Alliance for Regenerative Medicine (ARM)

Historic spring storm of FDA letters to stem cell clinic industry

FDA-letter-stem-cells

The FDA has stem cell clinics squarely on its radar screen now and it’s pulling the trigger with many letters going out to this problematic industry. In the past, sometimes years went by with no letters at all or one letter in total to stem cell clinics so this marks a major shift. Background on …

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Cell therapy trials for COVID-19 accelerate & some early reports

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Could various kinds of cell therapy help patients with COVID-19? A variety of cell therapies, mostly focused on mesenchymal stromal/stem cells (MSCs), have gotten cleared quickly in the U.S., China, and Israel and possibly other countries to be tested in patients with the novel coronavirus. I hope at least one proves helpful. It’s mostly a …

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Stem cell & regenerative medicine meetings for you to go to in 2019

Stem-Cell-Meetings-2019

I keep a yearly hub of stem cell & regenerative medicine meetings here on The Niche. Below I’ve pasted the list for 2019, which continues to grow. If you don’t see yours listed, send me an email with the info including a link (knoepflerATucdavisDOTedu). These meeting listings are not endorsements and I try to make …

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3X recent stem cell & regenerative medicine good news

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In the past month or two there has been a steady stream of good news in the stem cell and regenerative medicine world. Here are three examples. Fate Therapeutics announced the first US IND for an induced pluripotent stem cell (IPSC)-related product. Its cleared product, FT500, is an off-the-shelf natural killer-based cancer immunotherapy. I expect …

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Perspectives on Cures Act stem cell provisions possible benefits & risks

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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 …

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REGROW Act, Mark Kirk Lobbying & Contributions Yield Stem Cell Surprises

Center-for-Responsive-Politics

The money behind a piece of legislation can provide unique insights into the back story and this is definitely true for the REGROW Act that would reduce FDA oversight of the investigational use of stem cells in patients. Senator Mark Kirk of Illinois, who is facing probable defeat next week in his reelection bid according to …

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Alliance for Regenerative Medicine (ARM) Opposes REGROW Act, Risks to Patients Cited

Alliance-for-Regenerative-Medicine

The biggest debate today in the stem cell world is over how much regulation is needed for new, investigational stem cell therapies that are not as yet approved. Sometimes it feels very lonely being out there publicly advocating for appropriately thorough regulation of stem cell therapies and at times I get a lot of heat for …

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ARM Asks FDA for Clarification on Draft Guidance on Minimal Manipulation

Alliance-for-Regenerative-Medicine

In the last few months the FDA has taken steps toward crystalizing regulatory oversight of stem cell and more broadly cell and tissue-based therapies. These steps come in the form of several draft guidances  (see here, here, and here) . The Alliance for Regenerative Medicine (ARM) has responded to the draft guidance on Minimal Manipulation. For example, ARM has …

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