StemCell Therapy

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05-03-2012 10:46 Compilation video of before/after cases and some media coverage on Stem Cell Therapy at Val-U-Vet. For more information go to PetsLoveStemCells.com

See the article here:
Stem Cell Therapy for Pets? It's Science-FACT at Val-U-Vet in Florida - Video

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, today discussed the potential use of the companys cell encapsulation technology with modified stem cells to treat late stage cancers.

Stem cell therapy is not new to physicians dealing with blood and bone cancers, with stem cell transplants being an important treatment for growing new bone marrow since the 1970s. Recent studies have indicated the potential for using stem cells across a much broader range of cancers is becoming a reality, mostly a result of advances in cell and molecular biology techniques.

Traditional chemotherapy works by targeting the fast-growing cells common to cancer tumors. Unfortunately, chemotherapeutics dont differentiate between healthy and cancerous cells. Patients suffering from metastatic cancers, where tumors have spread to multiple areas of the body, often have substantial difficulties with the chemotherapy needed to treat their disease.

In one case, researchers at City of Hope and St. Jude Children's Research Hospital may have found a way to treat cancers that have spread throughout the body more effectively. They used genetically modified stem cells to activate chemotherapeutic drugs at the tumor sites, so that normal tissue surrounding the tumor and throughout the body remain relatively unharmed. The stem cells were designed to produce a specific enzyme that converts the nontoxic prodrug into the chemotherapeutic agent. This method also targets the brain tumor treatment to remain localized within the brain, similar to the pancreatic cancer clinical trial carried out by SG Austria, providing for high dosage chemotherapy without affecting surrounding tissues and avoiding the severe side effects normally associated with cancer therapy.

Nuvilex believes that incorporating Cell-in-a-Box encapsulation with this type of genetically modified stem cell, along with the proprietary cancer treatment being acquired, could significantly aid and improve patient outcomes.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, commented, We are hopeful for the day when late stage cancers can be routinely and safely treated using genetically modified cells like those used in the pancreatic cancer trial, increasing the ability of clinicians to avoid inducing side effects that typically accompany aggressive chemotherapy and/or radiation. Our cell encapsulation technology will enable practitioners to target tumors while preserving the health of the surrounding tissues. We continue to look for leading stem cell and oncology researchers to partner with us as we bring this technology to market.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of clinically useful therapeutic live encapsulated cells and services for encapsulating live cells for the research and medical communities. Through our effort, all aspects of our corporate activities alone, and especially in concert with SG Austria, are rapidly moving toward completion, including closing our agreement. One of our planned offerings will include cancer treatments using the companys industry-leading live-cell encapsulation technology.

Safe Harbor Statement

More:
Nuvilex Points Toward Cell Encapsulation Technology Future to Expand Stem Cell Use for Late Stage Cancer Treatments

By David Fitzpatrick and Drew Griffin, Special Investigations Unit

updated 9:23 PM EST, Thu March 8, 2012

Dr. Zannos Grekos, seen here in 2009, could have his license suspended.

STORY HIGHLIGHTS

(CNN) -- A Florida cardiologist could have his medical license revoked by state authorities who have accused him of performing illegal stem cell therapy on a patient who died during the procedure.

Florida's Department of Health ordered the emergency suspension of Zannos Grekos' medical license Wednesday, accusing the Bonita Springs doctor of violating an emergency order against using stem cell treatments in Florida and causing the death of an unidentified elderly patient. Grekos can appeal the order.

According to the license suspension order, Grekos performed a stem cell treatment this month on the patient, who was suffering from pulmonary hypertension and pulmonary fibrosis. Both diseases restrict blood flow to the heart.

"During said stem cell treatment, patient R.P. suffered a cardiac arrest and died," the suspension order said.

CNN first investigated Grekos' activities in 2009, when he said he was using stem cell therapy for a company called Regenocyte Therapeutic. His profile, listed on the company's website, describes Grekos as having "extensive experience in the field of stem cell therapy" and says he "was recently appointed to the Science Advisory Board of the United States' Repair Stem Cell Institute."

At the time of CNN's interview, Grekos said he extracted stem cells from patients and then sent the blood to Israel for laboratory processing. That processing, he said, resulted in "regenocytes," which he said would help heal crippling diseases, mostly associated with lung problems.

See the rest here:
Florida suspends doctor accused of illegal stem cell therapy

(CNN) -

A Florida cardiologist could have his medical license revoked by state authorities who have accused him of performing illegal stem cell therapy on a patient who died during the procedure.

Florida's Department of Health ordered the emergency suspension of Zannos Grekos' medical license Wednesday, accusing the Bonita Springs doctor of violating an emergency order against using stem cell treatments in Florida and causing the death of an unidentified elderly patient. Grekos can appeal the order.

