Stem Cell Therapy in Wisconsin with Delo Sports Medicine and Interventional Orthopedics – WeAreGreenBay.com

(WFRV) Theres a growing trend of regenerative medicine and in healing.

Dr. Marjorie Delo of Delo Sports Medicine and Interventional Orthopedics spoke to Local 5 Live with details on how they are using a patients own stem cells to help regenerate tissues for non-surgical tears, arthritis, and articular cartilage injuries.

The most common condition treated with stem cell is osteoarthritis, but meniscal and ligament tears, as well as cartilage injuries can also successfully respond to stem cell therapy.

Reach out to Delo Sports Medicine and Interventional Orthopedics for more information. They are located at 2595 Development Drive, Suite 140 in Green Bay. You can reach them by phone at 920-632-7248, online at delosportsmedicine.com.

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Rheumatoid Arthritis Stem Cell Therapy Market Industry Analysis to 2029 The Bisouv Network – The Bisouv Network

Global Rheumatoid Arthritis Stem Cell Therapy Market: Overview

Rheumatoid arthritis is an inflammatory disease of the bodys supportive tissues, usually affecting an individuals toes and fingers. Inflammation is triggered by an abnormal response to the bodys normally functioning tissues. This results in malformed joints and severe pain. Stem cells are novel cells that are generated in regenerative centers of the body. They can be transformed into any other cell type in the body with the right kind of stimulus.

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Stem cell therapy for rheumatoid arthritis works on the principle of such cellular replacement. Stem cells are injected into a patients body and are transformed on site into anti inflammatory cells that limit the spread of this disease. Stem cells work better than traditional inflammation suppressing medicines because they are more organic and act in a targeted manner. In light of the development of innovations in allopathic medicine and demand of people for better healthcare facilities, the market for rheumatoid arthritis stem cell therapy is expected to grow at a commendable pace from 2019 to 2029, opines TMRR.

Global Rheumatoid Arthritis Stem Cell Therapy Market: Competitive Landscape

Handful of pharmaceutical manufacturing facilities is seen to be involved in the production of stem cell therapy solutions.

Significant players n the market include.

Some of these manufacturers are established players in the pharmaceutical industry and have branched into the foray of stem cell therapy. Their established base for pharmaceutical therapy makes the distribution and marketing of stem cell therapy easier. Innovations in this market scenario are funded by these players to increase patient compliance with therapy.

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Global Rheumatoid Arthritis Stem Cell Therapy Market: Key Trends and Drivers

Global Rheumatoid Arthritis Stem Cell Therapy Market: Regional Analysis

North America and Europe currently lead in the rheumatoid arthritis stem cell therapy market. This might be because of the presence of a robust healthcare infrastructure that is under pressure from people for better facilities. Moreover, most innovatory laboratories are based in these regions and enjoy supple funding from regional governments. Population in these regions too is more aged than in other regions of the world. Hence, market growth for stem cell therapy should be good here.

The Asia Pacific region (APAC) is expected to register the fastest growth in this market in the coming years. A growing healthcare infrastructure that derives protocol from western medicine should support the growth of stem cell therapy. Population here is also expected to age in future decades, and an increasingly stressful lifestyle shall undoubtedly bring an increase in incidence of stressful conditions like rheumatoid arthritis.

Based on treatment type, the global rheumatoid arthritis stem cell therapy market can be segmented into:

Based on application, the global rheumatoid arthritis stem cell therapy market can be segmented into:

Based on distribution channel, the global rheumatoid arthritis stem cell therapy market can be segmented into:

Based on geography, the global rheumatoid arthritis stem cell therapy market can be segmented into:

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TMR Research is a premier provider of customized market research and consulting services to busi-ness entities keen on succeeding in todays supercharged economic climate. Armed with an experi-enced, dedicated, and dynamic team of analysts, we are redefining the way our clients conduct business by providing them with authoritative and trusted research studies in tune with the latest methodologies and market trends.

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Magenta Therapeutics Reports Fourth Quarter and Full-Year 2020 Financial Results and Recent Program – PharmiWeb.com

-- Magentas stem cell mobilization and targeted antibody-drug conjugate conditioning programs continue to advance, with four clinical trials ongoing or planned in 2021

-- Ended year with approximately $148.8 million in cash, cash equivalents and marketable securities and maintains guidance that its cash reserves are expected to fund its operating plan into 2023

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Magenta Therapeutics (Nasdaq: MGTA), a clinical-stage biotechnology company developing novel medicines to bring the curative power of stem cell transplants to more patients, today reported financial results for the fourth quarter and full-year ended December 31, 2020 and recent program highlights.

