Stem Cell Clinic

Newburgh Man Dies While Receiving Stem Cell Treatment in Florida

By Stem Cell Treatment

A homicide investigation in Florida has some far reaching ties to the Tri-State. A Newburgh man was there for stem cell treatment and died during the procedure. Richard Poling, 77, went to Florida for treatment of a lung disease he's battled for more than ten years, but he didn't make it through the procedure. Now the doctor he chose, Dr. Zannos Grekos, is at the heart of a homicide investigation. But his isn't the first story about Dr. Grekos that ends poorly. Barb Neuman's husband was diagnosed with a different lung disease, but went to the same doctor, in 2009. They mortgaged their home to afford more than $50,000 for the treatment. Unfortunately Neuman's husband died nine months later. But other patients speak highly of Dr. Grekos. Grekos' license had been restricted in 2011 for performing undisclosed stem cell research on a woman with breast cancer who later died. Neuman says she hopes her story can teach others a valuable lesson. No one has been arrested in the three deaths. The Florida State Surgeon General has issued an emergency suspension on Grekos' license, and Lee County Sheriff's Deputies are investigating the deaths.

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Newburgh Man Dies While Receiving Stem Cell Treatment in Florida

Osiris Therapeutics Reports Fourth Quarter and Full Year 2011 Financial Results

By Stem Cell Medical Center

COLUMBIA, Md.--(BUSINESS WIRE)--

Osiris Therapeutics, Inc. (NASDAQ: OSIR - News), the leading stem cell company focused on developing and commercializing products to treat medical conditions in inflammatory, cardiovascular, orthopedic, and wound healing markets, announced today its results for the fourth quarter and full year ended December 31, 2011.

Recent and Full Year Highlights

We are very pleased with the commercial performance of our two Biosurgery products, Grafix and Ovation, said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. As interest in stem cell products for surgical applications intensifies, Osiris remains uniquely positioned as the clear leader in this space. Additionally, with Prochymal being used around the world to treat patients with life-threatening GvHD through our Expanded Access program, our Therapeutic and Biosurgery units are carrying out our mission of bringing Smart Medicine, to patients, Right Now.

Fourth Quarter Financial Results

Net income for the fourth quarter of 2011 increased to $5.0 million, compared to $4.4 million for the fourth quarter of 2010. Revenues were $11.0 million in the fourth quarter of 2011, consisting primarily of the amortization of license fees from our collaboration agreements. Our fourth quarter Biosurgery product revenues were $0.8 million. Revenues during the fourth quarter of 2010 were $10.8 million. As of December 31, 2011, Osiris had $48.0 million of cash, receivables, and short-term investments.

Research and development expenses for the fourth quarter of 2011 were $4.2 million, compared to $5.0 million incurred in the fourth quarter of 2010. General and administrative expenses were $1.5 million for the fourth quarter of 2011 compared to $1.8 million for the same period of the prior year. Net cash used in operations for the quarter was $4.6 million.

Full Year 2011 Financial Highlights

Net income was $14.9 million for the fiscal year ended December 31, 2011 compared to $13.1 million in fiscal 2010. Revenues of $42.4 million were recognized in 2011, including $40.0 million from the Genzyme collaboration agreement, $1.0 million from the research, development and commercialization agreement with the JDRF and $1.3 million of revenues from our Biosurgery products. Revenues in 2010 were $43.2 million, which included $40.0 million from the Genzyme collaboration agreement, $0.5 million from the U.S. Department of Defense contract, $1.2 million from the JDRF agreement and a $1.0 million milestone earned on our license agreement with JCR Pharmaceuticals.

R&D expenses for the 2011 fiscal year were $19.2 million compared to $23.5 million in the prior year. G&A expenses in fiscal 2011 were $7.9 million, which include $2.4 million of non-cash share based payments. G&A expenses in fiscal 2010 were $6.5 million, including $0.7 million of share-based payments.

