Category Archives: Stem Cell Therapy

When considering stem cell therapy, it is important to understand, that our bodies produce different types of stem cells, and that different stem cells replicate and differentiate to repair and replace damaged and dead cells in different areas of our body. It is also important to understand that there are different ways of harvesting or gathering stem cells, some more effective than others. And quantity matters.

At Pangenics, our physicians use a closed and sterile 38 step process to collect a patients own live fat derived mesenchymal adult stem cells. This process allows for the collection and preparation of up to 50 million verified live stem cells from only 2 ounces of body fat. These mesenchymal stem cells are multipotent stem cells that have the ability to self renew, (replicate) and differentiate into a variety of cell types including bone cells, cartilage cells, muscle cells and fat cells. As a result, they are the correct type of stem cells to serve as a therapy for joint and spine conditions and injuries, and certain plastic surgery procedures that involve fat transfers.

The chart below is from a patients stem cell therapy records which is placed on their charts. We use a NucleoCounter, (laboratory grade) Cell Counter in every stem cell therapy case to record the number of live mesenchymal stem cells harvested and used in their therapy. During this patients therapy, we successfully harvested over 17 million of the patients own live mesenchymal stem cells and immediately used them for their therapy. Our doctors injected a large number of stem cells into the treatment areas and administered the remaining stem cells via IV.

While stem cell therapy cannot help all conditions and injuries, it has helped the majority of our patients suffering with joint and back pain and in certain plastic surgery procedures that involve fat transfer. Contact us to schedule a courtesy consultation or for more information about stem cell therapy in Jacksonville, Florida at Pangenics Regenerative Center.

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Stem Cell Therapy in Jacksonville at Pangenics Regenerative Center

Newswise An investigative stem cell-based therapy called PEC-Direct, designed to act as a replacement pancreas, has the potential to provide blood sugar control in patients with high-risk type 1 diabetes, suggests a clinical study presented Saturday, June 11 at ENDO 2022, the Endocrine Societys annual meeting in Atlanta, Ga.

The study found multiple patients using the new treatment had clinically relevant increases in C-peptide, a substance made in the pancreas along with insulin. C-peptide and insulin are released from the pancreas at the same time and in about equal amounts, so measuring C-peptide can show how much insulin the body is making.

This research represents the first instance in multiple patients of clinically relevant increases in C-peptide, indicative of insulin production, with a stem cell-based therapy delivered in a device, according to Manasi Sinha Jaiman, M.D., M.P.H., Chief Medical Officer of ViaCyte, Inc., in San Diego, Calif., the company that makes PEC-Direct.

Patients with type 1 diabetes eventually lose the ability to produce their own insulin to control blood sugar levels. Patients must frequently check those levels with finger sticks, inject multiple insulin shots or carry around bulky devices. The injection of insulin also carries the risk of accidentally lowering blood sugar to dangerous levels.

The PEC-Direct device is designed to provide a long-term, stable source of insulin to regulate glucose levels. The device comprises a pouch containing stem-cell derived pancreatic cells which mature into insulin-producing cells once implanted into the body to regulate glucose levels. The open device membrane allows blood vessels to grow into the device to contact the cells. To prevent an immune reaction, patients take immunosuppressive drugs.

The treatment is meant for patients with high-risk type 1 diabetes, who may be especially vulnerable to acute complications due to factors such as recurrent severe low blood sugar, or frequent and extreme blood sugar fluctuations that are difficult to control.

The study included 10 adults with type 1 diabetes who had received their diagnosis at least 5 years prior to the start of the study and were not able to tell when their blood sugar went too low (called hypoglycemia unawareness). Initial data from one patient showed clinically relevant levels of stimulated C-peptide and corresponding improvements in blood glucose control within six months after implantation of PEC-Direct. Since then, increased C-peptide levels were seen in multiple patients, along with decreases in HbA1C (a blood test that measures average blood sugar levels over the past three months) by as much as 1.5%, and decreases in the amount of insulin patients needed to administer by as much as 70%.

The results suggest stem cell-based replacement therapy has the potential to provide blood glucose control and could one day eliminate the need for injecting or dosing insulin externally, Jaiman said. The study provides further proof-of-concept that continued optimization of PEC-Direct has promise as a functional cure for type 1 diabetes.