Building on our momentum from 2020, we continue to advance our portfolio with now two active Phase 2 clinical trials evaluating MGTA-145 plus plerixafor in patients with blood cancers undergoing autologous and allogeneic stem cell transplant and an additional planned Phase 2 clinical trial evaluating stem cell mobilization and collection in patients with sickle cell disease in partnership with bluebird bio. We have also made additional progress in our preparations for an IND filing for our MGTA-117 targeted conditioning program based on communications with the FDA and the advancement of our IND-enabling studies, said Jason Gardner, D.Phil., President and Chief Executive Officer, Magenta Therapeutics. We very much look forward to generating clinical data during the course of 2021 in these multiple disease settings.

Program Highlights:

MGTA-145: Stem Cell Mobilization and Collection for Hematopoietic Stem Cell Transplantation and Gene Therapy

Magenta is developing MGTA-145 plus plerixafor to harness these agents complementary mechanisms to mobilize hematopoietic stem cells (HSCs) for collection and transplantation, including for use with gene therapies. The ability to provide rapid, reliable, predictable and safe mobilization and collection of HSCs in stem cell transplantation and gene therapy could position MGTA-145 plus plerixafor to be the preferred mobilization regimen across multiple diseases due to improved patient experience and collection outcomes.

MGTA-145 Current and Planned Activity:

MGTA-145 Recent and Upcoming Scientific Conference Presentations:

MGTA-117: Targeted Conditioning

Magenta is developing a platform of novel antibody-drug conjugates (ADCs) for conditioning, a step in the transplant process that currently relies on the use of systemic chemotherapy agents and radiation. Magentas targeted conditioning programs are designed to selectively eliminate stem cells and/or immune cells from a patient prior to transplant or gene therapy, and to reduce or potentially eliminate the need for high dose or high intensity chemotherapy-based regimens.

MGTA-117, Magentas most advanced conditioning program, is a CD117-targeted antibody conjugated to amanitin and intended for use in patients undergoing transplant. MGTA-117 is designed to deplete hematopoietic stem and progenitor cells to clear space in the bone marrow prior to transplant in support of long-term engraftment and improved disease outcomes in patients. MGTA-117 has shown high selectivity, potent efficacy and tolerability in multiple preclinical studies.

Targeted Conditioning Current and Planned Activity:

Targeted Conditioning Recent and Upcoming Scientific Conference Presentations:

Financial Results:

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2020, were $148.8 million, compared to $145.7 million as of December 31, 2019. Magenta anticipates that its cash, cash equivalents and marketable securities will be sufficient to fund operations and capital expenditures into 2023.

Research and Development Expenses: Research and development expenses were $12.3 million in the fourth quarter of 2020, compared to $18.7 million in the fourth quarter of 2019. The decrease was driven primarily by decreased preclinical costs for manufacturing related to the conditioning programs, lower manufacturing and clinical trial costs due to the discontinuance of enrollment in the Phase 2 clinical trial of MGTA-456 in inherited metabolic diseases in June 2020 and lower clinical trial costs for the MGTA-145 Phase 1 clinical trial which was completed in the first quarter of 2020.

General and Administrative Expenses: General and administrative expenses were $6.8 million for the fourth quarter of 2020, compared to $5.9 million for the fourth quarter of 2019. The increase was primarily due to an increase in personnel costs, professional services and insurance costs associated with Magentas expanded clinical trial preparations.

Net Loss: Net loss was $18.2 million for the fourth quarter of 2020, compared to net loss of $23.2 million for the fourth quarter of 2019.

About Magenta Therapeutics

Magenta Therapeutics is a clinical-stage biotechnology company developing medicines to bring the curative power of immune system reset through stem cell transplant to more patients with blood cancers, genetic diseases and autoimmune diseases. Magenta is combining leadership in stem cell biology and biotherapeutics development with clinical and regulatory expertise, a unique business model and broad networks in the stem cell transplant community to revolutionize immune reset for more patients.

