While American authorities have diverged over the proper tack to take on stem-cell research, Israeli scientists this week announced a pair of stunning advances in the field.
On Sunday, a team from Hadassah University Medical Center went public with what they say is the first study in which rats with Parkinson’s disease experienced improvement after the use of human embryonic stem-cell technology. The results were published in the journal Stem Cells.
A day later, at a conference in San Diego, a small Israeli company called Gamida-Cell announced results of what appears to be the first successful human clinical test of a commercial product derived from stem cells. Ten patients with late-stage leukemia went through treatment with StemEx, and five of them confounded expectations by living past the first 100 days.
Both Israeli advances suggest some of the extended global ramifications of President Bush’s 2001 decision to cut off federal funding for research on stem cells harvested from human embryos. Israel is among a small group of countries that have developed their own stem-cell regulations that permit most types of work in the field. Israel’s carefully regulated but open atmosphere for research has helped catapult it into the front ranks of a field that many consider the next frontier of science.
“What Israel has done in the laboratory and in their oversight mechanisms is a model for other nations to emulate,” said Georgetown University’s LeRoy Walters, an expert in the global dimensions of stem-cell research.
The work in Israel has encompassed two types of stem-cell research. The Hadassah project worked with embryonic stem cells, which are the main focus of controversy in America. The work by Gamida-Cell, on the other hand, was done with adult stem cells, drawn mostly from human umbilical cords. This type of research is not restricted in the United States, but some scientists said that work in this field has been dampened by Bush’s decision.
Both types of stem-cell research are at a turning point after California voters decided last month to allocate $3 billion in state funds to all types of stem-cell research over the next 10 years. Many observers say the measure will correct the American funding shortage created by Bush’s restrictions, and will dwarf what smaller countries like Israel and Singapore have done to date. Still, last week’s announcements demonstrate how Israel and a few other countries — including South Korea and England — already have taken advantage of the lull in American research to jump into front-line positions as the next phase of research begins.
Israel’s move toward the front rank began at the dawn of the embryonic stem-cell age, in 1998. In that year an Israeli scientist from the Technion - Israel Institute of Technology, Joseph Itskovitz, was on the University of Wisconsin team that first isolated and grew stem cells from a human embryo. The next scientist to achieve that feat was Benjamin Reubinoff, the Hadassah researcher who published the Parkinson’s results this week.
Interest in stem-cell research has been fueled by the promise that these cells appear to hold for curing intractable diseases, from cancer to heart disease to diabetes. Stem cells are primitive masses that can develop into more specialized cell types. Once multiplied, the cells can potentially be transplanted to replace damaged cells, like those in the pancreas that cause diabetes.
Embryonic stem cells are the most useful for research, many scientists say, because they can develop into almost any type of cell in the body. However, they are controversial for many conservative Christians, who regard destruction of the human embryo as manslaughter. In August 2001, President Bush announced that federal funding would only be available for research on embryonic stem-cell groupings, or lines, that had been cultivated before August 9, 2001.
In Israel, on the other hand, the law has developed in a different direction because of Judaism’s view that embryos are not considered full human beings. Israeli regulations first drawn up in 1998 have allowed for the continued harvesting of stem cells from embryos set for destruction at fertility clinics.
“In Israel there has really been no objection from the Orthodox rabbis,” Reubinoff said. “On the contrary, they have been very supportive after seeing the great potential.”
Since Bush’s rules took effect, Technion scientists have been among the top three groups in the world creating new embryonic lines.
Israeli scientists have taken advantage of Bush’s rulings in many elements of their work. A cottage industry has developed for Israeli stem-cell lines developed before Bush’s regulation. Of the 61 lines approved by Bush, 10 were developed by Israeli scientists. Lines have also gone to Germany, which also limits use of new stem-cell lines.
Israeli scientists also have won funding for stem-cell research from America’s National Institutes of Health, under grants available abroad only if American researchers are unable to do the work. Itzkovitz has a $1.2 million grant to provide classes at American universities that instruct on methods of multiplying existing embryonic cell lines.
The Israeli government is supporting the domestic work. In October 2003, the Ministry of Industry and Trade formed Consortium Bereshit (Hebrew for Genesis). The consortium is focused on moving technology from academic to commercial research, reflecting the government’s goal of fostering commercial products. The consortium has a five-year research budget of $20 million. More than 60% will go to private Israeli companies.
But the stem-cell funding from Israel’s government pales in comparison to what some other countries and American states are now devoting. Aside from California’s $3 billion initiative, Singapore launched its own $3 billion biomedical research initiative in 2000. China and Korea are also said to be earmarking considerable resources for stem-cell work. Observers question whether Israel can maintain its edge if its funding falls behind.
The need for private funding helps explain the forthrightness with which Israelis have trumpeted their achievements. Ehud Marom, CEO of Gamida-Cell, said that of the more or less $28 million his company has received thus far, $22 million came from private investors.
Right now, investors are pouring much of their money into adult stem-cell research, like that done by Gamida-Cell, rather than into embryonic stem cells. Embryonic research only began in 1998, and is said to be years away from yielding human applications. Adult stem-cell research, meanwhile, already has resulted in numerous human applications. This has created some concern among embryonic stem-cell advocates, who fear they will be crowded out without regard for the long-term consequences.
But there already are dozens of therapies used on humans from adult stem cells, particularly in the areas of cardiac and bone marrow diseases, like leukemia. Gamida-Cell is on the way to developing, with StemEx, the first product to sell in this arena.
With preliminary clinical trials just completed, Gamida-Cell is already gathering patients for the full clinical trial necessary for FDA approval. They are projecting that the final product might return some $30 billion.