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Endocrinologists are at the core of solving the most pressing health problems of our time, from diabetes and obesity to infertility, bone health, and hormone-related cancers. The Endocrine Society is the worlds oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions.

The Society has more than 18,000 members, including scientists, physicians, educators, nurses and students in 122 countries. To learn more about the Society and the field of endocrinology, visit our site atwww.endocrine.org. Follow us on Twitter at@TheEndoSocietyand@EndoMedia.

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Stem-Cell Based Therapy Shows Promise in Treating High-Risk Type 1 Diabetes - Newswise

Your treatment approach will depend on how advanced your cancer is, your overall health, what genetic mutations you have, if any, and other factors.

Myelofibrosis is very heterogenous [diverse], explains Mesa. Plans need to be quite individualized because not everybody is the same.

For example, a small subset of people with myelofibrosis who are low risk and minimally affected by the disease may be candidates for the simplest treatment of all: observation. This means the doctor will watch the cancer carefully, but the patient isnt on any active treatment.

Because of these risks, Mesa says stem cell transplants are performed in less than 10 percent of patients with myelofibrosis.

A stem cell transplant can, even in the best circumstances, have a 10 to 15 percent chance of fatal complications, Mesa says. To put that in perspective, open-heart surgery carries only a 1 percent risk.

Participating in a clinical trial may be an option for some people with myelofibrosis. These studies might allow you to receive a therapy that isnt yet available to the public.

Mesa says there are several drugs being studied in clinical trials that could be beneficial for people with myelofibrosis.

Be hopeful. There are a lot of new medicines in development, a lot of things that are being discovered, and a lot of people out there rooting for you even though this is a rare cancer, he says.

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What Is Myelofibrosis? Symptoms, Causes, Diagnosis, Treatment, and Prevention - Everyday Health

Conditional marketing authorization has been granted to the CD20xCD3 T-cell engaging bispecific antibody mosunetuzumab (Lunsumio) by the European Commission for the treatment of adult patients with relapsed or refractory follicular lymphoma who have previously received at least 2 prior systemic therapies, according to Roche.1

The basis of the approval is supported by findings of the phase 1/2 GO29781 trial (NCT02500407), which met its primary end point of complete response (CR) per independent review facility (IRF) assessment in 2021, with the bispecific antibody eliciting a CR rate of 60% (95% CI, 49%-70%) at a median follow-up of 18.3 months.

Further data revealed the overall response rate (ORR) achieved with the agent to be 80% (95% CI, 70%-88%), and that the median duration of response (DOR) was 22.8 months (95% CI, 9.7not estimable [NE]). Along with this, favorable tolerability was seen in patients with heavily pretreated follicular lymphoma who received mosunetuzumab.

We are delighted that Lunsumio is the first bispecific antibody approved in Europe for people with relapsed or refractory follicular lymphoma, said Levi Garraway, MD, PhD, Roches chief medical officer and head of global product development, in the press release. Lunsumios high response rates, off-the-shelf availability, and initial outpatient administration could transform how advanced follicular lymphoma is treated.

Within the multicenter, open-label, dose-escalation, and dose-expansion trial, mosunetuzumab was examined in patients with follicular lymphoma with grade 1 to 3a disease.2

Eligibility in the trial was open to patients with an ECOG performance status of 0 to 1 and to those who had previously received 2 or more systemic regimens, including at least 1 anti-CD20 antibody and 1 alkylating agent.

Every 3 weeks, as part of 21-day cycles through a step-up dosing approach in cycle 1, patients (n = 90) were administered mosunetuzumab. Within the first cycle, patients received mosunetuzumab at a dose of 1 mg on day 1, 2 mg on day 8, and 60 mg on day 15. For cycle 2, mosunetuzumab was given at a dose of 60 mg on day 1. In subsequent cycles, the bispecific antibody was given at 30 mg on day 1. For the patients who achieved a CR following cycle 8, they were subjected to 17 cycles of treatment. Additionally, there was no mandatory hospitalization for participants given the initial dose.

The primary end point of the trial was CR rate per IRF assessment, evaluated in comparison with the historical CR rate of 14%, and secondary end points included ORR, DOR, progression-free survival (PFS), safety, and tolerability.

