The investigator aims to complete the pre-clinical development and testing of an artificial pancreatic organ driven by cerebral spinal fluid by placing in CSF shunted in non-insulin dependent diabetic rhesus monkeys. To demonstrate the compatibility of xenogeneic islet cells to survive and to produce insulin in response to CSF glucose levels. The pharmacokinetics of substances placed into the CSF of monkeys via the Ommaya CSF reservoirs are comparable to those of human CSF. The investigators will evaluate long term host sensitization by xenogeneic islet cells using measurements of cellular and hormonal immune response for one year. The goal is to obtain FDA approval in order to offer this approach to IDDM patients with co-existing hydrocephalus in whom CFS shunts are already present. May also be available to brittle IDDM patients if diabetic hydrocephalic patients treatment are successful and currently low risk.

Proposed Commercial Applications

NOT AVAILABLE

Agency
National Institute of Health (NIH)
Institute
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Type
Small Business Innovation Research Grants (SBIR) - Phase II (R44)
Project #
5R44DK047145-03
Application #
6124791
Study Section
Special Emphasis Panel (ZRG7-SSS-W (05))
Program Officer
Harmon, Joan T
Project Start
1994-08-01
Project End
2001-08-31
Budget Start
1999-12-01
Budget End
2001-08-31
Support Year
3
Fiscal Year
2000
Total Cost
$386,493
Indirect Cost
Name
Cyborgan, Inc.
Department
Type
DUNS #
City
Bethesda
State
MD
Country
United States
Zip Code
20814