According to the license suspension order, Grekos performed a stem cell treatment this month on the patient, who was suffering from pulmonary hypertension and pulmonary fibrosis. Both diseases restrict blood flow to the heart.

"During said stem cell treatment, patient R.P. suffered a cardiac arrest and died," the suspension order said.

CNN first investigated Grekos' activities in 2009, when he said he was using stem cell therapy for a company called Regenocyte Therapeutic. His profile, listed on the company's website, describes Grekos as having "extensive experience in the field of stem cell therapy" and says he "was recently appointed to the Science Advisory Board of the United States' Repair Stem Cell Institute."

At the time of CNN's interview, Grekos said he extracted stem cells from patients and then sent the blood to Israel for laboratory processing. That processing, he said, resulted in "regenocytes," which he said would help heal crippling diseases, mostly associated with lung problems.

The president of the International Society of Stem Cell Research, Dr. Irving Weissman, told CNN at the time that "there is no such cell."

"There is nothing called a regenocyte," he said.

After CNN's initial report, Grekos said the name was "advertising" and was not intended to be scientific.

See original here:
Patient dies during procedure

Lindsay Porter's kidneys weighed 16 pounds before her transplant.

STORY HIGHLIGHTS

(CNN) -- By the time Lindsay Porter had her kidneys removed two years ago, they were bulging -- covered in cysts -- and together weighed 16 pounds.

Her abdominal area was so distended, "I looked nine months pregnant, and people regularly asked when I was due," Porter said.

As she prepared for a transplant to address her polycystic kidney disease, Porter, 47, had mixed feelings -- relief to have found a donor, tinged with resignation. She was looking forward to both a new kidney, and a lifetime on immune system-suppressing drugs.

"You get this brand new shiny kidney, and then they give you drugs that eventually destroy it," said Porter.

But that scenario may eventually change, if results of a new pilot study are replicated in a larger group of patients. The study, published Wednesday in the journal Science Translational Medicine, describes eight kidney transplant patients, including Porter, who received a stem cell therapy that allowed donor and recipient immune cells to coexist in the same body.

The effect, in a handful of those patients, was to trick the recipient's immune system into recognizing the donated kidney as its own.

When it works, patients become a sort of medical rarity called a chimera.

"Chimerism is a condition wherein two different genetic cell populations are present in the body, and both cell types are tolerated," said Dr. Anthony Atala, director of the Institute for Regenerative Medicine at Wake Forest Baptist Medical Center, who was not involved in the study, via e-mail.

Read the original here:
Transplant without lifetime of drugs?

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, today pointed out the potential for substantial partnership and licensing opportunities using the companys cell encapsulation technology for applications in stem cell research and medicine. Migration of implanted cells away from the target site and host rejection have been recognized as fundamental challenges faced by the stem cell community regarding their use in therapy, which the companys technology overcomes.

The technology being acquired from associate SG Austria is used to place live stem cells into strong, flexible and permeable capsules. These capsules can then be implanted into animals or humans for specific therapies. Stem cells can then exist at the desired location inside the capsules, prevented from migrating and protected from the immune system that aims to eliminate such foreign cells from the body.

Stem cell therapy is being used by clinicians throughout the world for treating such diverse diseases as spinal cord injury, amyotrophic lateral sclerosis, burns, glioma, multiple myeloma, arthritis, heart disease, stroke, Stargardt's Macular Dystrophy, and age-related macular degeneration, among others, most of which can be found at ClinicalTrials.gov.

Historically, researchers have faced numerous difficulties in succeeding with certain stem cell treatments, because of the problems associated with keeping stem cells alive for significant periods of time, stopping rejection and destruction by the recipients immune system, and keeping stem cells from migrating away from the desired sites. Cells encapsulated in SG Austrias porous beads have been shown to remain alive for long periods of time in humans, surviving intact for at least two years. Once encapsulated, cells are protected from the bodys immune system. Furthermore, encapsulated cells remain within the beads and are unable to migrate to other sites in the body.

In the February 29, 2012 research report, Goldman Small Cap Research stated, The Cell-in-a-Box approach could significantly advance the implementation and utilization of stem cells for a host of debilitating diseases and conditions, making it a uniquely valuable commodity. We believe that by partnering with leading players in the field, Nuvilex could find that companies with deep pockets would be happy to collaborate or license the delivery system and engage in further research which could result in meaningful development and licensing revenue.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, discussed the value for licensing the companys stem cell therapy, adding, By overcoming traditional barriers to effective stem cell therapy, namely viability, migration, and host rejection, we believe these new advances in medical science utilizing stem cells and encapsulation will enable us to take quantum leaps forward now and in the future. As a result of challenges SG Austria has overcome, new advances will be surprisingly close at hand and are part of the driving force behind our desire to work with a number of companies in this endeavor. Our primary goal has been and remains to use our technology to bring life changing treatments to patients on an expedited basis.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of clinically useful therapeutic live encapsulated cells and services for encapsulating live cells for the research and medical communities. Through our effort, all aspects of our corporate activities alone, and especially in concert with SG Austria, are rapidly moving toward completion, including closing our agreement. One of our planned offerings will include cancer treatments using the companys industry-leading live-cell encapsulation technology.