Of those enrolled in the study, the median age was 60 years (range, 29-90) with 61.1% being male. Patients with an ECOG performance status of 0 made up 58.9% of the participants while 41.1% had a status of 1. A total of 23.3% of patients had stage I-II Ann Arbor disease, and 76.7% had stage III-IV disease. Additionally, those enrolled in the trial mostly had received 3 prior lines of therapy (range, 2-10), and all patients had previously received anti-CD20 therapy and an alkylator.

Other prior systemic therapies patients received consisted of PI3K inhibitors (18.9%), immunomodulatory drugs (14.4%), and chimeric antigen receptor (CAR) T-cell therapy (3.3%). Patients who had previously had autologous stem cell transplant made up 21.1% of participants.

Moreover, 68.9% of individuals were refractory to the last prior therapy they received, 78.9% of patients were refractory to a previous anti-CD20 therapy, and 53.3% were double refractory to an anti-CD20 therapy as well as an alkylating therapy. A total of 52.2% of patients also had progression of disease within 24 months (POD24) of starting treatment.

Data presented at the 2021 ASH Annual Meeting revealed that mosunetuzumab had an investigator-assessed CR rate of 60% (95% CI, 49%-70%), and the CR rates produced with the agent in high-risk subgroups were similar to that of the overall study population.

Patients younger than 65 years of age (n = 60) had a CR rate with the bispecific antibody of 55% (95% CI, 42%-68%) compared with a CR rate of 70% (95% CI, 51%-85%) in patients aged 65 years or older (n = 30). With the agent, the CR rate was 74% (95% CI, 56%-87%) for those who previously received 2 lines of therapy (n = 34) and 52% (95% CI, 39%-65%) in patients who received 3 or more prior lines (n = 56). Patients who were relapsed or refractory to their last prior therapy (n = 62) and in those who were not (n = 28) demonstrated CR rates of 52% (95% CI, 39%-65%) and 79% (95% CI, 59%-92%), respectively.

Mosunetuzumab also produced a CR rate of 50% (95% CI, 35%-65%) in the group of individuals who were double refractory (n = 48) vs 71% (95% CI, 55%-84%) in those who were not. Further, the CR rate was shown to be 57% (95% CI, 42%-72%) for those with POD24 disease (n = 47) compared with 63% (95% CI, 47%-77%) in those who did not progress within 24 months (n = 43).

Median time to response was 1.4 months (range, 1.1-8.9), and the median time to first CR was 3.0 months (range, 1.1-18.9). The median PFS with mosunetuzumab was 17.9 months (95% CI, 10.1-NE).

In regard to safety, cytokine release syndrome (CRS) was the most common toxicity, which was observed in 39% of patients. Still, CRS was low grade with 14% of patients experiencing grade 2 CRS, and it was resolved by treatment completion. Other frequently observed adverse effects included neutropenia, hypophosphatemia, pyrexia, and headache.

Two phase 3 clinical studies are exploring the use of mosunetuzumab in the second-line setting: CELESTIMO (NCT04712097), investigating mosunetuzumab plus lenalidomide (Revlimid) for patients with follicular lymphoma, and SUNMO (NCT05171647), investigating mosunetuzumab plus polatuzumab vedotin (Polivy) for patients with diffuse large B-cell lymphoma.

Having additional treatment options for people with follicular lymphoma, where multiple prior lines of therapy have failed, is critical to help them achieve better outcomes, Elizabeth Budde, MD, PhD, a hematologic oncologist and associate professor at the City of Hope Comprehensive Cancer Center, added in the press release. It is exciting to have a new class of immunotherapy like Lunsumio, offering a readily available, chemotherapy-free and fixed-duration treatment, with great potential to provide durable remissions without the need to stay on treatment continuously.

Link:
European Commission Approves Mosunetuzumab for Patients with R/R Follicular Lymphoma - Targeted Oncology

The new report by Expert Market Research titled, GlobalHuman Embryonic Stem Cell MarketReport and Forecast 2022-2027, gives an in-depth analysis of the global human embryonic stem cell market, assessing the market based on its segments like applications and major regions. The report tracks the latest trends in the industry and studies their impact on the overall market. It also assesses the market dynamics, covering the key demand and price indicators, along with analysing the market based on the SWOT and Porters Five Forces models.