Magenta is based in Cambridge, Mass. For more information, please visit http://www.magentatx.com.

Follow Magenta on Twitter: @magentatx.

Forward-Looking Statement

This press release may contain forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995 and other federal securities laws, including express or implied statements regarding Magentas future expectations, plans and prospects, including, without limitation, statements regarding expectations and plans for presenting pre-clinical and clinical data, projections regarding future revenues and financing performance, our long-term growth, cash, cash equivalents and marketable securities, the anticipated timing of our clinical trials and regulatory filings, the development of our product candidates and advancement of our preclinical programs, the timing, progress and success of our collaborations, as well as other statements containing the words anticipate, believe, continue, could, endeavor, estimate, expect, anticipate, intend, may, might, plan, potential, predict, project, seek, should, target, will or would and similar expressions that constitute forward-looking statements under the Private Securities Litigation Reform Act of 1995. The express or implied forward-looking statements included in this press release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: uncertainties inherent in clinical studies and in the availability and timing of data from ongoing clinical studies; whether interim results from a clinical trial will be predictive of the final results of the trial; whether results from preclinical studies or earlier clinical studies will be predictive of the results of future trials; the expected timing of submissions for regulatory approval or review by governmental authorities; regulatory approvals to conduct trials or to market products; whether Magenta's cash resources will be sufficient to fund Magenta's foreseeable and unforeseeable operating expenses and capital expenditure requirements; risks, uncertainties and assumptions regarding the impact of the continuing COVID-19 pandemic on Magentas business, operations, strategy, goals and anticipated timelines, Magentas ongoing and planned preclinical activities, Magentas ability to initiate, enroll, conduct or complete ongoing and planned clinical trials, Magentas timelines for regulatory submissions and Magentas financial position; and other risks concerning Magenta's programs and operations are described in additional detail in its Annual Report on Form 10-K expected to be filed on or about March 3, 2021, its Quarterly Reports on Form 10-Q and its other filings made with the Securities and Exchange Commission from time to time. Although Magenta's forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Magenta. As a result, you are cautioned not to rely on these forward-looking statements. Any forward-looking statement made in this press release speaks only as of the date on which it is made. Magenta undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

2020

2019

2020

2019

12,256

18,714

50,615

59,208

6,809

5,923

28,087

23,761

19,065

24,637

78,702

82,969

(19,065

)

(24,637

)

(78,702

)

(82,969

)

897

1,400

3,766

6,200

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‘Phenomenal’ Results with CAR T-Cells in R/R Multiple Myeloma – Medscape

Patients with multiple myeloma that has continued to progress despite many lines of therapy have shown deep and durable responses to a new chimeric antigen receptor (CAR) T-cell therapy, idecabtagene vicleucel (ide-cel, under development by Bristol-Myers Squibb and Bluebird Bio).

An expert not involved in the trial described the results as "phenomenal."

Krina Patel, MD, an associate professor in the Department of Lymphoma/Myeloma at the University of Texas MD Anderson Cancer Center, Houston, said that "the response rate of 73% in a patient population with a median of 6 lines of therapy, and with one-third of those patients achieving a deep response of complete response or better, is phenomenal."

"We are very excited as a myeloma community for this study of idecabtagene vicleucel for relapsed refractory patients," Patel said.

The new data on ide-cell, from a trial in 128 patients, were published February 25 in the New England Journal of Medicine.

Lead investigator of the study Nikhil Munshi, MD, of Dana-Farber Cancer Institute, Boston, Massachusetts, commented: "The results of this trial represent a true turning point in the treatment of this disease. In my 30 years of treating myeloma, I have not seen any other therapy as effective in this group of patients."

Both experts highlighted the poor prognosis for this population of relapsed/refractory patients. Recent decades have seen a flurry of new agents for myeloma, and there are now three main classes of agents: immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies. Nevertheless, in some patients, the disease continues to progress. For patients who have failed all three classes of drugs, the median progression-free survival is about 3 to 4 months, with a median overall survival of 8 to 9 months.

Ide-cel is currently awaiting FDA approval, with a decision date slated for March 27.

Several CAR T-cell products are already marketed for use in certain leukemias and lymphomas, and there is another for use in multiple myeloma, ciltacabtagene autoleucel (cilta-cel, under development by Janssen), that is awaiting approval in Europe.

