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JDRF Funded Research

JDRF-Funded Research:

Name: CyThera, Inc ,
CyThera, Inc, USA
Lab Website:

Project duration: 01-NOV-2004 to 31-OCT-2005
Industry Grant

Project grant award: $230,000.00*

* Total Grant award amount may vary depending on budget adjustments and it is contingent upon research progress and availability of JDRF research funds.

File No: 15-2004-333

(Abstract Dt: 01-JUL-2003)

Therapeutic Area: Beta Cell Therapies

Grant Status: Inactive

Project Title

Derivation, characterization and distribution of embryonic stem cell lines

for project 1

Objective

Derive new Human embryonic stem cell (hESC) lines. Some of these lines will be produced using current good manufacturing practices (cGMPs) and some will be for research use only. Following cGMPs will result in cell lines suitable for eventual use in Human clinical trials.

Accomplishments

IRB approval has been secured for derivation of ESC lines from embryos donated with informed consent. The preparatory work to produce cGMP compliant cell lines has been completed, which broadly includes validation of our cGMP facility and equipment, and the development and implementation of Master Production and Control Records. cGMP compliant human fibroblast feeder cell banks have been completed. A Master Cell Bank and two MitomycinC inactivated Working Cell Banks were made. The Master Cell Bank was then extensively tested for infectious agents according to the FDA points to consider (PTC). One research grade line has been produced. This line, CyT203, was derived on human fibroblasts, and grows very well. It has a normal male karyotype as of the latest testing at passage 38, strongly expresses ES cell markers OCT4, SSEA-4, TRA-1-81 and TRA-1-60 and can form derivatives of all three germ layers in vitro. The line is free of HIV I /II, HTLV I/II, HCV, HBV, CMV, EBV, and bacterial contamination. Imprinting analysis demonstrated monoallelic expression from the SNRPN and KCNQ10T1 loci indicating a normal imprinting pattern. This line is available for distribution. Finally, we have produced our first cGMP grade hESC line, designated CyT49. This line was derived on cGMP grade human feeders, and grows well. A Master Cell Bank has been frozen using a controlled rate freezer.

Publications/Presentations

A manuscript is in preparation.

Who benefits from the research

The availability of these high quality lines can be of benefit to any research using hESCs. Ultimately, patients requiring cell replacement therapies will benefit, especially by the availability of the clinical grade line.

Future Plans

Characterization of surface markers, differentiation potential and karyotype of the first cGMP line are in progress. FDA required infectious agent testing will be initiated as soon as sufficient cells are available. We plan to produce additional cGMP compliant hESC lines.