Ocata does have a Wiki page, of course, but it needed a little updating. There’s a LOT that could potentially be added because so much exciting stuff has happened recently, and today I added the news about the official completion of Phase I/II and the EMA pivotal trial designation. There’s still a lot that could be done, but I’m really glad that the page exists in the first place. Go and take a look!
Here’s the Ocata page.
Here’s a cogent, intelligent, and rational comment to the news below:
3458qu9fqu4589q3u-!!!!! OMG I DON’T EVEN. O.o.
This moment has been brought to you by the Department of Medical Miracles to Come. 🙂
THIS IS WHAT WE’VE BEEN WAITING FOR!!! It’s the OFFICIAL announcement! Ocata can now start the second trial! They have pivotal trial status from the European Medicines Agency! This means that they can start marketing the drug after the next trial is over! It would be the FIRST stem cell based drug approved since 1956! Yes, I really DO think that we need all of these exclamation points!!!
Capslock? What capslock? 😉
Ahem. Anyway, check it out. 🙂
Ocata’s Press Release on the Completion of Phase I/II of SMD Trials
At the end of Part Six, we were finally about to learn the identity of the mystery man who’d spoken up at Tim Caulfield’s lecture the night before… and in Part Seven, we finally do…
Hey, all! Yep, today our story continues. When we left off at the end of Part 5, UC-Davis scientist and stem cell blogger extraordinaire, Paul Knoepfler, was about to take the stand to speak… and here he is. There’s also a teaser at the end for a BIG surprise tomorrow, in Part Seven…
“The FDA’s mission is to assist safety and efficacy and speed innovations,” Paul Knoepfler said in a soft voice. “The issue is getting the two to mix. Believe me, I do realize that a lot of people see this as an issue. But the thing is, no other regulatory body oversees stem cell medications in the U.S. And in the past, various drug mistakes have hurt or killed people. There’s no way around that. Thalidomide is a good example.”
Oh, please, please don’t show any slides of deformed babies, I silently prayed.
Whether it was because he’d read my mind or not, none of those were shown. I knew what had happened in the late 1950’s with thalidomide, a drug originally used as a mild sedative and sleeping pill. It was also given to pregnant women to lessen morning sickness, with tragic, unforgivable results. But what I hadn’t known was that the FDA had not approved the drug in the US, despite considerable business pressures at the time. Thalidomide had been marketed and sold in the rest of the world, starting in Germany. It was one of the most widely prescribed drugs of any kind in that era. If I hadn’t already been listening intently—which I was, of course, because this was Paul Knoepfler—then that was a fact that would have made me sit up and pay attention.
Posted in Stem cell ethics
Tagged celltex, controversy, fda, gene editing, genetic, gmo, gmo babies, human germline genetic modification, induced pluripotent stem cells, japan, paul knopfler, stap scandal, stem cells, takahashi, thalidomide, three person IVF
If you don’t have academic access to full-text articles in scientific journals, you generally have a very hard time getting them. Believe me… I know what that’s like. In fact, the saga of my odyssey to OHSU to try to get a journal article is coming up in the posts! But if you want to read the entire article that was mentioned a couple of posts down (and you really should,) a science professional has very graciously stepped up and offered to send the PDF to all requesters. So here’s what you do. Copy and paste:
and replace the at with @; you know the drill. We’re trying to evade the evil spambots. Request the article:
Stem cell treatment of degenerative eye disease.
Don’t forget to thank Irv! 🙂
So here it is, y’all– the fourth installment! This is the LAST “notes from raw slides” section, SO please keep hanging in there… because this is important. Reading these notes may not the most entertaining activity on earth; believe me, I know. (I had to transcribe them from horrible blurry pics!) But there’s a lot to be gleaned here. If you’ve ever wondered how a drug goes from concept to market, this is one you want to read. (Just go down to Slide 9.)
THE NEXT SPEAKER AT THE UC-DAVIS CONFERENCE…
If you haven’t seen this one already, you do NOT want to miss it!!
Stem cell treatment of degenerative eye disease.
A really great, broad overview of what’s going on with the usefulness of different types of stem cells and vision right now. It’s even BETTER if you have institutional access and can read the entire article… but either way, don’t miss this one.
At the end of Part 2, the opening night of the conference had just ended. We pick up the next day with the main speakers. More secrets of illegal stem clinics are revealed…
At the main conference the next day, I searched through tired-looking pastries on the side table, keeping a close eye on the other attendees. Virtually everyone seemed to be an academic. Paul Knoepfler was like an adorable teddy bear, huggable and self-effacing, all but blushing when I asked for a picture and an autograph.
There was the bouncy-ball-man again. He was leaning forward and talking loudly to a woman whose name tag proclaimed she was Alison Sorkin, a UC-Davis professor of bioscience. I tried to read his name tag, but he was turned away from me. He certainly did sound enthusiastic. A tall man leaned partly against a pillar, listening with a faint smile on his face, the corners of his eyes gently creased. I guessed his age at around sixty-five; he had the healthy, fit look of a man who had spent his life doing rigorous physical work. But his eyes were very sad. A woman stood listening to them all, a few feet away, her dark hair cut in a pixie shape around her soft face. Her hands nervously plucked at each other, and she seemed to be taking a series of short deep breaths, as if building a sentence that never quite got all the way to her lips. I wondered who all of them were. The identity of the woman mystified me just as much as the bouncy-ball man. I would be willing to bet that she wasn’t an academic either.
We all took our seats (and very uncomfortable ones they were, too,) and the presentations began.
Posted in Stem cell ethics
Tagged Cell Surgical Network, CSN, cures, FDA buyers' club, Gerhard Bauer, investigational drugs, Leigh Turner, Lisa Ikemoto, Neuralstem, paul knoepfler, stem cell clinics, stem cells, StemGenex, ted harata, tim caulfield, uc davis
At the end of part one, Tim Caulfield, keynote speaker at the conference, was addressing the problem of illegal stem cell clinics worldwide…
Tim Caulfield looked up. “So what’s the harm?” he asked.
I wasn’t sure if anyone in the audience was supposed to answer the question, but I did not have a good feeling about whatever was coming next.
Posted in Uncategorized
Tagged cures, dickey wicker, embryonic stem cells, FDA buyers' club, geron, hype, Neuralstem, ocata, oklahoma, paul knoepfler, regenerative medicine, right to try law, shirley vs sebelius, stem cells, tim caulfield
You’re not going to believe this one. Scientists at Harvard have discovered a stem cell technique that supposedly REPLACES EXERCISE. O.o. Come ON!
Look at this quote:
“It’s the first step toward a pill that can replace the treadmill,” said co-author Chad Cowan, associate professor in Harvard’s Department of Stem Cell and Regenerative Biology unit.
I’m very skeptical about this to begin with… all we know is that it supposedly works in mice, and we’ve been down that road before with stem cell trial results that didn’t translate to humans. But even if this pill worked (and that’s a HUGE if), it couldn’t replace all of the other benefits of exercise. Thin people who don’t exercise do not live any longer than overweight people who DO exercise (Steven Blair’s research on this question goes back over twenty years.) So statements like the one that Chad Cowan made are actually kind of irresponsible. Do we really need more excuses to not exercise? Can’t you just see someone reading that and thinking, “Oh, yay, now I don’t need to go to the gym anymore?” People don’t need anything else encouraging them to stay seated on the couch popping diet pills.