Stem Cell Clinic

Florida suspends doctor accused of illegal stem cell therapy

By Stem Cell Treatment

By David Fitzpatrick and Drew Griffin, Special Investigations Unit

updated 1:34 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 treatment on an elderly patient who died during the procedure.

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

According to the license suspension order, Grekos performed a stem cell treatment earlier 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's activities in 2009 and, at that time, he said he was using stem cell therapy for a company he 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 claimed would help heal crippling diseases, mostly associated with lung problems.

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Florida suspends doctor accused of illegal stem cell therapy

Eastday-Student who twice backed out of cell donation divides opinion

By Stem Cell Medical Center

A SHANGHAI student who registered as a stem cell donor but then twice backed out of donating at the last moment has found herself at the center of public debate.

The would-be recipient, a leukemia patient in neighboring Jiangsu Province, had already received medication to stop blood-forming functions in preparation for the transplant when the intended donor pulled out.

It was said that the would-be donor, who has not been named, had faced pressure from her family not to go ahead with the procedure.

The incident has stirred up discussion online, with some web users accusing the student of putting the patient's life in danger through her actions.

Some argued that donors should be legally prevented from backing out once the intended recipient has been given preparatory medication.

However, local medical officials said that donations should be based on freewill and that a donor must be allowed to change his or her mind.

The 23-year-old leukemia patient, Jiang Jing, is being treated in a hospital in Suzhou. As an emergency solution, a partial match was found yesterday using a sample from the Shanghai Stem Cell Blood Bank and cells from Jiang's mother. The success rate is likely to be around 60 percent, local doctors told Shanghai Daily.

Jiang was diagnosed with leukemia last April and a full match was found with the Shanghai college student who had registered as a donor with the Red Cross in the city.

The transplant had been scheduled for Tuesday and the patient had been receiving medication since late last month to stop her body forming blood cells.

But last Thursday, the donor said she did not want to proceed.

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Eastday-Student who twice backed out of cell donation divides opinion

Stem Cells Help Kidney-Transplant Patients Skip Rejection Drugs in Study

By Stem Cell Medicine

By Michelle Fay Cortez - Wed Mar 07 19:16:55 GMT 2012

Kidney transplant patients given a mixture of stem cells from their organ donor were able to quit taking anti-rejection medicine in a small study, suggesting that life-long reliance on the toxic drugs may be avoidable.

Five of eight patients treated were able to stop taking about a dozen pills a day to suppress their immune systems. The drugs, which prevent rejection and stop tissue from a donated kidney from attacking the patient, can damage the transplant and cause diabetes, infections, heart disease and cancer.

The breakthrough, reported in the journal Science Translational Medicine, mixed stem cells from the donors infection-fighting immune system with the patients natural immune system. The result enabled tissue from both to co-exist in the transplant patient without either being seen as foreign by the immune system, researchers said.

The results may potentially have an enormous, paradigm- shifting impact on solid-organ transplantation, wrote James Markmann and Tatsuo Kawai from Massachusetts General Hospital in Boston, in an editorial accompanying the study. Although only a taste of things to come, few transplant developments in the past half-century have been more enticing than these that put transplantation tolerance within our grasp.

The findings are particularly striking since the patients werent perfect tissue matches with the living donors. The mismatch traditionally makes it more difficult for the donated organ to survive since the patients immune system perceives the unfamiliar tissue as a threat.

Its been a longstanding goal in transplantation to achieve tolerance, to get the recipient to see the donor organ as part of itself, said Joseph Leventhal, a surgeon at Northwestern Memorial Hospital in Chicago and the lead author. A road to tolerance now exists, he said.

Having two immune systems blend into one is called a chimerism. The long-lasting effect seen in the study may stem from the manipulation of stem cells taken from the donor in advance of the surgery, according to the report.

The cells were sent to Suzanne Ildstad, director of the Institute of Cellular Therapeutics at the University of Louisville in Kentucky. There facilitating cells that help transplants take hold were identified and used to enrich the mixture, which was given to the patient the day after surgery.

The researchers didnt provide details on how they crafted the stem cell mix, which may make it difficult for other investigators to confirm the findings, Markmann and Kawai wrote.

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Stem Cells Help Kidney-Transplant Patients Skip Rejection Drugs in Study

Nimer named new director for University of Miami’s cancer center

By Stem Cell Medical Center

Medical breakthroughs discovered in the laboratory can take a long time to be put into practice in the examination room, often because there is little communication between research scientists and clinical physicians.

