- All PLX-treated groups showed improvements in survival rates compared to untreated groups
- PLX-R18 cells did not increase leukocyte levels in non-irradiated NHPs, indicating no requirement to determine levels of radiation exposure prior to administration
- Data will inform a pivotal trial that could support marketing authorization under the FDA’s Animal Rule regulatory pathway
Recently, I had the honor of interviewing Kyle Cetrulo, CEO of AuxoCell Laboratories. In this interview, we explore the upcoming Future of Regenerative Medicine Congress, as well as future directions for regenerative medicine at large. Enjoy. [Read more…]
Many governments, including the U.S. and Japan, are well aware of the dangers to their populations of exposure to high levels of radiation from nuclear accidents or dirty bomb attacks. Whereas Japan’s population was recently exposed at Fukushima following the tsunami of 2011, the U.S. Department of Defense has been stockpiling acute radiation syndrome (ARS) countermeasures as a precaution for many years.
The recent escalation of tensions between North Korea and the U.S. may give the American government cause to up its investment in ARS antidotes. During a military parade on April 15th, North Korea displayed weapons including an intercontinental ballistic missile (ICBM) that could be capable of reaching the U.S. ARS may have just become a larger threat to health than it was just a few weeks ago. [Read more…]
CryoHoldco is a stem cell bank holding company that is the market leader in Latin America and one of the top 10 largest cord blood banks in the world.
CryoHoldco is about five times larger (5X) than any other stem cell bank in Latin America—with more than 125,000 cord blood samples stored.
When cord tissue units are also included, it has more than 130,000 stem cell units in inventory. CryoHoldco was created in 2015 with the purpose of forming the premier stem cell banking company in Latin America.
The first asset that was acquired by CryoHoldco was Cryo-Cell Mexico, the first stem cell bank in Latin America.
Since investing in Cryo-Cell Mexico in mid 2015, CryoHoldco has been active in the market and has acquired a controlling interest in a regional stem cell bank in Mexico (Q4 of 2015), as well as acquired Stem Medicina Regenerativa (early 2016), the largest stem cell bank in Colombia.
CryoHoldco, Largest Cord Blood Bank in Latin America
Today, CryoHoldco represents the largest stem cell banking operation in Latin America.
The company features 130,000 stored cord blood and tissue samples, two state-of-the art lab and storage facilities in Mexico and Colombia, a growing network of 10,000+ affiliated doctors, and 100+ sales offices.
CryoHoldco’s state-of–the-art storage facility in Guadalajara, Mexico, has a capacity of 300,000 samples.
Finally, CryoHoldco has a diversified revenue stream and product offering, which includes: cord blood and cord tissue banking, as well as storage of mesenchymal cells derived from dental pulp. In 2016, the company is launching adipose tissue storage and a maternity bank.
Phase 3 study of NiCord commenced last month in blood cancer patients
Jerusalem, Israel, March 23, 2017 — Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today that orphan drug designation has been granted by the European Medicines Agency’s (EMA’s) Committee for Orphan Medicinal Products (COMP) regarding NiCord® as a treatment for haematopoietic stem cell transplantation, also commonly known as bone marrow transplantation (BMT).
“We are very encouraged that the EMA has widened NiCord’s orphan drug designation to include BMT, and believe it is an important recognition of the unmet needs in these indications,” said Gamida Cell president and CEO Dr. Yael Margolin. “This broadened regulatory designation adds a key layer of market exclusivity for NiCord as we move forward with our Phase 3 study and prepare for commercialization.” [Read more…]