A win for stem cells



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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Stem Cell Therapy For Knees

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

Stopping arthritis before it starts

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

Clinical Research on Treatment of Psoriasis by Human Umbilical Cord-derived Mesenchymal Stem Cells

Psoriasis is a chronic and recurrent inflammatory skin disease and its histological features are characterized by epidermal hyperplasia, increased angiogenesis and immune cell infiltration. Psoriasis prevalence is about 0.1%-3%, affecting approximately 125 million people worldwide. In China, there are about 10 million psoriasis patients.

Human umbilical cord-derived MSC (huc-MSC) has many advantages for the treatment of immune disease. Because it was demonstrated that huc-MSCs are effective in modulating immune cells and treating diseases and it has low immunogenicity. Furthermore, huc-MSCs do not raise ethical issue for clinical applications.

Some experimental results and cases has showed that mesenchymal stem cell (MSC) can prevent or treat psoriasis. This clinical study is conducted to provide more data to evaluate the effect and safety of treatment of psoriasis by human umbilical cord-derived mesenchymal stem cell.

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40 Pro Athletes Who Have Had Stem Cell Treatments


More and more athletes are turning to stem cell treatments, because the pressure to get back on the field is high and access to these experimental therapies is continuing to increase. Athletes commonly suffer serious injuries that could potentially end their careers and cause them serious long-term health complications. Most of them turn to surgery to resolve those injuries.

However, some of them are  pursuing stem cell treatments and regenerative therapies, because these procedures are less invasive than surgery and have the potential to speed and augment repair. While the effectiveness of these surgeries is largely unknown, what is clear is that a growing number of athletes are turning to this approach.

Athletes Who Have Undergone Stem Cell Treatments

This article outlines 40 pro athletes who have undergone stem cell treatments for their knees, hips, ankles, shoulders, and more. It also includes athletes who have pursued regenerative therapies, such as platelet-rich plasma (PRP) therapy.

In my case as a professional athlete, I received both of these therapies within a short time frame with each other, because there is evidence to indicate that PRP injections can positively impact stem cell treatment outcomes.

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40 Pro Athletes Who Have Had Stem Cell Treatments


What Is the Future of the Stem Cell Market in 2022?


Stem cell therapy continues to rally worldwide recognition as governments fund research and expand access. This once-controversial therapy is fast becoming one of medicine’s most exciting technologies. From FDA-approved therapies to in-house, physician-initiated autologous techniques, stem cell technology continues to evolve. 2022 promises to be an exciting year for the stem cell market.

The Stem Cell Market in 2022 and Beyond

Government and private funding is the main engine behind stem cell therapy’s persistent growth. Robust research has led to advances in all types of regenerative therapies, with stem cell technology at the forefront.

If anybody doubts the future of stem cells, they should look at their soaring market potential. Here are the top nine driving forces behind the stem cell market’s accelerating momentum.

1. Oncology Applications

While treating cancer with stem cells is not new, the field of cancer treatment is where stem cell therapy excels. With an aging population comes a global rise in cancer rates. While stem cell therapy can help treat certain forms of cancer, it has also proved helpful in combating the damaging effects of chemotherapy.

For over 50 years, hematopoietic stem cell transplants (HSCT) derived from bone marrow or cord blood have been used to treat many cancer forms. Hematopoietic stem cells are widely used in cancer treatments. The key to their popularity? Their ability to form a variety of cell types that constitute our blood and immune system.

Bone marrow transplants have been used to treat cancers such as:

  • Multiple myeloma
  • Neuroblastoma
  • Leukemia
  • Lymphoma (certain types)

Also, scientists and clinicians are learning how to better genetically match and administer these cells, as well as care for patients after stem cell transplantation. The result is the prevention of dangerous conditions like graft versus host disease (GvHD).

2. Dermatology

Dermatology is another area that lends itself to stem cell adoption. Autologous epidermal stem cells can treat various types of skin conditions, including severe burns. Renovacare’s Skin Gun™ is an example of a technology that uses the patient’s own skin as a stem cell source. A doctor can take a sample of a patient’s skin and place it in the Skin Gun™. The device “blends” the sample into a solution, which then can be sprayed as a thin mist on the affected area. The result is that the burn area readily accepts the genetically-similar sample and can go about regenerating skin locally.

Other dermatology conditions that can make use of stem cell therapy include wound healing, treatment of severe blistering, and skin manifestations of autoimmune diseases.

3. Regenerative Medicine

Stem cell therapy is, by definition, regenerative. But what about its applications for overall human longevity? If you want to get a glimpse into what the future holds for stem cell therapy, consider that stem cells may hold the key to staving off chronic disease as well as replacing old organs.

The net result? A drastically-slowed rate of aging and an average life expectancy well into one’s 80s (and beyond). It is said that the first human who will live to two hundred has already been born. Stem cell technology will undoubtedly play a large role in the long life of future generations.

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What Is the Future of the Stem Cell Market in 2022?