Stem Cell Research

[Vit42]

Excerpted from a recent issue of Businessweek below. It's amazing that Thailand not only participated in cutting edge research on stem cells but has yielded clinical trials that influenced fda decisions to move forward with u.s. clinicals. Full story in link: http://yahoo.businessweek.com/technology/c...8_PG3_tc024.htm

JUNE 2, 2005

NEWS ANALYSIS :TECH

Biotech, Finally

It has been 30 years of promising research and crushing commercial disappointments. Now a burst of breakthroughs may be the tipping point

Stem Cells

In 2001, Calvin Miller of Union City, N.J., had five heart attacks in six weeks. The former firefighter's heart was so damaged that he had no energy to complete simple tasks. Two years later, while traveling in Thailand, he heard about a clinical trial there in which stem cells were extracted from patients' bone marrow and injected into their damaged hearts. Researchers were hoping the cells would grow into new blood vessels and improve blood flow to the heart.

Miller enrolled on the spot. After one treatment, he is amazed by the difference. Before the stem cells were injected in January, he could only make it up two flights of stairs. Recently he walked 10 flights.

Scientists are hoping that stem cells, the next frontier of bio-medical research, will one day enable many different kinds of tissue regeneration in patients. The goal -- and it is very far off at this point -- is that stem cells could one day repair or replace diseased organs, severed spinal cords, damaged joints, and brain cells destroyed by Alzheimer's or Parkinson's.

SPEEDY REVIEW. Embryonic stem-cell research has garnered most of the headlines in this area, particularly after South Korean scientists announced in May that they had derived multiple stem-cell lines from a cloned human embryo. But it is the much less controversial research into adult stem cells that is closest to delivering new therapies.

Scientists still have much to learn about how adult stem cells work -- or even if they do. But there is progress. In May doctors at the University of Pittsburgh Medical Center, who worked with researchers in Thailand on Miller's trial, were cleared by the FDA to begin a U.S. study of adult stem cells in patients awaiting heart transplants. Earlier this year the FDA also gave the go-ahead to Aastrom Biosciences (ASTM ) to expand a multicenter trial using adult stem cells to repair severe bone fractures.

Osiris Therapeutics has launched two clinical trials of adult stem cells to treat damaged hearts and injured knees. And in January, Osiris' experimental treatment for graft vs. host disease, a life-threatening condition that afflicts patients who have had bone marrow transplants, became the first stem-cell therapy to win the a fast-track designation from the FDA, guaranteeing it a speedy regulatory review.

CHILLING RESEARCH. Despite the flurry of human tests, there are more questions than answers about adult stem cells. They are less flexible than embryonic stem cells -- which have the power to turn into any of the body's many tissues -- but are easier to control.

In the Thai trials and others like them, researchers found that some types of adult stem cells seem to have a natural ability to home in on damaged heart tissue, for example, but it is not clear what they do once they reach the target. There is no proof yet that the stem cells actually turn into heart cells. And while some patients' symptoms clearly improved, Dr. Amit N. Patel of the University of Pittsburgh says the degree of improvement is still questionable.

Consequently, researchers say it is unlikely that adult stem cells will be sufficient to fulfill the promise of this emerging area. Many are counting on embryonic stem cells. Embryonic stem-cell research is a must. Besides, the ban on federal funding for most embryonic cell research has put a chill on the whole field.

MOVING AHEAD. "There are a bunch of very talented developmental biologists who could be taking this on," says Jose Cibelli, professor of animal biotechnology at Michigan State University. "But they don't want to touch it."

Some states are trying to go where the federal government refuses to tread. California has pledged $3 billion over 10 years to embryonic stem-cell research. Connecticut lawmakers approved $1 billion. Massachusetts legislators overrode the governor's veto on May 31 to pass a law allowing therapeutic embryo cloning.

The science is certain to follow the money. As Wise Young, director of the collaborative neuroscience center at Rutgers University, notes, stem-cell technology "has the chance of being the most important advance to come along in the last 10 years."

It is worth remembering that, 20 years ago, scientists were saying the same thing about biotech advances that looked just as pie-in-the-sky. There has been plenty of hype and plenty of doomsaying in the interim, but the science kept moving ahead. As the many patients who have been helped well know, medicine would be a dreary enterprise if biotech hadn't delivered -- at last.

--------------------------------------------------------------------------------

By Catherine Arnst

With Arlene Weintraub in New York, John Carey in Washington, Kerry Capell in London, and Michael Arndt in Chicago

[chownah]

They are doing trials in Thailand,,,,,this doesn't mean they are developing the therapies here. They do this because its cheaper to do here and if there is a lawsuit its alot cheaper here than in the US. The third world has been supplying guinea pigs for western medicine for a long time....

