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Biotech / Medical : Stem Cell Research -- Ignore unavailable to you. Want to Upgrade?


To: SnowShredder who wrote (72)1/6/2005 11:18:22 PM
From: BulbaMan  Read Replies (1) | Respond to of 495
 
Cryo-Cell won the lawsuit. Here's the press release:

biz.yahoo.com

Press Release Source: CRYO-CELL International, Inc.
CRYO-CELL Announces Victory in Patent Litigation
Thursday December 16, 8:30 am ET
Delaware Court Finds No Infringement of PharmaStem's Patents

OLDSMAR, Fla., Dec. 16 /PRNewswire-FirstCall/ -- CRYO-CELL International, Inc. (OTC Bulletin Board: CCEL - News; the "Company") is pleased to announce that on December 14, 2004, the United States District Court for the District of Delaware issued an order entering a final judgment in favor of CRYO-CELL International, Inc. ("CRYO-CELL") in patent infringement litigation filed against it by PharmaStem Therapeutics, Inc. ("PharmaStem"). This order, which can be viewed at cryo-cell.com , effectively reverses every aspect of the October 2003 trial jury's verdict of patent infringement and damages award.

From an historical perspective, PharmaStem initiated patent litigation against CRYO-CELL and other umbilical cord blood banking firms in February 2002. After a trial in October 2003 before the Hon. Gregory M. Sleet and a jury, the parties filed post-trial motions, which were decided by Judge Sleet in an order dated September 15, 2004 (see CRYO-CELL's press release dated September 20, 2004). At that time, Judge Sleet granted the motion of CRYO-CELL and the other defendants for entry of judgment as a matter of law ("JMOL") on infringement of PharmaStem's U.S. Patent No. 5,192,553 ("the '553 patent") reversing the jury's verdict on the '553 patent. In the September 15 order, the court denied the defendants' motion for JMOL in their favor on infringement of U.S. Patent No. 5,004,681 ("the '681 patent"), but granted defendants' motion in the alternative for a new trial on that issue.

CRYO-CELL subsequently filed a motion asking the Court to reconsider the denial of JMOL on the '681 patent. The Court's December 14, 2004 order granted that motion, directing the entry of judgment in favor of CRYO-CELL and the other defendants on the '681 patent. The effect of this order is that final judgment has now been entered in favor of CRYO-CELL and the other defendants on PharmaStem's charges of infringement of both patents that were asserted in that case, marking a final disposition of the case in CRYO-CELL's favor. PharmaStem has the right to appeal the decision to the United States Court of Appeals for the Federal Circuit.

Mercedes Walton, CRYO-CELL's Chairman and interim CEO, commented, "We are very pleased that the Court has decided this case in the Company's favor. We believe that the Court's decision has vindicated our long-standing position that CRYO-CELL's U-Cord® preservation business does not constitute infringement of PharmaStem's patents, and we continue to believe that these patents will ultimately be rendered invalid. While we are certainly pleased with the final rulings of the Delaware Court, we regret the confusion and disruption created by this matter in the clinical and expectant parent communities during the course of the litigation. This decision is a landmark step in clarifying the right of CRYO-CELL to continue to serve the growing demand for the Company's services of preserving non-controversial umbilical cord blood stem cells."

About CRYO-CELL International, Inc.

Based in Oldsmar, Florida, CRYO-CELL is the world's largest U-Cord® stem cell banking firm, offering high-quality cord blood preservation exclusively for the benefit of newborn babies and possibly other members of their family. CRYO-CELL is accredited by the American Association of Blood Banks (AABB). CRYO-CELL is a publicly traded company. OTC Bulletin Board Symbol ... CCEL. Expectant parents or healthcare professionals may call 1-800-STOR-CELL (1-800-786-7235) or visit cryo-cell.com.



To: SnowShredder who wrote (72)1/24/2005 12:41:59 PM
From: SnowShredder  Read Replies (2) | Respond to of 495
 
Study Says All Stem Cell Lines Tainted

Interesting...Best of Luck, SS

story.news.yahoo.com

>>>>
Study Says All Stem Cell Lines Tainted

Mon Jan 24, 7:55 AM ET Top Stories - Los Angeles Times


By Karen Kaplan Times Staff Writer

All human embryonic stem cell lines approved for use in federally funded research are contaminated with a foreign molecule from mice that may make them risky for use in medical therapies, according to a study released Sunday.

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Related Links
• Current Human Embryonic Stem Cell Lines Contaminated - press release (Salk Institute)



Researchers at UC San Diego and the Salk Institute for Biological Studies in La Jolla report that if the stem cells are transplanted into people, the cells could provoke an immune system attack that would wipe out their ability to deliver cures for diseases such as Parkinson's, Alzheimer's and diabetes.