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The key highlights of the report include:

Market Overview (2017-2027)

Historical Market Size (2020): USD 0.7 billion Forecast CAGR (2022-2027): 10%

The human embryonic stem cell market is being driven by the thriving medical sector. The rising demand for embryonic stem cells can be attributed to the increasing prevalence of chronic diseases around the world owing to the rising adoption of unhealthy and sedentary lifestyle among the youth and middle-class population. The increased risk of premature death as a result of chronic diseases is a growing concern. Therefore, human embryonic stem cells are gaining popularity in the medical sector. Furthermore, the increase in research grants and private as well as public funding for the development of effective and safe stem cell therapy products is further aiding the market growth. The rising investments from key players towards enhancing human embryonic cell therapy is expected to aid the market growth in the forecast period. In post-COVID days, as the various sectors recover from the negative impacts of the pandemic, human embryonic stem cells are likely to witness a rise in demand.

Industry Definition and Major Segments

Human embryonic stem cells, also known as human embryonic stem cells are self-replicating cells derived from human fetal tissue or human embryos that develop into tissues and cells of 3 primary layers. Furthermore, human embryonic stem cells are pluripotent and are roughly 3-5 days old. It is highly versatile, as it may split into new stem cells and even transform into any type of cell in the human body, allowing it to regenerate or repair any diseased organ or tissue.

Read Full Report with Table of Contents: https://bit.ly/3x9uczx

The human embryonic stem cell market, on the basis of application, can be segmented into:

Regenerative Medicine Stem Cell Biology Research Tissue Engineering Toxicology Testing

The regional markets for human embryonic stem cell include:

North America Europe Asia Pacific Latin America Middle East and Africa

Among these, North America represents a significant share of the human embryonic stem cell market.

Market Trends

The rising population along with the rapidly evolving medical infrastructure of emerging economies like India and China is expected to provide an impetus to the human embryonic stem cell market. Furthermore, technological advancements and increasing research and development investments and initiatives are expected to generate opportunities in the market. Researchers and scientists are increasingly leaning toward the transformation of human embryonic stem cells into a number of mature cell types that represent various tissues and organs in the body, as embryonic cells provide unequalled data relating to a variety of disorders. The increasing efforts by the governments of various nations towards enhancing human embryonic stem cell therapy is likely to be another key trend bolstering the market growth in the forecast period.

Key Market Players

The major players in the market Astellas Pharma Inc, Stemcell Technologies Inc., Biotime INC, Thermo Fisher Scientific, Inc., among others. The report covers the market shares, capacities, plant turnarounds, expansions, investments and mergers and acquisitions, among other latest developments of these market players.

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Expert Market Research (EMR) is a leading market research and business intelligence company, ensuring its clients remain at the vanguard of their industries by providing them with exhaustive and actionable market data through its syndicated and custom market reports, covering over 15 major industry domains. The companys expansive and ever-growing database of reports, which are constantly updated, includes reports from industry verticals like chemicals and materials, food and beverages, energy and mining, technology and media, consumer goods, pharmaceuticals, agriculture, and packaging.

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Global Human Embryonic Stem Cell Market To Be Driven By The Rapid Technological Advancements In The Forecast Period Of 2022-2027 The Greater...

Researchers point out that another pancreatic cancer patient who received the same therapy did not respond to the treatment and died. But the highly personalized immunotherapy is being called "an important step along the way to devising treatments that might help lung, colon, and other cancers.

The New York Times:Reprogrammed Cells Attack And Tame Pancreatic Cancer In One WomanResearchers have managed to tame pancreatic cancer in a woman whose cancer was far advanced and after other forms of treatment had failed. The experiment that helped her is complex and highly personalized and is not immediately applicable to most cancer patients. Another pancreatic cancer patient, who received the same treatment, did not respond and died of her disease. Nonetheless, a leading journal The New England Journal of Medicine published a report of the study on Wednesday. (Kolata, 6/1)

AP:Novel Genetic Experiment Shrinks Tough-To-Treat CancerIn a novel experiment, a woman with advanced pancreatic cancer saw her tumors dramatically shrink after researchers in Oregon turbocharged her own immune cells, highlighting a possible new way to someday treat a variety of cancers. Kathy Wilkes isnt cured but said whats left of her cancer has shown no sign of growth since the one-time treatment last June. I knew that regular chemotherapy would not save my life and I was going for the save, said Wilkes, of Ormond Beach, Florida, who tracked down a scientist thousands of miles away and asked that he attempt the experiment. (Neergaard, 6/1)

