Today, the National Institutes of Health (NIH) announced the approval of the first 13* human embryonic stem cell (hESC) lines for use in NIH-funded research.  Children’s Hospital in Boston developed 11 of the approved lines and Rockefeller University in New York City developed two additional lines.

All of the approved lines were obtained from embryos left over by couples seeking treatment for infertility who consented to their use for research under the NIH’s Guidelines for Human Stem Cell Research.

In making the announcement, NIH Director Francis S. Collins, M.D., Ph.D., said

“I am happy to say that we now have human embryonic stem cell lines eligible for use by our research community under our new stem cell policy. In accordance with the guidelines, these stem cell lines were derived from embryos that were donated under ethically sound informed consent processes. More lines are under review now, and we anticipate continuing to expand this list of responsibly derived lines eligible for NIH funding.”

More than 30 NIH grants funded in the 2009 fiscal year totaling more than $20 million proposed to use hESCs. These grants have been restricted until approved lines became available on the NIH registry. This group of grants includes research using hESCs for the therapeutic regeneration of diseased or damaged heart muscle cells, developing systems for the production of neural stem cells and different types of neurons from hESCs in culture, and developing a cell culture system for the large scale production and self-renewal of hESCs.

With today’s announcement and following NIH approval, these grantees may obtain registry-listed hESCs, if they are appropriate for their project, from the owners of the lines and proceed with their research.

The NIH Human Embryonic Stem Cell Registry of approved hESCs is available online. You can also obtain additional resources and more information on stem cells and NIH research from the NIH online.

C3: Colorectal Cancer Coalition believes that stem cell research holds promise for expanding medical breakthroughs, and we support federal funding and policies that will give the researchers the tools they need to fight cancer and other diseases. That is why in January 2007, we chose to add our name to a letter that was sent to the US Senate and House of Representatives and signed by over 500 patient advocacy groups, health organizations, research universities, scientific societies, and religious groups.  Read more about C3’s support for stem cell research.

An additional 96 lines have been submitted to NIH for either internal administrative review or consideration by the external Working Group for Human Embryonic Stem Cell Eligibility Review and the NIH Advisory Committee to the Director (ACD), including more than 20 that will be considered by the ACD on December 4.

We will keep you updated on any new developments.

*Since this information was released, the number of available stem cell lines increased to 27.

Briefly: In research this week, human embryonic stem cells produced an immune response in mice with colon cancer, and discussing strong pain medicines with cancer patients reduces their pain by about 20 percent.

The Food and Drug Administration has found many dietary supplements contaminated with prescription drugs not listed on the label, some at several times higher than the recommended dose.  In other FDA news, Spectrum Pharmaceuticals was unable to get FDA approval for use of Fusilev® for metastatic colorectal cancer.

Research Reports

• Stem cell researchers at the University of Connecticut have laid groundwork for a possible cancer vaccine. Injecting human embryonic stem cells into mice with colon cancer induced a strong immune response that reduced tumor growth. Dr. Bei Liu, one of the study’s leaders said, “Although we have only tested the protection against colon cancer, we believe that stem cells might be useful for generating an immune response against a broad spectrum of cancers, thus serving as a universal cancer vaccine.
• Pooled analysis of 21 studies of cancer pain found that talking to patients about how the strong pain drugs worked, how best to take them, and myths about them improved pain relief by a full point on a 10 point scale.  In discussing the research at the United Kingdom’s National Cancer Research Institute’s Cancer Conference in Birmingham  on October 7, Professor Michael Bennett said, “Helping people manage pain is a major challenge for doctors and our research shows for the first time that education is an effective, easy and cheap way to do this.” Hear an interview with Professor Bennett from NCRI.

Other Headlines

• The FDA has identified over 140 contaminated dietary supplements, but this is only the tip of the iceberg according to American Roulette — Contaminated Dietary Supplements, an article in the New England Journal of Medicine. Many of the supplements contain drugs that aren’t listed on the label among so-called “natural” ingredients.  Supplements are regulated under the 1994 Dietary Supplement Health and Education Act (DSHEA) which does not require safety testing before dietary supplements can be placed on the market or label warnings about side effects.  However, they must include all ingredients on their labels and cannot have prescription medicine as an ingredient.  Some prescription stimulants in dietary supplements sold for weight loss are three times what would be a safe dose.
• The FDA has refused to approve Spectrum Pharmaceutical’s application to extend indications for Fusilev® (levoleucovorin) to include metastatic colorectal cancer. Their response to Spectrum said that the company’s submission did not demonstrate the Fusilev was not inferior to leucovorin.  However, they recommended that Spectrum meet with them to discuss options for continuing to seek approval for the use of the drug in colorectal cancer.  Spectrum says that they will seek an FDA meeting promptly.  Fusilev is the active part of the leucovorin (folinic acid) molecule and can be used at a lower dose than leucovorin.  Last year, when there was a shortage of leucovorin in the United States, some oncologists substituted Fusilev for leucovorin, which is a critical part of many colorectal cancer chemotherapy regimens.  Fusilev is FDA-approved to rescue overdoses of methotrexate but not to treat colorectal cancer.

Looking into the future, I have no doubt that we will use colon cancer stem cells to find more effective therapies for colon cancer patients and develop novel chemoprevention strategies.

I am collaborating with a basic scientist, Michael Kahn, from the USC Stem Cell Institute. He moved from the Fred Hutchinson Cancer Center to USC to develop novel strategies for cancer stem cells. As many of you know, California will spend over $3 billion over the next 10 years on stem cell research. I have no doubt in my mind that California will be the world leader in a couple of of years in stem cell research and the development of new therapies for a lot of different disorders including cancer.

Recently it has been shown that is possible to isolate cancer stem cells from patients with colon cancer. A group in Toronto (O’Brien) and in Italy (Ricci) were able to isolate tumor cells from colon cancer patients which were able to initiate growth in vitro and in vivo.

Over the last 6 months we have started to isolate CD133+ cells from our patients undergoing surgery for their primary tumor and liver metastases. Of course we ask for permission, and patients sign an informed consent. We have been successful  isolating these colon cancer stem cells and growing them in the laboratory.

The most important fact is that Dr. Kahn has developed a very promising drug to treat  these colon cancer stem cells effectively. We are so excited to be able to work with him and develop this drug for our patients. Both laboratories (Dr. Kahn’s and mine) are working around the clock to advance the understanding how colon cancer stem cells work and how important they are in the clinic.

To simplify their role in the treatment of colon cancer, imagine a tree with leaves. In many cases with chemotherapy we can remove the leaves from the tree but not take out the tree’s trunk, and the tree will grow back. We have a similar situation in patients with colon cancer. We often can shrink the tumor, but in many cases the tumor grows back, mainly because of the stem cells which are very resistant to chemotherapy.

We need a completely different treatment approach to eradicate them. One of these approaches is ICG-001 which Dr. Kahn developed. So far we have not seen any toxicity but have seen interesting effects on CD133+ cells and development of metastases.

It is critical in the future to understand these colon cancer stem cells to be able to identify better therapeutic strategies for patients with colon cancer. USC is on the forefront of this research and we are very excited about the recent progress of our research in colon cancer stem cells.