Stem Cell ResearchStem Cell ResearchFact Fact vs.vs. Friction Friction

David A. Prentice, Ph.D.Family Research CouncilWashington, D.C., USA

U.S. Senator Arlen Specter:“Embryonic stem cells are a fountain of youth.”

“Embryonic stem cells have the potential to cure all known maladies.”

Speaker of the House Nancy Pelosi:“Science has taken us to a place that is Biblical in its power to cure, and that is the embryonic stem cell research.”

“We’re saying science is an answer to our prayers.”

Regenerative Medicine with Stem Cells

Promises, Premises, and Published Data…

Claims unsubstantiated for embryonic stem cellsCurrent or potential embryonic stem cell problems:

• Difficult to establish and maintain• Difficulty in obtaining pure cultures in the dish• Potential for tumor formation and tissue

destruction• Questions regarding functional differentiation• Problem of immune rejection• Genomic instability• Few and modest results in animals, no clinical

treatments• Ethically contentious

Since 1998, the U.S. leads the world in publications on all stem cell research.

46% of all stem cell publications 2000-2004 by U.S. scientists (13,663); remaining 54% spread between 17 other countries;Germany is #2 (3,337).

85% of all hESC publications use NIH “approved” cell lines, even if the international researchers got no NIH money. Most use only TWO lines.

The Frozen Embryo Problem…

Human Cloning

Cloning (Somatic Cell Nuclear Transfer, SCNT)

Fetus Farming

Calla Pappademus, Stanford student who survived problems from egg donation

(see handsoffourovaries.com)

U.K. HFEA “Embryo” Bill

•Embryo research, therapeutic cloning, licenses•Human-animal hybrid embryos•Mitochondrial transplantation/3-parent embryos•“Saviour siblings”•Pre-implantation genetic diagnosis•Artificial ('stem cell derived') gametes•Fatherhood issues (“no need for a father”)•No consent required for use of donated DNA in some instances

U.S. FEDERAL LEGISLATION(Dickey-Wicker Amendment)

• LHHS Appropriations language (since 1996)SEC. 509. (a) None of the funds made available in this Act may be used for (1) the creation of a human embryo or embryos for research purposes; or (2) research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury or death greater than that allowed for research on fetuses in utero under 45 CFR 46.208(a)(2) and section 498(b) of the Public Health Service Act (42 U.S.C. 289g(b)).(b) For purposes of this section, the term ‘‘human embryo or embryos’’ includes any organism, not protected as a human subject under 45 CFR 46 as of the date of the enactment of this Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one or more human gametes or human diploid cells.

EXECUTIVE ORDERS• Bush—Federal funding for research on (78) existing human

embryonic stem cell lines, derived before Aug. 9, 2001• Bush—Research on Alternative Sources of Pluripotent Stem Cells

June 20, 2007• Obama—Federal funding for human embryonic stem cell lines

From IVF, embryos made specifically for research, cloned embryosMarch 9, 2009

• New NIH guidelines July 7, 2009:“Excess” embryos from reproductionNo requirements for frozen embryos or waiting periodNo requirement separation of IVF doctor & embryo researcherOpen-ended

• Lawsuit against NIH & HHS August 19, 2009:to stop implementation of new NIH guidelines

[Minsky] is also staunchly against regulating the development of new technologies. “Scientists shouldn't have ethical responsibility for their inventions, they should be able to do what they want,” he says. “You shouldn't ask them to have the same values as other people.”

from: Danielle Egan, Death special: The plan for eternal life, New Scientist 2625, 46, 13 October 2007

>100 publications since August 2006>500 human iPS cell lines reported, all since Nov 2007

Professor Shinya Yamanaka

• New York Times, Dec. 11, 2007:Inspiration can appear in unexpected places. Dr. Shinya Yamanaka found it while looking through a microscope at a friend’s fertility clinic… At the friend's invitation, he looked down the microscope at one of the human embryos stored at the clinic. The glimpse changed his scientific career.

"When I saw the embryo, I suddenly realized there was such a small difference between it and my daughters," said Dr. Yamanaka, 45, a father of two..."I thought, we can't keep destroying embryos for our research. There must be another way."

Improvements in Human Patients

Carol Franz before & after treatment with her own bone marrow adult stem cells for multiple myeloma.

Kaitlyn McNamara had a new functional bladder constructed from her own adult stem cells.

Stephen Sprague, treated in 1997 for chronic myelogenous leukemia, with umbilical cord blood stem cells.

Erik Haines, now 14 years old, was diagnosed with Krabbe’s Disease in 1994 and was the first patient to receive a cord blood transplant for this rare, inherited metabolic disease.

Rep. Chris Smith & Rep. Artur Davis, with Julius Erving (“Dr. J”) and patients successfully treated with umbilical cord blood stem cells.

Jaw regrown with adult bone marrow stem cells.

Skull bone grown for 7-year-old girl using adult stem cells from fat.

Anthony Dones with his father.Anthony was successfully treated for osteopetrosis with umbilical cord blood stem cells.

Jacki Rabon, 18, is walking with braces on a parallel bar six months after undergoing adult stem cell surgery to repair a spinal cord injury that left her paralyzed. Photo by Becki Rabon

Dennis Turner.Treated for Parkinson’s with

his own brain adult stem cells.

Doug Rice has seen dramatic improvements in his heart after treatment with his own bone marrow adult stem cells.

David Foege, treated for heart failure with his own blood adult stem cells, has gone from an ejection fraction of 15% to 58%

Roland Henrich suffered a stroke and was treated within 24 hours with his own bone marrow adult stem cells. Within 11 days after treatment he showed no signs of paralysis and said his first word since the stroke.

Jaider Abbud has gone over a year without insulin or other medication after treatment with his own bone marrow adult stem cells for juvenile diabetes.

Dr. Julio Voltarelli (left) and Dr. Richard Burt (right), with one of their patients successfully treated for Type I Diabetes using the patient’s own bone marrow adult stem cells.

Amy Daniels (systemic sclerosis), Barry Goudy (multiple sclerosis), and Jill Rosen (lupus) prepare to tell a Congressional briefing about their successful treatments using adult stem cells.

Claudia Castillo had a complete new trachea grown using her own adult stem cells. The transplant saved her lung and she is now doing well.

www.stemcellresearch.org

Adult Stem CellsMost promising source for treatments

Able to generate virtually all adult tissues

Can multiply almost indefinitely, providing numbers sufficient for clinical treatments

Proven success in laboratory culture

Proven success in animal models of disease

Proven success in current clinical treatments

Ability to “home in” on damage

Avoid problems with tumor formation

Avoid problems with transplant rejection

Avoid ethical quandarywww.frc.org

This is a critical moment in human history and for humanity, a defining moment for you and me… because these life issues in debate at the state, national, and global levels will define what it means to be human and who will be counted as human.

We must speak up,for such a time as this,

for those who have no voice.