Stem Cell Articles

[manouli]

clinical trials is the only way to see if you going to fix the problem.



Two stem cell-grown laryngotracheal transplants successful in Russia
Part of an international collaborative effort, two stem cell-grown laryngotracheal transplants are successful in Russia, using a US-made bioreactor.


FOR IMMEDIATE RELEASE


PRLog (Press Release) - Jun 27, 2012 -

The first two successful laryngotracheal transplants have been completed in Russia, using stem cells grown from the patients’ bone marrow. The cells were grown in a specially-designed bioreactor made by Harvard Bioscience, Inc., a Massachusetts-based company. The announcement was made by Harvard Bioscience.

more...

http://www.prlog.org/11910666-two-st...in-russia.html

[manouli]

Scientists try new trials all the time and they are learning if is going to be success by doing it.



Scientists transplant stem cells from patients with limb-girdle muscular dystrophy into mice
Published on June 28, 2012 at 2:51 AM · No Comments


inShare3

Stem cells from patients with a rare form of muscular dystrophy have been successfully transplanted into mice affected by the same form of dystrophy, according to a new study published today in Science Translational Medicine.

For the first time, scientists have turned muscular dystrophy patients' fibroblast cells (common cells found in connective tissue) into stem cells and then differentiated them into muscle precursor cells. The muscle cells were then genetically modified and transplanted into mice.

read...

http://www.news-medical.net/news/201...into-mice.aspx

[manouli]

Favourable Regulatory Environment in India Drives Indian Stem Cell Research, Finds Netscribes


Netscribes, launches a report on the Stem Cell Research in India 2012 as part of Netscribes’ Healthcare Industry report series.


Mumbai, India, July 08, 2012 --(PR.com)-- Netscribes a knowledge consulting Solutions Company, announces the launch of its Stem Cell Research in India 2012 report. The Indian government’s initiatives in stem cell research are providing a significant thrust to Stem Cell Research in India.

The report begins with the introduction section which offers a brief insight of the concept of stem cell therapy and banking and its scope as a therapy for most incurable diseases. The market overview section provides an insight of the Indian stem cell therapy and stem cell banking market in India. In addition to these, the report gives a snapshot of the current and expected stem cell banking customers.

read...

http://www.pr.com/press-release/425517

[manouli]

They should use both kind of stem cells. Both kind might be helpfull to sick and disable.


Surgeon uses adult stem cell therapy in spinal fusion clinical trial


The Argonaut Interview: Dr. Hyun Bae

By Gary Walker



Stem cell research remains a controversial topic throughout much of the nation, for religious as well as ethical reasons. Embryonic stem cells, which can differentiate into extraembryonic tissues and are derived from human embryos, are a particularly hot-button topic.

Scientists and researchers around the globe have been exploring the potential that adult regenerative stem cells could have on patients suffering from a variety of ailments, including spinal cord injuries, heart conditions and diabetes.


While stem cell research - especially clinic studies involving human embryos - remains highly politicized, Californians have shown their support for the controversial therapy. Voters approved a 2004 initiative that allocated $3 million toward human embryonic stem cell research.

Proposition 71 made California the largest state-funded scientific research initiative in the United States.

Three years ago, President Barack Obama signed an executive order that reversed President George W. Bush’s earlier policy of prohibiting the use of federal tax dollars for embryonic stem cell research.

Unlike embryonic cells, the use of adult stem cells in research and therapy is much less controversial. Dr. Hyun Bae, a spine surgeon at Saint John’s Health Center in Santa Monica, is the principal investigator in a clinical trial using adult stem cell technology. The hospital is one of only eight sites nationwide that have been chosen by the U.S. Food and Drug Administration for the studies.

http://www.argonautnewspaper.com/art..._stories/2.txt

[manouli]

He wants to move fast with human trials.




Stem Cell Expert Wants HIV Treatment to Spread like Wild Fire

An Australian stem cell expert has proposed that their research in treatment for HIV has advanced and the next step in the research will be its trials on human.

The world-famous Professor Alan Trounson, who at present is head of California Institute of Regenerative Medicine, has been working on cure for HIV and diabetes. He further assured that the cure is soon to include human trials.

more...

http://topnews.us/content/249444-ste...read-wild-fire

[manouli]

a lot of generous people, give all the time to a research.


Dr. Ralph N. Purcell: New Orthopedic Stem Cell Treatment Research Could Advance Medical Care
Regenerative Sciences has announced further development of its orthopedic stem cell treatment thanks to a $2M donation provided by John C. Malone, PhD. Noted orthopedic professional, Dr. Ralph N. Purcell regards this promising investment as one that can change the landscape of non-invasive treatments.

