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Category Archives: Stem Cell Therapy

Liow: No plans for stem cell law at the moment

Posted on October 30, 2012, Tuesday

KUALA LUMPUR: The Health Ministry did not have plans to introduce a stem cell Act at the moment, said the minister, Datuk Seri Liow Tiong Lai.

He said, the ministrys four guidelines on stem cell research sufficiently served as standards to which practitioners and scientists involved in stem cell research and therapy should adhere to, ensured patients were out of harms way.

The guidelines would provide a framework for researchers, clinicians and companies involved in research, clinical trials and manufacture of stem cells, he noted.

There is no stem cell act in this country. But the guidelines alone are sufficient to provide the grounds and ethical environment to carry out their work, Liow told reporters after launching the 1st National Stem Cell Congress here yesterday.

The four guidelines are National Standards For Haemopoietic Stem Cell Therapy, National Standards For Cord Blood Banking and Transplantation, National Standards For Stem Cell Transplantation and Guidelines On Stem Cell Research and Therapy.

Liow said: Before we came up with the guidelines, we formed a committee to discuss the details of the research. The committee also included Jakim and religious officials for their views.

He said the use of cell-based therapies should be done strictly under clinical trials.

Prior to the clinical trials, there must be sufficient evidence to show safety, quality and efficacy.

Meanwhile, Liow said stem cell therapy in Malaysia was developing well in government, as well as university hospitals, noting that the number of patients receiving bone marrow and stem cell transplantation for leukaemia and solid tumours was on the rise.

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Liow: No plans for stem cell law at the moment

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'Adequate guidelines for stem cell industry'

KUALA LUMPUR (Oct 29): The Health Ministry has no intention of introducing a Stem Cell Act as the current guidelines are believed to be sufficient to regulate the research being carried out in this growing field.

Minister Datuk Seri Liow Tiong Lai said his ministry has taken the lead to regulate this field by producing four guidelines that provide framework for researchers, clinicians and companies involved in research, clinical trials as well as manufacturing of stem cells.

These four guidelines and standards cover haemopoietic stem cell therapy; cord blood banking and transplantation; stem cell transplantation; and stem cell research and therapy.

Liow stressed that these guidelines, which were introduced in December 2006, with a second edition in July 2009, serve as standards to which practitioners and scientists must abide to in order to ensure no harm is done to the patient.

As such, he said there was no need to table a Stem Cell Bill in Parliament to monitor research and transplants in this field.

Liow said the ministry set up a National Sub-Committee for Ethics in Stem Cell Research and Therapy (NSCERT) as an oversight body for all stem cell research in the country, and religious authorities were consulted while drafting the guidelines.

When asked, Liow said that a fatwa was issued by National Fatwa Council to allow researchers to use the excess embryos, produced through IVF, that have been stored by Muslim couples for research.

In addition, all the stem cell therapy must be tested before use on human body.

Liow also gave some statistics on stem cell transplants in the country.

In 2009, a total of 213 haemopoietic stem cell transplants were performed and registered in this country, with 87.7% performed in public or university hospitals. The Ampang Hospital is the largest centre for this type of transplant and currently, there are 11 such centres in Malaysia.

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'Adequate guidelines for stem cell industry'

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No need for stem cell Act, says health minister

KUALA LUMPUR: EXISTING guidelines on stem cell research are sufficient to regulate the industry and the Health Ministry sees no need for a stem cell Act for now.

Health Minister Datuk Seri Liow Tiong Lai said guidelines on stem cell research were clear and were drafted with the help of stakeholders, including religious bodies.

He said the ministry had produced four guidelines:

* National Guidelines for Haemopoietic Stem Cell Therapy;

* National Standards for Cord Blood Banking and Transplantation;

* National Standards for Stem Cell Transplantation; and

* Guidelines on Stem Cell Research and Therapy

"We hope researchers follow these guidelines. The ministry does not intend to introduce any Act yet," he said after officiating the First National Stem Cell Congress here yesterday.

Liow said guidelines would be enough to provide a sound and ethical environment for researchers to carry out work. He said the public should also be informed of stem cell services available and be aware that stem cell research here was encouraging.

"In 2009 alone, 213 haemopoitic stem cell transplants were performed and registered in the country," he said.

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No need for stem cell Act, says health minister

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Stem cell therapy a cure-all? Not so fast

MANILA, Philippines Its supposed to cure various illnesses such as cancer, spinal cord injury and Parkinsons disease. Is stem cell therapy the cure-all that it is touted to be?

Health Undersecretary Teodoro Herbosa said it is important to note that stem cell treatments are still at the experimental stage.