KGW8:Portland Doctors 'First In World' To Apply New Cancer TherapyDoctors at the Providence Cancer Institute (PCI) in Portland are celebrating the successful application of a new immunotherapy to drastically reduce a patient's tumor size. ... With this single-patient success story, Dr. Eric Tran, with Earle A. Chiles Research Institute, and Providence oncologist Dr. Rom Leidner plan to expand trials to treat 24 more patients over the next two to three years. They noted similar efforts have not always been successful. (Ettlin, 6/1)

Also

Stat:How Companies Are Responding To Cancer Immunotherapy ShortageThe shortage of manufacturing slots for CAR-T cells, which has left myeloma patients dying on a wait list, came as a surprise to drugmakers and clinicians alike. When the Food and Drug Administration approved the first myeloma CAR-T product from Bristol Myers Squibb in spring of 2021, there were already four other lymphoma and leukemia CAR-T therapies on the market. Those werent facing severe supply constraints so people hadnt expected there to be issues supplying ide-cel, Bristols myeloma CAR-T, said Yi Lin, the director of the cell therapy program at the Mayo Clinic. But after the approval, the demand quickly overwhelmed Bristols ability to create CAR-T for myeloma and supply chain issues during the pandemic made it more difficult to ramp up production. (Chen, 6/2)

Stat:'How Do You Decide?' Cancer Patients Die Waiting For CAR-T TherapyWithin two years of being diagnosed with multiple myeloma, Shawn Goltzene had blasted through nearly all his options. An initial stem cell transplant couldnt hold off the cancer for more than half a year. With each new therapy his doctors tried, the cancer would surge out of remission within weeks striking the bones in his back and legs. We hit him with everything, the whole kitchen sink, said Krina Patel, the director of the myeloma cell therapy program at MD Anderson Cancer Center and Goltzenes clinician. She tried putting him on a clinical trial for an immunotherapy drug. It blew right through him. He quickly got to fourth-line therapy. (Chen, 6/2)

Austin American-Statesman:Dell Medical School Trying To End Desert In Austin Bladder Cancer CareDorothy De La Garza had frequent urinary tract infections. Then she was told she had "an overactive bladder." "Everyone assumes a woman is leaking because she's old," the 78-year-old from Austin said. After years of being on antibiotics on and off, and going to both a urologist and her primary care doctor for the same symptoms, De La Garza was diagnosed with bladder cancer in 2016."Bladder cancer is sneaky," she said.(Villalpando, 5/31)

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Pancreatic Cancer Therapy Experiment Saves Woman; Is It A Breakthrough? - Kaiser Health News

In a field populated by highly skilled and deeply compassionate nursing oncology professionals, Kathryn Buttner, B.S.N., RN, BMTCN, director of stem cell transplant and cellular therapy at the John Theurer Cancer Center, stands out by fulfilling her role with unique dedication, significant achievement and abundant grace.

Beginning as a staff nurse in stem cell transplant at Hackensack University Medical Center in 1999, Kate identified oncology and bone marrow transplant as areas of focus very early in her career while working with a 94-year-old patient during an oncology rotation and then with a 22-year-old patient. Though they were in opposite stages of life, she was inspired by each patients hope and determination and was motivated to meet their needs with cutting-edge technology and innate empathy.

As she sees it, Oncology patients give back more than you can ever give to them. It makes you want to move mountains to help them in any way you can.

A natural team builder focused on collaboration, Kate is passionate about facilitating excellent patient care and is adept at designing and implementing policies and procedures to ensure this. She is quick to credit her team. In leadership, in everything I do, its about the staff around me. Theyre with me every moment of the day to achieve what we achieve, she says.

Kate has been instrumental in operationalizing key initiatives, including helping start an onsite cellular therapy lab to provide CAR-T cell therapy to patients and pivoting during the COVID-19 pandemic to ensure the rapid creation of a high-titer convalescent plasma program while simultaneously sustaining the existing program. To this end, she is involved in updating a 12-chapter handbook for patients on bone marrow transplant.

Kate treats others as she would want to be treated, including team members and patients. Her work is centered on making sure they have the best experience possible, working with staff members every day to make sure theyre on the same page and doing the most they can do for their patients by giving them the respect they deserve and the dignity they need.

