DAVID GRANOVSKY

Posts Tagged ‘geron’

EMBRYONICS’ BLEAK FUTURE AND BOTCHED PAST

In ALL ARTICLES on November 15, 2011 at 6:42 pm

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EMBRYONICS’ BLEAK FUTURE AND BOTCHED PAST

BLEAK FUTURE

I just received a comment from MB and despite Geron and the rest of the world abandoning embryonic stem cells for adult, he is still optimistic about the future of embryonic stem cells (with a little plug snuck in for a company he probably owns stock in).

My original comment:

embryonic research has been 100% fruitless (in regard to generating
treatments) for well-funded and government supported scientists around the world for the last 13 years.  Embryonic stem cells are the only significant obstacles to embryonic stem cell treatments.  Adult stem cells on the other hand have successfully treated 10s of thousands over the past decade.

MB’s response:

hESCs (human embryonic stem cells) have only been around for 13 years compared to adult stem cells 30+ years…. give it some time… human embryonic stem cells (especially ACT’s embryo SAFE blastomere-derived) will be THE GOLD standard :)  watch and SEEE the difference…soon..

My response:

MB – Not even close.   Embryonic stem cells have been around for way longer than since James Thompson and friends derived the first human embryonic stem cell line at the University of Wisconsin-Madison in 1998.

To clarify:

“Research in the human stem cell field grew out of findings by Canadian scientists Ernest A. McCulloch and James E. Till in the 1960s.”

1963: Becker AJ, McCulloch EA, Till JE (1963). “Cytological demonstration of the clonal nature of spleen colonies derived from transplanted mouse marrow cells”. Nature 197: 452-4. PMID 13970094.

1963: Siminovitch L, McCulloch EA, Till JE (1963). “The distribution of colony-forming cells among spleen colonies”. Journal of Cellular and Comparative Physiology 62: 327-36. PMID 14086156.

1978: Stem cells were discovered in human cord blood

1981: First in vitro stem cell line developed from mice

1981 – Mouse embryonic stem cells are derived from the inner cell mass

That’s 30 years ago!

Evans, M.J. & Kaufman, M. Establishment in culture of pluripotential stem cells from mouse embryos. Nature 292, 151–156 (1981).

1981 – Martin, G.R. Isolation of a pluripotent cell line from early mouse embryos cultured in medium conditioned by teratocarcinoma stem cells. Proc. Natl. Acad. Sci USA 78, 7634–7638 (1981).

1984 – Andrews, P.W. et al. Pluripotent embryonal carcinoma clones derived from the human teratocarcinoma cell line Tera-2. Lab. Invest. 50, 147–162 (1984).

Blastomeres isolated from the ICM of mammalian embryos and grown in culture are known as embryonic stem (ES) cells. These pluripotent cells, when grown in a carefully coordinated media, can give rise to all three germ layers (ectoderm, endoderm, and mesoderm) of the adult body.

1986: Robertson, Elizabeth , et al. Germ-line transmission of genes introduced into cultured pluripotential cells by retroviral vector. Nature 323, 445 – 448 (02 October 1986)

1988: Embryonic stem cell lines created from a hamster

1995: First embryonic stem cell line derived from a primate

1995: Thomson, J.A. et al. Isolation of a primate embryonic stem cell line. Proc. Natl. Acad. Sci. USA 92, 7844–7844 (1995).

And then we get to what MB considers the “discovery of embryonic stem cells”:

1998 – James Thomson and coworkers derive the first human embryonic stem cell line at the University of Wisconsin-Madison.

Not to worry, though MB.  Adult stem cells HAVE been used in bone marrow transplants for over 40 years so they still have the upper hand in “time we’ve worked with them.”  Then again, it was only in 1998 that adult stem cells were considered for treating other illnesses.

Just out of curiosity, besides

“embryonic stem cells have proven 100% fruitless (in regard to generating treatments) for well-funded and government supported scientists around the world for the last 13 years,”

how do you plan on addressing these other embryonic stem cell issues to name a few?

  1. they create cysts and tumors that can develop into cancer at the site of the injection and injury
  2. rejection issues require immunosuppressive drugs for the ill patient
  3. embryonic stem cells (and induced pluripotent stem cells) carry the genetic anomalies of the donor
  4. they have to date treated zero diseases successfully
  5. scientists probably need to cure cancer first to use them
MIRROR THE RESULTS

MIRROR THE RESULTS

But if MB can mirror the results of  the success rate of adult stem cell treatments (~65% of patients have significant improvement in their incurable, chronic or terminal illnesses) and do so without the side effects alluded to above (adult stem cells have virtually zero side effects except for sometimes additionally fixing more than the intended organ/illness) then I would love to hear about it!