The trial involved 128 patients treated with ide-cel infusions. At the time of data cutoff for this report (January 14, 2020), 62 patients remained in the primary study. Of the 128 treated patients, the median age was 61 years and the median time since diagnosis was 6 years. About half (51%) had a high tumor burden (50% bone marrow plasma cells), 39% had extramedullary disease, 16% had stage III disease, and 35% had a high-risk cytogenetic abnormality, defined as del(17p), t(4;14), or t(14;16).

Patients in the cohort had received a median of six previous antimyeloma regimens (range, 3 to 16), and most of the patients (120, 94%) had undergone autologous hematopoietic stem cell transplants. In addition, the majority of patients (84%) had disease that was triple refractory (to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody), 60% had disease that was penta-exposed (to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab), and 26% had disease that was penta-refractory.

At a median follow-up of 13.3 months, 94 of 128 patients (73%) showed a response to therapy (P < .001), with 42 (33%) showing a complete or stringent complete response, and 67 patients (52%) showing a "very good partial response or better."

Overall median progression-free survival was 8.8 months at the 450106dose, but more than double that (20.2 months) for patients who achieved a complete or stringent complete response. Estimated median overall survival was 19.4 months, with an overall survival of 78% at 12 months. The authors noted that overall survival data are not yet mature.

After experiencing disease progression, 28 patients were retreated with ide-cel, with 6 patients showing a second response. The durations of response ranged from 1.9 to 6.8 months.

All patients in the cohort experienced adverse events, primarily grade 3 or 4 events that occurred in 127 patients (99%). The most common events reported were hematologic toxicities, including neutropenia in 114 patients (89%), anemia in 77 (60%), and thrombocytopenia in 67 (52%), and were at least partially related to the lymphodepleting chemotherapy administered before ide-cel infusion, the authors note. Cytokine release syndrome occurred in 107 patients (84%), primarily grade 1 or 2.

"Results of the KarMMa study support substantial antitumor activity for ide-cel across a target dose range of 150106to 450106CAR+ T cells," the authors conclude. "The 450106dose appeared to be somewhat more effective than the other doses."

"What this study further highlights is that higher cell dose tends to increase cell expansion, which correlates to improved response and duration of response," commented Patel.

Importantly, multiple vulnerable subgroups experienced impressive outcomes, such as those who are older or with high risk or extramedullary disease, she noted.

"My patients who have undergone this therapy, albeit on other clinical trials, all say that their quality of life during this time of remission is priceless," Patel added. "The is the first therapy in the relapsed refractory setting that allows patients to have a significant chemo-free period. We need to find more ways to do this for our patients."

The study was supported by Bluebird Bio and Bristol-Myers Squibb. Pa tel has served on the advisory board for Janssen and Bristol-Myers Squibb. She also reports a speaking engagement with Oncopeptides. Munshi acts as a consultant for several pharmaceutical companies, and many co-authors also have relationships with industry, as listed in the original article.

N Engl J Med. Published online February 25, 2021. Abstract

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Marker Therapeutics Announces Dosing of First Patient in Phase 2 Trial of MT-401 in Acute Myeloid Leukemia Following Stem Cell Transplant – PRNewswire

HOUSTON, March 3, 2021 /PRNewswire/ --Marker Therapeutics, Inc.(NASDAQ:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, today announced it has treated the first patient in the Company's Phase 2 trial of MT-401, its lead MultiTAA-specific T cell product candidate. The trial is enrolling patients with acute myeloid leukemia (AML) following an allogeneic stem cell transplant in both the adjuvant and active disease settings.

"We are pleased to have dosed the first patient with MT-401 in our Company-sponsored clinical trial, particularly in a patient population in which there remains a critical unmet need," said Mythili Koneru, M.D., Ph.D., Chief Medical Officer of Marker Therapeutics. "Today, adult patients with post-transplant AML have a 25 percent chance of 5-year survival. In various investigator-sponsored Phase 1 trials at the Baylor College of Medicine, our MultiTAA-specific T cell therapies have been generally well-tolerated and demonstrated durable anti-cancer responses across a broad range of cancersincluding post-transplant AML. Based on these results, we believe that MT-401 has the potential to become a meaningful treatment option for patients suffering from this disease."