Dr. Stephen D. Nimer, a renowned researcher and physician named Wednesday as director of the University of Miamis Sylvester Cancer Center, is vowing to bring equal emphasis to leading-edge scientific research and quality patient care. His goal: to make Miami a worldwide destination for cancer treatment.

I am going to devote my energies toward bringing the center to the next level, said Nimer, 57, who has pioneered novel therapies for cancer and advocated for more compassionate care of patients. I want to build on the greatness that exists here.

Nimers appointment comes nearly 18 months after the Sylvester Centers board launched a global search for a new director to succeed Dr. W. Jarrard Goodwin, who stepped down after 14 years at the helm to become chief medical officer for the center.

Joan Scheiner, board chair of the Sylvester Center, said Nimer is the perfect candidate to lead the 20-year-old center into the next stage.

Hes going to help us build the kind of cancer center we deserve, said Scheiner, who beat metastatic soft tissue sarcoma with the help of Sylvester Center doctors in the late 1990s. It validates our past and ensures a future with no limits.

A key member of one of the nations leading cancer centers Memorial Sloan-Kettering in New York Nimer is considered one of the worlds premier leukemia and stem cell transplant researchers and physicians.

During nearly two decades at Sloan-Kettering, Nimer established an inpatient program for patients with blood disorders, and a blood stem cell transplant program for adults with malignant blood diseases, focusing primarily on patients with non-Hodgkin and Hodgkin lymphoma, or multiple myeloma, a cancer of the plasma cells in the bone marrow.

Among Nimers notable achievements in the laboratory: developing a bone marrow transplant treatment using stem cells to eliminate cancer cells from the blood and coaxing tumor-reducing proteins out of stem cells, then using those proteins to help enhance the effects of chemotherapy and radiotherapy for cancer patients.

A prolific researcher who has authored more than 200 scientific publications in numerous medical journals, Nimer also has made important discoveries in the field of pre-cancerous oncogenes, which can mutate and trigger cancer.

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Nimer named new director for University of Miami’s cancer center

Stem cell research allows for mismatched kidney transplants

By Stem Cell Clinic

Donating a kidney may save a person's life - but only if the conditions are precise.

Kidney donors must be related and immunologically matched to their donors and even then, the recipient must take a lifetime of anti-rejection medications, which dont guarantee the organ won't be rejected.

But a new clinical trial from Northwestern Memorial Hospital in Chicago, Ill. has shown how stem cells can be used to trick a recipients immune system into believing the new organ has been part of that persons body all along.

The breakthrough has the potential to eliminate both the risks associated with kidney transplantation and the need for anti-rejection medications within one year after surgery.

Its the holy grail of transplantation, said lead author Dr. Joseph Leventhal, transplant surgeon at Northwestern Memorial Hospital and associate professor of surgery and director of kidney and pancreas transplantation at Northwestern University Feinberg School of Medicine in Chicago, Ill. This notion of being able to achieve tolerance through donor derived cells has been around for more than 50 years, but its translation to the clinic has been quite elusive. This article details the first successful attempt of this in mismatched and unrelated kidney recipients.

The research was published Wednesday in the journal Science Translational Medicine, and it is the first study of its kind in which the donor and recipient were not related and did not have to be immunologically matched. Only 25 percent of siblings are immunologically identical, severely limiting the possibility of being a kidney donor.

The procedure worked by extracting a little bit more from the kidney donor than just their kidney. They also donated part of their immune system. About one month before surgery, bone marrow stem cells were collected from the donor and then enriched with facilitating cells becoming stem cells that will ultimately fool the donors immune system allowing the transplant to succeed.

One day after the kidney transplant occurs, the facilitating cell-enriched stem cells are also transplanted in the recipient, which then prompts the formation of stem cells in the bone marrow. This then causes specialized immune cells similar to the donors immune cells to develop, creating a dual bone marrow system environment, so both the donors immune system and the recipients immune system function inside the persons body.

Leventhal said that the ultimate goal is for the recipient to initially take anti-rejection medications but then slowly wean off of them within a year. According to Leventhal, the drugs come with their own share of negative side effects.

The foundation of clinical transplantation revolves around the use of medicines and suppressive drugs to control the immune system, Leventhal said. These drugs have been very successful in reducing the rates of loss of organs due to acute rejection where side effects include increase risk of infection and cancer, and metabolic side effects, such as the increase risk of hypertension and bone disease. But the drugs themselves are potentially harmful to the organs we transplant. Despite our ability to reduce rates of acute rejection, most individuals go on to lose organs because of chronic (long-term) rejection.