Safe Harbor Statement

See more here:
Nuvilex Forecasts Vast Partnership Opportunities Using Breakthrough Stem Cell Technology

SILVER SPRING, Md.--(BUSINESS WIRE)--

Nuvilex, Inc. (OTCQB:NVLX), an emerging biotechnology provider of cell and gene therapy solutions, released information today about the companys cell encapsulation technology and the breakthrough in stem cell research which overcomes specific fundamental challenges faced in stem cell therapyhost rejection and migration of implanted cells away from the target site.

Stem cell therapy is believed by many medical researchers as holding a key to treating cancer, Type 1 diabetes mellitus, Parkinson's disease, Huntington's disease, Celiac Disease, cardiac failure, muscle damage, neurological disorders, and other chronic, debilitating diseases. There are presently >1,400 registered trials using stem cells that are recruiting patients (ClinicalTrials.gov). The encapsulation technology being advanced allows live stem cells to be implanted into robust, flexible and permeable capsules where they can replicate inside the capsules at the target site free from attack by the bodys immune system and free to undergo natural changes to become the appropriate cell type needed.

The Goldman Small Cap Research report, issued February 29, 2012, noted some inherent difficulties encountered in stem cell treatments, such as keeping stem cells alive for significant periods of time, potential rejection of the cells and subsequent destruction by the recipients immune system, and the migration of the stem cells away from the critical treatment site, while making a distinction that the Companys cell encapsulation technology overcomes these concerns.

The report also accurately recognized, Cells encapsulated in SG Austrias porous beads remain alive for long periods of time in humans, surviving intact for at least two years. Once encapsulated, cells are protected from the bodys immune system. Furthermore, encapsulated cells remain within the beads and do not migrate out of the beads to other sites in the body.

In assessing the overall importance of this technology to Nuvilexs overall business model, Goldman pointed out, The Companys acquisition of the Cell-in-a-Box approach along with the expertise of SG Austria could significantly advance the implementation and utilization of stem cells for a host of debilitating diseases and conditions, in addition to being used to target cancer cells, thus making it a uniquely valuable commodity. We believe that by partnering with leading players in the field, Nuvilex could find that companies with deep pockets would be happy to collaborate or license the delivery system and engage in further research which could result in meaningful development and licensing revenue.

Dr. Robert Ryan, Chief Executive Officer of Nuvilex, added, There is a broad range of expanding research supporting the use of stem cells to treat a variety of human diseases and conditions. Our technology allows for precise maintenance and localization of stem cells, preventing their loss from the critical area of need, that will enable us to potentially create miniature organs at specific sites and as a result we believe greater utilization of those stem cells at the site for their intended purpose, once implanted. As stem cell treatments advance, we expect Nuvilex to be at the forefront of developing new, significant, life changing therapies.

For a detailed review of the research report and valuation methodology, investors are directed to the Goldman Research Report.

About Nuvilex

Nuvilex, Inc. (OTCQB:NVLX) is an emerging international biotechnology provider of clinically useful therapeutic live encapsulated cells and services for encapsulating live cells for the research and medical communities. Through our effort, all aspects of our corporate activities alone, and especially in concert with SG Austria, are rapidly moving toward completion, including closing our agreement. One of our planned offerings will include cancer treatments using the companys industry-leading live-cell encapsulation technology.

The rest is here:
Nuvilex Announces Major Breakthrough in Stem Cell Research

The California stem cell agency today released its letter to leaders of the California legislature concerning the conflict of interest violation by the scientist who was then chairman of the panel that makes the de facto decisions on hundreds of millions of dollars in research grants.

The agency also posted the review summary of the application involved in the conflict of interest, which had been missing from its web site.

The incident occurred last April, but was not publicly disclosed by the $3 billion research enterprise until questions were raised this month by the California Stem Cell Report. The case involved John Sladek of the University of Colorado in Denver, then chairman of the CIRM grant review group, which makes decisions on the hundreds of grant applications. The CIRM board of directors has final approval but it almost never overturns a favorable recommendation from the grant panel.

Sladek resigned from the review group after CIRM staff discovered the conflict following the March 17 review session. CIRM called it a "technical violation."

The information provided today by CIRM added some details to the matter, including Sladek's statement that the conflict was inadvertent on his part.