[Vit42]

They are doing trials in Thailand,,,,,this doesn't mean they are developing the therapies here.  They do this because its cheaper to do here and if there is a lawsuit its alot cheaper here than in the US.  The third world has been supplying guinea pigs for western medicine for a long time....

<{POST_SNAPBACK}>

Wrong. They are developing the therapy here in thailand in collaboration with other countries. Read the o.p. carefully, one of the "guinea pigs" is an american. Don't ass-ume so much without the facts.

About TheraVitae

TheraVitae is an emerging healthcare company focused on using the patient's own stem cells in order to treat a variety of disorders, especially cardiovascular diseases. We are an international company, based in Bangkok, Thailand and Kiryat Weizmann, Israel, benefiting from collaborations with eminent physicians and scientists affiliated with well-known medical and academic institutions. Excellence, compassion and integrity are our credo. Only by combining the highest professional, ethical and moral standards will we achieve our patients' and our own goals - to bring them back to health.

Additional Information on Cell Therapy:

TheraVitae, Ltd.

36/72 PS Tower, 21/Fl., Sukhumvit 21, Klongtoey Nua, Bangkok 10110

Phone: 02-664-4290/3

Fax: 02-664-42-89

http://www.theravitae.com ;

http://www.vescell.com

About Chaophya Hospital Heart Center

The Heart Center at Chaophya Hospital is a modern facility offering advanced care to cardiac patients. It is comprised of experienced physicians, pediatricians, surgeons, anesthesiologists, nurses and supporting technicians all working in unison to treat and rehabilitate heart patients. The Heart Center facilities include The Heart Clinic, C.C.U., I.C.C.U., cardiac catheterization room, operating room, and rehabilitation center.

Chaophya Hospital

113/44 Soi Rungpracha Boromrachachonnee Road

Bangkok Noi, Bangkok 10700

Telephone: 02-434-1111, 02-884-7000

Facsimile: 02-434-6929

http://www.chaophya.com

[chownah]

They are doing trials in Thailand,,,,,this doesn't mean they are developing the therapies here.  They do this because its cheaper to do here and if there is a lawsuit its alot cheaper here than in the US.  The third world has been supplying guinea pigs for western medicine for a long time....

<{POST_SNAPBACK}>

Wrong. They are developing the therapy here in thailand in collaboration with other countries. Read the o.p. carefully, one of the "guinea pigs" is an american. Don't ass-ume so much without the facts.

About TheraVitae

TheraVitae is an emerging healthcare company focused on using the patient's own stem cells in order to treat a variety of disorders, especially cardiovascular diseases. We are an international company, based in Bangkok, Thailand and Kiryat Weizmann, Israel, benefiting from collaborations with eminent physicians and scientists affiliated with well-known medical and academic institutions. Excellence, compassion and integrity are our credo. Only by combining the highest professional, ethical and moral standards will we achieve our patients' and our own goals - to bring them back to health.

Additional Information on Cell Therapy:

TheraVitae, Ltd.

36/72 PS Tower, 21/Fl., Sukhumvit 21, Klongtoey Nua, Bangkok 10110

Phone: 02-664-4290/3

Fax: 02-664-42-89

http://www.theravitae.com ;

http://www.vescell.com

About Chaophya Hospital Heart Center

The Heart Center at Chaophya Hospital is a modern facility offering advanced care to cardiac patients. It is comprised of experienced physicians, pediatricians, surgeons, anesthesiologists, nurses and supporting technicians all working in unison to treat and rehabilitate heart patients. The Heart Center facilities include The Heart Clinic, C.C.U., I.C.C.U., cardiac catheterization room, operating room, and rehabilitation center.

Chaophya Hospital

113/44 Soi Rungpracha Boromrachachonnee Road

Bangkok Noi, Bangkok 10700

Telephone: 02-434-1111, 02-884-7000

Facsimile: 02-434-6929

http://www.chaophya.com

<{POST_SNAPBACK}>

Yes, it is important to have all of the facts and to not assume too much...so I'm presenting here some of the 'facts' that I found on your TheraVitae link. The following cut and past items were taken from the "Facilities" page of their link:

-----------------------

Israel Center: Research and Manufacturing

The Research and Manufacturing center, in Kiryat Weizmann, Israel, is responsible for manufacturing TheraVitae's advanced cell-based products and research into new cutting-edge cellular therapies, which is where the cell-based therapies are produced. This center also hosts the intensive activities of ongoing research, enhancing existing research programs as well as fostering new, strategic research initiatives that advance the state-of-the-art in manufacturing science.