The finding is a setback to the Bush administration's controversial policy that provides federal funding only for research using embryonic stem cell lines that were created before August 2001. Evidence that all such lines are contaminated supports long-standing concerns among researchers that the lines eligible for federal money are insufficient to propel research forward.

The scientists who wrote the study say it could take at least a year or two — if it is possible at all — to find a way to salvage the stem cells by wiping them clean of the mouse molecules.

"We don't know, but I'm trying to be optimistic," said Fred H. Gage, a professor of genetics at the Salk Institute who co-wrote the paper in the current issue of Nature Medicine.

The researchers said the safest course was to create fresh batches of stem cells that were free of contamination from animal molecules — a process that could also take years.

The need to develop new, uncontaminated embryonic stem cell lines would bolster the influence of the California Institute for Regenerative Medicine, a $3-billion funding agency established by state voters in November to circumvent President Bush (news - web sites)'s restrictions.

"This is why Prop. 71 is so important," Susan Fisher, a UC San Francisco professor of cell and tissue biology, said of California's stem cell research measure. "We will be able to do this basic research to be able to really produce a strong foundation on which this work can continue."

The new state agency allows the creation of new stem cell lines and will fund about $300 million a year in embryonic stem cell research for the next decade — more than 10 times the yearly spending at the federal level. The initiative marks the largest state investment in basic scientific research, an area traditionally funded by the National Institutes of Health (news - web sites).

The stem cell lines allowed under Bush's policy came from embryos donated by couples who no longer needed them for in vitro fertilization. In his 2001 address, Bush said: "This allows us to explore the promise and potential of stem cell research without crossing a fundamental moral line."

From the start, however, researchers questioned the viability of the Bush-approved stem cell lines. The president said more than 60 such lines existed worldwide. About 20 lines proved usable, although concerns persisted about the techniques that had been used to create and keep them alive.

When the stem cells were first isolated, they were grown in petri dishes lined with cells from mice and bathed in blood serum from calves and other animals. The animal material was used to encourage the stem cells to multiply while preserving their unusual ability to mature into any kind of human cell.

This "pluripotency" is why embryonic stem cells have been so promising for both researchers and patients. For example, doctors could treat patients with juvenile diabetes by growing replacements for islet cells that fail to make insulin.

Researchers have suspected that exposing the stem cells to animal products could have contaminated them with viruses, proteins or other molecules that could be dangerous to people. Now they have evidence it did.

According to the study, human stem cells have incorporated a type of sialic acid that is common in many mammals but isn't produced by people.

Potential contamination of the lines was discussed by Gage in October when he spoke to a National Academy of Sciences (news - web sites) panel drawing up ethical guidelines for such research.

When the acid, Neu5Gc, enters the human body — typically by eating meat or drinking milk — antibodies rush to attack it.



Dr. Ajit Varki, a professor in UC San Diego's department of cellular and molecular medicine, questioned whether stem cells containing the acid would also be vulnerable to attack if transplanted into humans. He and his colleagues exposed the stem cells to human blood serum that contained Neu5Gc antibodies.

"It kills the cells," said Varki, one of the authors of the study. "It's reasonable to assume the same thing would happen inside people."

The most straightforward solution would be to start again with new stem cell lines.

"If none of these funding issues and legal issues and ethical and moral issues existed, then it would make sense to start over," Varki said.

But to develop new lines, scientists must destroy 5-day-old embryos. Some religious leaders, social conservatives and others oppose the practice, saying it is tantamount to murder.

Bush's research restrictions have come under sharp attack from high-profile figures including former First Lady Nancy Reagan and actors Christopher Reeve, who died in October, and Michael J. Fox. The issue took center stage in last year's presidential campaign, and although Bush won reelection, advocates scored a victory with the passage of California's Proposition 71.

Since then, lawmakers in several other states, including Wisconsin, New York and New Jersey, have announced major funding proposals in part to keep top researchers and scientists from going to California. Even before the influx of money from states, many leading researchers chose to forgo federal funding, instead getting private grants that allowed them to create new embryonic stem cell lines.

Fisher said the other strategy of cleansing existing stem cells of the mouse acid might solve the immediate problem. But there is still the possibility that there are other animal molecules that could alter the cells and make them unsuitable for human use.

"Many people have been very uncomfortable with the derivation of human cell lines using mouse [cells] and animal proteins," said Fisher, who was not involved with the research published Sunday. "This is like being able to put your finger on why you're paranoid."

Times staff writer Megan Garvey contributed to this report.