About the AML Post-Transplant Study

About Marker Therapeutics, Inc.Marker Therapeutics, Inc. is a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications. Marker's cell therapy technology is based on the selective expansion of non-engineered, tumor-specific T cells that recognize tumor associated antigens (i.e. tumor targets) and kill tumor cells expressing those targets. This population of T cells is designed to attack multiple tumor targets following infusion into patients and to activate the patient's immune system to produce broad spectrum anti-tumor activity. Because Marker does not genetically engineer its T cell therapies, we believe that our product candidates will be easier and less expensive to manufacture, with reduced toxicities, compared to current engineered CAR-T and TCR-based approaches, and may provide patients with meaningful clinical benefit. As a result, Marker believes its portfolio of T cell therapies has a compelling product profile, as compared to current gene-modified CAR-T and TCR-based therapies.

To receive future press releases via email, please visit: https://www.markertherapeutics.com/email-alerts.

Forward-Looking Statement Disclaimer This release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company's expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements." Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: our research, development and regulatory activities and expectations relating to our non-engineered multi-tumor antigen specific T cell therapies; the effectiveness of these programs or the possible range of application and potential curative effects and safety in the treatment of diseases; and the timing, conduct and success of our clinical trials, including the Phase 2 trial of MT-401, as well as clinical trials conducted by our collaborators. Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stated in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company's most recent Form 10-K, 10-Q and other SEC filings which are available through EDGAR at http://www.sec.gov. Such risks and uncertainties may be amplified by the COVID-19 pandemic and its impact on our business and the global economy. The Company assumes no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

SOURCE Marker Therapeutics, Inc.

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Comments on: Scientists Uncover the Key to Proper Muscle Growth – SciTechDaily

Immunofluorescence analysis of a group of proliferating stem cells associated with a muscle fiber (grey). The stem cells produce Dll1 (red) and MyoD (green). Two of the cells produce MyoG (blue): They are differentiating to form a new muscle cell. Note that the overlay of blue, green, and red appears as white. Credit: Birchmeier Lab, MDC

Three oscillating proteins cause new muscle cells to emerge from muscle stem cells in a balanced manner. In a paper being published in the journal Nature Communications, a team led by MDC researcher Carmen Birchmeier explains in detail how this process works.

When a muscle grows, because its owner is still growing too or has started exercising regularly, some of the stem cells in this muscle develop into new muscle cells. The same thing happens when an injured muscle starts to heal. At the same time, however, the muscle stem cells must produce further stem cells i.e., renew themselves as their supply would otherwise be depleted very quickly. This requires that the cells involved in muscle growth communicate with each other.

Two years ago, a team of researchers led by Professor Carmen Birchmeier, head of the Developmental Biology/Signal Transduction Lab at the Berlin-based Max Delbrck Center for Molecular Medicine in the Helmholtz Association (MDC), showed that the development of stem cells into muscle cells is regulated with the help of two proteins, Hes1 and MyoD, which are produced in the progenitor cells in an oscillatory manner i.e., there are periodic fluctuations in the number of cells produced.

Both proteins are involved in the Notch signaling pathway, a widespread mechanism by which cells respond to external stimuli and communicate with other cells. The signaling pathway is named after its receptor Notch, onto which the ligand Delta, a cell surface protein, latches.

In our current study, we have provided unequivocal evidence that oscillation in muscle tissue is not just some strange phenomenon of the cells involved, but that these rhythmic fluctuations in gene expression are actually crucial for transforming stem cells into muscle cells in a balanced and controlled manner, says Birchmeier.

Together with researchers from Japan and France, Birchmeier and four other scientists at the MDC also uncovered the crucial role of a third protein that, along with Hes1 and MyoD, forms a dynamic network within the cells. As the team reports in the journal Nature Communications, this protein is the Notch ligand Delta-like1, or Dll1 for short. It is produced in activated muscle stem cells in a periodically fluctuating manner, with the oscillation period lasting two to three hours, Birchmeier explains, adding: Whenever a portion of the stem cells expresses more Dll1, the amount in the other cells is correspondingly lower. This rhythmic signaling determines whether a stem cell becomes a new stem cell or develops into a muscle cell.

