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Category Archives: Stem Cell Therapy

Professors Critique Stem Cell Medical Tourism

Posted: November 29, 2012 at 6:40 pm

A panel at the Harvard Law School Wednesday discussed the ethical debate over the use of embryonic stem cells in the United States, focusing on the burgeoning controversy surrounding the role of stem cell therapy in medical tourism.

Medical tourism, in which patients travel internationally to gain access to specific health care services, has become increasingly common, panelists said. They said that reasons for medical tourism range from basic hip replacement surgery to black market organ sales. As most stem cell therapies are not approved in the United States, numerous patients are going abroad to countries like China and Russia where treatment is legal.

Panelist I. Glenn Cohen, an assistant professor at the Law School, said that it was probable that a Chinese stem cell facility performs several hundred thousand of these treatments yearly. He said that numerous celebrities, including football quarterback Peyton Manning, have reportedly traveled abroad to receive stem cell treatment not approved by the FDA.

A number of facilities claim to use stem cells to cure a wide array of diseases. University of Alberta law professor Timothy Caulfield, another panelist, pointed out that a simple Google search leads potential patients to a plethora of websites which claim that diseases such as autism and cancer can be cured through stem cell therapy.

Its being offered as routine, its being offered as safe, its being offered as effective, Caulfield said, citing his own 2008 study on the subject, Of course, none of them being offered matched what the scientific literature said.

According to American history professor Jill Lepore, the hyper-acceleration of enthusiasm for stem cell therapy is reminiscent of a century ago when science journalism and government funding for science research began to blossom. Lepore pointed out how public excitement over scientific procedures has affected society in the past, popularizing cryonics research and the work of Eugene Steinach, who claimed his vasectomy operation reversed the aging process.

Panelists said that one issue with stem cell tourism is the number of health risks associated with such procedures, citing a number of instances where stem cell therapy caused serious harm.

They also noted that public discussion about stem cell therapy has been markedly positive, lending an air of legitimacy to stem cell therapy that hasnt been validated by research.

Articles criticizing stem cell tourism, on the other hand, have generally received a less favorable response. Caulfield told the audience that when he co-wrote an article in The Atlantic criticizing stem cell therapy, he was accused as being a nutball Canadian socialist bioethicist.

The panelists emphasized that more accurate information should be provided to the public regarding stem cell treatments.

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Professors Critique Stem Cell Medical Tourism

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Nose Offers Safe, Effective Pathway for Delivering Stem Cell Therapy to Brain Tumors

Posted: November 28, 2012 at 7:40 am

A group of researchers has found a safe, simple and effective way to deliver stem cells to treat brain tumors literally, through the nose. The results are published in the December issue of STEM CELLS Translational Medicine.

Durham, NC (PRWEB) November 27, 2012

Treatment options for gliomas, the most common type of primary brain tumors, are very limited due to their diffuse invasive nature and their ability to evade conventional chemotherapy and radiation treatments. Stem cells have shown great promise as a therapy, but how best to deliver them to the tumor site has proven a challenge.

The most frequently used method, surgical implantation, has a low survival rate for the stem cells plus the procedure itself can lead to complications such as inflammation. Injecting the cells into the blood stream is another way, but it carries an increased risk of the cells accumulating in peripheral organs, which could cause side effects and also means that not enough of the stem cells are getting to the targeted tumor.

We investigated the feasibility of intranasal administration of neural stem/progenitor cells [NSPC] as an alternative, said principal investigator Nils Ole Schmidt, M.D., of the University Medical Center Hamburg-Eppendorf, Hamburg, Germany. He and UMCHE colleague Matthias Reitz, M.D., oversaw the study, which also involved researchers from the University of British Columbia Hospital in Vancouver, Canada, and Chung-Ang University College of Medicine in Seoul, Korea.

The scientists tested their idea on three different glioma cell lines in mice. The results showed that not only did the stem cells make it to the targeted tumor, but that they did it quickly and without settling in any peripheral areas. Six hours after initial delivery, the stem cells had enriched within the tumor area. Twenty-four hours later, the number of cells in the tumor had increased even further with up to 24 percent of stem cells that had been applied as nose drops.

