Diabetes Reversed: FDA Authorizes Human Trials
posted 04/21/2006

After successfully demonstrating that a groundbreaking treatment
strategy can reverse type 1 diabetes in animal studies, the FDA has
given the go-ahead for researchers from the University of Pittsburgh
Medical Center to begin a phase I trial evaluating the treatment in
humans.

The FDA approved the start of a clinical trial to evaluate the safety
and feasibility of the treatment. The trial is expected to begin
sometime this spring and will include at least 15 patients over the
age of 18, with type 1 diabetes.

The treatment involves specific modification of dendritic cells.
University of Pittsburgh researcher Dr Massimo Trucco and his team
found that by removing dendritic cells from the blood during a two-to
four-hour procedure, some 20 million dendritic cells can be harvested.

Dendritic cells are cells found in the bloodstream and normally
function as one of nature's most efficient immune function cells. The
cells identify foreign substances such as cancer cells, process these
foreign substances, and then jumpstart the immune response by bringing
these foreign substances to the attention of T cells.

Once harvested, researchers then combine the dendritic cells with
specific blockers of molecules, known as CD40, CD80 and CD86, all of
which can be synthesized in a laboratory. This treatment strategy was
found to inhibit the interaction and destructive effect of T cells on
the insulin-producing beta cells of the pancreas, a process that is
known to be a critical part of how diabetes occurs.

Subcutaneous injection of dendritic cells into the abdominal/pelvic
area near the pancreas and lymph nodes, blocks the T cells as they
travel to the pancreas to destroy beta cells.

"We did this in mice, giving them six injections over the course of
several weeks. The injections interrupted the T cell and beta cell
interaction, allowing the beta cells in the pancreas to regenerate.
This enabled the pancreas of the mice to begin producing insulin
again," said Dr Trucco. "The injections proved capable of stopping
this vicious cycle, and through this process curing type 1 diabetes in
a mouse."

Source: Diabetes In Control