Category Archives: Cell Therapy

Advertising forstem cell therapies not supported by clinical researchoftenmadedirectly to patients and sometimes promoted as a cure for diseases like multiple sclerosis or Parkinsons is a growing problem that needs to be addressed and regulated, a team of leading experts say, calling suchstem cell tourism potentially unsafe. Stem cell tourism is the unflattering name given to the practice of encouragingpatients totravel outside their home country to undergo suchtreatment, typicaly at a private clinic. The article, titledMarketing of unproven stem cellbased interventions: A call to actionandrecently published inthe journal Science Translational Medicine, was co-authored by scientistswith universities and hospitals in the U.S., Canada, U.K., Belgium, Italy, Japan, and Australia. It focuses on the global problem of thecommercial promotion of stem cell therapies and ongoing resistance to regulatory efforts. Its authors suggest that a coordinated approach, at national and international levels, be focused on engagement, harmonization, and enforcement in order to reduce risks associated with direct-to-consumer marketing of unproven stem cell treatments. Treatments involving stem cell transplants are now being offered by hundreds of medical institutions worldwide, claiming efficacy in repairing tissue damaged by degenerative disorders like MS, even thoughthose claim often lack or are supported bylittle evidence . They alsonoted that … Continue reading →

An Oxford-based gene and cell therapy group has announced a major deal with Swiss pharmaceuticals company Novartis. Oxford BioMedica today revealed it signed a deal potentially worth more than $100m (77.1m) with Novartis for the supply of material for its new cell therapy, CTL019. The agreement builds on an existing relationship between the two companies that collaborated on CTL019, which will launch commercially later this year. Read more: Novartis earnings fall but new drug raises hopes The contract is for the supply of lentiviral vectors, which are used to generate CTL019, a treatment for an especially difficult type of leukaemia. Novartis has flagged the treatment as a potential blockbuster. The supply agreement is for the next three years, with the potential of an extension to five years, and it includes a $10m upfront payment for Oxford BioMedica. John Dawson, the boss of Oxford BioMedica, said: The new deal with Novartis will strengthen the group's balance sheet immediately and will support the group's continued growth over the next three years. The company is also set to receive royalty payments on future sales of CTL019, which analysts at Jefferies said could earn Oxford BioMedica between 65-75m a year assuming peak sales of … Continue reading →

By David Ikudayisi Stem Cell Therapy comes in different types. Embryonic Stem Cell Therapy involves the use of embryonic stem cells derived from the inner cell mass of a blastocyst, an early-stage pre-implantation embryo at 4 days old to around 12 days old, leading to the destruction of the blastocyst which raises ethical and religious issues. Therefore, this type of Stem Cell Therapy is not the focus of this piece. The focus is Adult Stem Cells (ADSCs) and Induced Pluripotent Stem Cells (iPSCs). iPSCs are produced in the laboratories by reprogramming adult cells to express embryonic stem cells characteristics whereas ADSCs are cells obtained from an adult patient who will also be the recipient of the same stem cells. In the United States, we must transplant the cells back to the same patient on the same day, while in some countries, the stem cells can be cultured to increase the quantity of stem cells before transplanting them back to the same patient who donated them. Stem Cell Transplantation is a complex process that needs the care of experts in Regenerative Medicine, a new speciality of medicine . In order to ensure that science remains as the vehicle for hope and … Continue reading →

LONDON Novartis has signed a major contract with Oxford BioMedica that could earn the British company more than $100 million (77.32 million pounds) over three years for supplying the Swiss drugmaker with material for its novel cell therapy CTL019. The deal, announced by Oxford BioMedica on Thursday, could help put the veteran biotech firm on a path to sustainable profitability. The contract is for the supply of lentiviral vectors used to generate CTL019, a new kind of treatment for hard-to-treat leukaemia that is expected to reach the market this year. A U.S. advisory panel will discuss the case for approving CTL019 at a meeting on July 12 and Novartis has already designated the treatment as a potential blockbuster. Oxford BioMedica will received $10 million from Novartis upfront, as well as payments for various performance incentives and bioprocessing and development services. It will also get a royalty on future sales of CTL-019. Jefferies analysts said this could earn Oxford BioMedica between 65 million and 75 million pounds ($84-97 million) a year, assuming CTL019 peak sales of at least $1 billion. The agreement also covers the supply of vectors for other undisclosed Chimeric Antigen Receptor T cell (CART) products. Excerpt from: Oxford … Continue reading →

This report describes and evaluates cell therapy technologies and methods, which have already started to play an important role in the practice of medicine. Hematopoietic stem cell transplantation is replacing the old fashioned bone marrow transplants. Role of cells in drug discovery is also described. Cell therapy is bound to become a part of medical practice. Stem cells are discussed in detail in one chapter. Some light is thrown on the current controversy of embryonic sources of stem cells and comparison with adult sources. Other sources of stem cells such as the placenta, cord blood and fat removed by liposuction are also discussed. Stem cells can also be genetically modified prior to transplantation. Cell therapy technologies overlap with those of gene therapy, cancer vaccines, drug delivery, tissue engineering and regenerative medicine. Pharmaceutical applications of stem cells including those in drug discovery are also described. Various types of cells used, methods of preparation and culture, encapsulation and genetic engineering of cells are discussed. Sources of cells, both human and animal (xenotransplantation) are discussed. Methods of delivery of cell therapy range from injections to surgical implantation using special devices. Cell therapy has applications in a large number of disorders. The most important … Continue reading →