Phoenix, AZ (PRWEB) July 13, 2012

Although stem cell advancements show innovative promise in the treatment of several medical conditions, the practice is one that is still highly controversial. It is for this reason that it is very difficult for medical researchers to attain the necessary funding to continue research to develop stem cell treatments for widespread medical use. However, according to a recent article from The Wall Street Journal, a $2M donation from Dr. John C. Malone will help one company known as Regenerative Sciences further research and development for orthopedic stem cell treatment. As a noted leader in sports medicine and orthopedics, Dr. Ralph N. Purcell applauds this generous act that he expects will further non-invasive solutions for those who suffer from a variety of painful ailments.



Read more: http://www.timesunion.com/business/p...#ixzz20ce2fv4o

[GRAMMY]

Stemming Commercial Stem Cell Hype

By Gary Schwitzer, Published: July 12, 2012

Take Posttest

I got a news release recently offering the chance to interview the doctor who “Performed Stem Cell Therapy on New York Yankees pitcher Bartolo Colon.”

The news release says the doctor was “eager to discuss”:

How can stem cell therapy help you function better? How can stem cell therapy offset the signs and symptoms of arthritis?
How can stem cell therapy help rebuild the cartilage in joints?
How does joint health impact our ability to stay active?
(and other stuff)

I asked one of our expert editors, Harold DeMonaco, to write about such promotions. This is his column.
————————————-
Few other treatment modalities exemplify what is both good and bad with American medicine as stem cell therapies. For years, we have been inundated with promises that cures for some awful diseases were just around the corner. And while there is progress, that progress has been painfully slow. That is until entrepreneurs stepped into the picture.
Stem cells can be derived from many different tissues. The most promising cells, mesenchymal stem cells, are harvested from bone marrow and fat. These cells, like any stem cell, can be programmed to do many functions. Enter the entrepreneurs. Companies like Celltex and Regenerative Sciences and others have quickly moved into the stem cell business supplying cells to physicians and researchers alike. Texas, in large measure due to the efforts of its governor, has become the epicenter of mesenchymal stem cell companies. Texas has recently made stem cell therapies not yet approved by the FDA legal to administer in the state under a set of minimal requirements.
Normally, this would be viewed by everyone as a good thing. Private investment in a technology has been shown to push innovation. Making new technologies available has been an economic engine for many parts of the country. But there is an important legal issue associated with stem cell processing. When do stems cells become drugs? If deemed to be drugs, their use and processing are subject to FDA oversight well beyond that of simple blood products. The distinction between drug and blood product is murky at best at the moment.
All prescription drugs are approved by the FDA after exhaustive clinical trials. The gold standard is the randomized, double blind, controlled trial where the drug, in this case stem cells, is compared to an inactive placebo. While there is debate about this approach, most would agree that it is a valid determination of the true value of a drug in the treatment or mitigation of a disease. Regardless of the study design employed, if mesenchymal stem cells are indeed drugs, they should be approved only after extensive clinical study. At least that is the FDA view.
A counter argument is that companies like Celltex and Regenerative Sciences are not altering a patient’s own cells. What they do is no different than what blood banks do with whole blood, separating out cells for specific use. Since platelets, whole blood, packed red cells and the like are not drugs, they are not subject to FDA oversight other than those activities specific to cell processing. Shouldn’t mesenchymal stem cells fall into the same paradigm? Of course, there is a third point of view from folks who don’t like anyone telling them what is good or bad for them. They are the “It’s my body and I’ll try if I want to” crowd.
There are a host of issues related to the use of stem cells for medical therapy. The above regulatory issues are important because they frame the clinical issues. If the cells are sufficiently manipulated to fall under the FDA’s drug regulations, they are subject to a long and arduous road to approval. Their sale would be limited to only those indications for which there was sufficient data. Their manufacture would be subject to more intense FDA scrutiny. Perhaps this is not the right approach. After all, the folks at the stem cell facilities know what they are doing and minimal oversight is all that should be necessary.
The folks at Celltex were recently visited by the FDA who found their processing of cells to be deficient.* According to the FDA report, Celltex has serious issues related to the sterility, uniformity and integrity of the stems cells it obtains from patients, stores, and grows for eventual use. Sound like good practices to you? Maybe, then, the FDA should have a larger oversight role. The FDA and Regenerative Sciences have been locked in a court battle since 2008 over whether or not stem cells, when used for specific therapies, are in fact drugs.
In either case, drug or not, the use of the stem cells processed by commercial sources by a physician, for any purpose, is the practice of medicine. The FDA does not and cannot regulate the practice of medicine. That is up to the individual states' boards of medicine. The good news is that physicians can innovate to their hearts' content. Any physician can use just about any commercially available product for any medical purpose. Again, the state’s board of registration of medicine is the only regulatory agency with oversight. Physicians then are free to use a patient’s own stem cells for any purpose. They do not need to have any agency or oversight approve the use. This regardless of the lack of the confirmation that the therapy would work, or [whether] it has a positive benefit-to-risk ratio.
Mesenchymal stem cells may prove to be of great benefit to people suffering from joint diseases. Unfortunately, there are no compelling data to support their use at the moment. There are ongoing clinical trials and answers may be forthcoming. For the moment, if a member of my family asked about seeking this treatment at a local clinic, I would advise them to either enter into a clinical trial or explore other options. I would want to make certain that the cells were handled properly, that I received my own stem cells and not someone else’s and that the effects of the treatment were being reviewed, so that a body of knowledge could be developed as to whether or not the treatment did more good than harm. Call me cautious. I think that the phrase “Caveat Emptor” is appropriate here.
Of course these are my views and not the views of my employer.
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* Addenda: The Houston Chronicle recently reported, “FDA report faults Houston stem-cell company.“ That’s Houston. As in Texas. As in: “The Sugar Land company involved in Gov. Rick Perry’s unlicensed adult stem-cell procedure is rife with basic manufacturing problems, according to the U.S. Food and Drug Administration.”
On July 3, Adam Feuerstein of TheStreet.com reported, How To Tell When a Drug Company Fibs About Clinical Trial Results,” about a company’s news release concerning its stem cell therapy in heart attack patients.
And on July 6, Larry Husten on the Cardiobrief blog added an update to the issues raised by Feuerstein:
“I have heard from several investigators in the trial that the Osiris press release was issued without any input or consultation from the site investigators. In fact, the site investigators, including several who are extremely experienced clinical trialists, have expressed frustration and disappointment because their input has not been sought at any point during the trial. In most multi-center trials it is common practice to consult with the sites, and in particular the top-enrolling sites. In this case, the highest enrolling sites have had no significant involvement in the trial design or conduct. One investigator said he “had never worked with a company like this.” Another member of the steering committee told me that the committee had not met in a long time and has not seen the trial data. In fact, steering committee members were not even aware that Mark Vesely, an assistant professor at the University of Maryland, was the principal investigator of the study. One steering committee member said he’d never heard of him before reading the press release.”
http://www.medpagetoday.com/GarySchw...mber_134303843