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Osiris Therapeutics Reports Fourth Quarter and Full Year 2011 Financial Results

New Industry Partnership to Strengthen Regenerative Medicine Industry in Canada

By Uncategorized

TORONTO, ONTARIO--(Marketwire -03/09/12)- The newest player in the regenerative medicine (RM) field in Canada is taking a collaborative approach to commercializing stem cell and biomaterials products. The Centre for Commercialization of Regenerative Medicine (CCRM) has created an industry consortium that is working together to address real-life bottlenecks in their RM product pipelines.

CCRM's scientific leadership is recognized by the global RM community as being world-leading. According to Michael May, CEO of CCRM, partnering with industry completes the puzzle. "By working with industry, CCRM captures business expertise that informs product development and commercialization. We already had access to some of the best scientific minds in the field and now we have access to seasoned industry experts. This is key to our success and will accelerate product development."

The members of the industry consortium represent the key sectors of the RM industry: therapeutics, devices, reagents, and cells as tools. CCRM has built three core development platforms: reprogramming, cell manufacturing, and biomaterials and tissue mimetics. The intellectual property and infrastructure of CCRM's six research institution partners and support from 20 leading RM companies will enhance Canada's already strong leadership role in the RM field.

"CCRM is uniquely positioned to meet the needs of industry and academia," explains Greg Bonfiglio, Chair of CCRM's Board of Directors. "CCRM boasts scientific expertise and state-of-the-art resources in its development lab and this combination will benefit the regenerative medicine community that can capitalize on our ability to complete projects quickly and cost competitively."

The industry consortium members are as follows:

About the Centre for Commercialization of Regenerative Medicine (CCRM)

CCRM, a Canadian not-for-profit organization funded by the Government of Canada's Networks of Centres of Excellence program and six academic partners, supports the development of technologies that accelerate the commercialization of stem cell- and biomaterials-based technologies and therapies. A network of academics, industry and entrepreneurs, CCRM aims to translate scientific discoveries into marketable products for patients. CCRM launched in Toronto's Discovery District on June 14, 2011.

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New Industry Partnership to Strengthen Regenerative Medicine Industry in Canada

Patient dies during procedure

By Stem Cell Treatment

(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.

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Patient dies during procedure

Doctor accused of illegal stem cell therapy suspended

By Stem Cell Treatment

(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.

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Doctor accused of illegal stem cell therapy suspended

Fly research gives insight into human stem cell development and cancer

By Stem Cell Medicine

Public release date: 8-Mar-2012 [ | E-mail | Share ]

Contact: Phyllis Edelman pedelman@genetics-gsa.org 301-351-0896 Genetics Society of America

CHICAGO, IL March 8, 2012 Stem cells provide a recurring topic among the scientific presentations at the Genetics Society of America's 53rd Annual Drosophila Research Conference, March 7-11 at the Sheraton Chicago Hotel & Towers. Specifically, researchers are trying to determine how, within organs, cells specialize while stem cells maintain tissues and enable them to repair damage and respond to stress or aging. Four talks, one on Thursday morning and three on Sunday morning, present variations on this theme.

For a fertilized egg to give rise to an organism made up of billions or trillions of cells, a precise program of cell divisions must unfold. Some divisions are "asymmetric": one of the two daughter cells specializes, yet the other retains the ability to divide. Chris Q. Doe, Ph.D., professor of biology at the University of Oregon, compares this asymmetric cell division to splitting a sundae so that only one half gets the cherry. The "cherries" in cells are the proteins and RNA molecules that make the two cells that descend from one cell different from each other. This collecting of different molecules in different regions of the initial cell before it divides is termed "cell polarity."

Dr. Doe and his team are tracing the cell divisions that form a fly's nervous system. "Producing the right cells at the right time is essential for normal development, yet it's not well understood how an embryonic precursor cell or stem cell generates a characteristic sequence of different cell types," he says. Dr. Doe and his team traced the cell lineages of 30 neuroblasts (stem cell-like neural precursors), each cell division generating a daughter cell bound for specialization as well as a self-renewing neuroblast. The dance of development is a matter of balance. Self-renew too much, and a tumor results; not enough, and the brain shrinks.

