We have released exciting new coverage of the stem cell industry. Check it out and let me know what you think?
In this interview with Dr. Riam Shammaa, Medical Director at the Canadian Centres for Regenerative Therapy (CCRT), we discuss FDA regulation of human cells, tissues, and cellular and tissue-based products (HCT/P’s), as well as the difference between 351 and 361 products. This is a timely interview, because the U.S. FDA recently filed federal complaints seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products. This interview will help you understand the FDA framework affecting HCT/Ps within the U.S, as well as the framework and recommendations implemented by Health Canada.
According to the Nikkei Asian Review, Kyoto University will start providing human embryonic stem cells (ES cells) to universities and private companies for clinical trials. The cells, like induced pluripotent stem cells (iPS cells), are capable of differentiating into all 200+ cell types present within the human body. Kyoto University produces ES cells using fertilized eggs from infertility treatments that would otherwise be discarded as medical waste. The university has already stockpiled iPS cells and provides them to universities and research institutions within Japan. The decision is expected to expand ESC research within Japan and support regenerative medicine (RM) breakthroughs.
BioLamina and collaborators have partnered with Novo Nordisk A/S, a Danish multinational pharmaceutical company, allowing Novo Nordisk to develop novel stem cell based therapies based on Biolaminins, human recombinant laminin cell culture matrices, developed and produced by BioLamina. Novo Nordisk announced that they are increasing their commitment to cell therapies, including areas outside of diabetes. The three cell therapy projects they have licensed are all based on BioLamina technology. These projects aim to treat Parkinson’s disease, heart failure and loss of vision, all severe chronic conditions.
ExCellThera Inc. announced that its lead platform, ECT-001, will be used as part of a new Phase I/II clinical trial in patients with multiple myeloma. ECT-001 will be used to expand blood stem cells from the umbilical cord, which have been shown to have higher tolerance for HLA mismatches than stem cells in an allogeneic transplant. The ECT-001 platform is a combination of a small molecule, UM171, and an optimized culture system. The platform is capable of expanding the number of stem and immune cells in a single unit of cord blood for therapeutic purposes in as little as seven days, twice as fast as any other solution.
MedRebels welcomes practicing physicians to a cumulative 3-day educational symposium on October 26-28, 2018 in Austin, TX. Lectures on cellular-based and other regenerative therapies and their clinical applications for orthopaedics and pain management. During these lectures and workshops, physicians and leading scientists will present current research and clinical studies. They will address clinical pearls for implementing cellular therapy into a physician’s practice. Physicians will receive hands-on cadaveric training utilizing ultrasound-guidance and fluoroscopy.
Nohla Therapeutics, a leading developer of universal, off-the-shelf cell therapies for patients with hematologic malignances, announced the closing of a $45 million Series B financing. Nohla will use the proceeds to complete the ongoing Phase 2 trials of its lead candidate, dilanubicel (NLA101), in allogeneic transplant and chemotherapy-induced myelosuppression, as well as support Phase 3 trial and commercial manufacturing needs. Dilanubicel (NLA101) is a universal donor, off-the-shelf, ex vivo expanded hematopoietic stem and progenitor cell product.
Over the past decade, the number of cell and gene therapy conferences has rapidly expanded from only a few per year to numerous events per month. In this article, we present a comprehensive list of cell and gene therapy conferences worldwide. These conferences include events focused on stem cells, cellular immunotherapies, and exosomes, as well as other types of cell and gene therapy applications.
China has a unique market for cord blood banking, because the government allows one cord blood bank per province and the licensed company functions as hybrid public/private bank. China Cord Blood Corporation (CCBC) holds the exclusive license for three of the regions and has partial ownership in a 4th province, giving it either exclusive or partial operating rights within regions that account for nearly 3/4ths of the annual births. In 2016, Sanpower Group and its subsidiary Nanjing Cenbest announced the acquisition of CCBC and Shandong Cord Blood Bank, positioning it to hold these licenses.
FBS is a staple of cell culture research, and yet lot consistency is so poor that it often causes experiments to vary or fail outright. Find out how Dr. Matthew Sikora solved his lab’s serum crisis and how to apply his findings in your own lab in this case study. You will learn how to improve your experimental reproducibility, standardize your lab with consistent media, and find the right reagents for your needs.
Cord blood conferences are expanding in number and frequency. Cord blood banking is the long-term storage of umbilical cord blood following the birth of a newborn. It is collected, because it is rich in hematopoietic stem cells (HSCs), a type of stem cell that is widely used in transplant medicine and can be used to treat over 80 different conditions. The matrix of the umbilical cord, called Wharton’s Jelly, is also a rich source of mesenchymal stem cells (MSCs), a cell type that is being explored in more than 800 clinical trials worldwide.
There are wide range of reasons to consider a stem cell donation. It can be for the donor’s own stem cell transplant. This arises if a patient develops a condition that causes cell destruction. Blood cell destruction is commonly associated with illnesses such as aplastic anemia, although chemotherapy and similar treatments can also damage blood cells. A loved one in need is another common reason for stem cell donation. Some people also donate to help a stranger if they are identified as a genetic match.
The Regenerative Medicine (RM) Industry is rapidly growing with more than 600 market competitors worldwide. Gene therapy is the use of genetic material to change the expression of a gene product, while cell therapies utilize living cells to create either direct or indirect effects within the human body. Often, technologies capable of restoring tissues and organs leverage cell and gene therapies, because tissues and organs are composed of differentiated cell types. However, technologies can directly impact the restoration of tissues and organs through the use of biomaterials, tissue engineering, and 3D bioprinting.
A great deal of funding has been flowing into the CAR-T sector over the past 24 months in the form of financing rounds, deal-making, asset agreements, and industry IPOs. To track these industry events, BioInformant has released a five-page CAR-T market brief summarizing all types of investments flowing into CAR-T companies worldwide. For a limited-time, you can claim this market brief for only $19 and get immediate access to CAR-T market insights.
In this 21-page, 50+ respondent survey, cell therapy manufacturing executives reveal when and why they choose to partner with a cell therapy contact manufacturing organization (CMO). It reveals the selection criteria that cell therapy executives use to select a CMO partner, as well as their perspectives on manufacturing capacity, geography, pure-play versus hybrid CMOs, and much more. The findings from this survey are fascinating and and we wouldn’t have known them without surveying cell therapy executives. For a limited-time, you can claim these market findings for only $97 (50% off).