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Stem cell research allows for mismatched kidney transplants

Internationally Recognized Leukemia Physician and Researcher to Lead Sylvester Comprehensive Cancer Center

By Uncategorized

MIAMI--(BUSINESS WIRE)--

Stephen D. Nimer, M.D., one of the worlds premier leukemia and stem cell transplant researchers and clinicians, has been named the new director of the Sylvester Comprehensive Cancer Center.

Nimer, the Alfred P. Sloan Chair in Cancer Research at Memorial Sloan-Kettering Cancer Center, will assume the key University of Miami Miller School of Medicine and UHealth-University of Miami Health System post this spring, bringing 30 years of pioneering research and clinical experience and an unquenchable passion for improving the lives of patients with cancer, and their families.

The focus will not be solely on taking care of the cancer, it will be on taking care of the patient, said Nimer, whose patient-centered philosophy has won him as much acclaim as his clinical and laboratory accomplishments. That means trying to understand as fully as possible each patients cancer the biology driving the cancer, and the impact of the cancer on the patients life in order to develop a personalized therapeutic approach suited to each individual.

Pascal J. Goldschmidt, M.D., Senior Vice President for Medical Affairs and Dean of the Miller School, and CEO of UHealth, said Nimer, who headed the Division of Hematologic Oncology at Sloan-Kettering for a dozen years, is the ideal physician-scientist to lead Sylvester into its third decade and to designation as one of the nations official comprehensive cancer centers by the NIHs National Cancer Institute.

Stephen possesses a unique combination of outstanding clinical skills and visionary scientific acumen in cancer research that will lead Sylvester to become the next top comprehensive cancer center in the U.S., Dean Goldschmidt said. He brings a true patient-centered approach to clinical care and leading-edge research that makes a real difference for our fellow humans. Cancer patients across South Florida and around the world will benefit from his expertise and leadership.

Dr. Nimer will be a spectacular leader for the Sylvester Comprehensive Cancer Center, said UM President Donna E. Shalala.This is a momentous development for the Miller School, the University of Miami, and all of South Florida.

Joseph Rosenblatt, M.D., who has served as interim director of Sylvester, said Dr. Nimers arrival will allow Sylvester to find its rightful place among the worlds premier cancer centers, and his leadership will usher in a new era for our cancer center, which I and our faculty anticipate with great enthusiasm.

Nimer, currently vice chair for faculty development at Sloan-Ketterings Department of Medicine, plans to develop and expand a number of services at Sylvester, including programs for breast cancer, lung cancer, prostate cancer and hematological malignancies, among others. He also plans to recruit more than 30 new scientists and physicians, develop key core facilities and expand the clinical and laboratory research capabilities.

He specifically hopes to recruit experts in areas such as bone marrow transplantation, mouse models of human cancer, and molecular diagnostics, as well as additional surgeons skilled in complex, curative and restorative procedures, such as breast reconstruction. He also will expand efforts in cancer prevention, screening and early diagnosis and in identifying those factors that predispose people to develop cancer.

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Internationally Recognized Leukemia Physician and Researcher to Lead Sylvester Comprehensive Cancer Center

Transplant without lifetime of drugs?

By Uncategorized

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.

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Transplant without lifetime of drugs?

Wayzata HS student takes stem cell research to national competition

By Stem Cell Treatment

by Tom Crann, Minnesota Public Radio

March 7, 2012

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St. Paul, Minn. A Minnesota teen will be one of 40 high school students nationwide competing for a top prize of $100,000 at the annual Intel Science Talent Search in Washington D.C. Thursday.

Evan Chen, a student at Wayzata High School, focused his research on a type of stem cell that could help replace and regenerate muscle lost by people suffering from muscular dystrophy.

Chen told Tom Crann of All Things Considered that he was inspired to do the research after meeting three boys from Taiwan who were in Minnesota seeking treatment for the disease.

"They left after the experiment; the treatment didn't work," Chen said. "I was pushed not only by my experience with them, but also my fascination with stem cells."

The advanced research Chen envisioned couldn't be done in a high school laboratory, so Chen approached local scientists for help.

"Eventually one sat down with me and we talked about the research I wanted to do," Chen said. "He was like, 'Sure, you can use my lab for this.'"

Chen and the other students will be judged by a panel of scientists. Other projects in the contest include an inexpensive system to detect landmines and a light-activated cancer treatment drug.