Tracing a cell lineage is a little like sketching a family tree of cousins who share a great-grandparent except that the great-grandparent (the neuroblast) continually produces more cousins. "The offspring will change due to the different environments they are born into," says Dr. Doe.

Julie A. Brill, Ph.D., a principal investigator at The Hospital for Sick Children (SickKids) in Toronto, investigates cell polarity in sperm cells. These highly specialized elongated cells begin as more spherical precursor cells. Groups of developing sperm elongate, align, condense their DNA into tight packages, expose enzyme-containing bumps on their tips that will burrow through an egg's outer layers, form moving tails, then detach and swim away.

The Brill lab studies a membrane lipid called PIP2 (phosphatidylinositol 4,5-bisphosphate) that establishes polarity in developing male germ cells in Drosophila. "Reducing levels of PIP2 leads to defects in cell polarity and failure to form mature, motile sperm," Dr. Brill says. These experiments show that localization of the enzyme responsible for PIP2 production in the growing end of elongating sperm tails likely sets up cell polarity. Since loss of this polarity is implicated in the origin and spread of cancer, defects in the regulation of PIP2 distribution may contribute to human cancer progression, she adds.

Stephen DiNardo, Ph.D., professor of cell and developmental biology at the Institute for Regenerative Medicine at the University of Pennsylvania, is investigating how different varieties of stem cells in the developing fly testis give rise to germ cells and epithelial cells that ensheathe the germ cells, as well as being able to self-renew. For each of these roles, stem cells are guided by their environment, known as their "niche."

In the fly testis, we know not only the locations of the two types of stem cells whose actions maintain fertility, but of neighboring cells. "We study how these niche cells are first specified during development, how they assemble, and what signals they use. Elements of what we and others learn about this niche may well apply to more complex niches in our tissues," Dr. DiNardo explains.

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Fly research gives insight into human stem cell development and cancer

BioTime to Present at ROTH 24th Annual Growth Stock Conference

By Uncategorized

ALAMEDA, Calif.--(BUSINESS WIRE)--

BioTime, Inc. (NYSE Amex:BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that Chief Financial Officer, Peter S. Garcia, will present a corporate overview of BioTime and its subsidiaries at the ROTH 24th Annual Growth Stock Conference. The presentation will take place on Tuesday, March 13, 2012, at 9:30 a.m. PDT at The Ritz-Carlton Hotel in Dana Point, California. The presentation will be webcast and available online at the Investors section of the website at http://www.biotimeinc.com and at http://wsw.com/webcast/roth26/btx/.

ROTH Capital Partners will host more than 400 growth companies at its annual investment conference, March 11-14, 2012, including more than 130 healthcare companies in the biotechnology, healthcare services, medical device, and pharmaceutical sectors.

About BioTime, Inc.

BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is developed through subsidiaries focused on specific fields of applications. BioTime develops and markets research products in the field of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate cell lines, culture media, and differentiation kits. BioTime's wholly owned subsidiary ES Cell International Pte. Ltd. has produced clinical-grade human embryonic stem cell lines that were derived following principles of Good Manufacturing Practice and currently offers them for use in research. BioTime's therapeutic product development strategy is pursued through subsidiaries that focus on specific organ systems and related diseases for which there is a high unmet medical need. BioTime's majority owned subsidiary Cell Cure Neurosciences, Ltd. is developing therapeutic products derived from stem cells for the treatment of retinal and neural degenerative diseases. Cell Cure's minority shareholder Teva Pharmaceutical Industries has an option to clinically develop and commercialize Cell Cure's OpRegen retinal cell product for use in the treatment of age-related macular degeneration. BioTime's subsidiary OrthoCyte Corporation is developing therapeutic applications of stem cells to treat orthopedic diseases and injuries. Another subsidiary, OncoCyte Corporation, focuses on the diagnostic and therapeutic applications of stem cell technology in cancer, including the diagnostic product PanC-DxTM currently being developed for the detection of cancer in blood samples, therapeutic strategies using vascular progenitor cells engineered to destroy malignant tumors. ReCyte Therapeutics, Inc. is developing applications of BioTime's proprietary induced pluripotent stem cell technology to reverse the developmental aging of human cells to treat cardiovascular and blood cell diseases. BioTime's newest subsidiary, LifeMap Sciences, Inc., is developing an online database of the complex cell lineages arising from stem cells to guide basic research and to market BioTime's research products. In addition to its stem cell products, BioTime develops blood plasma volume expanders, blood replacement solutions for hypothermic (low-temperature) surgery, and technology for use in surgery, emergency trauma treatment and other applications. BioTime's lead product, Hextend, is a blood plasma volume expander manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ CheilJedang Corp. under exclusive licensing agreements. Additional information about BioTime, ReCyte Therapeutics, Cell Cure, OrthoCyte, OncoCyte, BioTime Asia, LifeMap Sciences, and ESI can be found on the web at http://www.biotimeinc.com.

