Sentences with phrase «cell therapy safety»

Stem cell therapy safety and efficacy has to be established in a larger number of individuals and with a longer follow - up duration.

«First embryonic stem cell therapy safety trial in Asian patients.»

Not exact matches

These risks and uncertainties include: Gilead's ability to achieve its anticipated full year 2018 financial results; Gilead's ability to sustain growth in revenues for its antiviral and other programs; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy, Biktarvy and Vemlidy ®; austerity measures in European countries that may increase the amount of discount required on Gilead's products; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs); continued fluctuations in ADAP purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead's earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada, an uncertain global macroeconomic environment; and potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead's ability to initiate clinical trials in its currently anticipated timeframes; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Kite's ability to develop and commercialize cell therapies utilizing the zinc finger nuclease technology platform and realize the benefits of the Sangamo partnership; Gilead's ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead's ability to receive regulatory approvals in a timely manner or at all, for new and current products, including Biktarvy; Gilead's ability to successfully commercialize its products, including Biktarvy; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; Gilead's ability to successfully develop its hematology / oncology and inflammation / respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates, including GS - 9620 and Yescarta in combination with Pfizer's utomilumab; Gilead's ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead's future revenues and pre-tax earnings; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (the SEC).

No. 4: CAR - T takes a backseat Research into chimeric antigen receptor T - cell (CAR - T) therapy has captured the attention of investors over the past two years, but safety risks could emerge as trial sizes increase, and that could help shift attention to other promising anti-cancer approaches, including NantKwest's (NASDAQ: NK) natural killer cell approach and soon - to - IPO Editas» CRISPR / Cas approach.

While Nagy can get piggyBac to jump back out of his iPS cells, regulatory authorities considering the safety of experimental therapies are likely to remain nervous about cells that have been genetically manipulated.

Furthermore, regulations stipulate that each new cell line generated be independently tested and validated for safety, making it impractical to develop patient - specific cells for therapies.

To address this challenge, our research group is using nanoparticles not only to deliver more chemotherapy drugs to the target site within cancer cells, but also to compromise the function of the efflux pumps and thereby significantly improve safety and efficacy of cancer therapy.»

Regulations already in place in the European Union insist that stem cell therapies follow the same safety and efficacy rules as pharmaceuticals.

However, in the wake of fatalities from gene therapy and other technologies, as well as the potential for cancers associated with stem cell transplants, governments are understandably nervous about safety issues — not to mention the ethical maze of tinkering with fledgling life.

The proposed clinical trial, in which researchers would use CRISPR to engineer immune cells to fight cancer, won approval from the Recombinant DNA Advisory Committee (RAC) at the U.S. National Institutes of Health, a panel that has traditionally vetted the safety and ethics of gene therapy trials funded by the U.S. government and others.

A clinical trial in the Republic of Korea for patients with degenerative eye diseases is the first to test the safety of an embryonic stem cell therapy for people of Asian descent.

If these preclinical studies are successful, the researchers plan to further develop their CAR T cell therapy and test its safety and efficacy for different types of metastatic cancer in upcoming clinical trials.

In a new study scheduled for publication in The Journal of Pediatrics, researchers evaluated the safety and feasibility of using stem cell therapies on very preterm infants to prevent or treat BPD.

In contrast, the safety record of hematopoietic stem cell gene therapy is less clear, with a significant frequency of gene - therapy induced oncogenesis or clonal outgrowth reported in several hematopoietic stem cell trials [56], [57].

The complexity of the development of cells and gene therapy products are addressed by designing tailored studies to allow safety assessment of GTMPs and to fulfil GLP requirements and OECD principles.

To establish ethical and safety criteria to guide implementation of stem cell therapies in the clinic;

Within the stem cell field, unproven stem cell therapies, or «treatments» that lack rigorous scientific proof of their safety and effectiveness, have been a growing concern.

By considering patient experiences and feedback, researchers and advocates alike can learn more about the safety and efficacy of potential stem cell therapies.

Although that study also is designed primarily at assessing the therapy's safety, researchers are checking to see whether the cells restore any feeling or movement.

The rapidly developing global cell therapy market poses numerous industry challenges for drug development, process scalability, commercialization, and patient safety.

Once we know how this pathway works, and what happens to eye cells when it isn't around, we will conduct some safety experiments to make sure that the therapy we've devised to replace this cell growth pathway, when active in an adult eye, won't harm eye cells.

The first - in - human STEP ONE * trial is evaluating the safety and efficacy of ViaCyte's PEC - Encap (a.k.a. VC - 01 ™) product candidate, a stem cell - derived, encapsulated cell replacement therapy.

ViaCyte's VC - 01 ™ product candidate, a first - in - class cell replacement therapy for the treatment of type 1 diabetes, is currently being evaluated in a Phase 1/2 trial called STEP ONE, or Safety, Tolerability, and Efficacy of VC - 01 Combination Product in Type One Diabetes.

«The ability to direct a gene to a specific cell type and prevent expression in other cell types is a powerful new tool that allows us to bypass one of the most troubling safety concerns facing gene therapy,» said Michael Parmacek, MD, assistant professor of medicine at the University of Chicago and director of the study.

We have put a tremendous amount of effort and resources into bringing stem cell therapy to our patients at the highest possible standards of safety, delivery and care.

The ISSCR believes that the safety and efficacy of all stem cell and regenerative medicine therapies should be proven in systematic clinical trials, reviewed by the FDA, before they are sold to patients.

Summary: University of Chicago researchers have developed the first practical method to limit activity of therapeutic genes to a specific cell type (smooth muscle cells), clearing a major safety hurdle facing gene therapy.

The initial phase of clinical investigation is focusing on the safety of the cell replacement therapy combination products in patients.

While the culture and climate for stem - cell therapies is improving, Roop said, more research, like Colorado State University's stem - cell work on dogs and horses, is needed to ensure safety and learn long - term effects of stem - cell therapies.

The routine use of MSC cellular therapy with would benefit from a uniform cell source, with stable phenotype and function as well as providing a solution to potential safety issues.

Overall, SR - Tiget represents a multi-disciplinary research environment, which provides a unique blend of scientific expertise in the development of innovative gene and cell therapy strategies, access to relevant preclinical models to evaluate their efficacy and safety, as well as competence in conducting early phase clinical trials.

«I think as more data accumulates documenting safety, that will potentially accelerate getting more of these stem - cell therapies approved,» he said.

In two new publications in the journal Molecular Therapy, University of Cincinnati (UC) biomedical engineering professor Peixuan Guo, PhD, details successful methods of producing large RNA nanoparticles and testing their safety in the delivery of therapeutics to targeted cells.

Performs genome - wide profiling of vector integration sites as readout of cell growth at clonal level, in basic research studies and technology development, in preclinical safety studies and in gene therapy treated patients.

Studies on vector integrations are providing crucial information on vector biology, the dynamics of genetically modified cells, and the safety of gene therapy.

For more, see The effect of Saccharomyces boulardii on Candida albicans - infected intestinal cell lines Caco - 2 and Intestin - 407, and Efficacy and safety of the probiotic Saccharomyces boulardii for the prevention and therapy of gastrointestinal disorders.

Due to its advantages of both safety and affordability, it's non-invasiveness, and the fact that it's drug - free, Stem Cell Therapy by MediVet Biologics is the most logical cell therapy choice for the treatment of the followCell Therapy by MediVet Biologics is the most logical cell therapy choice for the treatment of the folTherapy by MediVet Biologics is the most logical cell therapy choice for the treatment of the followcell therapy choice for the treatment of the foltherapy choice for the treatment of the following: