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Lawsuit over League City stem-cell treatment headed for trial – Galveston County Daily News

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Lawsuit over League City stem-cell treatment headed for trial - Galveston County Daily News

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Making Moves Toward Cell Therapy for Diabetes – The Scientist

Insulin administration is the current mainstay of type 1 diabetes therapy, but it requires frequent injections and monitoring to provide patients with glycemic control.1 As cell therapies gain traction in the clinic for different disease states, researchers aim to optimize this approach for future diabetes treatments.2 Scientists are looking into islet transplantation as a promising alternative to insulin injections, primarily by creating islet-like cells from human pluripotent stem cell (hPSC) cultures.3

Priye Iworima, a bioprocess engineer at the University of British Columbia, developed a stem cell differentiation protocol for manufacturing insulin-producing cell therapies.

Priye Iworima and Tim Kieffer

Differentiating stem cells into high-quality insulin-producing cells on a large scale for therapeutic manufacturing is a common bottleneck in translational research. In a study published in Stem Cell Research & Therapy, a team of diabetes researchers led by Timothy Kieffer at the University of British Columbia investigated ways to improve scalable manufacturing and demonstrated key parameters for monitoring quality during cell therapy production.4 Their work provides insights for the larger-scale production of hPSC-derived pancreatic cells and suggests ways to standardize the manufacturing process.

The researchers applied a quality-by-design approach, which interrogates the experimental process as part of drug development rather than only testing the properties of the final product. They used this approach to investigate and improve insulin-producing cell manufacturing. In this instance, the process is the product as well, because what we are doing and how we are doing it could impact the quality of the cells that are being made, explained Priye Iworima, a bioprocess engineer from Kieffers laboratory who spearheaded this work.

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Iworima and her colleagues developed and optimized a seven-step cell manufacturing process that differentiates hPSC into insulin-producing islet-like clusters. At each differentiation step, they characterized bioprocess parameters such as cell proliferation, glucose consumption and lactate production rates, and cell fate biomarkers. The researchers enhanced cell yield by adjusting the cell culture process, and they revealed a gradual metabolic shift from glycolysis to oxidative phosphorylation that scientists can monitor as a quality control metric during scalable manufacturing.

Researchers grew functional islet-like clusters in miniature bioreactors.

Priye Iworima

This paper is interesting in that it fills in a gap, said stem cell biologist Joe Zhou from Weill Cornell Medicine, who investigates organoid-derived cell replacement therapies for diabetes and who was not involved in this study. In terms of how you scale production or do quality control, how do you industrialize a cell therapy from the lab toward the clinic? We see very few publications like that in this field.

Iworima believes that her findings will also help researchers evaluate whether intermediate cell products are useful for certain subsets of patients, which could shorten and simplify the manufacturing process. Eventually, we will have different cell products that may be best suited to the individual, whether it is the more terminally differentiated islet-like cluster, or whether it is the pancreatic progenitor, Iworima said.

Previous transplant studies with diabetic rodent models suggested that progenitor cells may be adequate for mature beta cell function postimplantation. The quality control parameters highlighted along the step-by-step process in this study could facilitate future translational applications for progenitor cells and fully differentiated cells alike.

If scientists can overcome in vitro manufacturing barriers such as scale and quality control limitations, cell culture methods for growing insulin-producing islet mimics may help diabetes cell replacement therapies reach patients. The journey of a laboratory protocol from the bench to bedsidepeople always talk about that. But most of the papers are about the bench, Zhou said. It will be good to have this knowledge out there so people do not have to reinvent the wheel. It will be very helpful.

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Making Moves Toward Cell Therapy for Diabetes - The Scientist

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Insights into cellular therapies for cancer treatment – Drug Target Review

Many exciting developments are expected to take place in immunotherapy and oncology in the next few years. We had the privilege of discussing the opportunities of various cell therapies with Dr Nair, Physician in Chief, who elucidates how Lehigh Valley Topper Cancer Institute is directing research towards better treatments, better outcomes, and better patient experience at a lower cost.

Stem cell transplants have saved patients lives time and time again, which led us to launch our own Stem Cell Transplant and Cellular Therapy Program. Stem cell transplants primarily help the immune response through the graft-versus-leukaemia effect, and we have to manage the graft versus host effect.