A HISTORY OF THE GERON EMBRYONIC STEM CELL FIASCO

In BUSINESS OF STEM CELLS on November 15, 2011 at 1:27 am

http://geekcentricity.com/wp-content/uploads/2010/09/Fiasco.jpg

Embryonic stem cell treatment are now an unrealized potential.

Adult stem cell treatments are a realized potential.

To see if your condition can be treated with Adult stem cells, please fill out this form: http://bit.ly/PATIENTQUESTIONNAIRE

GERON GIVES UP on EMBRYONIC STEM CELLS!

In STEM CELLS IN THE NEWS on November 14, 2011 at 11:13 pm

THE

WAR

IS

OVER!!

GERON THROWS IN THE TOWEL!If stem cell treatments were a boxing match, Embryonic stem cell treatments would be the 500 lb Gorilla and Adult stem cell treatments would be the small, unknown underdog.   Today, that Gorilla threw in the towel!

Despite the huge disparity in their media coverage, with positive Embryonic stem cell potential articles outnumbering all Adult stem cell articles by 1,000 to one, only Adult stem cells have a proven history of safety and efficacy, only Adult stem cell treatments are available today.  Click here to see if your condition can be treated with Adult stem cells:

While Geron and the US media, big Pharma, the AMA and the FDA have all given Embryonic stem cell their full throated support, the number of patients helped with adult stem cells is in the 10s of thousands while the number of patients helped by Embryonic stem cells in zero.

HORSE FALLING DOWN DURING RACEIf Embryonic treatments were a horse race, Geron would be the strongest horse in the field.  Geron would be the horse who was 9/10 of the way around the track with all other competitors still milling about in the starting blocks.  So what would make that horse stop dead in his tracks, fall flat on his face and walk away from the race?

What does it mean for the other Embryonic focused companies when the front runner pulls out of the race?

What would cause the leading Embryonic stem cell Pharmaceutical company with multiple Embryonic stem cell products in development to end all of their Embryonic stem cell programs? 

Product Product Description Application Development Stage
GRNOPC1 Oligodendrocyte Progenitor Cells Spinal Cord Injury Phase I Clinical Trial
GRNCM1 Cardiomyocytes Heart Disease Preclinical
GRNIC1 Islets Type 1 Diabetes Research
GRNCHND1 Chondrocytes Osteoarthritis Research
Hepatocytes ADME Drug Screening Research
GRNVAC2 Mature Dendritic Cells Cancer Immunotherapy Product Research
Immature Dendritic Cells Immune Rejection Research
Osteoblasts Osteoporosis Research

via Geron.com

Perhaps their clinical trial patients developed cysts and tumors as do all Embryonic stem cell patients.  Perhaps Geron decided to end their trials before these tumors and cysts turned into cancer so they could still say their product “has been well tolerated with no serious adverse events.”

Perhaps Geron couldn’t figure out how to address the need for immunosuppressive drugs required to implant a human with ALL Embryonic stem cells when there are many Adult stem cells that have no rejection issues.

Perhaps Geron couldn’t determine how to deal with Embryonic stem cells carrying the genetic abnormalities and maladies of the donor.

Or perhaps they read some of the quotes from my articles going back to March of 2009:

  • To date, ESC research has been 100% fruitless (in regard to generating treatments) for well-funded + government supported scientists around the world for the last 11 years.
  • Dr James Thomson, father of ESC research said: “…[ESC] are not being used in any clinical applications yet, while alternatives such as adult stem cells figure in scores of therapies.”
  • Ian Wilmut, who led the team that cloned Dolly the sheep, abandoned his license to attempt human cloning, saying that the researchers “may have achieved what no politician could: an end to the [ESC] debate.”
  • Dr. Bernadine Healy, former director of the NIH in U.S. News & World Report: “…[ESC], once thought to hold the cure for Alzheimer’s, Parkinson’s, and diabetes, are obsolete….. In fact, adult stem cells, which occur in small quantities in organs throughout the body for natural growth and repair, have become stars despite great skepticism early on.
Or maybe they reviewed the timeline for Embryonic stem cell success and realized they couldn’t afford 50 YEARS OF RESEARCH!
Dr. Colin McGuckin, a noted UK embryonic research leader at Newcastle U. before departing for more useful RSC research in France announced:

  • “For me, the unnecessary row over stem cells has obscured the very real issue that patients are waiting to be treated…The best estimates of the embryonic scientists in our own university in Newcastle is that embryonic stem cells may not be able to help people this side of 50 years. That’s my lifetime. And that’s worrying. We can’t wait that long.”
I do have to applaud their spin department.  It is a brilliant move to take the news story
“GERON GIVES UP ON EMBRYONIC STEM CELLS”
and spin it into
“GERON PUTS 100% FOCUS INTO CURING CANCER.” 
Even so, we are not fooled.  The red headed step child in the family always knows when they are neglected. 
They also published their press release at 4:05 Eastern so the regular stock market was closed and couldn’t react to the news. Unfortunately for them, their stock dropped over 20% in after hours trading.
Whatever the reason for Geron abandoning Embryonic stem cells, we can now finally exalt that THE WAR IS OVER and get on with Adult Stem Cell Treatments, the only stem cells to cure a human patient.

ADULT STEM CELL = ASC

  • SOURCE/DERIVED FROM•comes from blood, umbilical cords, bone marrow, placenta fat tissue, muscle, nasal neurological, breast milk, menstruation, dental pulp, and many more
  • PURPOSE IN BODY•they are the body’s natural healing cells
  • OBSTACLES+SIDE EFFECTS•~zero problems (virtually zero side effects)
  • TREATMENT HISTORY•used in bone marrow transplants to treat cancer for 40 years
  • TREATMENT HISTORY•can currently treat 130+ diseases safely and effectively (CP, MS, Autism, Diabetes, CHF, PAD, etc)
  • To see if your condition can be treated with Adult stem cells, please fill out this form: http://bit.ly/PATIENTQUESTIONNAIRE

via STEM CELLS 101

  • 100+ DISEASES treated around the world with adult stem cells!
  • 60-70% SUCCESS RATE typical therapeutic benefit on INCURABLE DISEASES!!
  • POTENTIAL CURES of Autism, Parkinson’s, AIDs, Diabetes, Heart Disease and more!
  • HUGE REWARDS of life extension!
  • SIGNIFICANTLY IMPROVED quality of life!

http://www.maniacworld.com/muhammad-ali-2.jpg

Geron to Focus on Its Novel Cancer Programs
Company Plans to Partner All Stem Cell Programs

MENLO PARK, Calif.–(BUSINESS WIRE)–Geron Corporation (Nasdaq: GERN) today announced that, effective immediately, the Company will focus on its first-in-class oncology programs. As a consequence, the Company will discontinue further development of its stem cell programs and is seeking partners for these novel assets.

“Our employees, collaborators and shareholders can be proud of the pioneering role they have played to advance our stem cell technology into the clinic”

“In the current environment of capital scarcity and uncertain economic conditions, we intend to focus our resources on advancing our Phase 2 clinical trials of imetelstat and GRN1005. These two novel and promising oncology drug candidates target major unmet medical needs and have important clinical development milestones occurring over the next 20 months,” said Geron’s Chief Executive Officer, John A. Scarlett, M.D. “By narrowing our focus to the oncology therapeutic area, we anticipate having sufficient financial resources to reach these important near-term value inflection points for shareholders without the necessity of raising additional capital. This would not be possible if we continue to fund the stem cell programs at the current levels.

…The decision to narrow Geron’s technology and therapeutic focus was made after a strategic review of the costs, value inflection timelines and clinical, manufacturing and regulatory complexities associated with the Company’s research and clinical-stage assets. With this decision, Geron is eliminating 66 full-time positions, representing 38% of its workforce. As a result, the Company expects one-time cash expenditures of approximately $5 million in the fourth quarter of 2011 and approximately $3 million in the first half of 2012. Geron expects to end 2011 with cash and investments in excess of $150 million.

Geron is seeking partners with the technical and financial resources to enable further development of its stem cell programs. “Our employees, collaborators and shareholders can be proud of the pioneering role they have played to advance our stem cell technology into the clinic,” said Dr. Scarlett. “Stem cells continue to hold great medical promise. We believe that our leadership role in the field and the quality of our stem cell assets — which are widely recognized as being among the most innovative, comprehensive and advanced cell therapy programs in the world — will be an important point of differentiation in our discussions to partner these assets.” In order to facilitate transfer of these programs to partners, Geron will retain a core group of employees from its stem cell operations through the end of the second quarter of 2012.