The June 15 letter to the speaker of the state Assembly and the leader of the state Senate was labelled "confidential disclosure." Signed by then CIRM Chairman Robert Klein, it said,

"While preparing the public summary for Basic Biology III Awards Application No. RB3-02119, CIRM staff discovered that Dr. Sladek had co-authored two papers in the last three years with a researcher on the application. Although the researcher’s name was included on the CIRM conflict of interest form, Dr. Sladek did not disclose these publications to CIRM."

As reported earlier, Sladek's participation did not affect the outcome on the application, which was not recommended for funding.

As is CIRM's practice, the review summary of the grant application did not identify the scientist seeking funding. The summary listed one reviewer with an unspecified conflict, Ali Brivanlou of Rockefeller University.

The letter was provided by CIRM at the request of the California Stem Cell Report, which also asked for the review summary of the grant application after discovering it was missing. James Harrison, outside counsel to the agency, said in an email that the summary was not posted because of a "programming error."

The summary can be found here. Here is the letter.Sladek/CIRM Conflict of Interest Letter to California Legislative Leadership

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

A conflict of interest on a grant application before the $3 billion California stem cell agency last year led to the resignation of the grant review committee's longstanding chairman, John Sladek of the University of Colorado.

The incident occurred last April but was not publicly disclosed by CIRM until the California Stem Cell Report (CSCR) raised a question earlier this month.

Sladek is professor of neurology, pediatrics and neuroscience at the University of Colorado in Denver and a former president of Cal Lutheran University in the Los Angeles area. He had served on the stem cell agency's grant review group since 2005 and as its chairman from 2009 until April of last year.

Responding to an email from CSCR, James Harrison of Remcho, Johansen and Purcell of San Leandro, Ca., outside counsel to the stem cell agency, said that CIRM's staff uncovered the conflict in April after the grant review session was concluded on March 17. Harrison described it as a "technical violation."

He said,

"While preparing the public summary for Basic Biology III (grant round)applications, CIRM staff discovered that Dr. John Sladek was one of several co-authors on scientific publications with a researcher who was listed as a consultant on a CIRM grant application."

Harrison said,

"This is a technical violation of CIRM's conflict of interest rules, which prohibit a member of the Grants Working Group ("GWG") from participating in the review of an application if the member has co-authored papers with a salaried investigator listed on a CIRM application within a three year window."

Harrison said Sladek's conflict did not violate the state's political reform act nor did he have a financial interest in the application.

Harrison continued,

"Nonetheless, in the spirit of setting an example of strict compliance, Dr. Sladek tendered his resignation from the GWG."

Asked for comment, Sladek said that Harrison's account was accurate and that he had nothing to add. (Both Harrison's and Sladek's verbatim comments can be found here.)

In December, the CIRM board of directors approved, on a unanimous voice vote of the 21 directors present out of 29, a resolution commending Sladek for serving in "exemplary fashion."

The stem cell agency disclosed specifics of the conflict of interest violation after the California Stem Cell Report discovered a vague reference to it in the transcript of the January meeting of the Citizens Financial Oversight and Accountability Committee, the only state entity specifically charged with oversight of the agency and its directors.

Members of the committee had raised questions about conflicts of interests at CIRM. At one point, Harrison said,

"We have also had occasion where we have had a conflict of a very technical nature on the grants working group which we addressed pursuant to our procedure and reported to the legislature."

It was that remark that triggered the request for more details.

Asked about the report to the legislature, Harrison said CIRM wrote a letter to the legislative leadership about the incident. We have asked for a copy of the letter, which we will carry when we receive it.

As of this writing, the review summary for the grant application (RB3-02119) in question was not available on the CIRM web. Normally all the summaries are posted. We have queried the agency concerning its absence.

Harrison also said that in the seven-year history of CIRM no other instances exist of grant review committee members having been determined to be in a conflict of interest after participation in a review.

Our comment: CIRM is to be commended for taking care of this situation quickly last April. Sladek correctly resigned promptly. However, failure to disclose the incident at the time does not reflect well on the California stem cell agency nor does it inspire confidence in the agency's now improving openness and transparency.

CIRM is an enterprise that has substantial built-in conflicts of interests – all legal courtesy of Prop. 71, the ballot initiative that created CIRM. Institutions linked to CIRM directors have received $1.1 billion of the $1.2 billion the agency has given away. A display of reticence in this conflict-of-interest case does little to quell the suspicions of those who have criticized the agency for "cronyism," including the journal Nature and some in the biotech business community and elsewhere. As for the description of the incident as a "very technical" violation, that amounts to a bit of PR. Either it is a violation or it isn't.