Notably, in just the last year or so, weve seen significant advances in post-transplant management, which has revolutionised our ability to do mismatch transplants. While historically it has been more difficult to find transplant matches for patients of biracial or mixed ethnicity, new developments are allowing a more diverse population to access life-saving transplants. Recent breakthroughs have made it possible for mismatch transplants to occur with a 50 percent match. Already, this breakthrough has allowed more patients to receive stem cell transplants that otherwise would not have been able to, leading to success stories.

This is a time when several promising treatments including mRNA vaccines, BiTE therapies and CAR-T cell therapy, are essentially in competition with each other they all have a common goal of treating the same disease, but they are approaching the objective from different angles. Ultimately, at Lehigh Valley Topper Cancer Institute we are going to follow the science in the direction that works for our patients. Its this sort of competition that makes being in cancer care an exciting time because we are working toward better and better treatments, better outcomes, and better patient experience at a lower cost.

With CAR-T cell therapy specifically, off-the-shelf CAR-T cell treatment options are the most exciting and prominent subjects of research right now, especially as treatments for conditions like thalassemia or sickle cell disease. This involves the use of CAR-T cell products derived from donor T cells, hence the term off the shelf, making it easier to standardise treatments. There is more to come for CAR-T cell treatments, and I would expect that perhaps in five years, oncologists and hematologists may have to rethink how they approach their fields since clinical research is moving at lightning speed.

While research to optimise BiTE molecules and refine their capabilities is ongoing, this is where most FDA approvals are taking place as the field is developing so rapidly. Two BiTE therapies are already on the market for the treatment of multiple myeloma, and I expect to see many more BiTEs to be unveiled this year. Before too long, I also anticipate the first BiTE for solid tumours will be approved for metastatic melanoma, judging by the speed of current research and approvals. BiTE treatments and mRNA vaccines are the two areas within immunotherapy that are evolving at warp speed. Both treatments harness the immune systems power to tackle cancer cells, which is a smart approach.

Ill also add that at Lehigh Valley Health Network, we have all the competencies to implement these treatments safely at the community level, and we are eager to follow the science since these treatments give our patients new treatment options, particularly our older patients that may not be eligible for other treatments. We are actively looking into opportunities to bring these leading-edge treatments to our patients.

Our priority at Lehigh Valley Topper Cancer Institute is bringing leading-edge treatment to our patients, and our new Stem Cell Transplant and Cellular Therapy Program is certainly an extension of that commitment. Importantly, the program opened last month, and I am excited that the program will allow us to bring the latest treatments directly to the community level. Similarly, as a member of the Memorial Sloane Kettering (MSK) Cancer Alliance, we can bring the latest innovations and treatments from the epicenter of research right here, to patients who may otherwise not have access to that same level of care and collaboration. Lehigh Valley Topper Cancer Institute is one of only three cancer centers in the country participating in the Memorial Sloan Kettering Cancer Center (MSK) Cancer Alliance, which gives us access to innovative care practices. In addition to this alliance, we also conduct our own research and participate in clinical trials to bring the benefits of medical research to the community level.

To this end, last August we opened our Cancer Center at Lehigh Valley HospitalHazleton campus. The impetus for opening this new cancer center was so LVHN patients, particularly those living in this rural area, could have access to our offerings without having to travel far for their care.

Our Stem Cell Transplant and Cellular Therapy Program is still in its infancy, as we just officially launched the programme in January. At this stage, we are evaluating patients with multiple myeloma as potential candidates for autologous stem cell transplants (ASCT), and patients with hematologic malignancies as candidates for allogeneic stem cell transplants (allo-SCT). Looking ahead, we are also looking to launch tumour-infiltrating lymphocyte (TIL) therapy which is expected to receive FDA approval soon as part of our program, for the treatment of metastatic melanoma. A major benefit of now having a Stem Cell Transplant and Cellular Therapy Program is that we are equipped to quickly adapt to new science in real-time and streamline the process of getting our patients the best treatments available.

Dr Amir Toor who is leading our Stem Cell Transplant and Cellular Therapy Program has more than 20 years of experience with autologous and allogeneic transplants, as well as expertise with cellular therapies for hematologic malignancies. He is well poised to head up our efforts with the new program.

We expect many developments to take place in immunotherapy and oncology in the next few years. One of the most exciting advancements right now deals in the solid tumour space for pancreatic cancer and melanomas. Early data on personalised mRNA vaccines in conjunction with checkpoint immunotherapy is very promising, and at Lehigh Valley Topper Cancer Institute, we are looking forward to getting more involved in mRNA vaccine treatments.

