2009-02-04

As an organization of physicians who care for desperately ill patients and scientists devoted to understanding the basic mechanisms of disease and discovering new therapies, the American Society of Hematology (ASH) is excited about the scientific potential of all avenues of stem cell research, particularly human embryonic and adult stem cells.

Background

Human embryonic stem cells are the fundamental building blocks of all cells in the body and may be able to develop into blood, bone, skin, skeletal and cardiac muscle, cartilage, brain, liver, pancreas and other specialized cells. Researchers are able to cultivate these cells from fertilized embryos that are left over from efforts to produce pregnancies. Adult stem cells can be derived from several different adult tissues, including bone marrow and blood, but are more differentiated than embryonic stem cells, and probably have less ability to form cells of all body tissues than do embryonic stem cells.

Recent studies in adult stem cell research have shown promise, but because these cells are not as pliable as embryonic stem cells, they may not be as useful for therapeutic interventions. Research into the transplantability and differentiation of human embryonic stem cells appears to have the greatest potential to lead to important therapies for a large number of intractable diseases.

In August 2001, the Bush Administration set a new policy for federal funding of embryonic stem cell research. President Bush declared that federal research funds could only be used on embryonic stem cell lines created before that date; at the time, several of the President’s scientific advisors believed that there were approximately 78 viable cell lines in existence and they would be sufficient for investigators to advance the embryonic stem cell field. President Bush argued that his new policy would prevent the creation and subsequent destruction of new embryos solely for the purpose of extracting stem cells. Moreover, in August 2001, researchers only had the technology to grow human embryonic stem cells using mouse “feeder cell” lines, therefore all the lines covered under the President’s policy are contaminated with mouse cells or mouse cell products.

Current Challenges

Since the implementation of the Administration’s policy on federal funding of embryonic stem cell research began in August 2001, several issues have arisen:

• While it originally appeared that research on 78 embryonic stem cell lines would be eligible for federal funding under the Administration’s policy, only 22 lines are actually available to investigators.
• All the stem cell lines that qualify for federal funding are contaminated with mouse feeder cells, making their therapeutic use for future human trials extremely unlikely.
• The cell lines eligible for federal funding are expensive to purchase, and there are contractual intellectual property issues as well as restrictions on their uses and further distribution to other investigators. Subsequent to the Administration’s policy announcement, privately-funded researchers have produced several new embryonic cell lines that are available for free to other investigators.
• With fewer opportunities for federal funding in human embryonic stem cell research, private sector and state efforts are gaining prominence, outside of the federal government’s oversight, control, and peer review mechanisms. Furthermore, several foreign countries are encouraging and/or actively investing in stem cell research, thereby posing the potential threat of loss of American scientific prominence in this emerging field, possible emigration of the best and brightest American scientists, and definite diminution in the number of talented foreign graduate students, postdoctoral fellows, and senior scientists who otherwise would come to the US for their training and to conduct research in this important area of scientific inquiry.

ASH Policy

ASH believes that stem cell research offers a significant degree of promise and hope to the approximately 100 million Americans suffering from deadly and debilitating diseases, including cancer, stroke, heart attack, Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis, diabetes, and traumatic brain and spinal cord injury. The Society supports federal funding of all avenues of stem cell research under National Institutes of Health (NIH) federal research guidelines and with appropriate public oversight. At this time, there is sufficient evidence to conclude that research into both embryonic and adult stem cell research is warranted to reach the goal of developing new therapies for patients with devastating diseases. ASH plans to continue to build the necessary consensus among scientists, policymakers, and the public that both human embryonic and adult stem cell research needs to be pursued vigorously to ensure the health and well-being of all Americans.

To this end, ASH endorses efforts to expand the list of human embryonic stem cell lines that are eligible for federal research funding as well as legislative and regulatory changes that would permit broad development and utilization of human embryonic stem cells and stem cell lines for research and potential therapeutic purposes. The lack of stem cell lines eligible for federal funding has created roadblocks in this field and slowed medical and scientific progress. ASH firmly believes that with more human embryonic stem cell lines available for federal funding, new opportunities will become available for scientific advancement. Likewise, with the ability to develop additional embryonic stem cell lines, more investigators will be attracted to careers in stem cell research in the United States. The Society believes that more US researchers using new human embryonic stem cell lines should ultimately equate to further scientific and medical progress that is beneficial to patients.

ASH supports the position that the large number of fertilized embryos that are currently left over in clinics from pregnancy procedures—if used according to all appropriate informed consent and donation practices—are a rich, genetically-diverse source of potential human embryonic stem cell lines. Also, recent advancements in the capability to grow embryonic stem cell lines without mouse feeder lines should translate into the unhindered ability to use embryonic stem cells in future human clinical trials. ASH’s only criteria for new embryonic stem cell lines is that they be capable of robust growth and made available to investigators at NIH, academic health centers, and research institutes throughout the nation and world.

ASH enthusiastically supports the continued development of the field of stem cell research and pledges the Society’s enduring commitment to move the science forward to help patients.

Founded in 1958, ASH represents nearly 13,000 clinicians and scientists committed to the study and treatment of blood and blood-related diseases. These diseases encompass malignant hematologic disorders such as leukemia, lymphoma, and myeloma; and non-malignant conditions including anemia and hemophilia; and congenital disorders such as sickle cell anemia and thalassemia. In addition, hematologists have been pioneers in the fields of bone marrow transplantation, gene therapy, and many drugs for the prevention and treatment of heart attacks and strokes.

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