Sladek's violation is the sort of thing not well understood by the public. Most public attention is focused on financial conflicts of interest in science. However, professional conflicts of interest involving scientists are among the most invidious. The California Stem Cell Report regularly hears complaints and suspicions about such dealings at CIRM: Big-name scientists receiving favored treatment, academic researchers unfairly evaluating applications from business researchers, younger researchers being shunted to background and more. All this as a billion dollars worth of applications have been evaluated behind closed doors with no public disclosure of the economic or professional interests of the reviewers. The stem cell agency would do well to improve its openness and transparency, particularly as it moves into ticklish and expensive relationships with industry. The first step would be to post on its web site the disclosure forms filed by its grant reviewers but withheld from the public by CIRM.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Here are the verbatim statements from James Harrison, outside counsel to the California stem cell agency, and John Sladek concerning Sladek's conflict of interest and resignation as chair of the agency's grant review group.

Harrison made these initial remarks first and provided a few other details later.

"While preparing the public summary for Basic Biology III (grant round)applications, CIRM staff discovered that Dr. John Sladek was one of several co-authors on scientific publications with a researcher who was listed as a consultant on a CIRM grant application.
"This is a technical violation of CIRM's conflict of interest rules, which prohibit a member of the Grants Working Group ("GWG") from participating in the review of an application if the member has co-authored papers with a salaried investigator listed on a CIRM application within a three year window.

"It should be noted, however, that Dr. Sladek's participation in the review of the application would not have constituted a conflict of interest under the Political Reform Act's conflict of interest standards because Dr. Sladek did not have a financial interest in the application. In addition, the amount of funding involved - approximately $3,000 of salary per year for three years, less than one percent of the total award - was not material, and Dr. Sladek did not stand to receive any financial benefit from the application. Finally, Dr. Sladek's participation in the review did not affect the outcome because the application was not recommended, or approved, for funding.

"Nonetheless, in the spirit of setting an example of strict compliance, Dr. Sladek tendered his resignation from the GWG."

Sladek's response to a question for comment:

"Mr. Harrison’s account  is accurate and there really isn’t anything to add other than I was pleased to serve CIRM and California  for several years and wish them well as they pursue such an important mission with respect to the potential for therapeutic applications to human disease and disorders. Thank you for your inquiry."

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http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

Qatar Conference Center

If our readers in the Middle East are looking for a first-hand assessment of the state of stem cell research, they might want to take in the four-day conference this week in Qatar, which features the president of the $3 billion California stem cell agency.

Alan Trounson is one of a number of international stem cell notables at the session at the new Qatar Conference Center in the tiny nation in the Persian Gulf. The country is putting on the conference as a means of developing its own stem cell research capabilities.

Qatar had a gross national product of $129 billion in 2010, with a per capita income of $138,000, according to the U.S. State Department. The population is about 1.7 million, more than 75 percent of whom are foreigners with temporary residence status.

In addition to Trounson, other California and CIRM-connected researchers are speaking at the conference in the Qatar center, which just opened in December.  They include David Baltimore, Nobel Laureate and a former director of the stem cell agency. A company Baltimore co-founded, Calimmune, of Tucson, Az., is sharing in a $20 million CIRM grant. Other CIRM grant recipients or representatives of recipient companies appearing at the conference are Irv Weissman of Stanford; Deepak Srivastava of the Gladstone Institute, and Ann Tsukamoto Weissman of Stem Cells Inc. of Newark, Ca.

Social activities at the conference include sand dune "bashing" in off-road vehicles, camel tracking along with a look at their "robot jockeys" and a visit to the original Arabic Oryx farm.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

The state of California plans to sell $2 billion in bonds next Thursday, but the California stem cell agency, which is entirely dependent on state borrowing, will have to wait until later this spring to see more cash.

J.T. Thomas, chairman of the stem cell agency, said he expected to see CIRM benefit from the next bond sale in April. The agency currently has sufficient funds to operate until about June, plus an arrangement with the state for continued funding if a timely bond sale is not completed.

The $3 billion stem cell agency was created in 2004 through a ballot initiative that authorized its funding through the sale of state bonds over a 10-year period. The interest on the bonds raises the total cost of the agency to taxpayers to about $6 billion. Likewise, the cost of a $20 million grant is actually more like $40 million.

Financially beleaguered California's interest costs have sharply increased in recent years as the state has borrowed $53.8 billion from 2007 to 2010. This year, interest costs will come to about $5.4 billion, nearly 6 percent of the state budget. Nine years ago, it was $2.1 billion or 2.9 percent, according a piece by Randall Jensen (no relation to this writer) of the Bond Buyer newspaper.

The expense of borrowing shrinks the amount of state money available for public schools, helping the medically indigent and other state purposes.

Next Thursday's bond sale will go to refinance debt at lower rates. This year, Gov. Jerry Brown and state Treasurer Bill Lockyer plan to sell only $5.2 billion in general obligation bonds, roughly one-fourth of what the state issued in 2009.

