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Category Archives: Stem Cell Therapy

IP to Grant Oversight: Study Calls for Host of Improvements at California Stem Cell Agency

Posted: May 20, 2012 at 3:56 pm

The $3 billion California stem cell
agency is laboring under a range of problems that include protection of
its intellectual property and management of its nearly 500 grants plus an inadequate ability to track its own performance, a seven-month
study said yesterday.

The performance audit by the Moss Adams accounting
firm of Seattle, Wash., made 27 recommendations for improvements,
including more effort to ease strain connected to the agency's
controversial dual executive arrangement. The study said that the
nearly eight-year-old agency has many "opportunities" to
"enhance performance reporting and decision making, strengthen
effectiveness and efficiency, retain essential human resources and
leverage technology."

In response to the report, the stem
cell agency said, "(M)anagement concurs with the findings and
recommendations....The recommendations are focused and constructive.
CIRM is already implementing many of these recommendations, and we
will be investigating the others in the coming months."

The performance audit is the first ever
made of the California Institute for Regenerative Medicine. The
audit is required by state law and was commissioned by the agency at
a cost of $234,944. For years, the agency for years had resisted calls for a
performance audit until it sought legislative approval in 2010 for
removal of a 50-person cap on its staff. Originally, the performance
audit legislation would have put the study in the hands of the only
state body charged with oversight of the agency and its board. CIRM,
however, was successful in lobbying to have that provision removed.

The 54-page report identified once
again a number of issues that have troubled the stem cell agency for
some years. Moss made 12 top priority recommendations, many of which
dealt with information technology and grants management. Many of the
recommendations focused on providing better and faster information on
performance outcomes, which the audit said has been slow to come and
hard to generate.

The report said,

"Key performance information is
not readily available to CIRM leadership and other stakeholders on an
ongoing basis. CIRM board members and senior management do not
receive regularly updated, enterprise-level performance information.
The ability to evaluate performance against strategic goals is
critical to effective leadership and program monitoring, evaluation,
and reporting."

The audit stated,

"CIRM does not effectively
communicate outcome-based performance internally or externally. As
such, CIRM does not focus on performance metrics as part of its
(staff) meeting process."

The report additionally said,

"CIRM does not have an integrated
financial information system....The use of spreadsheets results in
labor intensive processes to generate reports and respond to
information inquiries, since data must be pulled from multiple
spreadsheets, a process that may be prone to error. ...Spreadsheets
are not linked to each other or a master report. CIRM does not have a
comprehensive list of spreadsheets or instructions for how to
maintain the files or generate reports from them."

Moss Adams said that CIRM needed to do
a better job in "bond forecasting," a reference to the
California state bonds that finance virtually every aspect of the
agency's operations. CIRM directors were caught by surprise a few
years ago when they suddenly learned the agency was up against a
major cash crunch.

Some of the recommendations will
require more work from CIRM grantees and their technology transfer
offices in an effort to track intellectual property and grant outcomes.
The report also recommended a speed-up in CIRM's review of progress
reports from grant recipients, which have been lagging completion by
several months.

The dual executive arrangement, which
was written into law by Prop. 71, has troubled CIRM since nearly day
one. CIRM's own external review panel also identified it as problem
two years ago. The executive structure is virtually impossible to
change because of the political difficulty in making alterations in
the ballot initiative.

Moss-Adams said,

"The working relationship between
the chairman’s office and the president’s office has vastly
improved over the past year, but there are still opportunities for
improvement."

The performance audit recommended,

"Make every effort to manage and
operate as one cohesive organization, while recognizing the varying
roles, responsibilities, and authorities that exist with positions in
both the chairman’s office and president’s office."

One of the top 12 recommendations
involved CIRM's public relations/communications effort. CIRM
Chairman J.T. Thomas told directors last June that the agency was in
a "communications war."

Moss-Adams said,

"CIRM does not have a
communication plan, and there is lack of clarity on how to address
mission-based communication to CIRM’s various target audiences,
especially the general public....The best way to facilitate
results-based communications is to 1) quantify goals and outcomes in
CIRM’s strategic plan and 2) report on achievement of those goals
and outcomes by enhancing CIRM’s annual report with additional
performance-based information."