New data from the Phase 1 THINK clinical trial (NCT03018405) show that two metastatic colorectal cancer (mCRC) patients whose disease progressed following at least two prior therapies had stabilized the disease at a three-month follow-up after receiving the lowest dose level ofCelyads NKR-2 CAR T-cell therapy. The third person included in the dose cohort, a pancreatic cancer patient, had disease progression at three months, but the findings suggest that this CAR T-cell therapy inducesbetter results than standard of care, under which the time to disease progression is between 1.9 and 3.2 months. We are pleased to have observed these encouraging preliminary results in such a late stage population, Christian Homsy, Celyads CEO, said in apress release.Despite being dosed only at a tenth of the expected efficacious dose based on animal experiments, the results show a stabilization of the disease. We look forward to the next stages of the trial. The open-label THINK trial, conducted in the U.S. and Europe, is a dose escalation Phase 1 study to assess the safety and clinical activity of three administrations of NKR-2 cells across seven cancer types. The study is designed to include patients with five types of solid tumors (colorectal, ovarian, bladder, triple-negative … Continue reading →

With numerous different entities and millions of people affected, cancer continues to be one of the most prevalent diseases around the world. Scientists are working to find new treatment possibilities, and have been concentrating on the bodys own immune system for some time. Because cancer emerges from the bodys own cells, it is usually difficult for the immune system to distinguish good cells from bad ones, explains Prof Dr Elfriede Nner, head of the Tissue Control of Immunocytes Research Group at the Helmholtz Zentrum Mnchen. But there are ways to support the immune system in recognizing and combating cancer cells. Focus on T-cell therapy One approach is the so-called adoptive T-cell therapy, which involves removing immune cells from the body and genetically arming them. The cells are given new structures on the surface that accurately lead them to the cancer cells. One limitation in this form of therapy is that the binding between the immune cell and the cancer cell is often somewhat weak. Although this binding can be artificially strengthened, doing so also increases the risk of unwanted binding to healthy structures in the body, explains study leader Nner. She and her team were therefore searching for a different … Continue reading →

The Sartorius and Science Prize for Regenerative Medicine & Cell Therapy is focused towards scientists advancing research (basic or translational) within the relevant fields, with the winner receiving $25,000 in prize money and being published inScience magazine. Scientists who have gained a PhD or an MD during the past decade are invited to submit an essay on regenerative medicine, cell therapy, gene therapy or immunotherapy, as well as on materials or tissue engineering. The essays should be 1,000 words in length and should describe the applicants research and implications for regenerative medicine and cell immunotherapy, as well as include supporting documents. In addition to the cash prize and publication in Science, the winner will receive a Sartorius product package for free. Furthermore, up to three runner-up essays will be published in Science Online and the writers of the runner-up essays will also receive a cash prize of $5,000. This area [regenerative medicine and cell therapy] will play a major role in the future, said Gerry MacKay, member of the Sartorius Group executive committee and executive vice president of marketing, sales and services for Sartorius Lab Products & Services Division. Sartorius innovative bioanalytical tools help scientists answer fundamental and complex biological … Continue reading →

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "The Market For Cell Therapy Manufacturing - Strategies for Pricing, Cost Control, Reimbursement, Distribution, & More" report to their offering. This global strategic report provides detailed analysis of ten leading cell therapy companies worldwide, evaluating the strengths of each company, as well as identifying cell therapy products in development, manufacturing strategies, and partnerships. The report analyzes time frames for cell therapy product development, distribution channels, key trends and technologies impacting cell therapy manufacturing, cost control measures, and challenges and considerations affecting with cell therapy manufacturing. Additionally, the report identifies cell therapy products that have been reviewed and approved by internationally-recognized regulatory agencies, as well as products brought to market in the U.S. with FDA approval. It also specifies which cell therapies have since been pulled from market, due to factors such as low adoption rates, unsuccessful reimbursement strategies, or high cost of manufacturing. It provides an overview of the regulatory environment affecting cell therapy manufacturing in key countries worldwide, evaluating the importance of the recent FDA guidelines for Human Cell and Tissue-based Products (HCT/Ps) and the 21st Century Cures Act, as well as accelerated pathways for cell therapy approvals in … Continue reading →

Reader Charles Wang wrote in to ask if stem cell therapy is approved for use in Singapore. Stem cell therapy refers to the use of stem cells to treat various medical conditions. Mr Wang also asked if it is available, and where one can seek this treatment. Health reporter Linette Lai answered. Any new treatment must be backed by sufficient scientific evidence to ensure that it is safe and effective. However, there is not enough scientific evidence yet for stem cell therapy to be approved as a mainstream treatment in Singapore. There is not enough scientific evidence yet to ensure that stem cell therapy is safe and effective for it to be approved as a mainstream treatment in Singapore. PHOTO: ST FILE A Health Ministry spokesman said: "To date, stem cell therapy has not been substantiated by sufficient clinical evidence as a form of mainstream treatment for any diseases or ailments and is not available as a treatment in our public hospitals. "If any registered medical practitioners or institutions want to administer stem cells as a form of medical treatment, it will have to be conducted within the context of clinical trials." Excerpt from: askST: Is stem cell therapy available … Continue reading →