Related to this, as a member of the Memorial Sloan Kettering (MSK) Cancer Alliance, we are gearing up for a study that will give our patients access to a combination melanoma vaccine, which will bring new hope to patients who qualify.

Author bio

Dr Nair, Physician in Chief of Lehigh Valley Topper Cancer Institute

Dr Nair, Physician in Chief of Lehigh Valley Topper Cancer Institute, leads the health networks academic programmes. He is the Medical Director of the Lehigh Valley Topper Cancer Institute membership in the Memorial Sloan Kettering Cancer Center Alliance and has practiced oncology in the community setting for 30 years. He is the initial holder of The Auxiliary of Lehigh Valley Hospital Endowed Chair in Cancer.

Dr Nair received his medical degree from Jefferson Medical College. He completed his residency at Geisinger Medical Center and his fellowship at the University of Pittsburgh.

With clinical expertise in melanoma, kidney cancer and immunotherapy, Dr Nairs focus is to provide the highest quality cancer care, including standard and research treatments. He leads a variety of clinical trials at LVHN to provide leading-edge options to patients. Dr Nair started the hematology/oncology fellowship at LVHN and served as the initial program director.

Dr Nair has been a site principal investigator in the National Cancer Institute Cooperative Group Program for more than 25 years, and was the first Chair of the NCI Early Phase Central IRB. He has been a site principal investigator of more than 50 T-cell checkpoint inhibitor trials at Lehigh Valley Topper Cancer Institute.

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Insights into cellular therapies for cancer treatment - Drug Target Review

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Toddler Beats Childhood Leukemia After Car T-Cell Therapy – City of Hope

Can you do Spiderman? the visitor asks.

Like a shot, 6-year-old Julian Juju Castaneda Figueroa strikes the classic pose, crouched low, arm extended, head cocked sideways with eyes intensely focused forward. Superhero stuff.

And you know, its not too much of a stretch to give this cuddly, fidgety, always-in-motion first-grader the superhero label. Let him tell you why.

I want to be the fastest runner in my class, he says. Sometimes I get tired. But Im still faster than all the kindergarten kids. Know why? Because I have 3,000 boosters inside me!

Out of the mouths of babes.

He doesnt really remember what happened to him. If theres a negative memory, its all those needle biopsies, checking his bone marrow. I dont like the pokes, he says.

Mom, on the other hand, does remember. It is difficult for Nancy Figueroa to retell, without a few tears, how she and the little boy shes raising alone in Compton, California, endured a sudden, life-threatening diagnosis, chemotherapy that didnt work, CAR T immunotherapy that did, plus one stem cell transplant, then another. All before Jujus fourth birthday.

Figueroa said her son was a perfectly normal, healthy baby with no significant problems until age 2. Thats when everything changed, seemingly overnight, on May 9, 2019.

He woke up early, like 4 a.m., she recalled. He was crying and complaining about pain in his knee. He was walking with a limp.

She rushed Juju to the emergency room. X-rays and an ultrasound were normal. His bloodwork was not.

The doctor sits down next to me, said Figueroa, and says, Your son has leukemia.

I didnt get it at first. Cancer? What? I didnt understand. Then the doctor walks away and it hits me. I started crying. I called my mother, and shes crying. Then I called Jujus father, and he starts to cry.

Jujus diagnosis was acute lymphoblastic leukemia (ALL), the most common childhood cancer, with some 2,500 new cases each year. ALL in children is highly treatable, with up to a 90% survival rate. However, some cases like Jujus are classified as high risk for a number of reasons, including the patients age and their white blood cell count at the time of diagnosis.

Most children with ALL respond well to chemotherapy. High-risk patients can also be cured, but they require more aggressive chemotherapy. Jujus cancer stubbornly resisted the drugs. After switching his treatments four times without success, doctors referred Juju and his mom to City of Hope, where tens of thousands of patients have received lifesaving bone marrow and stem cell transplants.

Their new doctor tried to be reassuring as Figueroa and her son sat in the examination room.

Nothing really calms them, said Nicole A. Karras, M.D., a pediatric hematologist-oncologist and associate clinical professor at City of Hope Childrens Cancer Center. You just explain, This is what we can do. The fact is, in the last 10 years, were developed so many new therapies. And every year we learn so much more from kids like Julian.

To treat Juju, Karras recommended transplanting stem cells derived from stored umbilical cord blood obtained from the national cord blood bank. This method, in use since 1988, can sometimes be preferable to bone marrow transplants. A precise match is not necessary. Cord blood stem cells generally havent been exposed to infections yet, which means they havent developed immune reactions, so they are less likely to trigger graft-versus-host disease.