The study also revealed two major migration routes the olfactory nerve pathways and the tiny blood vessels that make up the bodys microvasculature system and a potential signal that attracted the cells to the malignant tumor. It is likely that guidance signals such as chemotactic factors released by the tumor itself and the adjacent reactive brain parenchyma drew in the stem cells, Dr. Reitz said.

Our study provides proof-of-concept that the non-invasive intranasal passage of NSPC is a highly attractive and efficient alternative method of cell administration for stem cell-based therapies in brain tumors. This offers the possibility of multiple treatments, potentially with different therapeutic payloads during the disease course, Dr. Schmidt added.

The study addresses an important aspect of any stem cell treatment identification of a safe and effective delivery method as the treatment advances toward clinical trials, said Dr. Anthony Atala, Editor of STEM CELLS Translational Medicine and director of the Wake Forest Institute for Regenerative Medicine. These results point to the potential of intranasal delivery as a convenient and non-invasive option for delivery.

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Fate Therapeutics Initiates Phase 2 Clinical Study of ProHema for the Treatment of Hematologic Malignancies

Posted: November 28, 2012 at 7:40 am

SAN DIEGO, Nov. 27, 2012 /PRNewswire/ -- Fate Therapeutics, Inc., a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators, announced today the initiation of a randomized, controlled, Phase 2 multi-center study of its investigational hematopoietic stem cell therapy, ProHema, in adult patients undergoing double umbilical cord blood transplantation (dUCBT) for hematologic malignancy. The advancement of ProHema into later-stage development builds upon positive results from a Phase 1b single-center study, interactions with the U.S. Food and Drug Administration and refinements to the product manufacturing process. The previously completed Phase 1b study achieved its primary objective of demonstrating safety and tolerability. The study also established early clinical proof-of-concept trends of accelerated neutrophil recovery, improved 100-day survival and low rates of graft-versus-host disease were evident, and durable and preferential reconstitution with ProHema occurred in 10 of 12 evaluable patients. ProHema is produced through a proprietary, two-hour, ex vivo modulation process, which has been shown to significantly activate key biological pathways involved in hematopoietic stem cell homing, proliferation and survival in preclinical models.

"Allogeneic umbilical cord blood transplantation holds great promise as a potentially curative treatment for children and adults with hematologic malignancies and many other life-threatening, non-malignant disorders," said Christian Weyer, M.D., M.A.S., President and Chief Executive Officer of Fate Therapeutics. "ProHema is being developed with the intent to improve outcomes in patients undergoing cord blood transplantation by facilitating both accelerated engraftment and durable reconstitution using a simple, point-of-care, ex vivo modulation process. The initiation of Phase 2 marks an important milestone for the company and brings us one step closer towards achieving this objective."

The Phase 2 study is expected to enroll at least 45 adult patients undergoing dUCBT for the treatment of hematologic malignancies. Patients will be randomized, with a ratio of 2:1, to receive either ProHema plus an unmanipulated cord blood unit or two unmanipulated cord blood units. The study will evaluate time to neutrophil and platelet recovery, incidence of serious infections and graft-versus-host disease, 100-day mortality and relative dominance of ProHema over the unmanipulated cord in contributing to reconstitution. Results are expected in 2013.

"The preclinical and clinical data obtained to date suggest that ProHema may address several of the unmet medical needs in the evolving field of hematopoietic stem cell transplantation," said Steven Devine, M.D., Professor of Medicine and Program Director of the Blood and Marrow Transplant Program at the Ohio State University and a principal investigator of the Phase 2 clinical study. "While further investigation is required, an intervention that enables early and durable reconstitution of the best-HLA-matched cord blood unit has the potential to improve patient outcomes and substantially enhance the therapeutic value proposition of cord blood transplant."

About ProHema

ProHema is an innovative cord blood-derived cell therapy containing pharmacologically-modulated hematopoietic stem cells (HSCs). ProHema is produced through a proprietary, two-hour, ex vivo cell modulation process that results in rapid activation of key biological pathways involved in homing, proliferation and survival of HSCs. In preclinical testing, ProHema has demonstrated the potential to accelerate engraftment and to drive durable hematopoietic reconstitution, without the need for multi-week expansion protocols. In an initial Phase 1b study in adult patients with hematologic malignancies undergoing double umbilical cord blood transplant (dUCBT), the median time to neutrophil recovery (> 500 cells/microliter) with ProHema was 17.5 days, which compares favorably to historical norms for patients undergoing dUCBT. In that study, ProHema provided the dominant source of hematopoiesis in 10 of 12 evaluable subjects, suggesting that treatment with ProHema may accelerate engraftment and drive durable and preferential reconstitution.