I have always had great admiration for Kates ability to lead so many people in different disciplines with such professionalism. I recently transitioned into a new role and have had the great pleasure of closely witnessing how much responsibility actually falls directly onto her plate.

Kate has the unique gift of being able to develop true relationships with her team. Her door is always open, and she is available to everyone on an individual basis and personal level. It has been one of the great honors of my nursing career to work with and learn from Kate.

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Dedication, Achievement and Grace in Cancer Care - Curetoday.com

This article was originally published here

Stem Cells Transl Med. 2022 May 28:szac032. doi: 10.1093/stcltm/szac032. Online ahead of print.

ABSTRACT

MSC (a.k.a. mesenchymal stem cell or medicinal signaling cell) cell therapies show promise in decreasing mortality in acute respiratory distress syndrome (ARDS) and suggest benefits in treatment of COVID-19-related ARDS. We performed a meta-analysis of published trials assessing the efficacy and adverse events (AE) rates of MSC cell therapy in individuals hospitalized for COVID-19. Systematic searches were performed in multiple databases through November 3, 2021. Reports in all languages, including randomized clinical trials (RCTs), non-randomized interventional trials, and uncontrolled trials, were included. Random effects model was used to pool outcomes from RCTs and non-randomized interventional trials. Outcome measures included all-cause mortality, serious adverse events (SAEs), AEs, pulmonary function, laboratory, and imaging findings. A total of 736 patients were identified from 34 studies, which included 5 RCTs (n = 235), 7 non-randomized interventional trials (n = 370), and 22 uncontrolled comparative trials (n = 131). Patients aged on average 59.4 years and 32.2% were women. When compared with the control group, MSC cell therapy was associated with a reduction in all-cause mortality (RR = 0.54, 95% CI: 0.35-0.85, I 2 = 0.0%), reduction in SAEs (IRR = 0.36, 95% CI: 0.14-0.90, I 2 = 0.0%) and no significant difference in AE rate. A sub-group with pulmonary function studies suggested improvement in patients receiving MSC. These findings support the potential for MSC cell therapy to decrease all-cause mortality, reduce SAEs, and improve pulmonary function compared with conventional care. Large-scale double-blinded, well-powered RCTs should be conducted to further explore these results.

PMID:35640138 | DOI:10.1093/stcltm/szac032

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Efficacy and Safety of MSC Cell Therapies for Hospitalized Patients with COVID-19: A Systematic Review and Meta-Analysis - DocWire News

CHICAGO, June 2, 2022 /PRNewswire/ -- According to the new market research report "Nerve Repair and Regeneration Market by Products (Neuromodulation Devices (Deep Brain Stimulation, Vagus Nerve Stimulation), Biomaterials (Nerve Conduits, Nerve Wraps), Application (Neurorrhaphy, Nerve Grafting, Stem Cell Therapy) - Global Forecast to 2027", published by MarketsandMarkets, the global Nerve Repair Market is projected to reach USD 11.6 billion by 2027 from USD 6.5 billion in 2022, growing at a CAGR of 12.1% from 2022 to 2027.

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Browse in-depth TOC on "Nerve Repair Market and Nerve Regeneration Market"313 Tables 42 Figures 236 Pages

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The Growth in this Nerve Repair Market can be attributed to the massive geriatric population, increasing research investments on the neurological disorders, high volume of nerve injury cases, and the high prevalence of neurological diseases.

In 2021, Neurostimulation and Neuromodulation Devices accounted for the largest share of the nerve regeneration market, by product.

By product, the nerve repair & regeneration market is segmented into neurostimulation and neuromodulation devices and biomaterials. The neurostimulation and neuromodulation devices segment is estimated to grow at the highest growth rate during the forecast period with the increasing government investments for neurologic disorders studies, and the favourable reimbursement.

By neurostimulation and neuromodulation application, internal neurostimulation and neuromodulation accounted for the largest market share in 2021.

Based on the neurostimulation and neuromodulation application, the nerve repair and regeneration market is segmented the neurostimulation and neuromodulation devices market is segmented into internal neurostimulation and neuromodulation applications and external neurostimulation and neuromodulation applications. The internal neurostimulation neuromodulation segment is expected to hold the largest share and is expected to register the highest CAGR during the forecast period. The largest share and high growth rate are driven by the increasing incidence of neurological disorders across the globe is driving the growth of this segment.