Geron plans to close the GRNOPC1 trial for spinal cord injury to further enrollment, although it will continue to follow all enrolled patients, accruing data and updating FDA and the medical community on their progress. In this trial, GRNOPC1 has been well tolerated with no serious adverse events

Read more

Related articles:

A HISTORY OF THE GERON EMBRYONIC STEM CELL FIASCO November 15, 2011

EMBRYONICS’ BLEAK FUTURE AND BOTCHED PAST November 15, 2011

To see if your condition can be treated with Adult stem cells, please fill out this form:

BENNY HILL IS ALIVE AND WELL AS BRITAIN GOES BLIND

In ALL ARTICLES on September 23, 2011 at 7:00 am

Remember in the final scene of every episode of Benny Hill where he does something really scandalous and then gets chased by the entire cast around and around in circles?  Turns out, Benny Hill is ALIVE AND WELL and advising Britain on their medical protocols!  http://www.webtvwire.com/wp-content/uploads/2010/06/the-benny-hill-show-logo.jpg

You see, Britain, like the USA, is chasing this fleet footed “embryonic stem cell treatment comedy of errors” around and around in circles just like in the Benny Hill episodes.  Every week, the same scene is played out with Benny running, the entire cast chasing and he never gets caught.  So in Art, so in life.  Britain is chasing embryonic stem cells used for treatment of optic diseases.  And remember…

  • Embryonic stem cells STILL have ZERO successful clinical trials
  • Embryonic stem cells STILL cause cysts and tumors that can become cancerous (wait 20 years and ask again though)
  • Embryonic stem cells STILL have rejection issues that require immunosuppressive drugs
  • Embryonic stem cells STILL carry the genetic anomalies of the donor
ON THE OTHER HAND…

So on top of wasting time chasing a cure with no prior history of success and huge negative side effects, thy are running right past a treatment with a huge history of success and safety and trials.

So cue up the cameras, get everyone in costume and let’s start that famous music going as everyone chases embryonic stem cell treatments around and around.  Wait! STOP! Hold it! CUT!

How on earth can we explain the entire medical community and government running right past what already works?  Got it! Give them all blindfolds!  That way they can be assured to miss the forest but they will hit every damn tree in it and so will the patients, patiently waiting for treatments which will never come!

…annndddd   ACTION!!!

Iris of a human eye

First trial of embryonic stem cell treatment in Europe gets green light

Patients in Britain with an eye disease that leads to blindness will take part in Europe’s first human embryonic stem cell trial

British surgeons are to take part in the first trial in patients of a human embryonic stem cell therapy to gain approval from regulators in Europe.

Surgeons at Moorfields Eye Hospital in London will inject cells into the eyes of 12 patients with an incurable eye disease called Stargardt’s macular dystrophy, one of the main causes of blindness in young people…

Read more

GERON’S EMBRYONIC “WASTE OF TIME” CONTINUES…

In ALL ARTICLES on September 21, 2011 at 9:51 pm

Here’s an 867 word article I’d like to not waste your time with.

http://www.epiphanymarketing.com/blog/wp-content/uploads/2010/03/waste-of-time-283x300.jpg

The premise is:  “The study is not meant to determine whether the stem cells can cure or even improve the patients’ condition, but to find out if the treatment itself is safe. Researchers will be monitoring patients over the following months and years to look for side effects, including possible benign tumor growth if the stem cells start to replicate, or adverse immune reactions.”

So let’s not waste your time, I’ll give you the results right now:

EMBRYONIC STEM CELL = ESC

  • SOURCE/DERIVED FROM•comes from embryos
  • PURPOSE IN BODY•split for 7 weeks until you have a fetus the size of a thumbnail
  • OBSTACLES+SIDE EFFECTS•they create cysts and tumors, rejection requires immunosuppressive drugs for the ill patient, they carry the genetic anomalies of the donor, etc
  • TREATMENT HISTORY•can currently treat zero diseases, probably need to cure cancer first to use them

Read it if you want but that’s really “all she wrote.”  Then again, this will allow billions to be pumped into embryonic research for treatments over “the following months and years” despite this fact…

SCREW THE EMBRYOS, THEY’RE IRRELEVANT!

———————————————

———————————————

Paralyzed patient in major Geron stem cell study

Erin Allday, Chronicle Staff Writer, Wednesday, September 21, 2011

A Bay Area patient who recently suffered a serious spinal cord injury and is now paralyzed from the waist down joined the world’s first-ever embryonic stem cell study in humans last week, when Stanford doctors injected 2 million cells designed to replace damaged neurons in the patient’s spine.

The patient, who is not being identified, is the fourth person to be enrolled in the clinical trial being run by Menlo Park’s Geron Corp. and the first person in California. The patient, whose participation in the trial was revealed Tuesday, received the stem cell injection Saturday at Santa Clara Valley Medical Center and is now at the rehabilitation center there.

