The National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health, has awarded City of Hope an $8.6 million contract to facilitate stem cell research from laboratory to clinical study. The five-year contract is the first from the NHLBI to focus on development and manufacturing of stem cell therapies.

The contract establishes City of Hope as the official partner for NHLBI-designated researchers who are developing cellular therapies derived from human embryonic stem cells and induced pluripotent stem cells.

Larry Couture is principal investigator on a contract focusing on carrying stem cell therapies from the laboratory to clinical studies. (Photo ©2007 Philip Channing)

Induced pluripotent stem cells are mature cells from skin or other organs that researchers genetically reprogram to mimic embryonic stem cells.

“This prestigious contract recognizes our unique stem cell research and manufacturing capabilities,” said Michael A. Friedman, M.D., president, chief executive officer and holder of the Irell & Manella Cancer Center Director’s Distinguished Chair. “We are pleased to help produce stem cell-based therapies that will lead to new treatments for people suffering from myriad diseases and conditions being treated at centers throughout the nation.”

City of Hope will manufacture the stem cell therapies in its Center for Biomedicine & Genetics. The center was designed and built specifically to produce biological molecules and cells to federally mandated standards for use as therapies.

Issued under the NHLBI’s Production Assistance for Cellular Therapies program, the contract aims to help stem cell researchers overcome the many hurdles met when moving potential new therapies from laboratory to clinical studies. This process, which includes obtaining Food and Drug Administration approval, often is the most expensive and complex portion of therapy development, according to Larry A. Couture, Ph.D., senior vice president of City of Hope’s Sylvia R. and Isador A. Deutch Center for Applied Technology Development and principal investigator on the contract.

“City of Hope is uniquely qualified to manufacture stem cell-based therapies, but we also have extensive expertise in navigating the challenges inherent in translating research from early lab studies to clinical trials,” Couture said. “The value to researchers is immense, but it’s the patients who we really hope to benefit with new therapies.”

The contract follows several major grants awarded to City of Hope by the California Institute for Regenerative Medicine, or CIRM, the state’s stem cell research agency.

“California research institutions are extraordinarily fortunate to have the cellular therapy production facilities and guidance of City of Hope,” said Bob Klein, chair of CIRM’s governing board. “Years of work may be eliminated by City of Hope’s production assistance in the race to save patient lives with safe and effective stem cell therapy.”

CIRM recently awarded City of Hope two grants totaling $36 million and an additional $3.6 million in contracts to provide manufacturing and support services for stem cell research at two other major Southern California research institutions.