Category Archives: Stem Cell Therapy

During a Targeted Oncology Case-Based Peer Perspectives virtual event, Jason Westin, MD, MS, director, Lymphoma Clinical Research, section chief, Aggressive Lymphoma, and associate professor, Department of Lymphoma/Myeloma, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, evaluated the management of a 63-year-old patient with diffuse large B-cell lymphoma (DLBCL).

Targeted OncologyTM: What is your initial impression of the therapy used in this case? How would you treat the patient?

WESTIN: Theres not a right or wrong approach here. We dont have any randomized data yet saying that R-CHOP is clearly wrong. We have data from retrospective [analyses] from MD Anderson Cancer Center, as well as a cooperative group publication, saying that outcomes appear inferior with R-CHOP versus R-EPOCH [rituximab, etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin]. But there are all types of biases when choosing to treat with R-CHOP for that patientis it because she was older and frail and couldnt tolerate EPOCH? [Its not a surprise that] elderly and frail patients dont live as long as patients who are more fit. Sometimes those kind of analyses have biases built into them that might favor the more aggressive treatment, just because of whom youre choosing to give it to. But I think most people feel that if the patient is able to tolerate a change in treatment, at least try it, at least see whether theyre able to tolerate R-EPOCH.

For many patients, R-EPOCH is not that much more toxic than R-CHOP. Its the same drugs; etoposide is added and stretched over 5 days, basically continuous infusion for the first 4 days and then the cyclophosphamide on day 5. It is the same dose for CHOP. So its more complicated for oncologists to give than the [regimen of] 1 day every 3 weeks in the infusion area. But in terms of patients, the adverse effects [AEs] generally line up to be similar. I also...give CNS [central nervous system] prophylaxis. Patients with double-hit lymphoma have a higher risk of CNS disease. Its not through the roof, but the incidence is usually somewhere in the 10% to 20% range of patients who could have a relapse in the brain.

How do you prefer to give patients CNS prophylaxis?

Theres no wrong answer, so whatever you like to use is OK. Many people use intrathecal [IT] chemotherapy because its easier than having to stop CHOP and give methotrexatewhat if theres renal dysfunction, or what if the liver function tests [get worse], and then you have to delay the next cycle?

For EPOCH, cytopenias are sometimes a challenge in that second week when youre trying to give somebody IT or intravenous [IV] methotrexate. Many people would give it as concurrent IT with EPOCH. There were data from the 2020 American Society of Hematology annual meeting that IT and IV might not [make a difference in AE recurrence].1 There was a large meta-analysis from multiple sites across the United States and internationally showing that for patients who are at high risk of CNS relapse, whether they receive treatment via IT or IV, both [delivery methods] still have a high risk of relapse in the brain. This is totally controversial, and the [definitive] answer is that we dont know.

Most people will continue to use IT or IV methotrexate. You just want to make sure if youre giving IV that youre maintaining the schedule and dosing intensity for the systemic chemotherapy, that youre not compromising and [there are] 5 weeks between doses of EPOCH so you can give them methotrexate in the middle.

What other regimens besides EPOCH are being used in this setting?

There are places around the world that dont use EPOCH. They use hyper-CVAD [cyclophosphamide, vincristine, doxorubicin, dexamethasone] or CODOX-M [cyclophosphamide, vincristine, doxorubicin, high-dose methotrexate]. In the United States, EPOCH [in] publications from the National Cancer Institute from Wyndham Wilson, MD, PhD, and Kieron Dunleavy, MD, showed good results in the mediastinal subtype and some patients with Burkitt lymphoma; Ive shifted over to using it.

EPOCH is a fairly widely used regimen, but its not [wrong to use] hyper-CVAD, CODOX-M, or the intensified regimen from Europe. Its basically [moving up] from R-CHOP to something more intense.

Which trials are relevant right now for the population with DLBCL?

Axicabtagene ciloleucel [axi-cel (Yescarta)] was the first CAR [chimeric antigen receptor] T cell approved for adults with DLBCL in the United States, based on the pivotal trial [ZUMA-1 (NCT02348216)].2 [Eligible patients had] no response to last chemotherapy or relapse less than 12 months after autologous stem cell transplant, so basically patients with refractory disease or who were relapsing post transplant. They had to have [received] a prior [anti-CD20 therapy] and a prior anthracycline, which most patients with DLBCL have had.

