Search Immortality Topics:

Page 403«..1020..402403404405..410420..»


Category Archives: Stem Cell Therapy

California Stem Cell Agency Boosting Disease Team Program to $543 Million


Directors of the California stem cell
agency are set to give away $20 million next Thursday and authorize
a handsome addition to their signature disease team effort, bringing
its total to $543 million.

It is all part of the $3 billion
agency's push to develop therapies prior to running out of money for
new grants in 2017.
The $20 million is expected to go to
the first two winners in the agency's new strategic partnership
program. CIRM says the effort is aimed at
creating “incentives and processes that will: (i) enhance the
likelihood that CIRM funded projects will obtain funding for Phase
III clinical trials (e.g. follow-on financing), (ii) provide a source
of co-funding in the earlier stages of clinical development, and
(iii) enable CIRM funded projects to access expertise within
pharmaceutical and large biotechnology partners in the areas of
discovery, preclinical, regulatory, clinical trial design and
manufacturing process development.”
CIRM reviewed six applications with two winning approval. The agency's governing board is expected to ratify the decision next week. None of the applicants have been identified by the agency, which routinely withholds that information prior to
board action even when applicants have identified themselves.
Addition of a new $100 million
disease team round will come on top of the second, $213 million disease
team awards approved last this summer. The first round, awarded in
2009, totaled $230 million.  The size of the new round could be altered by CIRM directors prior to approval. Also before the board is a $40 million
proposal to expand the industry-friendly strategic partnership effort
into a second round.
The thrust of the disease team effort
is to speed the process of establishing clinical trials and to finance
efforts that might founder in what the biotech industry calls a
valley of death – a high risk financial location, so to speak,
where conventional financiers fear to tread.
The new disease team round will require
“co-funding” from applicants but the agency did not specify what
it means by the term. The matter of matching funds has become an issue in awards to StemCells, Inc., of Newark, Ca., in this summer's
disease team round.
Next week's agenda additionally
contains a plan to tighten review of proposed research budgets in
grant applications, making it clear that CIRM staff will be
negotiating such matters even after the board approves grants and
loans.
So far no researchers have testified in
public on the budget plan although it could well have a significant
impact on their future efforts.
Additional matters will discussed as
well at the meeting in Burlingame, which also has a teleconference
location in La Jolla that will be open to the public. The address
and additional material can be found on the agenda.  

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/1gFmBSDEYCU/california-stem-cell-agency-boosting.html

Posted in Stem Cell Therapy | Comments Off on California Stem Cell Agency Boosting Disease Team Program to $543 Million

Researcher Alert: Stem Cell Agency to Take Up Grant Appeal Restrictions


The move by the $3 billion California
stem cell agency to curtail its free-wheeling grant appeal process
will undergo its first public hearing next week.

The proposals will mean that scientists
whose applications are rejected by reviewers will have fewer avenues
to pursue to overturn those decisions. The changes could take effect
as early as next year.
The move comes in the wake of a record
number of appeals this summer that left the board complaining about
“arm-twisting,” lobbying and “emotionally charged presentations.”
Among other things, the new "guidelines" attempt to define
criteria for re-review – “additional analysis” – of
applications involved in appeals, also called “extraordinary
petitions.” The plan states that re-review should occur only in
the case of a material dispute of fact or material new information.
(See the end of this item for agency's proposed definitions.)
In addition to alterations in the
appeal process, the CIRM directors' Application Review Task Force
will take up questions involving “ex parte communications.” The
agenda for the Oct. 24 meeting did not contain any additional
information on the issue but it likely deals with lobbying efforts on
grants outside of public meetings of the agency. We understand that
such efforts surfaced last summer involving the $$214 million disease
team round and Robert Klein, the former chairman of the stem cell
agency.
Klein appeared twice publicly before
the board on one, $20 million application by StemCells, Inc., the
first time a former governing board member has publicly lobbied his former
colleagues on an application. The application was rejected twice by reviewers – once
on the initial review and again later on a re-review – but it was
ultimately approved by directors in September on a 7-5 vote.
The board has long been troubled with
its appeal process but last summer's events brought the matter to a
new head. The issue is difficult to deal with because state law
allows anyone to address the CIRM governing board on any subject when
it meets. That includes applicants who can ask the board to approve
grants for any reason whatsoever, not withstanding CIRM rules. The board can also approve a grant
for virtually any reason although it has generally relied on
scientific scores from reviewers.
The proposals to restrict appeals are
designed to make it clear to scientists whose applications are
rejected by reviewers that the board is not going to look with favor
on those who depart from the normal appeals procedure.
While the board almost never has
overturned a positive decision by reviewers, in nearly every round it  approves some applications that have been rejected by reviewers. That has
occurred as the result of appeals and as the result of motions by
board members that did not result from public appeals.
Ten of the 29 board members are classified as patient advocates and often feel they must advance the cause of the
diseases that they have been involved with. Sometimes that means
seeking approval of applications with low scientific scores.
Here is how agency proposes to define
“material dispute of fact:”

