San Antonio, Texas, July 25, 2024 – ALS, or amyotrophic lateral sclerosis, is defined by the ALS Association (als.org) as a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. ALS symptoms vary and patients may lose the ability to speak, eat, move and breathe. There is no cure. The Mayo Clinic reports (mayoclinic.org) that no treatments can reverse ALS damage, but they may slow the progression of disease symptoms or help prevent complications. INCELL is committed to tackling innovative ALS therapy. [Read more…]
Organizations Who are Conducting Human Trials with iPSC-Derived Cellular Therapeutics
Induced pluripotent stem (iPS) cells are a type of stem cell that can be generated directly from adult cells. They were first developed in 2006 by Shinya Yamanaka and his team. iPS cells are engineered by reprogramming adult cells, such as skin cells, to revert to a pluripotent state, meaning they have the ability to differentiate into any cell type in the body. This reprogramming is typically achieved by introducing a combination of specific genes or gene factors into the adult cells, which resets their developmental clock. [Read more…]
Interview with Patrick Lucy, President and CEO of Lykan Bioscience
This is an interview with Patrick Lucy, President and CEO of Lykan Bioscience. Lykan is an innovative cell therapy-focused contract development and manufacturing organization (CDMO) headquartered in Hopkinton, MA. In this interview, we discuss the vision of Lykan Bioscience, its innovative and agile approach to CDMO services, and the company’s future goals. Enjoy! [Read more…]
What Is An RMAT? List of Publicly Announced RMAT Designations (102)
To date, what number of U.S. FDA-approved RMATs have been issued and to whom have they been awarded?
The answer is that 102 RMAT (Regenerative Medicine Advanced Therapy) designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 279 requests and issued 128, which means that a handful are not yet public knowledge. Therefore, a few companies are operating in stealth mode with regard to their RMAT designations and approximately 46% of RMAT applications get approved (128 approvals / 279 applications = 45.9%). [Read more…]
Stem Cell Infusion: What to Expect
In recent years, stem cell infusion has become a breakthrough technology. There have been multiple medical leaders citing regenerative medicine as the way of the future. Stem cells obviate our need to patch up the body or create stopgap measures for systems that don’t work. They instead promise to replace organs and tissues that no longer function, essentially rebuilding the body from the inside out. Naturally, science has not progressed to the point of spreading this technology across the globe. However, the growing availability and efficacy of stem cell infusion indicate this isn’t far off, either. [Read more…]
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