Clinical Trials for Ischemia Approved

Clinical Trials for Ischemia Approved

The biotech company Aldagen announced via press release that it has received approval from the FDA for a Phase I safety study using stem cells to treat critical limb ischemia. The trial will involve 20 patients; 10 of them will have bone marrow extracted and then injected into the muscles of the affected legs. The other 10 will also have bone marrow extracted, but stem cells will be harvested from it and the stem cells will be injected multiple times. There will be a three-month terminus and a six-month follow-up. The clinical sites have not yet been announced.

Stem Cell Ballot to be Appealed Again

Stem Cell Ballot to be Appealed Again

The Missouri group opposed to the proposed ballot initiative which would legalize embryonic stem cell research plans to appeal the Appeals Court’s decisions upholding a lower court’s decision that the language of the summary was not misleading. According to an AP story in the Kansas City Star, the Appeals Court is being asked either to reconsider or to transfer the case to the state supreme court.

I wonder how far this will go. Will the ruling be appealed all the way to the US Supreme Court? Will the US Supreme Court hear it if so? It seems to me that this points out some of the issues with legislating science—how can it be anticipated what non-scientists will understand? There’s already a dearth of good understanding of science among many people, of course some scientific language is going to be misunderstood by people who don’t have a background in it. Even putting it into “plain English” will leave room for misunderstanding and ambiguity, because that is what happens with language. I assume the judges will adopt the “reasonable person” standard—which may exclude unreasonable people….

Next Cloning Plan

Next Cloning Plan

Bloomberg ran an article today about plans by Harvard scientists to attempt human cloning (for therapeutic purposes). The researchers hope to learn more about diabetes, Parkinson’s disease, and Alzheimer’s disease, among others. The goal of the project is to create embryonic stem cells from donor eggs and DNA, and then to grow tissue from the embryonic stem cells. One of the scientists on the research team visited Hwang Woo-suk in Korea last year to learn techniques, the utility of which is now in doubt. The Harvard project has been cleared by three ethical review committees and two institutional review boards that oversee human research. Egg donors will not receive any compensation, which may make it difficult to find them; the procedure is painful and takes about 56 hours.

The article reported that the lab is in an undisclosed location because of fears of violence from pro-life activists. The University has gone to extensive lengths to make sure that all funding and support for it is “disentangled” from federal funding.

Obviously this will be an interesting project to watch. I wonder if they will be able to succeed with Hwang’s techniques, or if some other technique will need to be developed.