In their experiments with isolated stem cells, individual muscle fibers and mice, Birchmeier and her teamfurther investigated how the Hes1 and MyoD proteins are involved in muscle growth. Put simply, Hes1 acts as the oscillatory pacemaker, while MyoD increases Dll1 expression, says Dr.Ines Lahmann, a scientist in Birchmeiers lab and a lead author of the study along with Yao Zhang from the same team.These findings were demonstrated not only in our experimental analyses, but also in the mathematical models created by Professor Jana Wolf and Dr.Katharina Baum at the MDC, Birchmeier says.

With the help of gene-modified mice, the researchers obtained the most important evidence that Dll1oscillation plays a critical role in regulating the transformation of stem cells into muscle cells. In these animals, a specific mutation in the Dll1 gene causes production of the protein to occur with a time delay of a few minutes, Birchmeier explains. This disrupts the oscillatory production of Dll1 in cell communities, but does not alter the overall amount of the ligand.

Nevertheless, the mutation has severe consequences on the stem cells, propelling them to prematurely differentiate into muscle cells and fibers, reports Zhang, who performed a large portion of the experiments. As a result, he says, the stem cells were depleted very quickly, which resulted, among other things, in an injured muscle in the mices hind legs regenerating poorly and remaining smaller than it had been before the injury. Quite obviously, this minimal genetic change manages to disrupt the successful communication in the form of oscillation between stem cells, Zhang says.

Only when Dll1 binds to the Notch receptor in an oscillatory manner and thus periodically initiates the signaling cascade in the stem cells is there a good equilibrium between self-renewal and differentiation in the cells, Birchmeier concludes. The MDC researcher hopes that a better understanding of muscle regeneration and growth may one day help create more effective treatments for muscle injuries and diseases.

Reference: Oscillations of Delta-like1 regulate the balance between differentiation and maintenance of muscle stem cells by Yao Zhang, Ines Lahmann, Katharina Baum, Hiromi Shimojo, Philippos Mourikis, Jana Wolf, Ryoichiro Kageyama and Carmen Birchmeier, 26 February 2021, Nature Communications.DOI: 10.1038/s41467-021-21631-4

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ViaCyte and Gore Expand Collaboration to Develop Novel Membrane and Device Technologies that Enhance Delivery of Cell Replacement Therapies for…

"This agreement expands our relationship with Gore across our platform, including both open and closed devices, and across their proprietary capabilities to establish our path for a commercial cell-based therapy product," said Ian Smith, Executive Chairman of ViaCyte. "Initial clinical studies suggest Gore's novel membrane technology can support engraftment and pancreatic beta cell proliferation, while minimizing the host foreign body response, and we look forward to confirming these findings with clinical results on the first group of patients later this year."

ViaCyte is currently evaluating open and closed devices to deliver cell replacement therapies for type 1 diabetes (T1D) in Phase 2 clinical trials. These devices contain the cell therapy while enabling oxygen and nutrients to flow into the device and insulin, glucagon, and other hormones to flow out.

The closed encapsulation system was jointly developed by ViaCyte and Gore to improve engraftment, survival, and overall function of the implanted cells by mitigating the foreign body host response and providing protection from immune rejection. ViaCyte's stem cell platform is used to differentiate pluripotent stem cells into pancreatic cells. The cells are then contained in an encapsulation system, which is implanted subcutaneously. ViaCyte has shown that once implanted and successfully engrafted, the cells mature into beta cells that secrete insulin, alpha cells that secrete glucagon, and other cells of the human pancreas that naturally control blood glucose (sugar) levels. The closed encapsulation system is designed to protect the cells from the patient's immune system, thus eliminating the need for immune suppression drugs commonly used with other transplants. ViaCyte is the only company to show in clinical trials that implanted islet cells, differentiated from stem cells, are capable of producing insulin in T1D patients.

"Our collaboration with ViaCyte is a great example of how Gore's leading materials science and medical device expertise can be applied to complex medical problems," said Lauren Zambotti, Technical Leader, Gore PharmBIO Cell Encapsulation Products."We're excited to leverage Gore's capabilities to further advance materials and devices for optimization of the biologic activity with ViaCyte's cell therapy. Together, we have the potential to transform the lives of people suffering from diabetes."

