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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Purpose of review: Regenerative medicine through interventional pain procedures is evolving with data demonstrating efficacy for a number of pain states in recent years. Platelet-rich plasma (PRP), defined as a sample of plasma with a platelet concentration 3 to 5 times greater than the physiologic platelet concentration found in healthy whole blood, releases bioactive proteins which can restore anatomical function in degenerative states. PRP is dense in growth factors, such as platelet-derived growth factor, transforming growth factor-beta1, basic fibroblastic growth factor, vascular endothelial growth factor, and epidermal growth factors.
Recent findings: To date, well-designed case-control or cohort studies for the use of PRP have demonstrated efficacy in lumbar facet joint, lumbar epidural, and sacroiliac joint injections. At present, there is only level IV evidence indicating the need for larger and more carefully controlled prospective studies. PRP is utilized autogenously in order to facilitate healing and injection and has been studied in the long-term management of discogenic low back pain. In this regard, numerous studies have evaluated PRP to steroid injections in chronic pain states with favorable results. PRP represents an opportunity for a new strategy in the therapeutic treatment of degenerative states of spines, joints, and other locations throughout the body with evolving data demonstrating both safety and long-term efficacy.
To learn more about these treatments, please contact Miami Stem Cell (305) 598-7777 or by visiting: www.stemcellmia.com
A novel off-the-shelf bio-implant containing embryonic stem cells has the potential to revolutionize the treatment of cartilage injuries
More than a million Americans undergo knee and hip replacements each year. It’s a last resort treatment for pain and mobility issues associated with osteoarthritis, a progressive disease caused by degeneration of the protective layer of cartilage that stops our bones grinding together when we sit, stand, write, or move around.
But what if doctors could intervene and repair damaged cartilage before surgery is needed?
For the first time, researchers at the Keck School of Medicine of USC have used a stem cell-based bio-implant to repair cartilage and delay joint degeneration in a large animal model. The work will now advance into humans with support from a $6 million grant from the California Institute of Regenerative Medicine (CIRM).
The research, recently published in npj Regenerative Medicine, was led by two researchers at the Keck School of Medicine of USC: Denis Evseenko, MD, PhD, associate professor of orthopaedic surgery, and stem cell biology and regenerative medicine, director of the skeletal regeneration program, and vice chair for research of orthopaedic surgery; and Frank Petrigliano, MD, associate professor of clinical orthopaedic surgery and chief of the USC Epstein Family Center for Sports Medicine.
Osteoarthritis occurs when the protective cartilage that coats the ends of the bones breaks down over time, resulting in bone-on-bone friction. The disorder, which is often painful, can affect any joint, but most commonly affects those in our knees, hips, hands and spine.
To prevent the development of arthritis and alleviate the need for invasive joint replacement surgeries, the USC researchers are intervening earlier in the disease.
“In some patients joint degeneration starts with posttraumatic focal lesions, which are lesions in the articular (joint) cartilage ranging from 1 to 8 cm2 in diameter,” Evseenko said. “Since these can be detected by imaging techniques such as MRI, this opens up the possibility of early intervention therapies that limit the progression of these lesions so we can avoid the need for total joint replacement.”
That joint preservation technology developed at USC is a therapeutic bio-implant, called Plurocart, composed of a scaffold membrane seeded with stem cell-derived chondrocytes—the cells responsible for producing and maintaining healthy articular cartilage tissue. Building on previous research to develop and characterize the implant, the current study involved implantation of the Plurocart membrane into a pig model of osteoarthritis. The study resulted in the long-term repair of articular cartilage defects.
“This is the first time an orthopaedic implant composed of a living cell type was able to fully integrate in the damaged articular cartilage tissue and survive in vivo for up to six months,” Evseenko said. “Previous studies have not been able to show survival of an implant for such a long time.”
Evseenko said molecular characterization studies showed the bio-implant mimicked natural articular cartilage, with more than 95 percent of implanted cells being identified as articular chondrocytes. The cartilage tissue generated was also biomechanically functional—both strong enough to withstand compression and elastic enough to accommodate movement without breaking.
With support from the $6 million translational grant from CIRM, the researchers are using this technology to manufacture the first 64 Plurocart implants to be tested in humans.
“Many of the current options for cartilage injury are expensive, involve complex logistical planning, and often result in incomplete regeneration,” said Petrigliano. “Plurocart represents a practical, inexpensive, one-stage therapy that may be more effective in restoring damaged cartilage and improve the outcome of such procedures.”
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Stopping arthritis before it starts