Forward-Looking Statements

Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime's Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.

To receive ongoing BioTime corporate communications, please click on the following link to join our email alert list:

http://phx.corporate-ir.net/phoenix.zhtml?c=83805&p=irol-alerts

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BioTime to Present at ROTH 24th Annual Growth Stock Conference

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

By Stem Cell Treatment

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.

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

Doctor's license suspended after patient's death

By Stem Cell Treatment

BONITA SPRINGS, FL -

The state Surgeon General has issued an emergency suspension of the license of Dr. Zannos Grekos for providing a stem cell treatment to a patient contrary to previous restrictions placed on his license. The patient died during the treatment.

According to the emergency suspension order, in February 2011 Dr. Grekos was ordered not to perform any stem cell treatments on patients.

On March 2, 2012, Grekos is accused of treating an elderly man with pulmonary hypertension and pulmonary fibrosis with stem cells.

The suspension order says Grekos harvested tissue from the patient's abdomen that commonly contains stem cells. That tissue was sent to a lab to have the stem cells concentrated.

Those concentrated stem cells were then injected into the patient's bloodstream, according to the order.

The patient died of cardiac arrest during the treatment.

Because the stem cell treatment violated previous restrictions on Grekos' license, the state requested the emergency suspension of his license.

One section of the emergency suspension order states, "Nothing short of the immediate suspension of Dr. Grekos' license to practice medicine would be sufficient to protect the public from the danger of harm presented by Dr. Grekos."

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Doctor's license suspended after patient's death

Stem cell treatment tricks immune system into accepting donor organs, study shows

By Stem Cell Treatment

By Julie Steenhuysen

CHICAGO Scientists have found a way to trick the immune system into accepting organs from a mismatched, unrelated organ donor, a finding that could help patients avoid a lifetime of drugs to prevent rejection of the donated organ.

Of eight kidney transplant patients who have been treated with this new approach, five have managed to avoid taking anti-rejection drugs a year after their surgery, according to the study published on Wednesday in Science Translational Medicine.

And one patient, 47-year-old Lindsay Porter of Chicago, is completely free of anti-rejection drugs nearly two years after her kidney transplant.

This new approach would potentially offer a better quality of life and fewer health risks for transplant recipients

I hear about the challenges recipients have to face with their medications and it is significant. Its almost surreal when I think about it because I feel so healthy and normal, she said in a statement.

With conventional organ transplants, recipients need to take pills to suppress their immune systems for the rest of their lives. These drugs can cause serious side effects, including high blood pressure, diabetes, infection, heart disease and cancer.

This new approach would potentially offer a better quality of life and fewer health risks for transplant recipients, Dr. Suzanne Ildstad, director of the Institute of Cellular Therapeutics at the University of Louisville in Kentucky, who developed the new approach, said in a statement.

But some experts say the procedure, in which patients undergo a bone marrow transplant from an unmatched organ donor, is too risky, especially given the relative safety of kidney transplants.

We have to think about the risks and benefits. Since the current treatment is so stable, it really has to be safe, said Dr. Tatsuo Kawai, a transplant surgeon at Harvard Medical School, who wrote a commentary on the new approach in the journal.

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Stem cell treatment tricks immune system into accepting donor organs, study shows

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