Another performance assessment of the
stem cell agency is also underway. It is being conducted by the
prestigious Institute of Medicine and is costing CIRM $700,000. That
report is expected this fall.

CIRM's board of directors is scheduled
to consider the Moss Adams report at its meeting May 24.

Our take: While the findings and
recommendations of the performance audit were delicately worded in
many cases, they brought out issues that need to be addressed, many
of which have been around for a great deal of time. At their meeting
next week, CIRM directors should act very directly on the
recommendations. They can do that by requiring a written report each
month from CIRM Chairman J.T. Thomas and CIRM President Alan Trounson
on the specific steps that they are taking to implement the
performance audit's recommendations. Otherwise, the inevitable drift
will set in.

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California Budget Slashing Misses Stem Cell Agency

Posted: May 20, 2012 at 3:56 pm

The $3 billion California stem cell
agency dodged the governor's financial knife today.

This morning, Gov. Jerry Brown
announced sweeping cuts throughout California state government as he
attempted to close a new, $15.7 billion deficit. A report in the Los
Angeles Times said the governor was "grabbing any spare change available." But this afternoon, in response to a
query, Kevin McCormack, CIRM's spokesman, said,

"The answer is no, we won't be
affected."

The question arose because California's
financial picture is much bleaker than it was just four months ago.
And the stem cell agency's only real source of cash is money borrowed
by the state -- general obligation bonds.

Under Prop. 71, which created the
agency in 2004, the bond funds flow directly to the agency without
intervention by the legislature or the governor. However, Brown has
been chary of additional bond sales since they create an increasing
burden in the form of interest costs. Those costs must be financed
out of money that otherwise might go to the University of
California, K-12 schools and medical help for the poor.

Under an agreement arrived at last year, CIRM has what amounts to a $225 million line of credit with the
state, which should take care of its needs until January. The cash is
coming from short-term borrowing by the state instead of bonds.

The Brown Administration has cut back
on bond borrowing and intends to cut more this fall. According to the state Department of Finance, the cost of borrowing
has declined $173 million this fiscal year, down to $5.2 billion.
CIRM's share of the debt service is more than $200,000 a day.

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Prochymal approval makes Canada first country to OK stem cell therapy

Posted: May 20, 2012 at 2:10 pm

Toni Clarke BOSTON Globe and Mail Update Published Friday, May. 18, 2012 12:38PM EDT Last updated Friday, May. 18, 2012 12:56PM EDT

Osiris Therapeutics Inc. OSIR-Q said on Thursday that Canadian health regulators have approved its treatment for acute graft-versus host disease in children, making it the first stem cell drug to be approved for a systemic disease anywhere in the world.

Osiris shares rose 14 per cent to $6.00 in extended trading after the news was announced.

Graft versus host disease (GvHD) is a potentially deadly complication from a bone marrow transplant, when newly implanted cells attack the patient's body. Symptoms range from abdominal pain and skin rash to hair loss, hepatitis, lung and digestive tract disorders, jaundice and vomiting.

The disease kills up to 80 per cent of children affected, Osiris said. To date there have been no approved treatments for the disease. Canadian authorities approved the therapy, Prochymal, for use in children who have failed to respond to steroids.

Prochymal was approved with the condition that Osiris carry out further testing after it reaches the market. C. Randal Mills, the company's chief executive, said in an interview that could take three to four years.

Some investment analysts have been skeptical about Prochymal's future. In 2009, two late-stage clinical trials failed to show the drug was more effective overall than a placebo in treating the disease, though it showed promise in certain subgroups of patients.

Since then, the company has mined data from all its clinical trials to show that in patients with severe refractory acute GvHD those who have more or less failed all other therapies Prochymal demonstrated a clinically meaningful response at 28 days after therapy began in 61-64 per cent of patients.

In addition, treatment with Prochymal resulted in a statistically significant improvement in survival when compared with a historical control population of pediatric patients with refractory GvHD.

The Canadian authorities approved the drug on the basis of that data, the company said.

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Prochymal approval makes Canada first country to OK stem cell therapy

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Family hangs hope for boy on unproven therapy in India

Posted: May 20, 2012 at 2:10 pm

Indian clinic's stem cell therapy real?

