Archive by category | Clinical trials

More analysis on stem cell clinical trials

In response to my last post, I wondered what Chris Scott’s analysis of clinicaltrials.gov would say if he looked for fetal stem cells. He just told me he did the relevant search, and came up with nothing. In fact, one trial by StemCells that does use fetally derived cells does not say so in its clinical trial description. (See his post and several interesting comments at the link above.) Christopher Scott directs the program on stem cells and society at Stanford.  Read more

Clinical trials mentioning stem cells up over 200% from summer 2007

The number of U.S. registered clinical trials using stem cells increased from 709 at in summer 2007 to 2,319 today. For trials using stem cells in heart disease grew by 110% last year (from 118 to 56); Parkinson’s disease fell by 100% last year (from 1 to 0). That’s according to an index of clinical trials just posted by Stanford’s Chris Scott.  Read more

FDA puts plan for a neural stem cell trial on hold

The FDA has ordered a halt to NeuralStem’s plans for a neural stem cell trial in Lou Gehrig’s disease (amyotrophic lateral sclerosis). (See the company’s press release as well as a link to its December announcement that it had filed an IND) NeuralStem says that the FDA’s concerns and recommendations can be readily addressed.  Read more

First human embryonic stem-cell trial grabs headlines

There’s a lot of reading material on the fact that Geron now has the FDA’s blessing to start a clinical trial for spinal cord injury using cells derived from embryonic stem cells. But some of the patients who have been waiting most eagerly for this announcement will be disappointed. The trial, which is expected to begin this summer, will only accept patients whose injuries occurred recently, within a week or two of the experimental treatment.  Read more

Geron’s embryonic stem cell trial gets go ahead

The FDA has given permission for Geron to try an embryonic stem cell based therapy for spinal cord injury in up to 10 patients. The approval was granted on Wednesday, just a day after Barack Obama’s inauguration as president, but both FDA and Geron say the timing is coincidental, according to an article in the Wall Street Journal.  Read more

Genetically engineered neural stem cells approved for stroke trial

ReNeuron has just received permission to launch a clinical trial for stroke patients using neural stem cells. About a dozen patients will receive the cells at Southern General Hospital in Glasgow, Scotland. An article in the Financial Times chronicles the path to obtain regulatory permission to launch the trial in the UK. An article in NatureNews describes how the cells, derived originally from aborted fetuses, have been genetically engineered with an inducible gene to control cells’ growth. The prospect of transplanting genetically engineered cells worried advisors to the FDA’s panel on starting clinical trials with embryonic stem cells last year, though Geron is still pressing ahead on this front.  Read more

Stem-cell society condemns undocumented human treatments without oversight

The ISSCR today condemned unproven stem-cell treatments that are not designed to learn and report information and that are conducted without oversight, particularly if patients are charged for advertised medical services. Originally a task force within the ISSCR was supposed to release a draft of guidelines on Thursday. After disagreements about how specific the guidelines should be and how stringent a tone to take, the group decided instead to announce over-arching principles at its annual meeting.  Read more