Search Results for: 21st century cures

FDA Regenerative Advanced Therapy Designation Rules Are Up in Response to Cures Act

The 21st Century Cures Act specifies some new FDA rules about investigational stem cell-based regenerative medicine therapies and perhaps most importantly defined a new class of product called a “Regenerative Advanced Therapy” or RAT, which is entitled to an expedited review. The FDA already has a new page up on RATs, which specifies the specifics of …

FDA Regenerative Advanced Therapy Designation Rules Are Up in Response to Cures Act Read More »

Perspectives on Cures Act stem cell provisions possible benefits & risks

EnergyCommerceLogo_ORANGE-e1480522761962

The 21st Century Cures Act has some important provisions that would impact the stem cell and regenerative medicine field.  What is driving these efforts is a widespread sense that the status quo of regenerative medicine oversight isn’t working very well. I’m talking with key stakeholders and still trying to sort out my thoughts on the …

Perspectives on Cures Act stem cell provisions possible benefits & risks Read More »

Chat with Michael Werner of ARM on Cures Act regenerative medicine provisions

Michael-Werner-Pic

One of the hottest topics in the world of stem cells this year has been the REGROW ACT and at a larger level the movement for changes in FDA oversight of investigational regenerative medicine therapies (see my past posts on it here), so the related provisions in the 21st Century Cures Act are stirring much …

Chat with Michael Werner of ARM on Cures Act regenerative medicine provisions Read More »

Japan stem cell oversight system too lax?

HeartSheet-Japan-system-stem-cell-oversight

The Japan stem cell and regenerative medicine oversight system has been designed to move investigational therapies forward fast, much faster than the systems in other countries such as the U.S. But how well is it working so far? It’s an important question both for that country and more globally as the Japanese system was touted …

Japan stem cell oversight system too lax? Read More »

Mesoblast gets FDA RMAT; List of 10 total designations so far

Mesoblast-e1514313188176

Australian stem cell biotech Mesoblast announced that it has received regenerative medicine advanced therapy (RMAT) designation from the U.S. FDA. This is very good news for the company and an encouraging development for the field. Interestingly, last month the FDA clarified that there is expanded RMAT designation that can include gene therapies too. At the Meeting …

Mesoblast gets FDA RMAT; List of 10 total designations so far Read More »

Fat stem cells are drugs & more: FDA final guidances point to a new era

FDA-stem-cell-policy-flow-chart-e1510854295902

Are fat stem cells a drug? Today the FDA definitively indicated “yes” without leaving much of any room for exceptions on this question. This morning the FDA made a major announcement on stem cell policy regarding its current thinking on oversight of regenerative medicine and issued four guidances, including two each in final and in …

Fat stem cells are drugs & more: FDA final guidances point to a new era Read More »

Cynata stem cell trial update: CEO Ross Macdonald interview

Koch-et-al_2016_MCA-derived-MSC-Treatment-of-Hindlimb-Ischemia-in-Mice-e1498668676851

Stem cell clinical trials have a certain gravitational pull for me as I’m always fascinated by them and since the new Cynata trial is moving forward, I recently did an interview their CEO, Dr. Ross A. Macdonald to find out more. PK: Cynata’s recently initiated clinical trial aims to treat GVHD as have other stem …

Cynata stem cell trial update: CEO Ross Macdonald interview Read More »

US Stem Cell bid for FDA RMAT rejected?

US-Stem-Cell-Inc.-e1498151180952

Can a stem cell clinic business get FDA RMAT designation? At least one announced it was trying, but now seems to have given up. Stem cell clinic business US Stem Cell, Inc. has reportedly announced that it is at least temporarily abandoning its efforts at getting Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. The …

US Stem Cell bid for FDA RMAT rejected? Read More »

FDA warp speed RMAT approval nukes stem cell clinic excuses

warp-speed-e1496766911206

Many stem cell clinics are in a bind in 2017 in the new RMAT approval reality. Stem cell clinics say that they only want to help people by providing stem cell therapies to patients in a speedier way that they claim getting FDA approval for a trial just doesn’t allow, but that doesn’t ring true. …

FDA warp speed RMAT approval nukes stem cell clinic excuses Read More »