STORY HIGHLIGHTS

For more of CNN correspondent Drew Griffin's investigation of India's experimental embryonic stem cell therapy, watch "CNN Presents: Selling a Miracle," at 8 and 11 p.m. ET Sunday on CNN.

New Delhi (CNN) -- Cash Burnaman, a 6-year-old South Carolina boy, has traveled with his parents to India seeking treatment for a rare genetic condition that has left him developmentally disabled. You might think this was a hopeful mission until you learn that an overwhelming number of medical experts insist the treatment will have zero effect.

Cash is mute. He walks with the aid of braces. To battle his incurable condition, which is so rare it doesn't have a name, Cash has had to take an artificial growth hormone for most of his life.

His divorced parents, Josh Burnaman and Stephanie Krolick, are so driven by their hope and desperation to help Cash they've journeyed to the other side of the globe and paid tens of thousands of dollars to have Cash undergo experimental injections of human embryonic stem cells.

The family is among a growing number of Americans seeking the treatment in India -- some at a clinic in the heart of New Delhi called NuTech Mediworld run by Dr. Geeta Shroff, a retired obstetrician and self-taught embryonic stem cell practitioner.

Shroff first treated Cash -- who presents symptoms similar to Down Syndrome -- in 2010. "I am helping improve their quality of life," Shroff told CNN.

After five weeks of treatment, Cash and his parents returned home to the U.S.

That's when Cash began walking with the aid of braces for the first time.

Link:
Family hangs hope for boy on unproven therapy in India

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Scientists Discover Marker to Identify, Attack Breast Cancer Stem Cells

Posted: May 17, 2012 at 8:13 am

Cell surface protein blows potent cells cover; targeted drug works in preclinical tests

Newswise HOUSTON Breast cancer stem cells wear a cell surface protein that is part nametag and part bulls eye, identifying them as potent tumor-generating cells and flagging their vulnerability to a drug, researchers at The University of Texas MD Anderson Cancer Center report online in Journal of Clinical Investigation.

Weve discovered a single marker for breast cancer stem cells and also found that its targetable with a small molecule drug that inhibits an enzyme crucial to its synthesis, said co-senior author Michael Andreeff, M.D., Ph.D., professor in MD Andersons Departments of Leukemia and Stem Cell Transplantation and Cellular Therapy.

Andreeff and colleagues are refining the drug as a potential targeted therapy for breast cancer stem cells, which are thought to be crucial to therapy resistance, disease progression and spread to other organs.

Its been difficult to identify cancer stem cells in solid tumors, Andreeff said. And nobody has managed to target these cells very well.

The marker is the cell surface protein ganglioside GD2. The drug is triptolide, an experimental drug that Andreeff has used in preclinical leukemia research. The team found triptolide blocks expression of GD3 synthase, which is essential to GD2production.

Triptolide stymied cancer growth in cell line experiments and resulted in smaller tumors and prolonged survival in mouse experiments. Drug development for human trials probably will take several years.

Cancer stem cells are similar to normal stem cells

Research in several types of cancer has shown cancer stem cells are a small subpopulation of cancer cells that are capable of long-term self-renewal and generation of new tumors. More recent research shows they resist treatment and promote metastasis.

Cancer stem cells are similar to normal stem cells that renew specialized tissues. The breast cancer findings grew out of Andreeffs long-term research in mesenchymal stem cells, which can divide into one copy of themselves and one differentiated copy of a bone, muscle, fat or cartilage cell.

See more here:
Scientists Discover Marker to Identify, Attack Breast Cancer Stem Cells

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Stem cell banking firms to deploy marketing initiatives to boost sales

Posted: May 17, 2012 at 8:13 am

Kolkata, May 15:

Stem cell banking companies are looking at aggressive marketing initiatives to move into the mass market segment. Direct marketing to customers and reduction in price tag for storing umbilical cord blood are on the cards.

The umbilical cord blood and cord tissue are one of the richest sources of stem cells and have potential to treat over 75 serious ailments.

The average cost for storing these for a period of 21 years ranges between Rs 75,000 and Rs 90,000 in India.

According to Chennai-based Life Cell, high price points and lack of proper marketing have limited the penetration of cord blood banking in India. Affordability is the key factor in India.