There are drawbacks, though. Cord blood units contain a lower volume of stem cells and they engraft more slowly than bone marrow cells, leaving the patient vulnerable to infection for a longer period of time.

In Jujus case, no family member could provide an exact match, but a search turned up cord blood from a nonrelative that matched 99%. In certain circumstances, cord blood can be better than haplo a partial bone marrow match from a relative Karras said.

With any transplant, the long preparation process can be daunting, even frightening. Juju needed intense chemotherapy and radiation to destroy his diseased bone marrow before the transplant could happen. The process was rough on mother and son.

I didnt know what was going on, said Figueroa. I couldnt help him, and it was so hard to see him there, going through those changes. Especially the radiation. It burned his gums, his lips, his skin. He couldnt eat. He was crying. It made me nervous and scared.

But I just wanted him to be healthy. I felt, whatever makes him better, do it.

The cord blood transplant itself, which took place in late 2019, went so smoothly, said Figueroa, that she remembers thinking, Thats it? And for a while, Juju did get better, which made for a happy Thanksgiving and Christmas season. But by June 2020, there were signs that the cancer had returned.

He developed bruises on his back, said Figueroa, and he didnt want to eat much. They went for tests, but I already knew.

I was so angry and upset, she continued, tears flowing now. He was just 3 . She prayed, but I didnt want to believe anymore.

But Karras had a plan. She would use revolutionary CAR T cell therapy to once again bring Juju into remission, clearing the way for a second transplant, if necessary.

CAR T cell treatment works by re-engineering a patients own immune cells to seek out and destroy cancer. City of Hope researchers have led the way in CAR T cell development.

Considered an experimental process just a few years ago, CAR T cell therapy is now the standard of care for a variety of cancers, including relapsed ALL. There are six commercially available CAR T products including one Kymriah specifically for children.

Jujus CAR T treatment did what it was supposed to do. He went into remission, with minimal side effects. Karras performed another bone marrow biopsy to confirm all the cancer was gone. The test showed no active cancer cells, but also indicated a possibility that the malignancy could return. The CAR T treatment alone would not be enough. But a second transplant might provide a cure.

This time, Karras determined that Jujus father would be the best available donor. Figueroa admits this was complicated the couple is no longer together but she also insisted it wasnt hard to ask him and he did come through, agreeing to donate.

This was a fraught time for Juju and his mom. The failure of the first transplant and the need to go through the process all over again took an emotional toll. Karras and many others at City of Hope did their best to help.

Juju got really great care, and it was a team effort, said Karras. Before the second transplant, he and his mom were really traumatized and fearful. We gave them a lot of help so they could get better adjusted.

The effort was not lost on Mom.

Everyone at City of Hope is amazing, Figueroa said. Dr. Karras did everything that had to be done. Shes one of the greatest doctors Ive ever met, and I trust her completely.

The second transplant happened in early 2021. Juju endured a series of difficulties in the ensuing weeks: His liver and kidneys were not functioning properly. It was necessary to place him in intensive care until the transplanted cells began to work and his systems returned to normal.

After that, Juju kept getting better and better! said Mom, smiling. And now, more than two years later, Hes so good, I sometimes forget how sick he was. I have to look at the pictures to remind myself.

And how does Juju, with all those CAR T and stem cell boosters purring away inside him, feel about the folks who put them there?

City of Hope is great, he says.

Mom agrees, and adds one bit of advice to others facing similar challenges:

Never lose hope.

At City of Hope Childrens Cancer Center, our expert providers are dedicated to delivering world-class, personalized care for children, adolescents and young adults. Each patient is cared for by a multidisciplinary team of oncologists, hematologists, surgeons, radiation therapists, pathologists and supportive care staff, including child life specialists. Our team has access to leading-edge treatments, including our world-renowned stem cell and bone marrow transplantation programs and the latest clinical trials. Our specialists work together to develop a unique, targeted treatment plan for every patient while providing family support. Continuing care into adulthood for survivors, our Childhood, Adolescent and Young Adult Survivorship Program provides specialized follow-up care for patients who have completed treatment for cancer or a similar illness that was diagnosed before 40 years of age.