The trial enrolled 108 patients in 2 cohorts. The [cohort] well focus on is the DLBCL cohort. Generally, the schema for CAR T cells [is] a lymphodepleting chemotherapy thats given ahead of timecyclophosphamide and fludarabine. This is to help the T cells grow, not to control disease; this is to get a favorable cytokine and microenvironment for cell growth when those T cells are infused. These are autologous cells. Its a 1-time treatment of 2 106 CAR T cells, and in this trial, 99% of patients who were enrolled were able to [have their cells] manufactured and 91% were dosed with the cells.

This [study is] changing our management of disease for patients because the overall response rate [ORR] was 83% and 58% had a complete response [CR].3 In this population post transplant or in those who are refractory to heavy-duty chemotherapy, there is a progression-free survival [PFS] of 5.9 months. There was a [significant] proportion of patients who otherwise probably would have died of their disease.

What other CAR T-cell therapies are available?

The second CAR T-cell therapy that was approved for adults with DLBCL, tisagenlecleucel [tisa-cel; Kymriah], was based on findings of the pivotal JULIET study [NCT02445248].4 This schema was basically the same for all the CAR T-cell therapies where patients undergo apheresis, which is similar to but not the same for transplant apheresis. This is [for patients] not getting CD34-positive cells...giving T cells that are cryopreserved for tisa-cel. Theyre then shipped to manufacturing. Patients could get bridging therapy on this clinical trial, which was not the case for the ZUMA-1 trial. They had undergone lymphodepletion with chemotherapy for 5 days, 4 days, and 3 days before receiving the infusion of the CAR T cells on day 0, and then theyre followed.

The results of this clinical trial [showed] ORR was a little lower at 52% and CR rate at 40% [compared with ZUMA-1]. But for those with a CR, there was an impressive Kaplan-Meier curve that showed patients being a year or more out, and 80% or more of them are holding their response. Median overall survival was 12 months for patients who were infused on this study.

How do the available CAR T-cell therapies compare?

Comparing the 2 products I just mentioned that are already FDA approved, as well as the one with impending approval, lisocabtagene maraleucel [liso-cel]...there was fairly robust follow-up now, 27 months, 14 months, 18 months [with axi-cel, tisa-cel, and liso-cel, respectively]; were seeing median PFS level out around 6 months.3-5 We see the same plateau occur in all these CAR T-cell studies, where theres a proportion somewhere in the 30% to high 40% range of patients who are long-term responders. With tisa-cel and liso-cel, the median overall survival was 12 months and 21 months, respectively; for axi-cel, its not reached, which is awfully impressive for this otherwise refractory population.

The trade-off is that it works but can be toxic. The cytokine release syndrome that people talk about, which is the dreaded complication, was seen in the studies at relatively low frequency and was characterized as grade 3 or 4. The tisacel grade 3/4 AEs were higher [23%], but it used a different grading system than the other 2. If [the AEs were] graded with the same system, it was pretty similar, around 10% or so. All 3 of them have an incidence of grade 3 or 4 cytokine release syndrome, but its relatively infrequent. The neurotoxicity is different, however, and for axi-cel, about 1 in 3 patients will have grade 3 or 4 neurotoxicity, which is sometimes prohibitive for this being utilized outside specialized centers that do this frequently. These are some of the reasons that it can be a challenge to administer these drugs.

What other kinds of drugs are available in this setting, and what data support them?

Another option approved recently is polatuzumab vedotin [Polivy], an antibody-drug conjugate, plus bendamustine and rituximab [BR].6 Approval was based on a randomized phase 2 trial for patients with relapsed disease, and it was randomized to either BR or polatuzumab/BR. Patients could not receive [this regimen] after transplant, either allogeneic or autologous, if they had significant neuropathy or if they were eligible for autologous transplant.

The patients ages were typical for this population. The International Prognostic Index score was fairly well balanced, although it was a bit higher risk in the BR arm. The median number of prior lines of treatment was 2 in both arms and about the same for the proportion of patients who had more than 3 prior lines. Seventy-five percent of patients [in the polatuzumab arm] and 85% [in the BR-only arm] had been refractory to the most recent therapy, [so this was a] highly refractory group. The germinal center B-cell subtype was fairly even between these groups.