The study is not meant to determine whether the stem cells can cure or even improve the patients’ condition, but to find out if the treatment itself is safe. Researchers will be monitoring patients over the following months and years to look for side effects, including possible benign tumor growth if the stem cells start to replicate, or adverse immune reactions…

Read more

First patient to get stem cell therapy comes forward – LIES and MISDIRECTION

In BUSINESS OF STEM CELLS on April 7, 2011 at 12:52 pm

LIES & MISDIRECTION

There are HUGE problems with this article.  In no particular order…

http://repairstemcell.files.wordpress.com/2011/04/lies.gif?w=418&h=231

IT’s A LIE!

The title of the article is a bold faced, straight up LIE. “First patient to get stem cell therapy is identified”. For the record, ADULT stem cells have safely and effectively treated tens of thousands of patients to date (SAFELY AND EFFECTIVELY!), some with their own stem cells from their own bone marrow or fat tissue, some with stem cells from umbilical cords, etc.  In fact, bone marrow transplants have been used for about 40 years.  If you want to consider this a “stem cell therapy” then you should consider BMT’s a “stem cell therapy” also which adds thousands more to the tally.

http://steynian.files.wordpress.com/2008/07/misdirection.png?w=354&h=245

IT”s MISDIRECTION!

Embryonic stem cells have been known to cause cysts and tumors that can become cancer. Embryonic stem cells require immunosuppressiv drugs.  But wait a second folks!  this isn’t even embryonic stem cell therapy….cue the magician!

This is A DRUG MADE FROM EMBRYONIC STEM CELLS!  Why make drugs from embryonic stem cells when YOUR OWN adult stem cells can fix you? It’s about the money folk,s the cash, the profit margins.  Here’s a more detailed explanation – http://repairstemcell.wordpress.com/why-no-stem-cells-in-the-us/

What else:

Let’s not get too excited too soon…drugs have been known to have side effects.  At this stage, they are merely testing for safety.  If it is deemed safe or should I say: “safe” (and nobody turns on their TV to see the drug commercials with their allowable side effects followed by the commercials by the lawyers suing drug companies for heart, attack, death, stroke, and ED.) then perhaps one day you can get some at a drug store near you.  Lucky you!

What’s with all the secrecy? Secret teams? secret training? secret volunteer?  secret results?  When there is this much secrecy shrouding a medical treatment, watch out!  One of 2 things is happening.  This is a huge marketing ploy to generate hype so the most insignificant information released will be heralded with fanfare OR something is going to be hidden. Bank on it!

Or perhaps Geron, who is not mentioned until halfway down the page, finally got tired of announcing HUGE MEDICAL BREAKTHROUGH WITH EMBRYONIC STEM CELL TREATMENTS for 6 years in a row only to end up with egg on their face when nothing panned out, nobody got healed, nothing worked as well as adult stem cells.  Of course, they were able to artificially pump up their stock with every announcement so:  “while nobody got any closer to getting healed, the execs made a killing and the shareholders got screwed.”  For more on Geron, scroll down to the list of articles at the bottom of this one- http://repairstemcell.wordpress.com/2010/07/31/fda-oks-first-embryonic-stem-cell-research-trial-on-humans-despite-concerns/

http://farm4.static.flickr.com/3553/3814824363_6d55a1c8a7.jpg

First patient to get stem cell therapy comes forward

In the six months since scientists announced they had infused a drug made from human embryonic stem cells into a partially paralyzed patient’s spine, the identity of the recipient has been shrouded in secrecy.

Recently, rumors began circulating in Internet chat rooms that details about the closely guarded experiment were finally about to be revealed.

Now, a 21-year-old Alabama nursing student who was paralyzed from the chest down in a car crash in September has come forward to identify himself as the volunteer.

“I was the first patient,” Timothy J. Atchison of Chatom, Ala., said in a telephone interview with The Washington Post on Wednesday evening. “I’m doing well.”….

First patient to get stem cell therapy comes forward – The Washington Post.

FDA OKs First Embryonic Stem Cell Research Trial on Humans, Despite Concerns

In STEM CELLS IN THE NEWS on July 31, 2010 at 3:09 pm

Admiral Horatio Nelson was blinded in one eye early in his Royal Navy career. In 1801, during the Battle of Copenhagen cautious Admiral Sir Hyde Parker, in overall command of the British forces, sent a signal to Nelsons forces giving him discretion to withdraw. Naval orders were transmitted via a system of signal flags at that time. When this order was given to the more aggressive Nelson’s attention, he lifted his telescope up to his blind eye, said “I really do not see the signal”, and his forces continued to press home the attack.