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The Future of Dog Health: Scientists Develop Unprecedented Painless Method To Reprogram Canine Stem Cells – SciTechDaily

Researchers at Osaka Metropolitan University have innovatively reprogrammed canine stem cells from urine to create induced pluripotent stem cells (iPSCs) without feeder cells. This breakthrough in non-invasive, pain-free stem cell generation paves the way for new advancements in veterinary regenerative medicine and genetic disease research, offering hope for treating previously incurable diseases in dogs. Credit: Shingo Hatoya, Osaka Metropolitan University

Dog owners may need to learn to appreciate their best friends urine. Researchers at Osaka Metropolitan University have developed a new method thats efficient, non-invasive, and painless for reprogramming stem cells from dogs urine. This breakthrough paves the way for advancements in veterinary regenerative treatments for our four-legged companions.

Induced pluripotent stem cells (iPSCs) have been widely employed in studies on human generative medicine. With the growing importance of advanced medical care for dogs and cats, there is an expectation that new therapies utilizing iPSCs will be developed for these companion animals, just as they have been for humans.

Unfortunately, canine somatic cells exhibit lower reprogramming efficiency compared to those of humans, limiting the types of canine cells available for generating iPSCs. IPSC induction often involves using feeder cells from a different species. However, considering the associated risks, minimizing xenogeneic components is often advisable, signifying the need to improve the efficiency of reprogramming various types of canine cells in dogs without using feeder cells.

A research team led by Professor Shingo Hatoya and Dr. Masaya Tsukamoto from the Graduate School of Veterinary Science at Osaka Metropolitan University has identified six reprogramming genes that can boost canine iPSC generation by about 120 times compared to conventional methods using fibroblasts. The iPSCs were created from urine-derived cells using a non-invasive, straightforward, and painless method.

Additionally, the researchers succeeded in generating canine iPSCs without feeder cells, a feat that had been impossible until now. The team aims to disseminate their findings in the global research community, contributing to advances in regenerative medicine and genetic disease research in veterinary medicine.

As a veterinarian, I have examined and treated many animals, explained Professor Hatoya. However, there are still many diseases that either cannot be cured or have not been fully understood. In the future, I am committed to continuing my research on differentiating canine iPSCs into various types of cells and applying them to treat sick dogs, hopefully bringing joy to many animals and their owners.

Reference: Generation of canine induced pluripotent stem cells under feeder-free conditions using Sendai virus vector encoding six canine reprogramming factors by Masaya Tsukamoto, Kazuto Kimura, Takumi Yoshida, Miyuu Tanaka, Mitsuru Kuwamura, Taro Ayabe, Genki Ishihara, Kei Watanabe, Mika Okada, Minoru Iijima, Mahito Nakanishi, Hidenori Akutsu, Kikuya Sugiura and Shingo Hatoya, 21 December 2023, Stem Cell Reports. DOI: 10.1016/j.stemcr.2023.11.010

The study was funded by the Japan Society for the Promotion of Science, the Japan Science and Technology Agency, Anicom Specialty Medical Institute, Inc, and Osaka Metropolitan University.

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FDA Investigating Reports of T-Cell Malignancies Following CAR T … – AJMC.com Managed Markets Network

The FDA announced today it would investigate the risk of T-cell malignancy associated with chimeric antigen receptor (CAR) T-cell therapy, the customized treatments that have changed revolutionized care for patients with lymphoma and multiple myeloma since the first one was approved in 2017.

Although the overall benefits of these products continue to outweigh their potential risks for their approved uses, FDA is investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action, the agency said in a press release.

FDAs decision is the result of reports received from clinical trials and/or data sources that track postmarketing adverse events, according to the statement.

The announcement applies to all currently approved therapies, both BCMA-directed and CD19-directed genetically modified autologous CAR T-cell treatments. The agencys press release said, T-cell malignancies have occurred in patients treated with several products in the class, but it did not specify which ones. Approved treatments are as follows

In its statement, regulators stated that all gene therapy products carry the potential risk of causing secondary malignancies, which is labeled as a class warning in approvals for all products. Manufacturers are required to conduct 15-year long term follow-up observational safety studies as a result. However, early reports in STAT quoted experts who said they had not yet seen data showing such a risk.

FDA advised that patients and clinical trial participants currently undergoing treatment with CAR T-cell therapies should be monitored lifelong for new malignancies. Should one occur, the statement said, the manufacturer should report the event and obtain a patient sample to test for the presence of the CAR transgene.

The move comes 11 days before the American Society of Hematology, the worlds premier gathering of experts who treat cancers treated with CAR T-cell therapy, is set to start in San Diego, California.

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FDA Investigating Reports of T-Cell Malignancies Following CAR T ... - AJMC.com Managed Markets Network

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