Thailand Center: Clinical Development & Marketing

Located in Bangkok, Thailand, the Marketing Center is in charge of organizing marketing strategies and tactics including building a comprehensive business plan, public relations, advertising, collecting, and reporting every kind of domestic and foreign news, as well as providing information to the patients. The Thailand center is also the center for conducting the clinical trial with our advanced cell-based products in collaboration with Siriraj Hospital, Mahidol University, which is the oldest and largest medical school and hospital in Thailand.

---------------------------------------

It appears that this agrees with my previous post. From your link it says...the "intensive activities of ongoing research, enhancing existing research programs as well as fostering new, strategic research initiatives that advance the state-of-the-art in manufacturing science" type work is handled in Israel and the "organizing marketing strategies and tactics...."[and]"....conducting the clinical trial...." work is done in Thailand.

So...do you agree that my previous post is correct in its assertions "They are doing trials in Thailand,,,,,this doesn't mean they are developing the therapies here."?

Edited June 14, 2005 by chownah

[Vit42]

They are doing trials in Thailand,,,,,this doesn't mean they are developing the therapies here.  They do this because its cheaper to do here and if there is a lawsuit its alot cheaper here than in the US.  The third world has been supplying guinea pigs for western medicine for a long time....

<{POST_SNAPBACK}>

Wrong. They are developing the therapy here in thailand in collaboration with other countries. Read the o.p. carefully, one of the "guinea pigs" is an american. Don't ass-ume so much without the facts.

About TheraVitae

TheraVitae is an emerging healthcare company focused on using the patient's own stem cells in order to treat a variety of disorders, especially cardiovascular diseases. We are an international company, based in Bangkok, Thailand and Kiryat Weizmann, Israel, benefiting from collaborations with eminent physicians and scientists affiliated with well-known medical and academic institutions. Excellence, compassion and integrity are our credo. Only by combining the highest professional, ethical and moral standards will we achieve our patients' and our own goals - to bring them back to health.

Additional Information on Cell Therapy:

TheraVitae, Ltd.

36/72 PS Tower, 21/Fl., Sukhumvit 21, Klongtoey Nua, Bangkok 10110

Phone: 02-664-4290/3

Fax: 02-664-42-89

http://www.theravitae.com ;

http://www.vescell.com

About Chaophya Hospital Heart Center

The Heart Center at Chaophya Hospital is a modern facility offering advanced care to cardiac patients. It is comprised of experienced physicians, pediatricians, surgeons, anesthesiologists, nurses and supporting technicians all working in unison to treat and rehabilitate heart patients. The Heart Center facilities include The Heart Clinic, C.C.U., I.C.C.U., cardiac catheterization room, operating room, and rehabilitation center.

Chaophya Hospital

113/44 Soi Rungpracha Boromrachachonnee Road

Bangkok Noi, Bangkok 10700

Telephone: 02-434-1111, 02-884-7000

Facsimile: 02-434-6929

http://www.chaophya.com

<{POST_SNAPBACK}>

Yes, it is important to have all of the facts and to not assume too much...so I'm presenting here some of the 'facts' that I found on your TheraVitae link. The following cut and past items were taken from the "Facilities" page of their link:

-----------------------

Israel Center: Research and Manufacturing

The Research and Manufacturing center, in Kiryat Weizmann, Israel, is responsible for manufacturing TheraVitae's advanced cell-based products and research into new cutting-edge cellular therapies, which is where the cell-based therapies are produced. This center also hosts the intensive activities of ongoing research, enhancing existing research programs as well as fostering new, strategic research initiatives that advance the state-of-the-art in manufacturing science.

Thailand Center: Clinical Development & Marketing

Located in Bangkok, Thailand, the Marketing Center is in charge of organizing marketing strategies and tactics including building a comprehensive business plan, public relations, advertising, collecting, and reporting every kind of domestic and foreign news, as well as providing information to the patients. The Thailand center is also the center for conducting the clinical trial with our advanced cell-based products in collaboration with Siriraj Hospital, Mahidol University, which is the oldest and largest medical school and hospital in Thailand.

---------------------------------------

It appears that this agrees with my previous post. From your link it says...the "intensive activities of ongoing research, enhancing existing research programs as well as fostering new, strategic research initiatives that advance the state-of-the-art in manufacturing science" type work is handled in Israel and the "organizing marketing strategies and tactics...."[and]"....conducting the clinical trial...." work is done in Thailand.

So...do you agree that my previous post is correct in its assertions "They are doing trials in Thailand,,,,,this doesn't mean they are developing the therapies here."?

<{POST_SNAPBACK}>

Clinical trials, be it phase 1, 2 or 3, for efficacy and safety are part of any drug development process are are therefore considered part of the research! In fact, pure research without testing beyond the lab for medical products would absolutely be unacceptable by the fda. Clinical trials are considered applied research and are done wherever possible in order to shorten the development loop to market. "developing the therapies" is not done in the lab without it.