"The advisory is very clear. This is still an investigative form of therapy. Anecdotal reports are not enough evidence to say there is treatment, he said in an interview on ANC's Talkback with Tina Palma.

He said there are only two standard stem cell therapies considered effective and acceptable to the medical community.

"To date, I can only name two cases that are considered standard therapy. That is bone marrow transplantation--one for severe cancer, blood cancer and the other one is bone marrow transplantation after chemotherapy for any type of cancer, he said.

Herbosa said the Department of Health cannot confirm yet if stem cell treatment is indeed effective against certain diseases.

Dr. Tranquilino Elicao Jr., an oncologist who availed of the treatment in April in Frankfurt, Germany, said stem cell therapy cured his high blood pressure, sugar, cholesterol and uric acid.

He had 12 injections of cells, which came from lambs.

After a month, I had my blood tests. Everything went down to normal, Elicao said.

Elicao also said he is not taking medication anymore because he has regained his health.

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Stem cell therapy a cure-all? Not so fast

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California Stem Cell Agency First: Big Pharma Hook Up


BURLINGAME, Ca. – For the first
time, a Big Pharma company has hooked into the $3 billion California
stem cell agency, a move that the agency described as a “watershed”
in its efforts to commercialize stem cell research.

The involvement of GlaxoSmithKline
comes via a partnership with ViaCyte, Inc., of San Diego, Ca., in a
clinical trial, partially financed with a $10.1 million grant today
from the stem cell agency. The trial involves a human embryonic stem
cell product that has “the potential to essentially cure patients
with type 1 diabetes and provide a powerful new treatment for those
with type 2 disease,” ViaCyte said. Scientific reviewers for the agency, formally known as the California Institute for Regenerative Medicine(CIRM),  “characterized the goal of the proposed therapy as as the 'holy grail' of diabetes treatments.”
CIRM Director Jeff Sheehy, who is co
vice chair of the agency's grant review group, said the ViaCyte product
could be manufactured on a large scale and basically involves “taking
(small) pouches and popping them into patients.”
The stem cell agency's award triggered
arrangements between ViaCyte and Glaxo that will bring in financial
and other support from Glaxo. The exact amount of cash was not
disclosed. CIRM said Glaxo will “co-fund and, assuming success,
conduct the pivotal trial and commercialize the product.” Under the terms of the grant, Glaxo and ViaCyte will have to meet CIRM milestones in order to secure continued funding. 
Following board approval, Jason
Gardner
, head of the Glaxo stem cell unit, characterized the
arrangement as a partnership. He told the board that the company
intends to develop a “sustainable pipeline.”
Gardner credited CIRM President Alan
Trounson
with being instrumental in helping to put the arrangement
together, beginning with their first meeting three years ago.
Trounson said the deal will resonate not only in California but
throughout the world.
Paul Laikind, president of ViaCyte,
also addressed the board, stressing the importance of CIRM's
financial support for his company over past years. It has received
$26.3 million (not including the latest grant) from California taxpayers at a time when stem cell
funding was nearly dried up. He noted that small companies such as ViaCyte do not have the resources to carry a product through the
final stages of clinical trials and subsequent production. Gardner also said,

“When the commercial funding avenues
have become much more risk averse, CIRM support (has ensured) that
promising, innovative cell therapy technologies are fully explored.”

In comments to the California Stem Cell
Report,
Elona Baum, CIRM's general counsel and vice president for
business development, described the award as a “watershed” for
the eight-year-old agency, linking the agency with Big Phama for the
first time. Much of CIRM's current efforts are aimed at stimulating
financial commitments from large companies, which are necessary to
commercialize stem cell research.
Arrangements between Big Pharma and
small companies are not unusual and can vanish quickly. However, the
CIRM-ViaCyte-Glaxo deal sends a message to other Big Pharma companies
and smaller ones, perhaps clearing away concerns that have hindered
other deals that could involve the stem cell agency.
The stem cell agency is pushing hard to
fulfill the promises of the 2004 ballot campaign that created CIRM.
Voters were led to believe that stem cell cures were virtually around
the corner. None have been developed to date.

Source:
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Trounson Going Halftime in January and February


BURLINGAME, Ca. -- The president of the $3 billion California stem cell agency, Alan Trounson, will be working half-time while living in Australia during January and February of next year.

Trounson told the governing board of the agency of his plans at the beginning of its meeting here morning. He said he needs to spend more time with his family, which lives in Melbourne.

Trounson has an 11-year-old son with whom Trounson said he hasn't spend much time in the last 18 months.  Trounson said he intends to teach his son to surf. Trounson's daughter also will be getting married in February.

Meanwhile, directors are currently discussing approval of grants in its $20 million-plus strategic partnership round.

Source:
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