Category Archives: Stem Cell Therapy

In May 2023, the FDA granted accelerated approval to epcoritamab-bysp (Epkinly) for the treatment of adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma (HGBL), following 2 or more lines of systemic therapies. Shortly thereafter, in June 2023, the FDA granted accelerated approval to glofitamab-gxbm (Columvi) as a fixed duration treatment for patients with R/R DLBCL not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after 2 or more lines of systemic therapy.

In this episode of The Vitals, Laura Zitella, MS, RN, ACNP-BC, AOCN, who is a hematology nurse practitioner in the Hematology, Blood, Marrow Transplant, and Cellular Therapy (HBC) program at UCSF Health and associate clinical professor in the Department of Physiological Nursing at the University of California San Francisco, joins Oncology Nursing News to discuss how these newly approved bispecific antibodies are expanding third-line treatment options for patients with DLBCL.

Bispecific antibodies are antibodies that generally have at least 2 antigen binding sites: 1 binding site is to the antigen of interest on the cancer cell, and in lymphoma, that's often CD19, or CD20. The other antigen binding site is to CD3, which is a T-cell marker.

Unfortunately, we do not cure all patients with second-line therapy, [and] the bispecifics are used for third-line therapy, where we have historically had limited treatment options.

One of the big advantages of bispecific antibodies is that they are off-the-shelf; they do not need to be manufactured, and they are available immediately.

Epcoratimab is a subcutaneous [administration] bispecific antibody, whereas glofitamab is an intravenous [administration]. Both require step-up dosing, which means that you start with a small dose and then the subsequent doses are a little bit higher, and a little bit higher until you reach your treatment dose.

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Laura Zitella Discusses the Growing Arsenal of Bispecific Antibodies ... - http://www.oncnursingnews.com/

FRIDAY, Dec. 1, 2023 (HealthDay News) -- The repeat head injuries suffered by football players, boxers and other athletes appear to affect brain health long after players have given up their sport.

New research from Johns Hopkins University in Baltimore could explain why: The persistence in the brain of inflammation tied to the original injury or injuries.

The findings show that participating in repeated collision sports like football may have a direct link to long-term inflammation in the brain, study senior author Dr. Jennifer Coughlin said in a university news release.

She's an associate professor of psychiatry and behavioral sciences at Hopkins.

Key to the new findings is a brain "repair protein," with the unwieldy name of 18 kDa translocator protein -- shortened to TSPO.

Whenever a brain sustains injury, TSPO levels quickly rise as the brain tries to heal. TSPO is closely associated with immune cells in the brain called microglia, Coughlin's group noted.

It was thought that spikes in TSPO were only temporary. However, prior studies revealed that levels of the pro-inflammatory protein can remain elevated for up to 17 years.

In the new study, the Hopkins team examined PET and MRI brain scans of 27 former NFL players, taken between 2018 and early 2023.

They used the scans to compare levels of TSPO in the football players' brains to those seen in brain scans of 27 former pro college swimmers -- athletes who would not be expected to have sustained head injuries.

The swimmers and the football players were all male and ranged between 24 and 45 years of age.

Brain levels of TSPO were higher, on average, in scans taken from the football players versus those from the swimmers.

Football players also performed notably worse than swimmers on tests that tracked learning and memory skills.

These findings are relevant to both collision sport athletes and other populations that suffer from single or reoccurring mild TBIs, including those experienced during military training and repeated head-banging behaviors in children, Coughlin said in a Hopkins news release.

Should treatments to lower brain TSPO be given to older individuals with a history of head injury? Probably not, the researchers cautioned.

Since TSPO is associated with [brain] repair, we dont recommend the use of drugs or other interventions at this time," Coughlin explained. "Instead, we will continue to monitor TSPO levels through more research, in order to test for sign of resolution of the injury with more time away from the game.

Following more research, it might be possible to find treatments that can safely reduce long-term inflammation in the brain, the researchers said.

With that in mind, Coughlin's group plans to track TSPO levels in the brains of former NFL athletes over time, seeing which brains heal and which do not. That could give clues to new treatments or guidelines that would encourage long-term healing.

