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Studies of adult stem cells expanded with NASA-created techniques indicate the cells do not turn cancerous

Press Release From: Regenetech Inc.
Posted: Thursday, May 5, 2005

HOUSTONóRegenetech Inc., a Houston-based, adult-stem-cell company, said today recent scientific studies of adult stem cells expanded with its NASA-created techniques indicate the cells do not turn cancerous.

Last week researchers from Spain and Denmark reported in the journal "Cancer Research" that under certain circumstances adult stems cells can turn cancerous if allowed to multiply outside the body for a lengthy period.

Regenetech said that two recently completed scientific studies demonstrated the effectiveness and safety of its proprietary expanded stem cell process thereby making its process the most successful procedure of expanded stem cells known.

Regenetech, a three-year-old biotech firm, works with NASA under its license and Reimbursable Space Act Agreement. The firm uses the patented IntrifugeTM system ††process to dramatically multiply adult stem cells to a far greater degree than has been demonstrated previously.

One of the two studies, known as "mFish" or multicolor fluorescence in situ hybridization, detects aberrations in human cells. This study, conducted at NASA's Johnson Space Center in Houston, found there was no chromosome damage or change in the expanded adult stem cells 90 days after their expansion.

The second study, known as the "nude mouse" study, was conducted by the independent firm of Charles Rivers Laboratories Inc. of Wilmington, Mass.

The mice have no hair, thus the name, but more importantly, they have no thymus, leaving them without the ability to mount most types of immune responses.

The nude mice test indicated the expanded stem cells caused no tumors in the mice within 85 days of the injection of the expanded cells.

"These studies were significant to Regenetech," said Arless Hutchinson II, company president. "While we have demonstrated for some time that we can significantly expand adult stem cells, we needed to make sure that there were no harmful effects created by the use of expanded cells.

"The mFish study confirms that the cells are not genetically or chemically modified, which would be a major problem when the cells are transplanted for therapeutic use," Hutchinson said. "And the nude mice study indicates that the cells do not create tumors when transplanted."

Regenetech's core technology was developed at NASA during the last 20 years, said Dr. Donnie Rudd, Regenetech's chief scientist.† The research began in an effort to determine whether human cells and tissue could be grown in space and used for transplant should the need arise during long-term manned exploration.

Approximately 18 years ago, Dr. Thomas Goodwin, currently project scientist on NASA's Integrated Cell Science Project, joined the space agency's research to determine whether human cells could grow significantly in the weightless atmosphere of outer space. On Earth, cells have previously not been shown to grow significantly outside the body.

The research proved successful, which led to the development of the IntrifugeTM system which simulates the weightlessness of outer space and allows the significant expansion of adult stem cells.

Approximately three years ago, Regenetech's founders obtained the license rights to the NASA patents developed by Dr. Goodwin and other NASA scientists.

Under the Reimbursable Space Act Agreement, Regenetech financially supports Dr. Goodwin's research and provides for the company's research to be performed at NASA in Houston.

Dr. Rudd has created a number of new inventions relating to the use of expanded cells and filed patent applications on them. Additionally, Rudd and Goodwin developed several new inventions together. Regenetech now owns the license to 13 NASA patents and possesses 30 additional patent applications of its own. The company also has the rights to several inventions jointly developed with NASA.

In addition to its impact on space travel, Regenetech's technology is being explored for human application such as pancreas regeneration, which would cure diabetes, heart regeneration and the regeneration of other human organs. The company has licensed its technology for the treatment of sickle cell disease and Myelodysplastic syndromes.

The company's scientific advisory board includes Dr. Mehboob Hussain of the University of Chicago, one of the world's top diabetes research doctors, Dr. David Wu of the University of Rochester, Dr. Robert Dennis of the University of North Carolina, and Dennis Drehkoff of the Chicago office of the patent law firm of Ladas & Parry.

Regenetech's office is located at 1120 NASA Parkway, Suite 220A, Houston, Texas, just outside the main entrance to NASA's Houston Johnson Space Center. Regenetech can be contacted at (888) REGENETECH (888-734-3638) or (832) 414-9035.

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