Only when the prices come down will we see more customers opting for the service. We are working on it (bringing down prices), Mr Mayur Abhaya Srisrimal, Executive Director Life Cell, told Business Line.

Stem cell bankers have already rolled out easy finance options such as EMIs to make the services attractive. CordLife, for instance, offers EMI facility for 12-24 months.

This has helped boost our sales. We have been acquiring 350-400 clients each month, said Managing Director, Mr Meghnath Roy Chowdhury.

Finance, however, is not the only stumbling block. Cord blood bankers have, so far, been depending largely on hospital network for signing up clients. Bangalore-based Ms Deepa Shankar, who is expecting and is due for delivery in June, recently opted for Life Cell services through the hospital.

It's not a sustainable approach. We need to get into direct marketing for pushing up volumes growth, Mr Srisrimal points out. To strike a cord with the would-be mothers, the company has roped in Lisa Ray as brand ambassador. Ms Ray was cured of multiple myeloma courtesy stem cell therapy.

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Lenalidomide prolongs disease control for multiple myeloma patients after stem cell transplant

Posted: May 16, 2012 at 9:10 pm

Public release date: 15-May-2012 [ | E-mail | Share ]

Contact: Elisa Williams willieli@ohsu.edu 503-494-4530 Oregon Health & Science University

PORTLAND, Ore. Multiple myeloma patients are better equipped to halt progression of this blood cancer if treated with lenalidomide, or Revlimid, following a stem cell transplant, according to a study co-authored by a physician with the Oregon Health & Science University Knight Cancer Institute.

The study, published in the New England Journal of Medicine, found a 63 percent reduction in the risk of progressive myeloma or death for the stem cell transplant patients that were treated with lenalidomide maintenance therapy.

"These results add to the evidence that the combination of standard therapies such as stem cell transplantation with the emerging biologic therapies, like lenalidomide, have extended the lives of multiple myeloma patients," said Richard Maziarz, M.D., of the OHSU Knight Cancer Institute who was one of the study's co-authors. Maziarz serves as medical director of the Adult Stem Cell Transplantation Program & Center for Hematologic Malignancies at the OHSU Knight Cancer Institute. "We know that for at least three years following a transplant that maintenance therapy with this drug vastly improves the chances that the cancer won't come back and worsen."

These data were supported by similar Phase III studies reported from France and Italy in the same issue of the New England Jounal of Medicine demonstrating that maintenance therapy after stem cell transplantation was associated with improved disease control.

Multiple myeloma is a cancer that affects plasma cells, a type of white blood cell normally responsible for producing antibodies. In patients impacted by multiple myeloma, collections of abnormal plasma cells accumulate in the bone marrow, interfering with the production of normal blood cells. The study focused on patients who received an autologous hematopoietic cell transplant (AHCT). AHCT procedures use patients' own blood stem cells.

While lenalidomide increased a patient's ability to stave off progression of the disease, questions remain regarding future approaches recognizing that quality of life measurements were not incorporated within these studies, that long-term safety issues remain unclear as there was a small but discernable risk of second cancers observed in the treated patients. In addition to the need for that cost-benefit analysis, a comparison remains to be performed with other emerging myeloma maintenance therapies.

This Phase III study of lenalidomide was conducted at 47 medical centers and involved 568 patients. It was sponsored by the National Cancer Institute (NCI). Revlimid's manufacturer, Celgene Corp., provided the NCI with lenalidomide for this research.

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Lenalidomide prolongs disease control for multiple myeloma patients after stem cell transplant

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Stem cell therapy to treat a chimp's torn ACL may prove beneficial for humans

Posted: May 16, 2012 at 9:10 pm

Veterinarians hope a new medical procedure can treat a 25-year-old chimpanzee with a torn ACL, or anterior cruciate ligament, at the "Save the Chimps" in Florida.

The procedure involves injecting the chimp with her own stem cells.

"With chimps we don't want to do a lot of surgical work, put hardware in their knee, they tend to pull out that sort of thing," said Veterinarian Linda Gregard, M.D.

Dr. Darrell Nazareth with the Florida Veterinary League has been using stem cells to treat dogs with arthritis for the past two years, but this is his first chimp.

