Grekos' attorney: Another physician treated patient who died

Interview with Dr. Zannos Grekos Grekos contests that his office has done ...

LEE COUNTY A week after Dr. Zannos Grekos was accused of performing a stem cell treatment on a patient who died, his attorney said another physician was treating the patient at the Bonita Springs practice.

And there was no stem cell treatment performed, only liposuction, said Richard Ozelie, the Boca Raton attorney representing Grekos.

Ozelie does not identify the other doctor but said in a statement Wednesday that the Lee County Sheriffs Office and the Lee County Medical Examiners Office both have that information.

The patient, identified by state authorities through the initials R.P., did have liposuction at the Regenocyte medical facility in Bonita Springs, Ozelie said in the statement. The Sheriffs Office later identified the man who died as Richard Poling , 77, of Newburgh, Ind.

The attorney issued the one-page statement because of concerns with the accuracy of media coverage after the state Department of Health suspended Grekos license March 7. The case has received some national media attention.

The next day, the Sheriffs Office launched a criminal investigation into Grekos practice, Regenocyte, 9500 Bonita Beach Road, Suite 310.

Sheriffs Office spokesman Lt. Larry King had no comment Wednesday and said the agencys investigation is continuing.

In the suspension order, the state health department said Grekos infused or directed that the patient have concentrated stem cells infused into his blood stream. The state order said the patient suffered cardiac arrest and died.

The emergency suspension was issued because Grekos violated a license restriction from February, 2011, not to do anything with autologous stem cell treatment or bone marrow aspirate, according to the state order.

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Grekos' attorney: Another physician treated patient who died

Epigenetic signatures direct the repair potential of reprogrammed cells

When skin cells are reprogrammed, many of their cellular properties are recalibrated as they aquire stem cell properties and then are induced to become skin cells again. In order for these "induced" stem cells to be viable in treatment for humans (tissue regeneration, personalized wound healing therapies, etc.), researchers need to understand how they retain or even improve their characteristics after they are reprogrammed.

Since the initial discovery of reprogramming, scientists have struggled with the unpredictability of the cells due to the many changes that occur during the reprogramming process. Classifying specific epigenetic signatures, as this study did, allows researchers to anticipate ways to produce cell types with optimal properties for tissue repair while minimizing unintended cellular abnormalities.

The researchers used reprogrammed cells to generate three-dimensional connective tissue that mimics an in vivo wound repair environment. To verify the role of the protein (PDGFRbeta) in tissue regeneration and maintenance, the team blocked its cellular expression, which impaired the cells' ability to build tissue.

"We determined that successful tissue generation is associated with the expression of PDGFRbeta. Theoretically, by identifying the epigenetic signatures that indicate its expression, we can determine the reprogrammed cells' potential for maintaining normal cellular characteristics throughout development," said first author Kyle Hewitt, PhD, a graduate of the cell, molecular & developmental biology program at the Sackler School of Graduate Biomedical Sciences, and postdoctoral associate in the Garlick laboratory at Tufts University School of Dental Medicine (TUSDM).

"The ability to generate patient-specific cells from the reprogrammed skin cells may allow for improved, individualized, cell-based therapies for wound healing. Potentially, these reprogrammed cells could be used as a tool for drug development, modeling of disease, and transplantation medicine without the ethical issues associated with embryonic stem cells," said senior author Jonathan Garlick, DDS, PhD, a professor in the department of oral and maxillofacial pathology and director of the division of tissue engineering and cancer biology at TUSDM.

Jonathan Garlick is also a member of the cell, molecular & developmental biology program faculty at the Sackler School and the director of the Center for Integrated Tissue Engineering (CITE) at TUSDM.

More information: Hewitt KJ, Shamis Y, Knight E, Smith A, Maione A, Alt-Holland A, Garlick JA. Journal of Cell Science. "PDGFRbeta Expression and Function in Fibroblasts Derived from Pluripotent Cells is Linked to DNA Demethylation" Published online February 17, 2012, doi: 10.1242/jcs.099192

Provided by Tufts University

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Epigenetic signatures direct the repair potential of reprogrammed cells

Washington Center for Pain Management Begins Enrollment in United States Stem Cell Therapy Study in Subjects With …

EDMONDS, Wash., March 14, 2012 /PRNewswire/ --Washington Center for Pain Management is participating in a nationwide FDA-cleared adult stem cell study testing novel treatment for chronic low back pain and has enrolled its first patient. The study will test the use of Mesenchymal Precursor Cells (MPCs) adult stem cells derived from bone marrow that will be directly injected into the lumbar disc. The minimally invasive procedure may offer an alternative to back surgery for eligible patients with chronic pain from degenerative discs.

An estimated 30 million people in the United States suffer from back pain. Degenerative disc disease is the most common cause of low-back pain, which develops with the gradual loss of a material called proteoglycan, which cushions the bones of the spine and enables normal motion.

Most patients with low-back pain respond to physical therapy and medications, but in advanced cases, artificial disc replacement or spinal fusion -- removal of the degenerated discs and the fusion of the bones of the spine -- is necessary. However, these surgeries often are not entirely effective.

