When the US Congress approved, and President Obama signed into law, the 21st Century Cures Act last year there was guarded optimism that this would help create a more efficient and streamlined, but no less safe, approval process for the most promising stem cell therapies. Even so many people took a wait and see approach, … Continue reading jCyte gets FDA go-ahead for Fast Track review process of Retinitis Pigmentosa stem cell therapy
Food and Drug Administration
Listening is fine. Action is better. Why patients want more than just a chance to have their say.
Type in the phrase “the power of the patient voice” in any online search engine and you’ll generate thousands of articles and posts about the importance of listening to what patients have to say. The articles are on websites run by a diverse group from patients and researchers, to advocacy organizations and pharmaceutical companies. Everyone … Continue reading Listening is fine. Action is better. Why patients want more than just a chance to have their say.
Newest member of CIRM Board is a fan of horses, Star Trek and Harry Potter – oh, and she just happens to be a brilliant cancer researcher too.
An addition to the family is always a cause for celebration, whether it be a new baby, a puppy, or, in our case, a new Board member. That’s why we are delighted to welcome City of Hope’s Linda Malkas, Ph.D., as the newest member of the CIRM Board. Dr. Malkas has a number of titles … Continue reading Newest member of CIRM Board is a fan of horses, Star Trek and Harry Potter – oh, and she just happens to be a brilliant cancer researcher too.
Three people left blind by Florida clinic’s unproven stem cell therapy
The report makes for chilling reading. Three women, all suffering from macular degeneration – the leading cause of vision loss in the US – went to a Florida clinic hoping that a stem cell therapy would save their eyesight. Instead, it caused all three to go blind. The study, in the latest issue of the … Continue reading Three people left blind by Florida clinic’s unproven stem cell therapy
License to heal: UC Davis deal looks to advance stem cell treatment for bone loss and arthritis
There are many challenges in taking even the most promising stem cell treatment and turning it into a commercial product approved by the Food and Drug Administration (FDA). One of the biggest is expertise. The scientists who develop the therapy may be brilliant in the lab but have little experience or expertise in successfully getting … Continue reading License to heal: UC Davis deal looks to advance stem cell treatment for bone loss and arthritis
A ‘Call to Action’ for change at the FDA
It’s bad enough to have to battle a debilitating and ultimately deadly disease like Huntington’s disease (HD). But it becomes doubly difficult and frustrating when you feel that the best efforts to develop a therapy for HD are running into a brick wall. That’s how patients and patient advocates working on HD feel as they … Continue reading A ‘Call to Action’ for change at the FDA
‘Right To Try’ laws called ‘Right To Beg’ by Stem Cell Advocates
In recent years, ‘Right to Try’ laws have spread rapidly across the US, getting approved in 32 states, with at least three more states trying to pass their own versions. The organization behind the laws says they serve a simple purpose: ‘Right To Try’ allows terminally ill Americans to try medicines that have passed Phase … Continue reading ‘Right To Try’ laws called ‘Right To Beg’ by Stem Cell Advocates
Why Goldilocks could provide the answer to changing the way FDA regulates stem cells
One of the hottest topics of the past year in regenerative medicine has been the discussion about the need for regulatory reform at the Food and Drug Administration (FDA) so it’s no surprise that topic was the subject of the first main panel discussion at the 2016 World Stem Cell Summit in West Palm Beach, … Continue reading Why Goldilocks could provide the answer to changing the way FDA regulates stem cells
Creating a “Pitching Machine” to speed up our delivery of stem cell treatments to patients
When baseball players are trying to improve their hitting they’ll use a pitching machine to help them fine tune their stroke. Having a device that delivers a ball at a consistent speed can help a batter be more consistent and effective in their swing, and hopefully get more hits. That’s what we are hoping our … Continue reading Creating a “Pitching Machine” to speed up our delivery of stem cell treatments to patients
Funding stem cell research targeting a rare and life-threatening disease in children
If you have never heard of cystinosis you should consider yourself fortunate. It’s a rare condition caused by an inherited genetic mutation. It hits early and it hits hard. Children with cystinosis are usually diagnosed before age 2 and are in end-stage kidney failure by the time they are 9. If that’s not bad enough … Continue reading Funding stem cell research targeting a rare and life-threatening disease in children
The Stem Cellar 