About Fate Therapeutics, Inc.

Fate Therapeutics is a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators. The Company's first clinical program, ProHema, is an innovative cord blood-derived cell therapy containing ex vivo pharmacologically-modulated hematopoietic stem cells and is being developed to improve hematopoietic reconstitution in patients undergoing stem cell transplant. In addition, Fate Therapeutics has preclinical programs of novel in vivo stem cell modulators for skeletal muscle regeneration and hearing restoration. To advance its discovery and development efforts, the Company applies its award-winning, proprietary, induced pluripotent stem cell technology to generate rare cell populations and model disease. Fate Therapeutics is headquartered in San Diego, CA, with a subsidiary in Ottawa, Canada. For more information, please visit http://www.fatetherapeutics.com.

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Fate Therapeutics Initiates Phase 2 Clinical Study of ProHema for the Treatment of Hematologic Malignancies

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Dramatic Rise in Stem Cell Therapy Use in 2012

Posted: November 28, 2012 at 7:40 am

PHILADELPHIA, Nov. 26, 2012 /PRNewswire/ --RRY Publications LLC today announced that the use of stem cell therapies in 2012 significantly exceeded forecasts which were originally presented at the February 2012 New York Stem Cell Summit. Said Robin Young, stem cell industry analyst and host of the New York meeting: "The range and scope of stem cell therapeutic use in the United States grew much faster than we'd forecasted earlier this year. Virtually all of the increases we're seeing are for adult stem cell therapies and, in particular, the use by physicians of both allograft and autologous stem cell products. It would not be an exaggeration to call this unexpected and remarkable growth."

Mr. Young's revised forecast of stem cell commercialization revenues for 2013-2020 will be presented at the February meeting in New York.

The companies, scientists and physicians that are at the forefront of this remarkable increase in stem cell therapeutic use will be presenting at the 8th Annual New York Stem Cell Summit. Listed below is the preliminary lineup of presenters for the 8th Annual Stem Cell Summit.

The Stem Cell Summit, an intensive one-day event, allows attendees to learn about the latest developments in the stem cell marketplace, evaluate the groundbreaking stem cell products physicians are using today, and discover the growing market potential in terms of revenues. For 2013, the Summit will feature 30+ presenters, a research review and debate session, and a special track on expanding the range of stem cell therapies.

The 8th Annual Stem Cell Summit will take place on Feb. 19, 2013, at Bridgewaters in the heart of New York City's historic South Street Seaport. The preliminary roster of companies featured will include representatives from 2012 presenters and new 2013 presenters.

Aastrom Biosciences, Inc.

Advanced Cell Technology

Aldagen, Inc.

AllCells, LLC.

Aruna Biomedical, Inc.

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Dramatic Rise in Stem Cell Therapy Use in 2012

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Dramatic Rise in Stem Cell Therapy Use in 2012

Posted: November 27, 2012 at 7:40 pm

PHILADELPHIA, Nov. 26, 2012 /PRNewswire/ --RRY Publications LLC today announced that the use of stem cell therapies in 2012 significantly exceeded forecasts which were originally presented at the February 2012 New York Stem Cell Summit. Said Robin Young, stem cell industry analyst and host of the New York meeting: "The range and scope of stem cell therapeutic use in the United States grew much faster than we'd forecasted earlier this year. Virtually all of the increases we're seeing are for adult stem cell therapies and, in particular, the use by physicians of both allograft and autologous stem cell products. It would not be an exaggeration to call this unexpected and remarkable growth."

Mr. Young's revised forecast of stem cell commercialization revenues for 2013-2020 will be presented at the February meeting in New York.

The companies, scientists and physicians that are at the forefront of this remarkable increase in stem cell therapeutic use will be presenting at the 8th Annual New York Stem Cell Summit. Listed below is the preliminary lineup of presenters for the 8th Annual Stem Cell Summit.

