September 24, 2020

The Niche

Knoepfler lab stem cell blog

Right To Try (RTT)

3 min read

The year of 2018 has already been a wild one for stem cell news. There are many developments on a variety of fronts. Here are some of the most notable news bites of the last month or so. RMAT Wave. The FDA continues its warp-speed issuance of Regenerative Medicine Advanced Therapy (RMAT) designations with 20 such designations now in the public domain with Cellerant Therapeutics’ announcement and possibly a few more not yet out there. I wrote about the “carrot” of RMATs as relative …Read More

7 min read

At the request of the FDA, the DOJ is suing for permanent injunctions against two stem cell clinic firms, U.S. Stem Cell, Inc. and California Stem Cell Treatment Center (and for the latter, its parent chain of around 100 clinics, Cell Surgical Network). What does this big development mean in practical terms and how might it play out? For some discussion and potential answers, I turned again to Professor Patricia Zettler of George State University School of Law, an expert on stem cell oversight, the …Read More

3 min read

On one level a reasonable argument can be made for letting terminally ill patients have a right to try experimental as yet unproven therapies, but in the real world Right-To-Try laws have many downsides. On the whole, they are likely to be negative for patients as a group.  Raising the stakes is a push for a federal Right-To-Try law in the U.S. A bill passed the U.S. Senate so a law is a real possibility in coming months. What are the problems and risks? …Read More

2 min read

The U.S. Senate just passed a bill that if it becomes law would codify Right-To-Try as a federal law, meaning terminally patients across the U.S. could ask their physicians and drug manufacturers to be given still investigational therapies such as still unproven stem cell therapies in development. The bill’s official name is “The Trickett Wendler Frank Mongiello Jordan McLinn,and Matthew Bellina Right to Try Act of 2017.” Its goal is summarized this way, “To authorize the use of unapproved medical products by patients diagnosed …Read More