The idiom,

“turning a blind eye,”


is used to describe the process of ignoring unpopular orders or inconvenient facts or activities.

http://wheelhouseadvisors.files.wordpress.com/2009/05/see_no_evil.jpg?w=240&h=360

FDA TURNS A BLIND EYE TO EMBRYONIC STEM CELL PROBLEMS


WHAT DID THE FDA HAVE TO IGNORE IN ORDER TO GRANT APPROVAL TO GERON TO GO AHEAD WITH THEIR EMBRYONIC STEM CELL TREATMENT TESTING ON HUMANS WITH SPINAL CORD INJURY?

1.  Most of the standard preclinical trial process

  • Preclinical testing – When a drug is discovered that seems to have medical potential, a drug company will test it exhaustively in animals, looking for signs it may be poisonous, cause cancer, or cause birth defects. Animal studies will also be used to estimate the initial drug doses to be tested in humans.When animal experiments are finished, the company asks the FDA for permission to begin clinical trials. The FDA only grants approval once they are satisfied that the animal experiments are sound and that clinical trials are likely to be safe. from

2.  Adult stem cells have successfully treated spinal cord injuryfor years (successfully!

3.  Embryonic stem cell treatments often cause cysts and tumors.  All embryonic scientists and even Geron have openly admitted this.

4.  Embryonic stem cell treatment rejection problems and the immunosuppressive drugs required tooffset them

  • Oh, well…What do spinal cord injury patients need with a healthy immune system when they are trying to get better anyway?

P.S. And by the way, please note that every single one of these issues is scientific; not moral, ethical or religious.

FDA OKs First Embryonic Stem Cell Research Trial on Humans, Despite Concerns

by Steven Ertelt
LifeNews.com Editor
July 30
, 2010

// Washington, DC (LifeNews.com) – The Obama administration has approved the bid by cloning company Geron to undertake the first trial involving the use of embryonic stem cells in humans. They have never been used before in people because the cells cause tumors and have been plagued by immune system rejection issues when tried in animals.

Scientists and pro-life advocates say human embryonic stem cells are not ready for trial because problems associated with the cells in animals haven’t been solved.

The Food and Drug Administration had initially placed the trial on hold but Geron indicated today that the agency is now allowing it to proceed with an early stage trial on a stem cell therapy for acute spinal cord injury.

The FDA placed a hold on the trial last August, when evidence showed Geron’s GRNOPC1 encountered safety issues when used in animal studies. Geron’s own data showed higher frequency of small cysts within the injury site in the spinal cord of animals injected with the embryonic cells.

“We are pleased with the FDA’s decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed,” said Thomas B. Okarma, Geron’s president, in a public statement today. The company’s stock rose in value following the announcement.

Previously, Dr. John A. Kessler, chairman of neurology and director of the stem cell institute at Northwestern University, said the first application from Geron for the embryonic stem cell trial was flawed.

“We really want the best trial to be done for this first trial, and this might not be it,’’ he said at the time.

Responding to the news today, Dr. David Prentice, a former biology professor at Indiana State University who is now a fellow at the Family Research Council, tells LifeNews.com those concerns should still exist.

“It’s unfortunate that the FDA has released Geron from the safety hold on their embryonic stem cell trial,” he said. “Even many pro-embryonic stem cell scientists have expressed reservations about Geron’s trial, that it is not proven even in rats. The concern for many of us is that Geron is endangering patient’s health and very lives, to make a political point and increase their stock price.”

Prentice also said the trial’s approval makes it so the use of adult stem cells, which are safely helping patients battling more than 100 diseases and conditions already, continue to be ignored.

“In the meantime, adult stem cells have already shown published scientific evidence for safety and successful repair of spinal cord injury in patients. Only adult stem cells offer both an ethical and successful path to healing,” he said.

Prentice also explained that the trial isn’t precisely the first one involving embryonic stem cells — making it so media outlets need to fully explain what Geron is doing.

“They inject cells derived from embryonic stem cells; in this case a cell type called an oligodendrocyte, which is a cell that forms a sheath, like insulation, around nerve fibers,” he said. “So they don’t inject growing embryonic stem cells, but the cells are indeed directly derived from embryonic stem cells, and actually are not completely differentiated, but only part-way (“precursors”).”

“The theory is that once inside the body, the cells will finish specializing to the final cell type, and form an insulative covering over exposed nerves in the spinal cord,” he told LifeNews.com.

Last August, Evan Snyder, a neuroscientist who heads up the stem cell research center at the Burnham Institute for Medical Research in San Diego, warned the research may not be ready for humans.

“There’s a lot of debate among spinal cord researchers that the pre-clinical data itself doesn’t justify the clinical trial,” Snyder, who is working on using neural stem cells himself, says.