The Stem Cell Summit, an intensive one-day event, allows attendees to learn about the latest developments in the stem cell marketplace, evaluate the groundbreaking stem cell products physicians are using today, and discover the growing market potential in terms of revenues. For 2013, the Summit will feature 30+ presenters, a research review and debate session, and a special track on expanding the range of stem cell therapies.

The 8th Annual Stem Cell Summit will take place on Feb. 19, 2013, at Bridgewaters in the heart of New York City's historic South Street Seaport. The preliminary roster of companies featured will include representatives from 2012 presenters and new 2013 presenters.

Aastrom Biosciences, Inc.

Advanced Cell Technology

Aldagen, Inc.

AllCells, LLC.

Aruna Biomedical, Inc.

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Dramatic Rise in Stem Cell Therapy Use in 2012

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Introducing Stem Cell Therapy Using Oral Placenta Stem Cells | Stem Cell Malaysia – Video

Posted: November 25, 2012 at 8:40 pm


Introducing Stem Cell Therapy Using Oral Placenta Stem Cells | Stem Cell Malaysia
stemcellmalaysia.com Stem cell therapy can take on various forms and choices. Due to the advent of technology, stem cell therapy using oral placenta stem cells is now available. For more information on stem cell therapy, please visit Stem Cell Malaysia at stemcellmalaysia.comFrom:stemcells2012Views:3 1ratingsTime:05:23More inScience Technology

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California Stem Cell Agency Still in Talks on $40 Million for StemCells, Inc.

Posted: November 25, 2012 at 8:00 am


The California stem cell agency and
StemCells, Inc., are still trying to reach agreement on a deal in
which the company would receive $40 million from the state's
taxpayer-funded research effort.

The sticking point is the $40 million
in matching funds required from the Newark, Ca., firm under the terms
of the two awards approved in July and September. The latter award
was okayed on a 7-5 vote by the governing board after it was rejected
twice by the agency's reviewers.
On Monday the California Stem Cell
Report
queried the agency about the status of the awards. Kevin
McCormack
, the agency's spokesman, replied,

“We are still in talks with them over
the terms of the funding. Hopefully, we'll have an agreement soon.”

He did not elaborate further.
CIRM staff normally reviews
applications after they are approved by the agency's governing board
to be sure that all conditions are being met. However, in the case of
the September award to StemCells, Inc., CIRM's governing board took
the unusual step of publicly stating that the firm must demonstrate
it has the $20 million in matching funds before it receives any
payments from CIRM. The board did not take that sort of public
position on the $20 million grant approved earlier in the summer,
although matching funds are required in that case as well.
The former chairman of the $3 billion
stem cell agency, Robert Klein, appeared twice before the board to
lobby for approval of the second award to StemCells, Inc., which is a
publicly traded firm.. It was the first such appearance by Klein
before his former colleagues since leaving the agency in June 2011.
Action on the StemCells, Inc., awards
attracted attention from the Los Angeles Times last month. Pulitzer
Prize-winning columnist Michael Hiltzik wrote that the process was “redolent of cronyism.” He said a “charmed relationship”
existed among StemCells, Inc., its “powerful friends” and the
stem cell agency.

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Texas Flap Looms Over California Stem Cell Agency’s Grant Appeals

Posted: November 25, 2012 at 8:00 am


In nine days, the California stem cell
agency plans to take another crack at finding ways to curb its
free-wheeling appeal process involving scientists whose applications
for millions have been rejected by reviewers.

It is a matter of considerable interest
to researchers who need the cash to keep their labs running and remain in good standing with their host institutions.
The stem cell agency's governing board this fall created a task force to deal with the appeals issue after a
record-breaking number of researchers made public appeals featuring
emotional patient advocates. Even the former chairman of the agency,
Robert Klein
, made a two-time pitch for one applicant. Board members
later complained publicly about “arm-twisting,” lobbying and“emotionally charged presentations.”
The agenda for the Nov. 30 task force
meeting in Oakland -- with teleconferencing sites in San Francisco,
Irvine, Palo Alto, Seattle and Rochester, N.Y. -- contains few clues
on what the panel is hoping to specifically accomplish in next week's
90-minute session.
But interested researchers can check
the transcript from the Oct. 24 meeting, during which CIRM President
Alan Trounson described the problem as “very critical.” He said,

“I think this is a very serious
matter that could really bite us very hard in a similar way to what's
happened in Texas. Unless we come up with some kind of process that
really addresses the science, it's a very large concern.”