ViaCyte and Gore have shown that the encapsulation system, incorporating Gore's novel membrane technologies, reduces the foreign body response and improves engraftment, cell survival, and function in both clinical studies and preclinical models. Data from the Phase 2 clinical study (ClinicalTrials.gov Identifier: NCT04678557)of the first product candidate with the new Gore membrane (VC01-103) is expected in the second half of this year.

About Gore

W. L. Gore & Associates is a global materials science company dedicated to transforming industries and improving lives. Since 1958, Gore has solved complex technical challenges in demanding environments from outer space to the world's highest peaks to the inner workings of the human body. With more than 10,500 Associates and a strong, team-oriented culture, Gore generates annual revenues of $3.7 billion. http://www.gore.com

About ViaCyte

ViaCyte is a privately held regenerative medicine company developing novel cell replacement therapies based on two major technological advances: cell replacement therapies derived from pluripotent stem cells and medical device systems for cell encapsulation and implantation. ViaCyte has the opportunity to use each technology individually or together to address critical human diseases and disorders that can potentially be treated by replacing lost or malfunctioning cells or proteins. The company's first product candidates are being developed as potential long-term treatments for type 1 diabetes patients to achieve glucose control targets and reduce the risk of hypoglycemia and diabetes-related complications. To accelerate and expand the company's efforts, ViaCyte has established collaborative partnerships with leading companies, including CRISPR Therapeutics and W.L. Gore & Associates. ViaCyte is headquartered in San Diego, California. For more information, please visit http://www.viacyte.comand connect with ViaCyte on Twitter, Facebook, and LinkedIn.

SOURCE ViaCyte, Inc.

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ViaCyte and Gore Expand Collaboration to Develop Novel Membrane and Device Technologies that Enhance Delivery of Cell Replacement Therapies for...

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QC Kinetix (Round Rock) Offers Stem Cells Therapy As Viable Pain Management Alternative To Surgery In Round Rock, TX – Press Release – Digital Journal

Pain can arise due to several reasons. Whatever the cause may be, many people who suffer from chronic pain are afraid to take action due to being told that surgery is the only option. However, the professional team at QC Kinetix (Round Rock) is glad to bring a viable alternative in the form of regenerative medicine in Round Rock, TX.

Round Rock, TX - Pain can arise due to several reasons. Whatever the cause may be, many people who suffer from chronic pain are afraid to take action due to being told that surgery is the only option. However, the professional team at QC Kinetix (Round Rock) is glad to bring a viable alternative in the form of regenerative medicine in Round Rock, TX. The doctors at QC Kinetix (Round Rock) can address common painful conditions through regenerative medicine techniques while also eliminating the risks and complications associated with the surgical approach.

Whether as a result of a sports injury or other accident, patients who suffer from chronic pain are welcomed to visit the specialists at QC Kinetix (Round Rock) to get started on a path to health and wellness. QC Kinetix (Round Rock) and its highly qualified team offers patients personalized services that begin with assessing their condition, establishing a diagnosis, and developing a viable treatment plan to address the pain.

Promising to do their best through regenerative medical treatment options like stem cells therapy, the spokesperson for the pain clinic said: "Whether the cause of your discomfort is musculoskeletal pain, sports injury, arthritis, low testosterone, or something else, our experienced doctors will suggest the right treatment to avoid worsening symptoms and prevent surgery. We aim to provide patients with proper care to regain their confidence and live a happier life. While there are many regenerative treatments, our stem cell therapy in Round Rock, TX, is effective for different types of pain conditions and injuries. During your first visit to the clinic, our orthopedic team will examine you thoroughly, determine the cause of your problem, and discuss possible solutions."

Depending on the patient's problem, the regenerative medicine professionals may suggest one treatment approach, whether Round Rock stem cells treatment or class IV laser therapy or a combination of stem cell therapy with PRP or laser therapy, to achieve the desired results.

The doctors can also customize a treatment plan for each patient's symptoms and conditions to ensure that they get an effective outcome. QC Kinetix (Round Rock) and its team addresses a wide range of conditions affecting patients across the joints, muscles, and tendons. As part of the conditions addressed, the regenerative medicine experts treat conditions like torn rotator cuff, shoulder pain, tennis elbow, golfer's elbow, wrist pain, ankle pain, tendon and ligament tears, low back pain, foot and hand pain, finger and toe pain, torn Achilles tendon, and others. Patients will enjoy the advantages of treatment procedures like ultrasound, stem cell therapy, class IV therapy, platelet-rich plasma (PRP therapy), and regenerative cell therapy.