Snyder says the mice Geron used to conduct pre-human trial research had more excessive injuries [than] scientists would normally prefer to see prior to trying the procedure on human patients.

He suggests that Geron should have done experiments involving larger animals before seeking FDA permission to use the controversial embryonic stem cells in humans.

Those concerns existed as early as 2005 and may not have been addressed.

Snyder said then that Geron should do more animal testing first to make sure the tests would be on the same injuries humans have.

“I’m not convinced they have done that yet,” Snyder said.

Jerry Silver, a neuroscience professor and stem-cell researcher at Case Western Reserve University in Cleveland, told Knight Ridder back in November 2005 that Geron was moving too fast and needed to do more tests on animals before seeking human patients.

“Frankly, I cannot conceive of a human trial with the use of human embryonic stem cells following immediately from experiments in rodents only,” he said then. “Many treatments that work in rodents to alleviate disease fail miserably in humans.”

Geron came under criticism earlier this year when news surfaced that the application Geron Corporation submitted to the FDA to become the first to engage in human trials of embryonic stem cells was timed with a trigger to make it so it would be considered during the Obama administration. The cloning company worried it would not be approved during the administration of President George W. Bush.

Just days after Obama took office, the FDA suddenly decided to approve Geron’s application for the controversial study.

COMMENT:

“There’s stupidity and then there’s just “dumbassedness”. The Obama Administration and FDA okays using embryonic stem cells in humans when every scientist in the field knows they cause tumors and other deadly side effects.” -Boonie

MORE ON GERON and STEM CELLS FOR SPINAL INJURIES:

GERON ZOMBIE ARTICLES RISE FROM THE DEAD

In ALL ARTICLES on March 6, 2010 at 5:24 am

Can an article that died over a year ago, rise from the grave and start walking around on the internet?  This one did!  On first reading, I honestly could not even tell if the article was real or not…was old or new…

This seems to be an undated article from Reuters that reads like some of the articles that came out a year ago.  If you do a keyword search for “FDA” + “Geron” on Reuters.com, they show no such article that has come out recently.  Only the one’s from Jan/Feb 2009…
http://www.reuters.com/search?blob=fda+geron&pn=1

BUT if you google it, it comes up in the last 2 days and it seems to be on a handful of different papers…

BUT many of those papers are all a part of the Canada.com network…

very weird stuff!

The stock price in the article is off of course.  Geron was at $4.8 before the announcement over a year ago and then jumped to $8 before crashing back to $4 again…dashing the hopes of spinal cord victims and shareholders who were too slow to get out in time.

So I think someone may be doing a fake media campaign…raising articles from the dead like zombies…changing them slightly…removing the dates on them…posting them as “current” articles…impersonating both Reuters and their Health and Science Editor, Maggie Fox…

or maybe canada.com just got very confused…

but if this was purely accidental…

why were the dates removed from them?  All of them.

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FDA allows first test of human stem cell therapy
By Maggie Fox, Health and Science Editor, ReutersComments (1)
Ampoules containing a medium for stem cell storage are displayed.
Ampoules containing a medium for stem cell storage are displayed.
Photograph by: Peter Macdiarmid, Reuters

WASHINGTON (Reuters) – The U.S. Food and Drug Administration has cleared the way for the first trial to see if human embryonic stem cells can treat people safely, a company involved in the controversial research on Friday.

Geron Corp, a California biotechnology company, said it plans a clinical trial to try to use the stem cells to regrow nerve tissue in patients with crushed, but not severed, spinal cords.

The issue of human embryonic stem cell research has been a political touchstone, with anti-abortion forces backed by former president George W. Bush arguing the technique involves the destruction of human embryos. Advocates say it could transform medicine.

“For us, it marks the dawn of a new era in medical therapeutics. This approach is one that reaches beyond pills and scalpels to achieve a new level of healing,” Geron Chief Executive Dr. Thomas Okarma said in a telephone briefing.

Shares of Geron rose more than 53 percent to $8 in mid-morning trading on Nasdaq after touching $8.38.

Geron will recruit eight to 10 recently injured patients and inject them with small numbers of human embryonic stem cells manipulated to become the oligodendrocyte cells that insulate nerves, and that produce compounds to stimulate the growth of nerve cells.

Okarma said there was no political significance to the announcement coming the same week as President Barack Obama took office. Obama has been widely expected to lift restrictions on federal funding and support of human embryonic stem cell research.

An FDA spokeswoman said, “Before FDA allowed the study to proceed, Geron worked with FDA to address important scientific questions.”