The findings were published recently in the journal JAMA Network Open.

More information

There's more on the health impact of sports-related concussion at the University of Michigan.

SOURCE: Johns Hopkins University, news release, Nov. 29, 2023

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Persistent Inflammation Could Drive Brain Issues in Former Football ... - HealthDay

This leukemia treatment uses strong drugs that travel throughout the childs body to kill cancer cells. Chemotherapy is the main treatment for ALL, acute myeloid leukemia (AML), and acute promyelocytic leukemia (APL).

Chemotherapy for leukemia can be given in a few different ways:

If your child is getting chemotherapy through an IV, they might have a small procedure first to place a small plastic tube called a port into a blood vessel under their skin. The chemotherapy will go into this tube to prevent them from going through multiple needle sticks over the many months or years of treatment.

Usually, chemotherapy is divided into three phases:

During this period, which lasts about a month, your child will receive a combination of different chemotherapy drugs. The goal is to put their cancer into remission, meaning there are no more signs of leukemia cells in their blood and bone marrow.

Children with ALL and AML may also get chemotherapy into their cerebrospinal fluid (the fluid around their brain and spinal cord) to kill any leukemia cells that may have spread there. This type of chemotherapy is delivered through a spinal tap.

More than 95 percent of children with ALL and up to 90 percent of those with AML will go into remission within a month after starting on induction treatment, says the American Cancer Society. This means there are no signs of cancer cells in their bone marrow and blood. The cancer isnt necessarily cured at this stage, but it is under control.

During this intense treatment period, your child will make many trips to the doctor. They may also need to stay in the hospital periodically to manage any treatment complications, like infections.

This next phase starts once your child is in remission, and it lasts for several months. Consolidation is a more intense phase that involves getting a combination of several chemotherapy drugs to kill any remaining cancer cells. Kids with high-risk leukemia (their cancer has certain gene changes that make it more resistant to treatment or more likely to return) may get additional chemotherapy drugs to prevent the cancer from coming back.

The last phase of treatment is designed to prevent the cancer from relapsing. Kids with ALL will get a combination of medicines, but often in lower doses than in the first two phases, according to the Leukemia and Lymphoma Society.

There is no maintenance phase for AML. Instead, children with this cancer will get higher doses of chemotherapy for a shorter period of time often less than a year, according to the American Cancer Society.

Because chemotherapy doesnt target cancer cells specifically, it can also kill some healthy cells. The most common side effects with this treatment are:

Most side effects will go away once your child finishes treatment. Their oncologist can prescribe medicines to prevent some of them, including nausea, vomiting, tiredness, and bleeding.

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Childhood Leukemia Treatment Options: Chemotherapy, Stem Cell ... - Everyday Health

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COVID-19 outcome is not affected by anti-CD20 or high-titer ... - Nature.com

THURSDAY, Nov. 30, 2023 (HealthDay News) -- Tinnitus, or "ringing in the ears," affects up to 1 in every 10 people and can be disabling for some.

Now, scientists at the Massachusetts Ear and Eye Infirmary believe they may have discovered a key cause of the condition: A degeneration of nerves crucial to hearing.

We wont be able to cure tinnitus until we fully understand the mechanisms underlying its genesis. This work is a first step toward our ultimate goal of silencing tinnitus," said study senior author Stphane Maison, a principal investigator at Mass Eye and Ear and clinical director of the Mass Eye and Ear Tinnitus Clinic.

The buzzing, ringing and even roaring of tinnitus can impair everyday life.

Beyond the nuisance of having persistent ringing or other sounds in the ears, tinnitus symptoms are debilitating in many patients, causing sleep deprivation, social isolation, anxiety and depression, adversely affecting work performance and reducing significantly their quality of life, Maison said in a Mass Eye and Ear news release.

Numerous theories have been floated as to the origins of tinnitus. As far back as 2009, researchers at Mass Eye and Ear discovered that folks can develop the condition even after they test normal on a standard hearing test.