“A material dispute of fact should
meet five criteria:(1) An applicant disputes the accuracy of a
statement in the review summary;(2) the disputed fact was significant
in the scoring or recommendation of the GWG(grant review group); (3) the dispute pertains
to an objectively verifiable fact, rather than a matter of scientific
judgment or opinion;(4) the discrepancy was not addressed through the
Supplemental Information Process and cannot be resolved at the
meeting at which the application is being considered; and
(5) resolution of the dispute could affect the outcome of the board’s
funding decision."

Here is how the agency proposes to
define “material new information:”

“New information should: (1)be
verifiable through external sources; (2) have arisen since the
Grants Working Group(grant review group) meeting at which the application
was considered; (3) respond directly to a specific criticism or
question identified in the Grants Working Group’s review; and (4)
be submitted as part of an extraordinary petition filed five business
days before the board meeting at which the application is
being considered."

Next week's hearing is scheduled for
Children's Hospital in Oakland with a teleconference location at UC
Irvine
. Addresses can be found on the agenda.

Source:
http://feedproxy.google.com/~r/blogspot/uqpFc/~3/6sbxGqQJ77Y/researcher-alert-stem-cell-agency-to.html

Posted in Stem Cell Therapy | Comments Off on Researcher Alert: Stem Cell Agency to Take Up Grant Appeal Restrictions

ReNeuron progresses stroke clinical trial

LONDON (ShareCast) - ReNeuron has reported further progress in the clinical trial of its ReN001 stem cell therapy for disabled stroke patients, known as the PISCES study.

The third and penultimate batch of three patients have all been successfully treated with ReN001 and discharged from hospital with no acute safety issues arising. This follows approval last month by the independent Data Safety Monitoring Board (DSMB) for the study to proceed to completion of dosing of this batch of patients.

The PISCES study continues to run to plan, with no cell-related serious adverse events reported in any of the patients treated to date, the clinical-stage stem cell specialist reported. The remaining three, high-dose cohort patients to be treated in the PISCES study have been identified and evaluated as potentially eligible for treatment, with patient enquiries continuing to come into the Glasgow clinical site and a number of patients consequently identified as reserve candidates for the study. Subject to DSMB approval, these final three patients are scheduled to be treated in January and March 2013.

In June of this year, interim data from the PISCES study from the first five patients treated was presented by the Glasgow clinical team at the 10th Annual Meeting of the International Society for Stem Cell Research (ISSCR) in Yokohama, Japan (EUREX: FMJP.EX - news) . Reductions in neurological impairment and spasticity were observed in all five patients compared with their stable pre-treatment baseline performance and these improvements were sustained in longer term follow-up.

Based on the above progress, the company announced last month that, ahead of plan, it had submitted an application to the UK regulatory authority to commence a multi-site Phase II clinical trial to examine the efficacy of ReN001 in patients disabled by an ischaemic stroke.