"We're not using embryonic stem cells, we're not taking embryos and taking their stem cells from there. We're just using the patient's own tissue," said Dr. Nazareth.

The technology harnesses the bodies own ability to heal itself and doctors hope it could find wider use in humans.

After injecting two billion stem cells into Angie's knee, doctors will find out in the next two to three weeks if the stem cell therapy treatment was successful.

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Stem cell therapy to treat a chimp's torn ACL may prove beneficial for humans

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Scientists Discover Marker to Identify, Attack Breast Cancer Stem Cells

Posted: May 16, 2012 at 9:10 pm

Cell surface protein blows potent cells cover; targeted drug works in preclinical tests

Its been difficult to identify cancer stem cells in solid tumors, Andreeff said. And nobody has managed to target these cells very well.

Cancer stem cells are similar to normal stem cells

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Scientists Discover Marker to Identify, Attack Breast Cancer Stem Cells

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StemCells, Inc., Hoping for as Much as $40 Million from California Stem Cell Agency

Posted: May 13, 2012 at 3:59 pm

StemCells, Inc., said today it has
applied for as much as $40 million in funding from the California
stem cell agency for two projects dealing with Alzheimer's disease
and cervical spinal cord injury.

The announcement came in a news release
dealing with the publicly traded firm's quarterly earnings. The applications are part of a $240 million round expected to be acted on in late July by the board
of the $3 billion California stem cell agency. Funding for
businesses in the disease team round is expected to come through a
loan.

StemCells, Inc., of Newark, Ca., said,

"In January 2012, we submitted two
applications to the California Institute of Regenerative Medicine
(CIRM) for 'Disease Team Therapy Development Research Awards,' one
for Alzheimer's disease and one for cervical spinal cord injury. A
research award may be up to $20 million, payable over four years, to
fund preclinical and IND-enabling activities with the aim of starting
human clinical trials within a four-year window."

Applications in the round were reviewed
behind closed doors in April. CIRM also has a policy of not releasing the
names of applicants until its board acts and then only if an
applicant is approved. CIRM says it does not want to embarrass firms
that do not win approval. That includes individual researcher names
as well as the names of such institutions as the University of
California.

During discussion of grant applications by the CIRM board, directors are not told the names of the applicants,
just the number of the application. If board members have conflicts
of interest on specific applications, they are barred from voting on
and discussing the application. The names of applicants have
occassionally slipped out. Sometimes their identities can also be
discerned by information contained in the summaries of the reviews of
the applications, which become available on the CIRM web site shortly before the directors act. The summaries normally carry scientific scores and recommendations for funding.

Most companies seeking funding from
CIRM do not identify themselves in advance, although they do if they
appeal a negative decision by reviewers. The board has ultimate
authority for approval of grants but has almost never rejected a
recommendation for funding by reviewers.

StemCells Inc. was founded by Irv Weissman of Stanford, who sits on its board of directors. Weissman is also on its scientific advisory board along with Fred Gage
of Salk and David Anderson of Caltech. Weissman and Gage have won
substantial grants from CIRM.

StemCells Inc.'s stock price closed at
92 cents yesterday. Its 52-week high was $8.20, and its 52 week low
was 70 cents.

Here is a link to an analyst's report
on the company.

(Editor's note: An earlier version of this item incorrectly stated that the disease team round will be acted on later this month.)

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Page 224«..10 20..223224225 226..230 240..»

Category Archives: Stem Cell Therapy

IP to Grant Oversight: Study Calls for Host of Improvements at California Stem Cell Agency

California Budget Slashing Misses Stem Cell Agency

Prochymal approval makes Canada first country to OK stem cell therapy

Family hangs hope for boy on unproven therapy in India

Scientists Discover Marker to Identify, Attack Breast Cancer Stem Cells

Stem cell banking firms to deploy marketing initiatives to boost sales

Lenalidomide prolongs disease control for multiple myeloma patients after stem cell transplant

Stem cell therapy to treat a chimp's torn ACL may prove beneficial for humans

Scientists Discover Marker to Identify, Attack Breast Cancer Stem Cells

StemCells, Inc., Hoping for as Much as $40 Million from California Stem Cell Agency

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