Story continues

By Biomaterials application, direct nerve repair/neurorrhaphy accounted for the largest market share in 2021.

Based on application, the nerve repair & regeneration market is segmented into direct nerve repair/neurorrhaphy, nerve grafting, and stem cell therapy. In 2021, the direct nerve repair segment accounted for the largest share of the market. This can be attributed to the increasing incidence of neurological disorders across the globe.

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North America was the largest regional market for nerve repair & regeneration market in 2021.

The nerve repair market is segmented into five major regions, namely, Europe, North America, the Asia Pacific, Rest of the World (Latin America, and Middle East & Africa). North America held the largest share of the nerve regeneration market in 2021, followed by Europe. The largest market share of North America is driven by the high incidence of strong presence of industry players, neurological disorders, and favourable reimbursement policies in the region.

Some of the major players operating in the global nerve repair market include Medtronic, plc. (Ireland), Boston Scientific Corporation (US), and Abbott Laboratories (US). The other players operating in the market are Axogen Corporation (US), Baxter (US), LivaNova PLC (UK), Integra LifeSciences (US), Neuronetics Inc. (US), Nevro Corp (US), NeuroPace Inc. (US), Polyganics (Netherlands), Soterix Medical Inc (US), Synapse Biomedical Inc. (US), Aleva Neurotherapeutics SA (Switzerland), Collagen Matrix Inc. (US), KeriMedical (Switzerland), BioWaveGO USA (US), NeuroSigma Inc. (US), tVNS Technologies GmbH (Germany), GiMer Medical (Taiwan), Checkpoint Surgical Inc. (US), Renishaw PLC (UK), Alafair Biosciences, Inc. (US), electroCore, Inc. (US), BlueWind Medical (Israel), Helius Medical Technologies (US), and BioControl Medical (Israel).

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Nerve Repair and Regeneration Market worth $11.6 billion by 2027 - Exclusive Report by MarketsandMarkets - Yahoo Finance

Richard Stone, MD: How do we treat the patient like this?

Eunice Wang, MD: In this instance, Id look at the overall presentation of the patient. AML [acute myeloid leukemia] therapy in the current era requires that we individualize the treatment regimen for the patient and disease. This woman has undergone intensive or definitive therapy for her breast cancer. Shes still functionally active, has an excellent performance status, and doesnt have any evidence of organ dysfunction, eg, liver, kidney, or heart. Her activity level is normal. Shes continuing to work full-time, chasing high school students around.

Id think about offering her an intensive chemotherapy approach, potentially followed by allogeneic stem cell transplant for curative intent. Because we know that in most patients with a secondary therapyrelated AML, the best outcomes are achieved by the performance of an allogeneic stem cell transplant as postconsolidation therapy. What are your thoughts on this?

Richard Stone, MD: I agree with everything you said. When I think about intensive chemotherapy, I think about whether the patient can tolerate it and whether it will benefit the patient. Because there are certain patients who can tolerate intensive chemotherapy, but Im not sure [they] would benefit from it. Its still an open question. In other words, patients with a TP53 mutation and complex karyotype may not benefit from intensive chemotherapy. They may not [have] better [results] with azacitidine and venetoclax, but at least theyre not going to be as sick.

Without any proof, I have a predilection to treat the patients [with high-risk disease] with less intensive chemotherapy, because it isnt likely to be worse and will likely be better tolerated. Thats unproven at the moment. For this patient, Id use an intensive approach because of her age, favorable mutational status, and good performance status. I have a similar view that she should get an intensive regimen. What do you think are the choices for an intensive regimen?

Eunice Wang, MD: This patient is over the age of 60, which makes it more straightforward. But based on her age and the diagnosis of a secondary therapyrelated AML, my preference would be to treat her with CPX-351, or liposomal cytarabine-daunorubicin. That offers her the best opportunity to be free of disease in 3 to 5 years.

There were the results of a phase 3 randomized clinical trial where patients aged 60 to 75 [years] with secondary AML were [randomly assigned] to receive up-front induction of chemotherapy with either CPX-351that liposomal formulation is dosed on days 1, 3, and 5[or] the standard continuous infusion [of] cytarabine and daunorubicin, our 7+3 gold standard. In that trial, patients could get 2 cycles of the CPX-351 induction or 7+3. They could get consolidation with a CPX-351 vs a 5+2. Eligible patients could then go on to subsequent transplant.