"Millions of Americans are debilitated by chronic low back pain," says Dr Hyun Joong Hong MD, the lead investigator at The Washington Center for Pain Management. "This promising therapy is at the cutting edge of medical science and has the potential to create a paradigm shift in our approach to minimally invasive solutions to this disease."

Researchers will enroll approximately 100 study participants. About fifteen participants will be enrolled at The Washington Center for Pain Management and the rest at 11 other medical centers throughout the United States. The trial is scheduled to last for three years.

Washington Center for Pain Management is enrolling study participants suffering from moderate low-back pain for a minimum of six months and whose condition has not responded to other, conventional treatments.

Once enrolled, patients are randomly assigned to one of four treatment groups:

Patients will receive a single injection of their assigned test agent directly into the center of the target discs within their spine and will be monitored for safety. Patients will also be monitored using imaging to identify any changes in their disease condition or disease progression. Use of pain medications, self-reports of pain, subsequent surgical interventions and assessments of disability, quality of life, productivity and activity will be evaluated. Repair of the disc and reduction of chronic back pain will be assessed in each patient.

Promising results have been observed in prior research using animal models when stem cells were investigated for the repair of damaged spine discs. The cells were well tolerated in these study animals.

This study is sponsored by Mesoblast Limited, a world leader in the development of biologic products for the broad field of regenerative medicine. Mesoblast has the worldwide exclusive rights to a series of patents and technologies developed over more than 10 years relating to the identification, extraction, culture and uses of adult Mesenchymal Precursor Cells (MPCs). The MPCs are derived from young adult donors' bone marrow and are immune tolerant.

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Washington Center for Pain Management Begins Enrollment in United States Stem Cell Therapy Study in Subjects With ...

StemCells, Inc. Reports Fourth Quarter and Year End 2011 Financial Results and Provides Business Update

NEWARK, Calif., March 13, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (Nasdaq:STEM - News), a leading stem cell company developing and commercializing novel cell-based therapeutics and tools for use in stem cell-based research and drug discovery, today reported financial results for the fourth quarter and year ended December 31, 2011 and provided a business update.

"The StemCells team made significant progress in 2011 with regard to two critical goals for the Company, namely accelerating and broadening our HuCNS-SC neural stem cell clinical trial agenda for diseases of, and injuries to, the central nervous system, while at the same time reducing our operating cash burn. We are now uniquely positioned as the only stem cell company pursuing clinical trials for disorders of all three organs of the CNS, the brain, spinal cord and eye," said Martin McGlynn, President and CEO of StemCells, Inc. "We have strong preclinical data underlying all our clinical trials, much of which has already been published in peer-reviewed journals, but we realize that the true test of our proprietary cell-based technology will be in the clinic. In this regard, I am pleased to confirm StemCells remains on track to report safety and efficacy data from our recently completed Phase I Pelizeaus-Merzbacher disease trial at the European Leukodystrophy Association meeting to be held in Paris, March 31-April 1. We are confident that executing our clinical trial agenda, while controlling our cash burn, is the best way to build lasting shareholder value."

Fourth Quarter and Recent Business Highlights

Therapeutic Product Development

Tools and Technologies Programs

Other Business Activities

Fourth Quarter 2011 Financial Results

For the fourth quarter of 2011, the Company reported a net loss of $7,212,000, or $(0.47) per share, compared with a net loss of $8,957,000, or $(0.70) per share, for the fourth quarter of 2010. Loss from operations in the fourth quarter of 2011 was $7,313,000, which was 5% lower when compared to the $7,706,000 loss from operations in the fourth quarter of 2010. Included in net loss and loss from operations in the fourth quarter of 2011 is a charge of $655,000 for the write-off of an acquired intangible asset.

Total revenue during the fourth quarter of 2011 was $541,000, compared to $699,000 in the same period of 2010. The decrease of 23% from 2010 to 2011 was due to both lower product sales and lower licensing and grant revenues. Total revenues in the fourth quarter of 2010 were higher due to a particularly strong quarter in our SC Proven business as well as the receipt of a milestone payment under a licensing agreement of approximately $438,000 in 2010.

Total operating expenses in the fourth quarter of 2011 were $7,807,000, compared to $8,341,000 in the fourth quarter of 2010. Excluding the impairment of the intangible asset, which is included as an operating expense, total operating expenses in the fourth quarter of 2011 were $7,152,000, or 14% lower than the same period in 2010. In the fourth quarter of 2011, research and development expenses totaled $4,834,000, or 18% less than in the same period of 2010, while selling, general and administrative expenses totaled $2,290,000, or 8% lower. The significant reduction in operating expenses was primarily attributable to the Company's cost containment efforts, including the reduction in force effected in May 2011.

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StemCells, Inc. Reports Fourth Quarter and Year End 2011 Financial Results and Provides Business Update

Newburgh Man Dies While Receiving Stem Cell Treatment in Florida

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

Patient dies during procedure

(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

(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

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

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

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

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

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

Doctor's license suspended after patient's death

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