data science meet.
Cell and gene therapies offer hope to millions of people living with genetic and some degenerative diseases. These new treatment options are a paradigm shift. They don’t just treat symptoms. They help the body repair itself from within.
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Stem cell therapy for knees has the potential to provide relief to a lot of people. Knee pain is an common condition that affects millions of Americans and people around the world. Considering the daily load that legs bear, a problem with your knees can limit movement. Knee pain can substantially reduce your quality of life and anti-inflammatory medication can only do so much. Suffice it to say, there exists significant interest in finding solutions to address knee pain and to restore healthy joint function.
That’s where stem cell therapy for knees comes in.
Why Is Stem Cell Therapy For Knees Important?
With the growing power of regenerative medicine, more physicians are now able to offer affordable, cost-effective and – most importantly – long-lasting treatments that address pain in the short and long term. Stem cell therapy for knees carries with it the possibility to make knee joint pain obsolete.
Despite the promise of regenerative therapy, however, it’s still important to perform due diligence before making a decision. This requires understanding some facts about knee pain. These facts include what causes it, how stem cell therapy provides relief, how it works, and who’s a good candidate.
The Prevalence and Problem of Knee Pain
More than a third of Americans suffering from arthritis experience severe joint pain (arthritis), the number rising to 15 million in 2014. A recent Korean study concluded that 46.2% of people over 50 suffered some type of knee pain, of which roughly 32.2 percent are men and 58.0 percent are women.
Unfortunately, treatments are limited. Cortisone injections can cause secondary issues at the site of injection. Patients may suffer joint infection, nerve damage, skin thinning, temporarily greater pain, tendon weakening, bone thinning, and bone death. These are clearly not minimal risks. Other treatments include knee replacement surgery. This also carries all the normal risks of anesthesia and invasive procedures, and anti-inflammatory medications, which are the prevailing cause of acute liver failure in the United States.
One can easily see the appeal of a simple injection. So exactly how does stem cell therapy work? What are recovery times like, what conditions does it treat, and who can get the treatment? These are critical questions to ask before embarking on a course of stem cell therapy. In fact, they should be asked even before setting up a consultation.
The main conditions treated by stem cell injections include knee osteoarthritis, cartilage degeneration, and various acute conditions, such as a torn ACL, MCL, or meniscus. Stem cell therapy may speed healing times in the latter, while it can actually rebuild tissue in degenerative conditions such as the former.
That’s a major breakthrough. Since cartilage does not regenerate, humans only have as much as they are born with. Once years of physical activity have worn it away from joints, there is no replacing it. Or at least, there wasn’t before stem cell therapy. Now, this cutting-edge technology enables physicians to introduce stem cells to the body. These master cells are capable of turning into formerly finite cell types to help the body rebuild and restore itself.
How Does Stem Cell Therapy Work?
Although it may sound like an intensive procedure, stem cell therapy is relatively straightforward and usually minimally invasive. These days, physicians have many rich sources of adult stem cells, which they can harvest right from the patient’s own body. This obviates the need for embryonic stem cells, and thereby the need for moral arguments of yore.
Mesenchymal stem cells (MSCs) are one of the main types used by physicians in treating knee joint problems. These cells live in bone marrow, but increasing evidence shows they also exist in a range of other types of tissue. This means they can be found in places like fat and muscle. With a local anesthetic to control discomfort, doctors can draw a sample of tissue from the chosen site of the body. The patient usually doesn’t feel pain even after the procedure. In some cases, the physician may choose to put the patient under mild anesthesia.
They then isolate the mesenchymal stem cells. Once they have great enough numbers, physicians use them to prepare stem cell injections. They insert a needle into the tissue of the knee and deliver the stem cells back into the area. This is where they will get to work rebuilding the damaged tissue. Although the mechanisms aren’t entirely clear, once inserted into a particular environment, mesenchymal stem cells exert positive therapeutics effects into the local tissue environment.
Mechanisms of action of mesenchymal stem cells appear to include reducing inflammation, reducing scarring (fibrosis), and positively impacting immune system function.
That’s not quite enough to ensure a successful procedure, however. That’s why stem cell clinics may also introduce growth factors to the area. These are hormones that tell the body to deliver blood, oxygen, and nutrients to the area, helping the stem cells thrive and the body repair itself.
Physicians may extract these growth factors from blood in the form of platelet-rich plasma (PRP). To do this, they take a blood sample, put it in a centrifuge and isolate the plasma, a clear liquid free of red blood cells, but rich in hormones needed for tissue repair.
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Stem Cell Therapy For Knees
Low back pain (LPB) is the main cause of disability worldwide with enormous socioeconomic burdens. A major cause of LBP is intervertebral disc degeneration (IDD): a chronic, progressive process associated with exhaustion of the resident cell population, tissue inflammation, degradation of the extracellular matrix and dehydration of the nucleus pulposus. Eventually, IDD may lead to serious sequelae including chronic LBP, disc herniation, segmental instability, and spinal stenosis, which may require invasive surgical interventions. However, no treatment is actually able to directly tackle IDD and hamper the degenerative process. In the last decade, the intradiscal injection of stem cells is raising as a promising approach to regenerate the intervertebral disc. This review aims to describe the rationale behind a regenerative stem cell therapy for IDD as well as the effect of stem cells following their implantation in the disc environment according to preclinical studies. Furthermore, actual clinical evidence and ongoing trials will be discussed, taking into account the future perspective and current limitations of this cutting-edge therapy.