Polatuzumab had an objective response rate of around 45% and a CR rate of 40%. Bendamustine is not the best drug combination for patients, [and BR had a] 17.5% objective response rate.

The PFS was statistically significant, 9.5 versus 3.7 months for the investigator review as well as the central review [HR, 0.36; 95% CI, 0.21-0.63; P < .001]. Every subgroup favored the polatuzumab/BR regimen.

Bendamustine has toxicities, but polatuzumab/BR has a bit more in terms of the cytopenias. Neutropenia was more common. Febrile neutropenia was fairly even. A bit more neutropenia but not more febrile neutropenia. Then the peripheral neuropathy, which we know from this drug class...is an issue. Not so much with bendamustine, but about 40% of patients had some degree of mild neuropathy on the polatuzumab side.

Have there been other approvals in this setting?

Selinexor [Xpovio] was approved [in 2020 based on results of the SADAL] trial [NCT02227251].7 This evaluated patients with relapsed DLBCL who were transplant ineligible. They had to be at least 60 days post treatment or 14 weeks if they had less than a partial response. So this was not a refractory population.

The response rates [were] 28% ORR, 12% CR, and its fairly similar across the different cell of origin subtypes. There was a good group of patients who got some benefit even if they didnt get a CR, and theres no patient variable that came out as a predictor for response.

Treatment AEs [included] thrombocytopenia as the big one. It was basically 60% or so of patients have some degree of thrombocytopenia; 15%, grade 4. About half the patients had some nausea, some anorexia, and some weight loss. Seventeen percent of patients discontinued because of treatment AEs, and 5 patients died because of treatment AEs.

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Westin Evaluates Management of DLBCL With CAR T-Cell Therapy - Targeted Oncology

ISLAMABAD-London Aesthetics & Rejuvenation Centre [LARC], helmed by Dr. Tauqir Ahmad, proudly announced their collaboration with the worlds leading stem cell therapy, R3 Stem Cell International to introduce the stem cell therapy treatments in Pakistan, with an exclusive experiential afternoon held at LARC in Lahore recently.Dr. David L. Greene, the visionary founder & CEO of R3 Stem Cell International flew in from USA to attend the event, where he talked about his vision for Pakistan while giving consultations to the attendees. The event was further attended by some of Lahores most distinguished and influential media personalities. The event and PR was managed by Lotus.Dr. Tauqir Ahmad, regarded as one of the first practitioners in the UK to start practicing the injections of Botox, launched LARC in Pakistan with a mission to achieve excellence in aesthetics and to be at the forefront of research and development of new treatments. With this collaboration, Dr. Tauqir Ahmad has brought the worlds most scientifically advanced stem cell therapy and treatments to Pakistan for this ever-expanding industry which will be executed by his expert team in Pakistan including Dr. Badie Idris (Medical Director), Dr. Sara Mubasshar (Clinical Dermatologist), Dr. Yasmin Chaudhry (Aesthetic Physician), Dr. Zulfiqar Salim (Plastic Surgeon), Dr. Saeed Qureshi (Bariatric Surgeon), Dr. Sheila Anwar (Aesthetic Gynaecologist) and Dr. Abdul Basit (Orthopaedic Surgeon).

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Stem cell therapy treatment introduced in Pakistan - The Nation

The report contains an overview explaining Stem Cell Therapy Market on a world and regional basis. Global Stem Cell Therapy market report is a definitive source of information and provides the latest market research, evolving consumer trends with actionable information about new players, products, and technologies. Our analysts have statistical data to provide information about the statistical report, including the factors that drive and impede the market growth.

The study is an integrated effort of primary and secondary research. The report provides an overview of the key drivers affecting the generation and growth limitation of Stem Cell Therapy market. In addition, the report also examines competitive developments, such as mergers and acquisitions, new partnerships, new contracts, and new products in the world market. The past trends and future prospects presented in this report make it very comprehensible to market analysis. Furthermore, the latest trends, product portfolio, demography, geographic segmentation, and market regulatory framework Stem Cell Therapy were also included in the study.

