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The world’s biggest clinical trial of stem cells is underway in Brazil, the WSJ reports, an effort that could shake up scientific and commercial expectations for regenerative medicine.
The Brazilian trial involves so-called “adult” stem cells that can be harvested from a mature individual’s own tissue — in this case, bone marrow. (By contrast, controversial but more potent embryonic stem cells must be extracted from a days-old embryo that is usually destroyed in the process.) According to Antonio Regalado’s story, the 1,200 person test aims to see if those bone-marrow cells can reverse a dangerous swelling of the heart that frequently results from a common parasitic infection called Chagas disease. The disease is spread by barbeiros, or “kissing bugs” (see image), which are rife in poorer regions of the country.
Work on adult stem cells has long had a shaky reputation among scientists because the field is rife with unverified claims, often peddled by shady clinics eager to sign up desperate patients. The Brazilian effort is significant both in its scale and its rigor, since the test is specifically designed to ensure that any successful results aren’t simply due to random chance, researcher bias or placebo effect. (Similar but far smaller trials are under way in Poland, Austria, Finland and Denmark.)
Researchers will inject 600 Chagas patients with an “espresso cup’s worth” of their own bone marrow in hopes that the stem cells it contains will regenerate damaged heart tissue. (Another 600 will get placebo saline injections.) The treatment, however, remains controversial, especially in light of recent research that suggests bone-marrow stem cells have little, if any, ability to transform themselves into muscle tissue. The journal Nature, in fact, recently called for a moratorium on tests of adult stem cells in heart disease until their properties are better understood.
The trial, however, also offers a cautionary note to the biotechnology industry, since the Brazilian government is explicitly interested in developing a cost-effective treatment — what one involved researcher calls “a poor man’s cell therapy.” Cells derived directly from a patient can’t be patented, which could greatly limit their commercial attractiveness.
In related news, researchers today reported using bone-marrow stem cells to halt, and possibly even reverse, the course of “type one” diabetes in 14 of 15 recently diagnosed patients. In this trial — which, coincidentally enough, also took place in Brazil — researchers effectively “reset” the immune systems of patients by using their own marrow cells, a process similar to the way physicians treat leukemia with bone-marrow transplants. In all but one patient, the treatment appeared to halt the immune system’s attack on insulin-producing cells in the pancreas. The results were published today in the Journal of the American Medical Association.