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Patient Advisory: Sneaking Stem Cells Out of USA May Be Illegal Smuggling

August 26, 2013 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 12 Comments

Some stem cell clinics are pressuring their own patients into potentially breaking federal law through something like smuggling. A big problem for certain clinics is how to bring the paying American customer (i.e. the patient) and the biological product that they are selling derived from the patient’s stem cells together outside the reach of the …

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Stem cells for a better sex life? Part 1 overview

August 16, 2013 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 6 Comments

The stem cell field is seeing stem cells increasingly advertised as the basis for improving people’s lives in countless ways, including a better sex life. Some of the hope for stem cells making life better is legit, while other stuff is bogus. One area that is getting significant attention commercially is how stem cell interventions …

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Jeong Chan Ra Arrest: Can RNL Bio (알앤엘바이오) Survive?

July 13, 2013 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 4 Comments

Over at Health in the Global Village, Leigh Turner yesterday published an excellent piece updating us all on the latest news on Korean stem cell company RNL BIo (알앤엘바이오) and its leader, Dr. Jeong Chan Ra (라정찬 ). Addition: The story was reported in several Korean news outlets including Hani here. A video here by MBC News of Korea, one …

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Janet Rossant, ISSCR President, on her goals, cloning, non-compliant clinics, iPS cells, and future of field

July 8, 2013 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 1 Comment

New ISSCR President, Dr. Janet Rossant, kindly agreed to do an interview with me focused on the future of ISSCR, her plans for her tenure, and some key issues in the field. Dr. Rossant is Chief of Research at The Hospital for Sick Children in Toronto. 1. The stem cell arena is a very rapidly changing one …

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Stem cell black market emerging in the U.S.

December 11, 2012 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 1 Comment

Have I got a stem cell for you! We hear a lot about the dangers of an increasing number of rogue stem cell clinics, but another critical trend has flown more under the radar: direct marketing of stem cells to doctors. This is big business and arguably one of the biggest threats to patients. In …

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Celltex response to FDA says transplants stopped: what are the other key points?

October 20, 2012 February 1, 2021 / By Professor Paul Knoepfler, Ph.D.

The Houston Chronicle has posted the response letter from Celltex to the FDA in regard to the FDA Warning Letter issued to Celltex. The Chronicle also has a piece up on the warning letter that is a great read here. My thoughts on the possible paths for Celltex moving forward can be found here. The …

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As stem cell industry explodes, can a static FDA keep up?

September 19, 2012 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 8 Comments

There are legitimate arguments about the degree to which the FDA should regulate stem cell clinics and the point-of-care, for-profit stem cell industry. I’ve held debates about that on my blog with argument on both sides including a very valuable debate between Dr. Chris Centeno and Doug Sipp. However, increasingly it is looking like the …

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My ongoing Q&A with Celltex on their stem cell drug production methods

August 9, 2012 February 1, 2021 / By Professor Paul Knoepfler, Ph.D.

How does Texas stem cell clinic Celltex make their stem cell drug? This is a very key question as the answers will help the stem cell field evaluate this drug’s potential safety and efficacy. I’m calling it a “drug” because the FDA called Celltex a “drug manufacturer” and by all past FDA precedent as well …

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Great interview with Lee Buckler on stem cell industry, regulatory issues, and Celltex

July 3, 2012 February 1, 2021 / By Professor Paul Knoepfler, Ph.D. / 8 Comments

As I’ve been writing this blog for the last couple years it has served as a catalyst for me to meet dozens of really interesting people. One such person is Lee Buckler, a true stem cell industry guru. Given all the complex events of late in the stem cell field, I asked Lee if he …

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Centeno and Sipp interview on FDA stem cell oversight

May 1, 2012 March 16, 2021 / By Professor Paul Knoepfler, Ph.D. / 34 Comments

I have interviewed two folks on the very important US vs. Regenerative Sciences legal case: Dr. Chris Centeno and Doug Sipp. More background on the case can be found at the FDA Law Blog. I thank them both for their time and for sharing their unique perspectives. I have specific rules for these interviews and …

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