[GRAMMY]

COLUMBIA, Md. (TheStreet) -- Osiris Therapeutics(OSIR_) "disappeared" important data when the company announced results Monday from a mid-stage study of its stem cell therapy Prochymal in heart attack patients.

Naturally, Osiris didn't come out and tell investors that it was issuing a misleading press release on the Prochymal heart attack study. Instead, the company claimed the study was a success. That's not true. Figuring out Osiris' deception wasn't that difficult if you know how to parse the language of clinical trial results and look at independent sources of information for the truth.

Ride along with me as I pick apart Osiris' statements regarding the Prochymal heart attack study. Interpreting clinical trial results with a skeptical eye is a crucial tool for all biotech investors, so apply these skills universally whenever a drug or biotech company tries to convince you that its drug works. Hopefully, you'll find most companies are telling the truth, but sadly and too often, bullish pronouncements about boffo clinical trial data are just spin jobs ginned up to plaster over problems and bad data.

Here's what Osiris issued Monday:
Osiris Therapeutics, Inc. announced today interim one-year results from its groundbreaking clinical trial evaluating Prochymal (remestemcel-L) for the treatment of patients experiencing first-time acute myocardial infarction. The trial is the largest study of allogeneic or "off-the-shelf" stem cells ever conducted in heart attack patients. A total of 220 patients were given a single infusion of either Prochymal or placebo through a standard intravenous line within seven days of an acute heart attack.

Not much to quibble with here except it's helpful to know that Osiris enrolled the first heart attack patient to this study in April 2009, so it took more than three years to complete and report "interim" results. ClinicalTrials.gov [a great, independent source of clinical trial information, by the way] lists the completion date for this study as December 2011, so Osiris appears to be reporting results six or seven months late.

continued:

http://www.thestreet.com/story/11605...l-results.html

[manouli]

The path from stem cell to maturity
July 16, 2012



Gene regulation mechanisms are active at every level of development, from the passage of stem cell through to differentiated cell. On from there to maintenance of identity of the mature, functioning cell, regulation is maintained through cellular memory mechanisms.

The "Integrated approaches to study gene regulation during cellular differentiation" (Integer) project is aiming to investigate all levels of gene regulation with a multidisciplinary and integrated approach to research. Specifically, during cell differentiation study, regulation of trans-acting factors and genetic material has come under the microscope.

Protocols established by Integer include 4C or 3C ChIP sequencing and RNA-binding protein immunoprecipitation (RIP) sequencing. For visualising intra-nuclear associations, cryo-FISH imaging techniques were used. Appropriate cell lines were established for the planned genomic work and, to analyse the sequencing data, software tools were refined and optimised.

read...

http://phys.org/news/2012-07-path-st...-maturity.html

[manouli]

Stem Cell research Helps Find Development of Cancer

Stem cell research has proved to be quite useful for people. In a recent revelation, it has been revealed that through the use of stem cell research, a group of international researchers have been able to develop a marker, which will help them to understand about how the cancer develops in liver and pancreas.

read....
http://www.topnews.us/content/249500...lopment-cancer