Bill Passes in House that Would Remove Barriers to Islet Cell Transplantation

in Courtney Paquette, Fall 2004 Newswire, New Hampshire, Washington, DC
October 14th, 2004

By Courtney Paquette

WASHINGTON 10/14/04–With the Walk for Diabetes on Saturday in Portsmouth, the search for a cure for the more than a million Americans who have Type 1 diabetes comes into focus.

Last week, the search got a boost when the Congress passed a bill, co-sponsored by Rep. Jeb Bradley, R-N.H., and Rep. Charles Bass, R-N.H., that would remove some of the barriers to research on islet cell transplantations, a procedure that, if successful, would free Type 1 diabetics of insulin injections.

The problem, addressed by the bill, was that the procurement of islet cells, which are obtained from a donor pancreas, was not a qualifying procedure under organ procurement laws, as islet cell transplantation was classified as an experimental procedure

Not only did this block make it difficult for researchers to obtain pancreases, but it gave them little incentive to do so, as they wouldn’t be certified to transplant cells from them anyhow. Also, in order to receive federal grants, an organization needs to be certified to perform organ transplants or procurement procedures.

The legislation, the Pancreatic Islet Cell Transplantation Act of 2004, removed that block by making islet cell transplantation research a qualifying procedure..

The act also provides for an annual review by an oversight committee from the National Institutes of Health that will assess, among other things, the adequacy of federal funding and ways to increase the supply of islet cells, including procurement of organs from animals, or xenotransplantation.Bradley said the issue took on new importance for him after a visit in April to the McKelvie Middle School in Bedford, where he said a dozen children with Type 1 diabetes spoke about the difficulties of living with the disease.

“It just brought home to me how important. pancreatic islet cell research is in order to give us opportunities to cure these debilitating diseases,” said Bradley.

Bass, in a press release, said, “This breakthrough medical research deserves every opportunity to successfully treat patients afflicted with diabetes. It has the potential to improve and save lives.”

In Type 1 Diabetes, the immune system destroys the insulin-producing islet cells in the pancreas. According to the Mayo Clinic website, in pancreatic islet cell transplantation researchers remove islets from the pancreas of a deceased donor. A transplant for a 154 pound person requires one million islets, the amount in two pancreases.

Islets are injected into the liver via a catheter, because the cells grow well in the liver and the liver can perform as a back-up pancreas to produce insulin. The entire procedure can be done with a local anesthesia and takes less than an hour.

Islet cell transplantations done in the 1990’s did not succeed in freeing patients from insulin injections for more than a year. But in 2000, Dr. James Shapiro of the University of Alberta in Edmonton, Canada, reported that seven of his transplantation patients had sustained insulin-production.

A spokesperson for the National Institutes of Health would not comment of why there were barriers to this procedure and what the dangers were with islet cell transplantation, but according to the institute’s website, the dangers include anemia, nerve damage, meningitis and vulnerability to infection. Another obstacle is the scarcity of pancreases, as only 6,000 are available each year.

Alternatives to harvesting cells from adult pancreases include stem cells and pancreases of animals.

The National Institute of Diabetes and Digestive and Kidney Diseases announced two weeks ago that it plans to award $75 million over five years to clinical centers in Iowa City, Miami, Minneapolis, Philadelphia, Canada and Sweden to study islet transplantation, according to a press release.

The transplantation act went to the White House Oct. 13 but the President has not signed it, according to a spokesman in the press office.  The White House spokesman said he did not know when the President would sign it.

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