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

The California stem cell agency today released its letter to leaders of the California legislature concerning the conflict of interest violation by the scientist who was then chairman of the panel that makes the de facto decisions on hundreds of millions of dollars in research grants.

The agency also posted the review summary of the application involved in the conflict of interest, which had been missing from its web site.

The incident occurred last April, but was not publicly disclosed by the $3 billion research enterprise until questions were raised this month by the California Stem Cell Report. The case involved John Sladek of the University of Colorado in Denver, then chairman of the CIRM grant review group, which makes decisions on the hundreds of grant applications. The CIRM board of directors has final approval but it almost never overturns a favorable recommendation from the grant panel.

Sladek resigned from the review group after CIRM staff discovered the conflict following the March 17 review session. CIRM called it a "technical violation."

The information provided today by CIRM added some details to the matter, including Sladek's statement that the conflict was inadvertent on his part.

The June 15 letter to the speaker of the state Assembly and the leader of the state Senate was labelled "confidential disclosure." Signed by then CIRM Chairman Robert Klein, it said,

"While preparing the public summary for Basic Biology III Awards Application No. RB3-02119, CIRM staff discovered that Dr. Sladek had co-authored two papers in the last three years with a researcher on the application. Although the researcher’s name was included on the CIRM conflict of interest form, Dr. Sladek did not disclose these publications to CIRM."

As reported earlier, Sladek's participation did not affect the outcome on the application, which was not recommended for funding.

As is CIRM's practice, the review summary of the grant application did not identify the scientist seeking funding. The summary listed one reviewer with an unspecified conflict, Ali Brivanlou of Rockefeller University.

The letter was provided by CIRM at the request of the California Stem Cell Report, which also asked for the review summary of the grant application after discovering it was missing. James Harrison, outside counsel to the agency, said in an email that the summary was not posted because of a "programming error."

The summary can be found here. Here is the letter.Sladek/CIRM Conflict of Interest Letter to California Legislative Leadership

Source:
http://californiastemcellreport.blogspot.com/feeds/posts/default?alt=rss

A conflict of interest on a grant application before the $3 billion California stem cell agency last year led to the resignation of the grant review committee's longstanding chairman, John Sladek of the University of Colorado.

The incident occurred last April but was not publicly disclosed by CIRM until the California Stem Cell Report (CSCR) raised a question earlier this month.

Sladek is professor of neurology, pediatrics and neuroscience at the University of Colorado in Denver and a former president of Cal Lutheran University in the Los Angeles area. He had served on the stem cell agency's grant review group since 2005 and as its chairman from 2009 until April of last year.

Responding to an email from CSCR, James Harrison of Remcho, Johansen and Purcell of San Leandro, Ca., outside counsel to the stem cell agency, said that CIRM's staff uncovered the conflict in April after the grant review session was concluded on March 17. Harrison described it as a "technical violation."

He said,

"While preparing the public summary for Basic Biology III (grant round)applications, CIRM staff discovered that Dr. John Sladek was one of several co-authors on scientific publications with a researcher who was listed as a consultant on a CIRM grant application."

Harrison said,

"This is a technical violation of CIRM's conflict of interest rules, which prohibit a member of the Grants Working Group ("GWG") from participating in the review of an application if the member has co-authored papers with a salaried investigator listed on a CIRM application within a three year window."

Harrison said Sladek's conflict did not violate the state's political reform act nor did he have a financial interest in the application.

Harrison continued,

"Nonetheless, in the spirit of setting an example of strict compliance, Dr. Sladek tendered his resignation from the GWG."

Asked for comment, Sladek said that Harrison's account was accurate and that he had nothing to add. (Both Harrison's and Sladek's verbatim comments can be found here.)

In December, the CIRM board of directors approved, on a unanimous voice vote of the 21 directors present out of 29, a resolution commending Sladek for serving in "exemplary fashion."

The stem cell agency disclosed specifics of the conflict of interest violation after the California Stem Cell Report discovered a vague reference to it in the transcript of the January meeting of the Citizens Financial Oversight and Accountability Committee, the only state entity specifically charged with oversight of the agency and its directors.

Members of the committee had raised questions about conflicts of interests at CIRM. At one point, Harrison said,

"We have also had occasion where we have had a conflict of a very technical nature on the grants working group which we addressed pursuant to our procedure and reported to the legislature."

It was that remark that triggered the request for more details.

Asked about the report to the legislature, Harrison said CIRM wrote a letter to the legislative leadership about the incident. We have asked for a copy of the letter, which we will carry when we receive it.

As of this writing, the review summary for the grant application (RB3-02119) in question was not available on the CIRM web. Normally all the summaries are posted. We have queried the agency concerning its absence.

