CytoTherapeutics Inc. has initiated the first clinical trial of itsencapsulated islets for treating people with diabetes, thecompany announced Monday.

The Phase I trial, which is being conducted under aninvestigator-sponsored investigational new drug (IND)application, is designed to determine whether polymer-encapsulated pancreatic islets -- isolated from human cadavers-- can be transplanted safely and survive in patients witheither type I diabetes (insulin-dependent) or type II (adult-onset), as well as in healthy volunteers.

In particular, the researchers are trying to determine whetherthe capsule can protect the islets from rejection andautoimmune destruction.

The polymer membranes that surround the islets have beenconstructed so that they allow the passage of nutrients andoxygen to keep the encapsulated cells alive, but prevent thepassage of antibody molecules and various cells that coulddestroy the encased islets.

The trial will be conducted at Washington University School ofMedicine in St. Louis by David Scharp and Paul Lacy. The twohave an ongoing unencapsulated islet transplantation programin kidney transplant patients who are receivingimmunosuppressive drugs, explained Thomas Wiggans, chiefoperating officer of CytoTherapeutics (NASDAQ:CTII) ofPrividence, R.I.

The researchers will now determine whether "the membraneswill protect the islets without any immunosuppression,especially in patients with type I diabetes who have a ferociousimmune response to islets," Wiggans said.

To determine whether the islets survive, the researchers willremove the implants, a procedure that requires only minorsurgery since the capsules are placed subcutaneously, Wigganstold BioWorld. He added that Lacy has already demonstrated inrodent models that encapsulated islets implantedsubcutaneously (as opposed to intraperitoneally) were able torelease insulin with "good kinetics."

CytoTherapeutics' ultimate goal for treating diabetes, accordingto Wiggans, is "to have an artificial pancreas." But the conceptof a bioartificial pancreas is not a new one, and more than onecompany has tried and failed to develop a technology thatworks. For the company's technology, which it calls EndoCrib,"the proof is in the performance," Wiggans told BioWorld.

-- Jennifer Van Brunt Senior Editor

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