A literature analysis was performed for this narrative review. A database search of PubMed, Scopus and ClinicalTrials.gov was conducted using “stem cells” combined with “intervertebral disc”, “degeneration” and “regeneration” without exclusion based on publication date. Articles were firstly screened on a title-abstract basis and, subsequently, full-text were reviewed. Both preclinical and clinical studies have been included.
The database search yielded recent publications from which the narrative review was completed.
Based on available evidence, intradiscal stem cell therapy has provided encouraging results in terms of regenerative effects and reduction of LBP. However, multicenter, prospective randomized trials are needed in order confirm the safety, efficacy and applicability of such a promising treatment.
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Stem cell treatment and biology as a multicellular embryonic concept or adult organismas a symbol for cellular therapy as a 3D illustration.
As we age, so do our eyes; most commonly, this involves changes to our vision and new glasses, but there are more severe forms of age-related eye problems. One of these is age-related macular degeneration, which affects the macula — the back part of the eye that gives us sharp vision and the ability to distinguish details. The result is a blurriness in the central part of our visual field.
The macula is part of the eye’s retina, which is the light-sensitive tissue mostly composed of the eye’s visual cells: cone and rod photoreceptor cells. The retina also contains a layer called the retinal pigment epithelium (RPE), which has several important functions, including light absorption, cleaning up cellular waste, and keeping the other cells of the eye healthy.
The cells of the RPE also nourish and maintain the eye’s photoreceptor cells, which is why one of the most promising treatment strategies for age-related macular degeneration is to replace aging, degenerating RPE cells with new ones grown from human embryonic stem cells.
Scientist have proposed several methods for converting stem cells into RPE, but there is still a gap in our knowledge of how cells respond to these stimuli over time. For example, some protocols take a few months while others can take up to a year. And yet, scientists are not clear as to what exactly happens over that period of time.
Mixed cell populations
“None of the differentiation protocols proposed for clinical trials have been scrutinized over time at the single-cell level — we know they can make retinal pigment cells, but how cells evolve to that state remains a mystery,” says Dr Gioele La Manno, a researcher with EPFL’s Life Sciences Independent Research (ELISIR) program.
“Overall, the field has been so focused on the product of differentiation, that the path undertaken has been sometimes overlooked,” he adds. “For the field to move forward, it is important to understand aspects of the dynamics of what happens in these protocols. The path to maturity could be as important as the end state, for example for the safety of treatment or for improving cell purity and reducing production time.”
Tracking stem cells as they grow into RPE cells
La Manno has now led a study with Professor Fredrik Lanner at the Karolinska Institute (Sweden) profiling a protocol for differentiating human embryonic stem cells into RPE cells that is actually intended for clinical use. Their work shows that the protocol can develop safe and efficient pluripotent stem cell-based therapies for age-related macular degeneration. The study is published and featured on this month’s cover of the journal Stem Cell Reports.
“Standard methods such as quantitative PCR and bulk RNA-seq capture the average expression of RNAs from large populations of cells,” says Alex Lederer, a doctoral student at EPFL and one of the study’s lead authors. “In mixed-cell populations, these measurements may obscure critical differences between individual cells that are important for knowing if the process is unfolding correctly.” Instead, the researchers used a technique called single-cell RNA sequencing (scRNA-seq), which can detect all the active genes in an individual cell at a given time.
Looking at intermediate states
Using scRNA-seq, the researchers were able to study the entire gene expression profile of individual human embryonic stem cells throughout the differentiation protocol, which takes a total of sixty days. This allowed them to map out all the transient states within a population as they grew into retinal pigment cells, but also to optimize the protocol and suppress the growth of non-RPE cells, thus preventing the formation of contaminant cell populations. “The aim is to prevent mixed cell populations at the time of transplantation, and to make sure the cells at the endpoint are similar to original RPE cells from a patient’s eye,” says Lederer.
What they found was that on the way to becoming RPE cells, stem cells go through a process very similar to early embryonic development. During this, the cell culture took up a “rostral embryo patterning,” the process that develops the embryo’s neural tube, which will go on to become its brain and sensory systems for vision, hearing, and taste. After this patterning, the stem cells began to mature into RPE cells.
Eye-to-eye: transplanting RPE cells in an animal model
But the point of the differentiation protocol is to generate a pure population of RPE cells that can be implanted in patients’ retinas to slow down macular degeneration. So the team transplanted their population of cells that had been monitored with scRNA-seq into the subretinal space of two female New Zealand white albino rabbits, which are what scientists in the field refer to as a “large-eyed animal model.” The operation was carried out following approval by the Northern Stockholm Animal Experimental Ethics Committee.
The work showed that the protocol not only produces a pure RPE cell population but that those cells can continue maturing even after they have been transplanted in the subretinal space. “Our work shows that the differentiation protocol can develop safe and efficient pluripotent stem cell-based therapies for age-related macular degeneration,” says Dr Fredrik Lanner, who is currently making sure the protocol can be soon used in clinics.
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