Trounson's Texas reference was to the
mass resignations of reviewers at that state's $3 billion cancer
research effort. Questions have been raised about integrity of its grant review process and the program's political and biotech industry
relationships. James Drew of the Dallas Morning News produced a bit of an overview this week. In another piece, Eric Berger of the
Houston Chronicle provided quotes from emails from the infighting on
a controversial $18 million grant.
Changes in California's grant appeal process may well
be also discussed at the agency's board meeting Dec. 12 in Los Angeles.
The board hopes to wrap up its action by late January.
Here is a link to an item with more specifics on material presented to the task force in October. Here is a link to an August 2012 list of articles and documents related to the CIRM appeals process.
Interested parties can address comments
to the agency at info@cirm.ca.gov.   

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Pomeroy Moving On, Will Leave Stem Cell Board

Posted: November 25, 2012 at 8:00 am


Claire Pomeroy, one of the longtime
members of the governing board of the $3 billion California stem cell agency,
will be leaving her position at UC Davis and the stem cell board next
June.

Pomeroy yesterday announced her departure from Davis as vice chancellor for human health services and
dean of the medical school. In a telephone interview, she told the
California Stem Cell Report that she is examining a “few select
opportunities” to work at a national level on health reform and
health policy issues.
Claire Pomeroy
UC Davis photo
Pomeroy, 57, will be spending time in
Washington, D.C., working on health issues on behalf of the
University of California during the transition period before she
leaves her position in California.
Pomeroy came to UC Davis 10 years ago,
shortly before the Golden State's stem cell agency was created in
2004. At that time, UC Davis had what she called a “fledgling”
stem cell research effort. Today the school has chalked up $128 million in
grants from the stem cell agency, ranking fifth among institutions
funded by the agency.
She said that creation of the stem cell
agency “catalyzed development of our program,” which she said has
risen to “national prominence.”
Pomeroy's service on the stem cell
agency board was also instrumental in attracting a $100 million grant
from the Moore Foundation to start a new school of nursing at UC
Davis in 2009. Through her service on the board, she met Ed Penhoet,
who also served on the board and was one of the co-founders of Chiron
and then president of the Moore Foundation. Subsequently, Penhoet
called her for lunch to discuss her thoughts on nursing education,
and developments moved on from there.
The $100 million commitment was the
nation's largest grant for nursing education, according to the Moore Foundation.

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‘The Knoepfler Award:’ Recognizing Risk and Those Who Make a Difference

Posted: November 25, 2012 at 8:00 am


A UC Davis stem cell researcher-blogger has announced a “stem cell person of the year” award
complete with a $1,000 cash prize that he is putting up himself.

Paul Knoepfler, who may be the only
stem cell scientist in the U.S. actively blogging on the subject,
said he has decided to put his money where his mouth is. 
Since announcing the contest in a Nov.13 blog item, Knoepfler has already received eight nominations,
including one for a scientist. Three days after the item aappeared, UC Davis
featured Knoepfler in a press release that included a video of
Knoepfler explaining the effort.
Paul Knoepfler
UC Davis photo

He said he wanted to go beyond “old
fashioned awards” given by “stodgy committees.” Knoepfler said he
is seeking to recognize that stem cell research is “transcending the
lab.”

The goal of the award, Knoepfler said,
is “to advance the stem cell field and give credit to those who
make a real difference.”
Knoepfler wrote,

“The criteria are that the person
made a truly outstanding difference in the stem cell field for 2012.
The winner could be a scientist, a patient advocate, someone in
industry, a student, a physician…really anyone who has made the
field better. For non-scientist nominees I’m particularly
interested in those who took personal risks or gave of themselves to
help others. For scientists I am looking for outstanding scientific
achievement and in particular out-of-the-box thinking. Folks in any
country are eligible.”

Deadline for nominations is Dec. 17.
Self-nominations are permissible. Knoepfler plans to pick five
finalists and interview them by phone. He also plans an online vote
that he said  “may” influence his decision.
Complete details are available on Knoepfler's blog

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