Harrison also said that in the seven-year history of CIRM no other instances exist of grant review committee members having been determined to be in a conflict of interest after participation in a review.

Our comment: CIRM is to be commended for taking care of this situation quickly last April. Sladek correctly resigned promptly. However, failure to disclose the incident at the time does not reflect well on the California stem cell agency nor does it inspire confidence in the agency's now improving openness and transparency.

CIRM is an enterprise that has substantial built-in conflicts of interests – all legal courtesy of Prop. 71, the ballot initiative that created CIRM. Institutions linked to CIRM directors have received $1.1 billion of the $1.2 billion the agency has given away. A display of reticence in this conflict-of-interest case does little to quell the suspicions of those who have criticized the agency for "cronyism," including the journal Nature and some in the biotech business community and elsewhere. As for the description of the incident as a "very technical" violation, that amounts to a bit of PR. Either it is a violation or it isn't.

Sladek's violation is the sort of thing not well understood by the public. Most public attention is focused on financial conflicts of interest in science. However, professional conflicts of interest involving scientists are among the most invidious. The California Stem Cell Report regularly hears complaints and suspicions about such dealings at CIRM: Big-name scientists receiving favored treatment, academic researchers unfairly evaluating applications from business researchers, younger researchers being shunted to background and more. All this as a billion dollars worth of applications have been evaluated behind closed doors with no public disclosure of the economic or professional interests of the reviewers. The stem cell agency would do well to improve its openness and transparency, particularly as it moves into ticklish and expensive relationships with industry. The first step would be to post on its web site the disclosure forms filed by its grant reviewers but withheld from the public by CIRM.

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Here are the verbatim statements from James Harrison, outside counsel to the California stem cell agency, and John Sladek concerning Sladek's conflict of interest and resignation as chair of the agency's grant review group.

Harrison made these initial remarks first and provided a few other details later.

"While preparing the public summary for Basic Biology III (grant round)applications, CIRM staff discovered that Dr. John Sladek was one of several co-authors on scientific publications with a researcher who was listed as a consultant on a CIRM grant application.
"This is a technical violation of CIRM's conflict of interest rules, which prohibit a member of the Grants Working Group ("GWG") from participating in the review of an application if the member has co-authored papers with a salaried investigator listed on a CIRM application within a three year window.

"It should be noted, however, that Dr. Sladek's participation in the review of the application would not have constituted a conflict of interest under the Political Reform Act's conflict of interest standards because Dr. Sladek did not have a financial interest in the application. In addition, the amount of funding involved - approximately $3,000 of salary per year for three years, less than one percent of the total award - was not material, and Dr. Sladek did not stand to receive any financial benefit from the application. Finally, Dr. Sladek's participation in the review did not affect the outcome because the application was not recommended, or approved, for funding.

"Nonetheless, in the spirit of setting an example of strict compliance, Dr. Sladek tendered his resignation from the GWG."

Sladek's response to a question for comment:

"Mr. Harrison’s account  is accurate and there really isn’t anything to add other than I was pleased to serve CIRM and California  for several years and wish them well as they pursue such an important mission with respect to the potential for therapeutic applications to human disease and disorders. Thank you for your inquiry."

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Qatar Conference Center

If our readers in the Middle East are looking for a first-hand assessment of the state of stem cell research, they might want to take in the four-day conference this week in Qatar, which features the president of the $3 billion California stem cell agency.

Alan Trounson is one of a number of international stem cell notables at the session at the new Qatar Conference Center in the tiny nation in the Persian Gulf. The country is putting on the conference as a means of developing its own stem cell research capabilities.

Qatar had a gross national product of $129 billion in 2010, with a per capita income of $138,000, according to the U.S. State Department. The population is about 1.7 million, more than 75 percent of whom are foreigners with temporary residence status.

In addition to Trounson, other California and CIRM-connected researchers are speaking at the conference in the Qatar center, which just opened in December.  They include David Baltimore, Nobel Laureate and a former director of the stem cell agency. A company Baltimore co-founded, Calimmune, of Tucson, Az., is sharing in a $20 million CIRM grant. Other CIRM grant recipients or representatives of recipient companies appearing at the conference are Irv Weissman of Stanford; Deepak Srivastava of the Gladstone Institute, and Ann Tsukamoto Weissman of Stem Cells Inc. of Newark, Ca.

Social activities at the conference include sand dune "bashing" in off-road vehicles, camel tracking along with a look at their "robot jockeys" and a visit to the original Arabic Oryx farm.

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The state of California plans to sell $2 billion in bonds next Thursday, but the California stem cell agency, which is entirely dependent on state borrowing, will have to wait until later this spring to see more cash.

J.T. Thomas, chairman of the stem cell agency, said he expected to see CIRM benefit from the next bond sale in April. The agency currently has sufficient funds to operate until about June, plus an arrangement with the state for continued funding if a timely bond sale is not completed.