That led them to a condition dubbed cochlear synaptopathy -- a kind of "hidden" hearing loss involving loss of the auditory nerve.

In their study, Maison's group examined patients who had normal hearing on tests, but also had tinnitus.

They confirmed a loss of auditory nerve function among these patients, as well as a kind of hyperactivity in the patients' brainstems.

The study was published Nov. 30 in the journal Scientific Reports.

Our work reconciles the idea that tinnitus may be triggered by a loss of auditory nerve, including in people with normal hearing, Maison said.

His team now plans to conduct research aimed at seeing whether a restoration of auditory nerve function might banish tinnitus.

The idea that, one day, researchers might be able to bring back the missing sound to the brain and, perhaps, reduce its hyperactivity in conjunction with retraining, definitely brings the hope of a cure closer to reality, Maison explained.

More information

Find out more about tinnitus at the National Institute of Deafness and Other Communication Disorders.

SOURCE: Massachusetts Ear and Eye Infirmary, news release, Nov. 30, 2023

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New Clues to What Might Drive Tinnitus - HealthDay

New research has identified 38 direct-to-consumer businesses marketing stem-cell treatments and exosome therapies for COVID-19 infections and, especially, long COVID, despite lacking approval by US Food and Drug Administration and other regulatory body in the United States. Descriptions of the businesses and an analysis of their marketing strategies are published in Stem Cell Reports.

The 38 businesses operated or facilitated access to 60 clinics, almost all in the United States and Mexico, the authors said. The businesses were identified via web-based searches including "stem cell COVID treatments," "stem cell clinic treating COVID-19," and "exosome therapy for COVID-19."

Once businesses were identified, the researchers, from the University of California, Irvine, tracked how many clinics the companies operated, and they searched social media sites and platforms for the businesses.

Twenty-four of the 60 clinics (40%) listed on websites of theidentified businesses were in theUnited States, 22 (37%) were in Mexico, four (7%) were in Ukraine, and two (3%) were in the Cayman Islands. Guatemala, Malaysia, Panama, Philippines, Poland, Spain, Thailand, and the United Arab Emirates had one clinic each (around 2% per country).

Thirty-six of the 38 marketed their stem cell and exosome products as treatments for long COVID, six advertised them as "immune boosters," five claimed to treat patients in the acute infection phase, and two claimed their products were preventive.

Twenty businesses (53%) sold umbilical cord blood or umbilical cord tissuederived mesenchymal stem cells, and 16 (42%) marketed exosomes. Methods for treatment delivery varied, with 58% reportedly using intravenous infusions, and 21% claimed they nebulized their product. Eleven businesses (29%) did not specify how they administered their products, the authors said.

Only nine of the businesses clearly advertised how much services cost, with the lowest treatment available at $2,950. The most expensive was $25,000, and the average listed cost for patients was $11,322.

Almost all online and social media advertising was aimed toward relieving symptoms of long COVID, including brain fog and fatigue.

The patients being targeted by such marketing claims are particularly vulnerable.

"The patients being targeted by such marketing claims are particularly vulnerable, " said Leigh Turner, PhD, lead author and a bioethics professor in the University of California, Irvine Department of Health, Society, and Behavior in a press release from Cell Press, the journal's publisher.

"They're suffering, and in some cases, they've been suffering for a long time, making them highly susceptible to misleading marketing representations and persuasive marketing pitches.

In a conclusion on the study, the authors wrote that, until evidence of efficacy is studied and approved by regulatory bodies, vulnerable patients will be exploited by online businesses.

"Further clinical research should provide insight into whether specific stem cell-based interventions or exosome products are backed by sufficient evidence of safety and efficacy related to treating or preventing COVID-19 to warrant premarketing approval or emergency use authorization by national regulators," the authors wrote. "Absent such evidence, patients are vulnerable to being exploited by businesses using direct-to-consumer online advertising to make persuasive but unjustified claims about treating or preventing COVID-19."

Link:
Unapproved stem-cell therapies marketed to people with long COVID - University of Minnesota Twin Cities