stem cells Archives - Page 16 of 129

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

January 25, 2017 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 1 Comment

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 …

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Update on patients lawsuit against stem cell clinic, Stemgenex

January 23, 2017 May 12, 2023 / By Professor Paul Knoepfler, Ph.D. / 6 Comments

The website Law360 has an interesting update on the proposed class action lawsuit against the San Diego stem cell clinic Stemgenex. Note that it seems you can read the full Law360 article without a subscription if you open the site in Chrome as your web browser. See more background on Stemgenex and on this case …

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What is your favorite stem cell/regen med biotech & why?

January 20, 2017 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 8 Comments

I’m putting together a list of stem cell and regenerative medicine biotech companies for a blog post, including both public and private. I’ve got a good list already, but want it to be fairly comprehensive. I’m also curious what readers think are the most promising ones and why. So weigh in with comments please or …

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Tom Price & MiMedx: a stem cell connection?

January 18, 2017 June 6, 2022 / By Professor Paul Knoepfler, Ph.D. / 5 Comments

What’s the deal with Trump’s HHS Secretary pick Rep. Tom Price (now testifying before the Senate) and the amniotic tissue/stem cell company MiMedx that’s caused some buzz in the last 48 hours? I’ve been following MiMedx for a few years since it received an untitled letter from the FDA and I noted its claim of one its …

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My 2017 New Year’s Stem Cell Resolution

January 12, 2017 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 3 Comments

CIRM is doing a fun, positive challenge to the stem cell community to post stem cell resolutions for the new year. You can read more about it here. Be sure if you post yours on Twitter to include the #StemCellResolution hashtag. Have fun! Below is my resolution in video form.

STAP cells (stap細胞) are real deal says new Vacanti patent declaration

January 10, 2017 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 14 Comments

STAP is back? Really? No, I don’t believe so, but there’s an interesting development and twist on the STAP cell front. Just a few days ago on January 4, 2017 Dr. Charles Vacanti, the originator of the STAP cells concept, submitted a declaration to the USPTO affirming the belief that STAP cells are real and requesting that …

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Stem Cell Person of the Year 2016: Patient Advocate Ted Harada

January 8, 2017 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 2 Comments

Patient advocate Ted Harada is the recipient of this year’s Stem Cell Person of the Year Award. Congrats also to the runner-up, HD patient advocate Judy Roberson. The three of us together are pictured at left. You can read about the 20 nominees here and see the vote results that picked the 10 finalists here. …

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TGIF: Week’s Stem Cell Headlines, Papers, & Resources

January 6, 2017 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 1 Comment

What are the latest developments in stem cells and regenerative medicine in this first week of 2017 and right before the end of the past year? Here are some of the headlines and papers that have popped up that seem notable or surprising. Be sure to also check out our stem cell & regenerative medicine …

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Clinics can’t retract problems like stem cell facelift gone wrong

January 4, 2017 April 20, 2023 / By Professor Paul Knoepfler, Ph.D. / 8 Comments

What happens for patients and clinics after a stem cell facelift gone wrong? What about other cell injection problems? Cell therapies raise new challenges and risks. You can stop taking a pill or an injection treatment. However, you can’t stop or retract stem cell treatments if there’s a bad side effect. Unlike other kinds of …

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Stem cell wish list for 2017

January 2, 2017 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 13 Comments

Last week I posted my list of 2017 predictions for the stem cell field. Today a couple of days into 2017 I’m more focused on hope than realism. What would I wish for in the stem cell and regenerative medicine arena in the coming year? More stem cell clinical trial data posted and published. There are …

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