This trial is designed to recruit from a well-defined population of patients between two and four months after their stroke, which the company and its clinical collaborators currently believe will be the optimum treatment window for the therapy. Subject to continuing positive progress with the PISCES study, and subject to regulatory and ethical approvals, the company hopes to be able to commence the Phase II stroke study in mid-2013. The proposed study is expected to take up to 18 months to complete.

ReNeuron's ReN001 stem cell therapy is being administered in ascending doses to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition.

This news should also have positive read-across for Aim-listed Angel Biotechnology (Berlin: A3G.BE - news) , which supplies the stem cells used in the study.

CM

Here is the original post:
ReNeuron progresses stroke clinical trial

Posted in Stem Cell Therapy | Comments Off on ReNeuron progresses stroke clinical trial

Husband testifies wife 'was looking for a cure' and found Bonita stem-cell doctor

The Grekos hearing is scheduled to resume today. The location is the Collier County Courthouse in room 4-D, according to a case filing Monday.

The hearing before J. Lawrence Johnson, an administrative law judge from Tallahassee, is scheduled to last four days. The Collier County Courthouse is located at 3315 U.S. 41 E.

Photo by Allie Garza

Zannos Grekos

EAST NAPLES The patient was friends with the mother of Dr. Zannos Grekos, a Bonita Springs cardiologist who performed stem cell therapy on people with debilitating illnesses.

Chemotherapy for breast cancer several years earlier had left the 69-year-old patient, Domenica Fitzgerald, with numbness in her legs. She was unable to walk for more than 10 minutes. She hoped Grekos and his stem cell treatment could help.

"She was looking for a cure. She wanted to get well," her husband, John "Jack" Fitzgerald, testified Tuesday.

A four-day administrative hearing started Tuesday in a Collier County courtroom for a state Department of Health complaint against Grekos. The state says he committed medical malpractice and violated other standards of care when he performed a stem cell treatment on the patient on March 24, 2010. The patient suffered brain damage.

The state is only identifying the patient in its complaint by her initials, D.F. The Daily News learned of her identity by a public records request to the Collier County Medical Examiner's Office of all people who died on April 4, 2010, in the county. That was the day that Fitzgerald died after being taken off life support.

The state last year restricted Grekos' license after her death and ordered him not to do anything with stem cells with other patients. His license was fully suspended earlier this year when the state said he violated the order by treating another patient who also died.

Go here to see the original:
Husband testifies wife 'was looking for a cure' and found Bonita stem-cell doctor

Posted in Stem Cell Therapy | Comments Off on Husband testifies wife 'was looking for a cure' and found Bonita stem-cell doctor

Harvard Ophthalmologist Dr. Ula Jurkunas Introduces Stem Cell Transplant for Eyes

Grants Pass, OR (PRWEB) October 16, 2012

Harvard Ophthalmologist and Corneal Stem Cell Researcher Ula Jurkunas, MD, has announced an important new stem cell transplant procedure for the eyes.

Speaking on the Sharon Kleyne Hour Power of Water radio show, Dr. Jurkunas, predicted that the procedure will offer a significant benefit to patients with certain corneal diseases, and corneal injuries such as chemical and thermal burns (The cornea is the eyes clear portion).

Stem cell research has been in the news because the 2012 Nobel Prize for Medicine was awarded for stem cell research.

Dr. Jurkunas explained to host Sharon Kleyne that the human eye produces its own adult (non-embryonic) stem cells. These are found between the limbus (where the clear cornea meets the white of the eye) and the conjunctiva (the red meaty tissue in the eyes inner corner). Their function is to replenish corneal cells to keep the cornea clear and healthy.

Production of corneal stem cells, according to Dr. Jurkunas, can become impaired due to a disease entity such as an infection, severe allergy, severe dry eye, immunological disorder or chronic inflammation; or due to injury such as a chemical or thermal burn. These traumas can cause the cornea to become cloudy and ulcerated. Prior to the present corneal stem cell research, there had been no reliable, non-invasive treatment for these conditions.

