NIH Delays Grant Comparing Amniotic, Embryonic, and Placental Stem Cells

The National Institutes of Health (NIH) is refusing to approve a grant application that would provide the pre-clinical data to potentially move stem cell therapies for diabetes, myocardial infarction, and macular degeneration into human clinical trials.

I spoke with Robert Lanza, stem cell scientist and one of the grant authors, yesterday by phone. What I learned should anger both opponents and supporters of embryonic stem cell (ESC) research.

Lanza told me that the $3.5 million three-year grant request aimed to characterize the abilities and properties of four different types of stem cell lines: the Bush-approved ESCs, ESCs derived using Advanced Cell Technology's non-destructive method, placental stem cells, and amniotic fluid stem cells (AFSCs).

The team's goals included determining which cell lines could become which cell types (e.g., insulin-producing, neural, mesoderm) and which cell lines produced the most effective cells to treat various diseases in animals. As some ESC lines may be better than other ESC lines at certain functions, the tests would also be performed between cell lines of the same type.

The results of the in-vivo (live animal) tests would determine which stem-cell line would be best to use to treat each disease. Perhaps ESCs would show the most promise for neural conditions (macular degeneration) while AFSCs would be most promising for diabetes, or placental stem cells could be most promising for everything.

The team behind this proposed study hoped to discover the answer these questions, but the NIH blamed Bush's stem-cell regulations for preventing it from going forward.

The problem was outlined, in part, by a Boston Globe article on Monday. The article focuses on how the language governing stem cell research is actually impeding it, but fails to clarify an important point -- what's actually causing the delay.

Current regulations, imposed by President Bush in 2001, restricting federal funding to only those ESC lines derived prior to August 9, 2001 disqualify the grant application as is because it asks for funds to study newer ESC lines. But newer regulations issued by Bush in April may allow the grant to move forward, as it would allow federal funding for ESCs that were obtained "without creating [...] destroying, discarding, or subjecting to harm a human embryo or fetus."

The Globe article focuses much of its attention on how the NIH is unsure if Lanza's (Advanced Cell Technology's) technique actually harms the embryo -- which is an important question -- but it misrepresents the most infuriating aspect of this story.

The group submitted a proposal to the NIH in February, then waited.

Eventually, the NIH told the team that it had referred the proposal to a different review group. Then, in a series of e-mails, the agency backed off further, first encouraging the applicants to drop Lanza's cells from the proposal and, finally, when the team refused to do so, informing them that the application was being sidelined indefinitely for "administrative review."

Lanza told me that he did offer to drop his cells from the proposal if they presented a problem, but the NIH wouldn't go along with it. The NIH asked them to resubmit the application without his cells, which would have pushed the new application to the back of the line in the review process.

Lanza offered me the following excerpts from his email exchange with the NIH to prove that he did make the offer:

While I appreciate that the NIH is dealing with complicated new issues for this grant application, I think you can also understand the concern that researchers in this field will have that such as review process proceeds sub rosa. In the case of the research proposed in mine and similar grant applications, months of review may translate into lost opportunities to make differences in the lives of many many patients. Again, I respectfully submit that this grant application is entitled to a timely and meaningful review....In my original email to you, I offered to remove the blastomere derived line from the application if the administrative review concluded that this part of the proposed research could not be funded. I saw this as fair means to permit the parallel review process to occur. My concern of course is keeping the current application in the que and moving forward, rather than having the clock effectively reset to the next review period.

With Lanza's cells out of the application, as he offered, the grant could have been approved even under the current regulations. The NIH apparently didn't see this as fair, which is unfortunate.

Are ESCs really better than their amniotic or placental counterparts? This grant could tell us, but the answer will take longer to get here thanks to the NIH.

Policy puts future of stem cell tests in doubt [Boston Globe]