I've been reading about the so-called REGROW Act and so far haven't been able to find out any concrete details about how it might speed patient access to cell-based therapies sooner. Paul Knoepfler is hysterically opposed to it, so that it a promising sign. Anyone know the actual details?
What is the REGROW Act and how will it help patients?
- Thread starter gh253
- Start date
You are right, Knoepfler's opposition can be seen as an endorsement!I've been reading about the so-called REGROW Act and so far haven't been able to find out any concrete details about how it might speed patient access to cell-based therapies sooner. Paul Knoepfler is hysterically opposed to it, so that it a promising sign. Anyone know the actual details?
Patients For Stem Cells has been tracking this. My husband and I met twice with Senator Patty Murray's aides to support it. We just posted this blog in support.
Patients Support REGROW Stem Cell Legislation
Our post includes a link to a very important panel discussion put on by Bipartisan Policy Commission. They help Congress write legislation. Former Senaot Bill Frist is leading the regenerative medicine initiaties, and he's also an MD.
April 12, 2016 Advancing a New Policy Framework for Regenerative Cell Therapy
Go to the page and scroll down to watch the discussions with the legislative aides working on this legislation, two patients that gave their riveting stories, and many experts working with adult stem cells. See Second Panel with Arnold Caplan, who discovered Mesenchymal Stem Cells in 1991 and their life saving properties.
Email this BPC event to your Congressional reps so they understand the importance of Senator Mark Kirk's REGROW legislation.
Cell Therapy Now is a website with over 40 organizations supporting REGROW, and includes an “advocacy tool kit” that explains in detail how you can become involved, and reach out to your Congressional representatives.
So far this bill looks great for any university trial of stem cells, like expanded cells, which we don't have access to unless we go out of country, like I did for MS with Celltex. These are the cellular therapies FDA treats as drugs, and that means 10 years and $1 billion before approval and insurance approval. REGROW says it will cut this in half, so 5 years and $500 mil, plus more patients will be able to enroll in the trials during the 5 year conditional approval process. So it's great for serious illness the university trials are pursuing like neuro-degenerative, MS, Parkinson's, Alzheimer's, cardiovascular, stroke, diabetes. Expanded, high dose cellular therapy is referred to a "351 product" by FDA.
But what is unclear: the impart on same-day low dose "361 product" like the 800 U.S. clinics offer. Many claim this is a good therapy for the serious conditions I listed, but if that were the case, why aren't the universities investigating low dose cells for these conditions? So that may be a good thing if that gets curtailed.
But the concern is "361 product" is also used by orthopedic physicians to fix arthritis and fix bad knees and hips and other orthopedic conditions, usually for a good price around $3,500 for a knee. You'll see I asked this as Question #1 in my blog. Have not yet gotten an answer. The concern is that the longer, more expensive 351 approval process would now apply to 361. The other category of interest to many in this forum is lung treatments at clinics like the Lung Institute, which works well even with low dose cells.
I wish I'd been able to get definitive answers on this. It would be great if y'all would contact your Congressional reps, your stem cells doctors, anybody who needs to know about this, and help me tract down some facts. It is a little bit scary that this law could go into effect without a firm picture on what the results will be.
The REGROW legislation may come to floor debate within 3 weeks, so please take action soon, and let us know what you find out.
SammyJo