Corneal stem cell transplantation, Dr. Jurkunas explains, has the advantage of utilizing the patients own tissue as donor cells. Stem cells may be taken either from healthy tissue elsewhere in the diseased eye, from the patients other eye, or from the patients inner cheek (which has many similarities to eye tissue and also produces adult stem cells). Donor stem cells are then isolated and grown in culture. The final step is to transfer them to the affected cornea using a stem cell bandage.

The procedure, says Dr. Jurkunas, has resulted in dramatic corneal clearing and sight restoration. Although research is ongoing and the procedure remains experimental, corneal stem cell therapy is available in clinical trials. Widespread applications of the procedure, including routine testing for corneal stem cell deficiency, are anticipated. Stem cell therapy, according to Dr. Jurkunas, could eventually be used for macular degeneration, glaucoma and other eye diseases.

Dr. Jurkunas stressed the importance of water and hydration in maintaining a healthy tear film and cornea. The tear film covering the cornea is 99% water and is essential to the light refraction that enables vision. Dry eye and related eye infections, according to Dr. Jurkunas, can damage both the cornea and adjacent stem cell producing tissues that enable the cornea to repair itself. Water in the tear film stimulates the healthy production of stem cells. Water is also critical to keeping stem cells viable during transplantation.

Mrs. Kleyne and Dr. Jurkunas agree that non-invasive therapies using the bodys own tissues, such as corneal stem cell transplantation, could eventually prove indispensable in combating the worldwide health effects of global drying and dehydration.

Read the original here:
Harvard Ophthalmologist Dr. Ula Jurkunas Introduces Stem Cell Transplant for Eyes

Posted in Stem Cell Therapy | Comments Off on Harvard Ophthalmologist Dr. Ula Jurkunas Introduces Stem Cell Transplant for Eyes

Beauty salon ‘offers’ stem cell therapy

With all the publicity about the miraculous effects of stem cell therapy, the Department of Health (DOH) should prepare itself for the possibility that the new procedure would be performed by unqualified, and completely clueless, people.

I passed a beauty parlor recently and saw a huge poster on its door announcing the arrival of stem cell therapy. I was instantly reminded of botched breast enhancement and nose jobs performed by salon personnel who seemed to think it was as easy to learn complicated surgical procedures as it was to train to cut hair or do manicures and pedicures.

The DOH should start warning the public not to fall for these special offers just because they are available at giveaway rates.

Modern lifestyle problem

Experts have repeatedly talked about problems brought about by modern lifestyles. Changing diets and stress are two of the best known. Dr. Jaime G. Ignacio, section chief of gastroenterology at Veterans Hospital and head of the Digestive Malignancy Council of the Philippine Society of Gastroenterology, said constipation could be one of the consequences of the combination of these two factors.

Speaking at an event hosted by Boehringer Ingelheim, maker of Dulcolax (generic name Bisacodyl), a formulation for constipation relief, Ignacio, who, as a gastroenterologist is a specialist in digestive system disorders, defined the problem as having fewer than three bowel movements in a week (normal ranges from three times a week to three times a day).

He said constipation itself was not a disease but it could sometimes be a symptom of something serious, like colorectal cancer. But he said about 95 percent of cases were acuteoccurring suddenly and lasting for only a short periodresulting from some sudden lifestyle or hormonal changes, the taking of medication, lack of exercise, etc.

Ignacio said acute was easy to treat, with products like Dulcolax to solve the problem. But, if left unattended, acute constipation could lead to a chronic or long-term condition, which was the more worrisome, and would need medical attention.

He said constipation should be treated as soon as the problem had lasted for four or more days.

Constipation is part of modern living. [Like other diseases] prevention is the key. Safe and effective treatment is available [if needed], Ignacio stressed.

Read the rest here:
Beauty salon ‘offers’ stem cell therapy

Posted in Stem Cell Therapy | Comments Off on Beauty salon ‘offers’ stem cell therapy