Description:

Market Segment according to type covers:

Market segment by applications may be broken down into:

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Fundamental Highlights

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The following section also highlights the supply-to-consumption gap. In addition to the above data, the growth rate of Stem Cell Therapy market in 2026 is also explained. Moreover, consumption charts by type and application are also given.

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World Market Report Stem Cell Therapy Industry primarily covers 10 sections in the table as follows:

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Stem Cell Therapy Market Information, Figures and Analytical Insights 2020 2026 - The Courier

Vancouver, British Columbia, Jan. 29, 2021 (GLOBE NEWSWIRE) -- Stem Cell Therapy Market Size to Reach USD 5,040 Million by 2028 | Rising Public-Private Investments and Developing Regulatory Framework for Stem Cell Therapeutics will be the Key Factor Driving the Industry Growth, States Emergen Research

The global stem cell therapy market size was valued at USD 342.7 Million in 2019 and is anticipated to reach USD 3,693.6 Million by 2027 at a CAGR of 36.2%, over the forecast period, according to most recent analysis by Emergen Research.

Growing prevalence of chronic diseases will drive the growth of the stem cell therapy market. Increased investment in research activities, development of advanced genetic techniques, and rise in public-private partnership will contribute to the growth of the stem cell therapy market.

Stem cells are used to improve health and manage disease. The growing popularity of regenerative medicine has encouraged the growth of stem cell therapy market. Regenerative medicines are used to replace, repair, and regenerate tissues affected by disease, injury, and aging process. Regenerative medicines are used in research to find a cure for diabetes, Parkinson's, and Alzheimer's disease.

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However, ethical concerns regarding embryonic stem cells and less developed research infrastructure will hinder the stem cell therapy market's growth.

Companies Profiled in Stem Cell Therapy Market Research Report:

Virgin Health Bank, Celgene Corporation, ReNeuron Group plc, Biovault Family, Precious Cells International Ltd., Mesoblast Ltd., Opexa Therapeutics, Inc., Caladrius, Neuralstem, Inc., and Pluristem.

Key Highlights of Report

Check Our Prices@ https://www.emergenresearch.com/select-license/83Emergen Research has segmented the global stem cell therapy market in terms of type, application, end-users, and region:

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Stem Cell Therapy Market Size to Reach USD 5,040 Million by 2028 | Rising Public-Private Investments and Developing Regulatory Framework for Stem Cell...

Tricia Derges, a member of the Missouri House of Representatives and doctor, has been indicted by a grand jury for among other things allegedly injecting people with amniotic fluid and telling them mesenchymal stem cells made it a miracle cure. Derges has pled not guilty, and IFLScience cannot assess the accuracy of the charges. However, the case brings attention to growing use of unproven and dangerous stem cell treatments.

The case against Derges is being taken by Tim Garrison, the U.S. Attorney for Missouri's Western District. Garrison alleges Derges acquired stem cell-free amniotic fluid and told patients it contained stem cells that would cure a variety of conditions, charging them four times what the fluid cost her to inject them with it. Garrison charged Derges with false statements over the use of the fluid, as well as illegal distribution of controlled substances and wire fraud in relation to other activities at the clinics she runs.

Among long posts on her Facebook page professing her innocence, Derges posted a picture of David and Goliath, writing, I actually thought that I was making a difference. What I didnt account for was how much satan would fight back.

Whatever the truth of the allegations in Derges' specific case, by charging astate representative, Garrison has highlighted what is definitely a growing problem: deceptive use of stem cell therapies.

Multipotent stem cells have the remarkable capacity to convert into the cells that make up many bodily tissues. The hematopoietic stem cells have been used for decades to treat leukemia with well-proven results. Hundreds of other applications are either under investigation in the laboratory, or currently in clinical trials, but a much smaller number have been approved by America's FDA and equivalent bodies worldwide.

Understandably, many people don't feel able to wait, making them vulnerable to quack doctors for whom stem cells are the 21st Century snake oil. Unlike embryonic stem cells, which often originate from abortions, amniotic stem cells are seen as an alternative acceptable to pro-life individuals. However, having been discovered more recently, research into them is less advanced, making any therapeutic value speculative.