The $3 billion stem cell agency was created in 2004 through a ballot initiative that authorized its funding through the sale of state bonds over a 10-year period. The interest on the bonds raises the total cost of the agency to taxpayers to about $6 billion. Likewise, the cost of a $20 million grant is actually more like $40 million.

Financially beleaguered California's interest costs have sharply increased in recent years as the state has borrowed $53.8 billion from 2007 to 2010. This year, interest costs will come to about $5.4 billion, nearly 6 percent of the state budget. Nine years ago, it was $2.1 billion or 2.9 percent, according a piece by Randall Jensen (no relation to this writer) of the Bond Buyer newspaper.

The expense of borrowing shrinks the amount of state money available for public schools, helping the medically indigent and other state purposes.

Next Thursday's bond sale will go to refinance debt at lower rates. This year, Gov. Jerry Brown and state Treasurer Bill Lockyer plan to sell only $5.2 billion in general obligation bonds, roughly one-fourth of what the state issued in 2009.

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Jason Bell

BONITA SPRINGS Jimmy and Jennifer Bell were scrambling to save their 5-year-old-son, Jason, last fall.

Shell-shocked with a diagnosis that their youngest child had primary pulmonary hypertension, a rare lung disorder, they decided to take a chance. If not, a heart-lung transplant would be their son's only chance.

They put their trust in a Southwest Florida cardiologist, Dr. Zannos Grekos, more than 1,000 miles from their Texas home. They learned Grekos performs an experimental stem cell therapy that possibly could help. That's despite a lack of clinical studies and scientific papers.

The U.S. Food and Drug Administration hasn't approved stem cell therapy despite a buzz of optimism of its potential for repairing damaged tissue.

"I was willing to do anything to give my son a fighting chance," said Jimmy Bell, 43, who owns a landscaping company in Keller, a suburb of Fort Worth. "When you are given no other option, you've got to try something."

The treatment would involve a trip to Bonita Springs where Grekos has his practice, Regenocyte; a trip to the Dominican Republic where the treatment would be done, and an up-front payment of $57,000.

"They looked at his medical records first. They didn't know if they could treat him," Bell said. "Once they agreed to treat him, I talked to Grekos. It was the greatest news in my life. I broke down. I just knew this was going to be the miracle to save his life."

* * * * *

The family wired the money in late October 2011 to a Regenocyte account in the Dominican Republic, according to a copy of the paid invoice furnished to the Daily News.

Read more here:
Texas family turned to Bonita stem cell doctor, but 5-year-old died before 'miracle'

Cardiac cellular therapies are undergoing global clinical trials with "encouraging early results" and these economical options will soon be available in India which could bring relief to patients who cannot afford the currently available expensive surgical treatments, says Indian American cardiac surgeon Dr Mukesh Hariawala.

Delivering a special invited plenary lecture on the "Novel Cellular Therapies for Heart Disease" at the recently concluded Healthcare India 2012 convention in New Delhi, the renowned cardiac surgeon asserted that the new developments in cardiac cellular therapies would bring down the alarming healthcare costs globally.

Dr Hariawala is internationally acclaimed as a pioneer of cardiovascular surgical techniques using Therapeutic Angiogenesis. He said Therapeutic Angiogenesis is a fast emerging science of stimulating growth of new blood vessels in the heart which acts as natural bypasses to areas lacking in blood supply.

Dr Hariawala demonstrated angiogenesis along with bypass surgery, lasers and stem cell injections as a novel "Combo Therapy."

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The laser energy acts by creating channels in the diseased heart muscle which also triggers Angiogenesis. Stem cells are then injected directly into coronary arteries feeding the diseased territory or in the stimulated lasered muscle during the open heart surgery. This option could be very helpful in Indian patients with diffused distal small caliber coronary arteries and diabetes, who are not amicable to routinely offered current interventions, he said.

Dr Hariawala acknowledged that only a combination of these four therapies could give it the "Therapeutic Threshold Power" and bring about optimum results and relief of patients symptoms. Standalone, each of these therapies is weak to treat a large muscular pumping organ like the heart.

Stem cells have a therapeutic role and hold enormous promise for the future as they are harvested from the patient's own tissues. Currently, adult stem cell extraction is done from one's own hip bone and patients do not have to worry about rejection phenomenon occurring as they are native cells unlike transplanted from another donor. In the future, stem cell banks could proliferate allowing donors to freeze and store cells for family members who could be treated for many diseases, he added.

Harvard-trained Dr Hariawala's studies have been published in several scientific surgical journals and medical text books.

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Angiogenesis and Stem Cell Therapy Key to Treating Heart Patients: Dr Mukesh Hariawala