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Why the FDA should not green-light 3-parent reproduction

February 26, 2014 / Professor Paul Knoepfler, Ph.D. / 7 Comments

An FDA committee began a meeting yesterday that continues today to consider permitting new assisted reproduction-based “3-parent” technology that could address mitochondrial disorders, a serious human health problem. The technology also raises complex health issues of its own and invokes ethical questions. The goal of the FDA meeting is articulated this way: “the committee will […]

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Interview with Robert Klein on CIRM’s Future

February 10, 2014 / Professor Paul Knoepfler, Ph.D. / 1 Comment

What does the future hold for CIRM? I asked former CIRM Board Chair and Prop 71 leader, Robert Klein, about that and more in the interview below. He also says some particularly exciting clinical trial and other developments in the stem cell field are coming soon. What got you excited for the very first time

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Osiris FDA Letter: Trick or Treat?

October 29, 2013 / Professor Paul Knoepfler, Ph.D. / 3 Comments

Osiris, a cellular therapy biotech, recently received a so-called “untitled letter” from the FDA. The text of the letter seems on the whole negative in my opinion, while the company’s public reaction to the letter on the other hand could be seen paradoxically as rather cheery. What’s going on here? With Halloween coming, one has

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Osiris success with Diabetic foot ulcers is a giant step

August 13, 2013 / Professor Paul Knoepfler, Ph.D. / 8 Comments

Stem cell & cellular medicine biotech, Osiris, reported a major success today with its cell-based treatment of Diabetic foot ulcers. The data are about as good as it gets. The company’s Grafix product for the ulcers was three times more effective than the control. A cross-over phase where those given the control were switched to

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Tribute to CIRM Vice-Chair, Duane Roth

August 5, 2013 / Professor Paul Knoepfler, Ph.D. / 2 Comments

Duane Roth, the Vice-Chair of the California Stem Cell Agency CIRM and the leader of CONNECT, an organization promoting entrepreneurship in the San Diego area, died yesterday. Roth had been in a serious solo cycling accident on July 21. Roth had a long, successful career in biotech including having founded Alliance Pharmaceutical Corp. He was

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BioTime CEO Mike West Interview Part 2: Geron & hESC

July 1, 2013 / Professor Paul Knoepfler, Ph.D. / 3 Comments

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When you want to both know the real history of the pluripotent stem cell-based biotech industry and perspectives on its future, there are only a handful of people to turn to and one of them is definitely Dr. Michael West, CEO of BioTime. I’m doing a several part series of blog posts on a lengthy

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Delightful overview of ISSCR 2013 by guest blogger Dr. Susan Lim

June 20, 2013 / Professor Paul Knoepfler, Ph.D. / 2 Comments

This is a guest post on ISSCR 2013. By Dr. Susan Lim A record 4100 delegates attended the 11th Annual Meeting of the International Society for Stem Cell Research (ISSCR), held at the Convention and Exhibition Center in Boston from 12-15 June 2013. Co-sponsored by the Harvard Stem Cell Institute, the Meeting featured 7 Plenary

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Interview with Gil Van Bokkelen of Athersys

May 20, 2013 / Professor Paul Knoepfler, Ph.D. / 1 Comment

Today’s post is an interview I did with Dr. Van Bokkelen covering 10 questions. Dr. Gil Van Bokkelen is Chairman and CEO of Athersys, Inc., a company that has focused heavily on stem cells and regenerative medicine for more than a decade. For more on Dr. Van Bokkelen’s background see additional bio section at the end of

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Transdifferentiation or direct reprogramming of fibroblasts to oligodendrocyte progenitors

April 18, 2013 / Professor Paul Knoepfler, Ph.D. / 1 Comment

Back-to-back papers (here and here) in Nature Biotechnology report the transdifferentiation (now often simply referred to as “direct reprogramming”) of plain old fibroblasts into brain cells called oligodendrocyte progenitor cells (OPCs). OPCs are a remarkably useful kind of brain cell that generates myelin, which insulates nerves. OPCs are thought to have great therapeutic potential for

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Great news as Sherley v Sebelius officially over: Supreme Court Takes a pass

January 7, 2013 / Professor Paul Knoepfler, Ph.D.

Today the Supreme Court agreed to review three cases, none of which were Sherley v Sebelius. What a great day! For those curious, Certiorari Granted (subheading on Supreme Court announcement) means the Court has granted review of these cases. This is wonderful news for patients, the stem cell field, and probably biotech Advanced Cell Technology

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