Dirges' vocal opposition to abortionpresumably made amniotic cells attractive to her for this reason, but Garrison alleges the fluid Derges was using didn't even contain stem cells. Moreover, he claims the University of Utah where Derges bought the fluid told her that, so she would have known it couldn't possibly have been effective.

Derges gained a medical degree from the Caribbean Medical University in Curaao and ran a series of low-cost medical clinics, where volunteers saw patients and recommended to her what medication to prescribe. Although licensed as an assistant physician, Derges was not accepted into a post-graduate residency program and was not licensed as a physician. She fought to change licensing rules, and ran for Missouri state District 140, narrowly winning the Republican primary before being unopposed last November. Since being elected, Derges has made changing the law on physician licensing her first priority.

In a statement, Garrison allegedDerges used the fluid on patients with everything from Lyme disease to erectile dysfunction and kidney disease, despite the improbability a single fluid would cure such different ills. Although Derges' clinics are famous for charging just $5 for an ordinary visit, the costs of this treatment averaged $40,000 per patient.

The program came to Garrison's attention after she appeared on television claiming the same amniotic fluid should be used to treat COVID-19 and making similar claims on Facebook.

H/T Springfield News Leader

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Missouri State Representative Indicted Over Alleged Stem Cell Therapy Scam - IFLScience

SAKAI, Japan Just like humans, mans best friend deals with all sorts of chronic and degenerative conditions as they age. For dogs however, scientists have fewer ways of reversing life-threatening illnesses compared to human patients. Now, a team in Japan has successfully developed a technique which creates new stem cells from a dogs blood. Their study opens the door for new therapies which can regenerate a dogs body just like stem cells do in people.

In humans, these baby cells have the potential to grow into a variety of specialized cells, an ability called pluripotency. After scientists transplant these stem cells into a patient, they guide their differentiation into the specific kind of cells which completes their task. The new cells can then regenerate damaged tissues, reversing the effect of various diseases. While stem cell research for humans is a widely studied topic, researchers say little work is done with pets.

The new study, led by Associate Professor Shingo Hatoya from Osaka Prefecture University, focuses on induced pluripotent stem cells (iPSCs) in canine blood samples. Study authors say iPSCs are a type of stem cell which can be programmed from a developed cell. Scientists can do this by introducing specific genes into the cell. The genes code for specific proteins (transcription factors) which trigger the change from a developed cell into a pluripotent stem cell.

Another good thing about iPSCs is they multiply rapidly, providing a sustainable supply of usable stem cells for medical treatments.

We successfully established an efficient and easy generation method of canine iPSCs from peripheral blood mononuclear cells Dr. Hatoya in a university release.

The study authors call this a breakthrough in veterinary science. Hatoya hopes in the near future, it may be possible to perform regenerative medicinal treatments in dogs.

This isnt the first time scientists have experimented with iPSCs from canine blood cells. Researchers say these attempts used viral vectors to deliver the stem cell-triggering transcription factors.

In the new study, the Japanese team tested a different combination of factors to create pluripotency. Most importantly, researchers say they had to control how the reprogrammed cells multiplied in the host.

Scientists use viral vectors, which encode these transcription factors, to infect cells and convert them into iPSCs. Unfortunately, since these vectors merge with the hosts genetic material, these pluripotency factors can actually cause tumors if they are transplanted into a dog.

To avoid this, researchers created footprint-free stem cells using a special type of viral vector. This particular vector generates iPSCs without mixing with the hosts genes. It can also be automatically silenced by microRNAs in the cells. The OPU team grew these cells in a special environment which contained a small-molecule cocktail that enhances pluripotency. The results successfully produced cells which developed germ layers the basis of all organs.

Study authors say their findings provide a clear path to easy stem cell treatments for dogs. However, they add that their research may also have a ripple effect in the human medical world as well.

We believe that our method can facilitate the research involving disease modeling and regenerative therapies in the veterinary field, Dr. Hatoya says. Dogs share the same environment as humans and spontaneously develop the same diseases, particularly genetic diseases.

The team believes finding a cure for diseases in mans best friend may also open the door to curing illnesses still plaguing mankind.

The study appears in the journal Stem Cells and Development.

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Breakthrough stem cell therapy may reverse life-threatening conditions in dogs - Study Finds