The 5-year results were published in 2021 and substantiate the early findings that led to FDA approval, where about 18% in the CPX-351 group and 8% in the 7+3 group were alive and disease-free at 5 years. Of the patients who had gotten CPX-351 followed by transplant, most impressively, 53% were alive. The overall survival for those patients who had gone to subsequent transplant from CPX-351 hadnt been reached yet. I was impressed with that because in the past, patients who got therapy-related AML rarely went into remission or long-term response. Very few of themless than 10% with standard therapy[survived for] 3 to 5 years. Based on those data, Id be offering CPX-351 to this patient.

The only question would beand I throw this back to youwhat if she were 59 [years old]? Would you treat her similarly? Because the trial was for patients aged 60 to 75 years. If she were 55 or 45 [years old], would you do the same thing? Or would you restrict your interpretation of that trial to the [patients aged] 60 to 75?

Richard Stone, MD: Thats a great question. The FDA believes you could extend the [use] of CPX-351 to younger folks because they approved it in an age-agnostic fashion, which was surprising because, as you pointed out, the data were only [from results of] patients aged 60 to 75 [years]. Its possible that a 7+3 regimen would have been better than CPX-351 for younger patients. They did a trial in all ages, [but] it didnt show better results. They did a trial with older adults, and it was only the ones who had secondary AML who seemed to benefit from CPX-351 compared with 7+3. Its a little unclear, but I believe its because CPX-351 seems to release ARA-C [cytosine arabinoside] and daunorubicin, a so-called favorable molar ratio, to kill the cells. Thats more theoretical, but its true. It also [remains] in the bone marrow a little longer, which accounts for its mild suppression. Maybe thats another reason why its a little better.

The answer to your question is that Id use it in a younger patient who had secondary AML. Curiously, in another post hoc analysis done by R. Coleman Lindsley, [MD, PhD], of the CPX-351 vs 7+3 trial that you mentioned, [patients] with TP53 mutations didnt benefit from CPX-351 compared with 7+3. Thats another situation where you throw up your hands. [These] were [patients aged] 60 to 75, but Id use it in the right patient under 60 [years of age]. In fact, theres an ongoing trial in Europe for patients regardless of their history of MDS [myelodysplastic syndrome] or prior treatment that will compare 7+3 with CPX-351. Maybe it will turn out to be a better induction regimen than 7+3 alone. We need to wait and see.

We talked about CPX-351 compared with azacitidine-venetoclax in the retrospective studies that were published at the American Society of Hematology meeting. CPX-351 is similar to 7+3 chemotherapy, but different in that its given episodically on days 1, 3, and 5. As you mentioned, its possible to give this [treatment] outpatient if the patient isnt ill, and we do that too. It saves hospitalization. Its also financially toxic to the inpatient service to pay for CPX-351, which is very expensive compared with 7+3. But you may save money by not admitting the patient for as many days. We bring them in on day 10 at the start of their expected nadir, because almost all of them will [have] some fever and neutropenia, and its easier to have them in the hospital when that happens than outpatient [service].

We find CPX-351 to be well tolerated in general, with no hair loss, minimal GI [gastrointestinal] toxicity, and as you mentioned, prolonged myelosuppression. Those are the main considerations with CPX-351. Its cardiotoxic. Its hard to know how it compares with standard daunorubicin, or even doxorubicin, for those who have secondary AML. [For] your patient, its important to consider the prior doxorubicin if they were treated for breast cancer or another cancer. We get echocardiograms frequently for our CPX-351 patients. Any other thoughts about that, Eunice?

Eunice Wang, MD: As you mentioned, there are a lot of things to recommend in terms of the toxicity profile. Our patients are excited about the fact that they dont lose their hair and [wont] be inpatient for 40, 50, or 60 days. In general, there are still the complications from infection, but the ability to do part of the regimen outpatient and then do all the regimen outpatient in the consolidation setting while waiting for possible transplant improves quality of life. [It] has been demonstrated in other studies that, as compared with 7+3 and standard consolidation, patients have almost 50% improved quality-of-life scores on various questionnaires when asked about the comparison between the 2. Thats an important thing to keep in mind as were tailoring therapy for the patient and the disease.

Transcript edited for clarity.

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CPX-351 in Treatment of AML and Clinical Considerations - OncLive