CHEAP AND EASY

Okarma said the treatment should eventually become cheap and easy to mass produce because the cells can be grown in vats. He believes the cells may be useful for other diseases such as multiple sclerosis, in which nerve cells are stripped of their insulating sheaths, and perhaps strokes.

Financial analysts celebrated. Stephen Brozak and Daniel Mallin of WBB Securities LLC said it could “as important to drug therapy as the discovery of … penicillin.”

Dr. Robert Lanza of the rival Massachusetts-based Advanced Cell Technology, which is also seeking to create therapies using human embryonic stem cells, called the decision a “huge advance for the entire field”. This sends a message that we’re ready at last to start helping people,” he said.

Stem cells are the body’s master cells, giving rise to all the tissues, organs and blood. Embryonic stem cells are considered the most powerful kinds of stem cells, as they have the potential to give rise to any type of tissue.

Researchers are also trying to find ways to use so-called adult stem cells, taken from bone marrow and elsewhere in the body, and have learned how to transform ordinary skin cells into stem-like cells. But scientists argue that no one knows which route will work so all avenues must be pursued.

The Phase I trial will be designed to show that patients do not develop tumors, or damage to their nervous systems. But Okarma believes it will also indicate whether the stem cells might repair the damaged spinal cords.

“These are living cells that will divide, make more of themselves and migrate throughout the lesion after injection,” he said.

While the patients will get low doses of immune-suppressing drugs for the first two months, Okarma is confident the cells will escape immune system recognition and patients will not have to endure the treatments that organ and tissue transplant recipients usually do. Treatment on the first patient should begin this summer.

Okarma said the company has a strong balance sheet, free of debt, and “ample to fund the company through this trial”.

(Additional reporting by Susan Heavey, Doina Chiacu and Toni Clarke; Editing by Alan Elsner and Julie Steenhuysen)

© Copyright (c) Reuters
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THE EMBRYONIC STEM CELL HOAX: A HISTORY OF THE GERON SCANDAL

In ALL ARTICLES on February 20, 2010 at 11:43 pm

02/20/2010

THE EMBRYONIC STEM CELL HOAX: – A HISTORY OF THE GERON SCANDAL

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For six years, the American people’s understanding of stem cells has been overwhelmed by rampant misinformation and deception. We were led to believe the future of medicine lies in Embryonic Stem Cells (ESC) and that Repair (adult) Stem Cells (RSC) are “snake oil.”
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These skewed stories of ESC hope and RSC failure intentionally misled the American people in general and forced spinal cord patients to pay for the false-hope of ESC treatments in order to line the pockets of the  ESC promoters.
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GERON RULED BY POLITICAL AGENDA

In BUSINESS OF STEM CELLS on February 17, 2010 at 11:41 pm

This is from the UK Times. -dg

02/17/2010

Geron engineered stem cell application so Obama could announce approval

When the US Food and Drug Administration agreed to approve the world’s first trial of a therapy based on human embryonic stem cells just over a year ago, the timing of its announcement was intriguing.

The Bush Administration had been highly obstructive of embryonic stem cell research, imposing a ban on most federal funding of such studies, which Barack Obama had pledged to overturn. Then, just days after President Obama’s inauguration, the FDA suddenly decided that the time was right to give Geron Corporation permission to start its patient trials.

It certainly looked like more than a coincidence, and the decision was widely interpreted as evidence of a sea change in the US Government’s attitude to stem cell research. But the FDA insisted that the timing was incidental — it had simply ruled on Geron’s application 30 days after it was received, as it was required to do.

It now turns out that the timing was more than a coincidence. When I met up with Geron’s chief executive, Tom Okarma, in London this week, he revealed that the announcement was deliberately planned for the immediate aftermath of President Obama’s inauguration. But it was the company, not the FDA, which set this in motion: Geron deliberately timed its application so it would be decided just after President Bush left office, so that the Obama Administration would be able to announce it.

Dr Okarma told me:

“Many people hypothesised the first time that the lifting of the hold was due to the Administration change. We have no information and no indication that that was the case. We engineered the timing, because our final submission was timed such that the 30-day window occurred after the inauguration of President Obama. That was our design, not really an Administration change. That was our timing. We did not want this to come up under the Bush Administration. We designed it.”

So a loose end is tied up. Geron’s trial, incidentally, was subsequently delayed, following the discovery of cysts in experimental animals given its stem-cell spinal injury therapy. The company now hopes to start trials in the third quarter of this year.

VIA http://timesonline.typepad.com/science/2010/02/geron-engineered-stem-cell-application-so-obama-could-approve-it.html

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