Visit QC Kinetix (Round Rock) at 511 Oakwood Blvd Suite 203, Round Rock, TX, 78681. Book a free consultation via phone at (512) 593-4303 or visit their website.

Media ContactCompany Name: QC Kinetix (Round Rock)Contact Person: Justin CrowellEmail: Send EmailPhone: (512) 593-4303Address:511 Oakwood Blvd Suite 203 City: Round RockState: TXCountry: United StatesWebsite: https://qckinetix.com/round-rock/

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QC Kinetix (Round Rock) Offers Stem Cells Therapy As Viable Pain Management Alternative To Surgery In Round Rock, TX - Press Release - Digital Journal

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Will Immunotherapy Work as Salvage Therapy for Patients with Testicular Germ Cell Tumors? – UroToday

Its now been 3.5 years since I last wrote anything about testicular germ cell tumors and ongoing clinical trials.1Although we still cure most men afflicted with this disease, we have not made any major new therapeutic advancements since I wrote that last article. Approximately, 15-20% of patients with metastatic germ cell tumors will relapse following initial chemotherapy. Even in this situation, approximately 50% can still be cured with salvage treatments, either with more conventional cisplatin-based chemotherapy or with high-dose chemotherapy and autologous stem cell rescue.2-4 However, patients with cisplatin-refractory disease or progressive disease following high-dose salvage chemotherapy and autologous stem cell rescue, harbor an extremely dim prognosis. In these situations, palliative chemotherapy, with regimens containing oxaliplatin, is limited in efficacy, and targeted biologic therapies have also shown limited efficacy.5

Immune checkpoint inhibitors have already shown promise in other genitourinary malignancies, such as urothelial,6 renal cell7and even select prostate carcinomas.8 There is also some rationale surrounding the use of immune checkpoint inhibitors for men with treatment-refractory testicular germ cell tumors. For example, spontaneous testicular tumor regressions, commonly called a burned out testicular tumor, can at least partially be attributed to a hosts immune microenvironment, not just alterations in tumor vascularization.9 Additionally, abundant expression of program death-ligand 1 receptor (PD-L1) is present in both seminomas and nonseminomas.10 There is also greater infiltration of PD-1 expressing cells in testicular tumors over normal testicular tissue, and this also has relationship with pathological tumor vasculature that may allow for intratumoral migration of immune cells.11

Immune signatures also provide some indirect insights on the role of the immune system at different stages and prognoses of testicular germ cell tumors. For example, CTLA-4 expression is correlated with better prognostic features, such as decreased lymphovascular invasion and lower disease stage.12 Meanwhile, more advanced stages of disease have an immune-exclusive microenvironment, with decreased T-cell and NK-cell signatures and increased regulatory T cell, neutrophil, mast cell, and macrophage signatures.13

There is emerging data on the clinical efficacy of PD-(L)1 antibody therapy for testicular germ cell tumors. Both pembrolizumab and nivolumab have provided some early hints of efficacy in case reports/series.14-16 Subsequently, 3 clinical trials have been published on this topic. Both pembrolizumab17 and avelumab,18 were tested as monotherapy, and both trials were terminated early due to lack of efficacy. Similarly, the single agent arm of durvalumab, with or without tremelimumab trial, was closed to accrual due to the majority of patients exhibiting hyperprogression.19 Yet, there were some signs of efficacy in the combination arm, with one patient having a partial response and another patient with radiographically stable disease and serum tumor marker decline.

The above data imply that single checkpoint inhibitor therapy is unlikely to make major strides in the field of treatment-refractory testicular germ cell tumors. Yet, there may still be promise for combination therapy. Future approaches may include inhibition of multiple checkpoints, altering the immune exclusive microenvironment, and/or incorporation of agents that alter tumor vascularization to allow more cytotoxic T cells into the tumor microenvironment. As a result, we need to support the development and accrual of more immunotherapy combination clinical trials. Below, I have highlighted some ongoing immunotherapy trials that include patients with treatment-refractory testicular germ cell tumors.

Highlighted Trials

References:

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Will Immunotherapy Work as Salvage Therapy for Patients with Testicular Germ Cell Tumors? - UroToday

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