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Wayzata HS student takes stem cell research to national competition

Fourteenth Patient Dosed in Neuralstem ALS Stem Cell Trial

By Stem Cell Treatment

ROCKVILLE, Md., March 7, 2012 /PRNewswire/ -- Neuralstem, Inc. (NYSE Amex: CUR) announced that the second patient to receive stem cells in the cervical (upper back) region of the spine was dosed on February 29th in the ongoing Phase I trial of its spinal cord neural stem cells in amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). Patient 14 is also the first woman to be treated in the trial. Stem cell transplantation into the cervical region of the spinal cord couldsupport breathing, a key function that is lost as ALS progresses. The first twelve patients in the trial received stem cell transplants in the lumbar (lower back) region of the spinal cord only.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )

"This cohort of patients represents another first for our trial, as we transplant cells directly into the gray matter of the spinal cord in the cervical region," said Karl Johe, PhD, Neuralstem's Chairman and Chief Scientific Officer. "We are delighted that the surgeries are progressing in a region that could have a significant impact on the quality of life for ALS patients. With the safe transplantation of our 14th patient, we are well are on our way to demonstrating the safety of our novel procedure."

About the Trial The Phase I trial to assess the safety of Neuralstem's spinal cord neural stem cells and intraspinal transplantation method in ALS patients has been underway since January 2010. The trial is designed to enroll up to 18 patients. The first 12 patients were each transplanted in the lumbar (lower back) region of the spine, beginning with non-ambulatory and advancing to ambulatory cohorts. The trial has now progressed to the final six patients. Each is in the cervical (upper back) region of the spine. The entire 18-patient trial concludes six months after the final surgery.

About Neuralstem Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia and chronic stroke. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in chronic spinal cord injury.

Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company has received approval from the FDA to conduct a Phase Ib safety trial evaluating NSI-189, its first small molecule compound, for the treatment of major depressive disorder (MDD). Additional indications could include schizophrenia, Alzheimer's disease and bipolar disorder.

For more information, please visit http://www.neuralstem.com and connect with us on Twitter and Facebook.

Cautionary Statement Regarding Forward Looking Information This news release may contain forward-looking statements made pursuant to the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Neuralstem's technologies constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem's periodic reports, including the annual report on Form 10-K for the year ended December 31, 2010 and the quarterly report on Form 10-Q for the period ended September 30, 2011.

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Fourteenth Patient Dosed in Neuralstem ALS Stem Cell Trial

Stem Cell-Seeded Cardiopatch Could Deliver Results for Damaged Hearts

By Stem Cell Treatment

Durham, NC (PRWEB) March 07, 2012

A new type of stem cell-seeded patch has shown promising results in promoting healing after a heart attack, according to a study released today in the journal STEM CELLS Translational Medicine.

Ischemic heart disease, caused by vessel blockage, is a leading cause of death in many western countries. Studies have shown the potential of stem cells in regenerating heart tissue damaged during an attack. But even as the list of candidate cells for cardiac regeneration has expanded, none has emerged as the obvious choice, possibly because several cell types are needed to regenerate both the hearts muscles and its vascular components.

Aside from the choice of the right cell source for tissue regeneration, the best way to deliver the stem cells is up for debate, too, as intravenous delivery and injections can be inefficient and possibly harmful. While embryonic stem cells have shown great promise for heart repairs due to their ability to differentiate into virtually any cell type, less than 10 percent of injected cells typically survive the engraftment and of that number generally only 2 percent actually colonize the heart.

In order for this type of treatment is to be clinically effective, researchers need to find ways to deliver large numbers of stem cells in a supportive environment that can help cells survive and differentiate.

In the current cardiopatch study, conducted by researchers from the Faculty of Medicine of the Geneva University in collaboration with colleagues at the Ecole Polytechnique Federale de Lausanne (EPFL), cardiac-committed mouse embryonic stem cell (mESC) were committed toward the cardiac fate using a protein growth factor called BMP2 and then embedded into a fibrin hydrogel that is both biocompatible and biodegradable. The cells were loaded with superparamagnetic iron oxide nanoparticles so they could be tracked using magnetic resonance imaging, which also enabled the researchers to more accurately assess regional and global heart function.

The patches were engrafted onto the hearts of laboratory rats that had induced heart attacks. Six weeks later, the hearts of the animals receiving the mESC-seeded patches showed significant improvement over those receiving patches loaded with iron oxide nanoparticles alone. The patches had degraded, the cells had colonized the infarcted tissue and new blood vessels were forming in the vicinity of the transplanted patch. Improvements reached beyond the part of the heart where the patch had been applied to manifest globally.

Marisa Jaconi, PhD, of the Geneva University Department of Pathology and Immunology, and Jeffrey Hubbell, PhD, professor of bioengineering at the EPFL, were leaders on the investigative team. Their findings could make a significant impact on how heart patients are treated in the future. Altogether our data provide evidence that stem-cell based cardiopatches represent a promising therapeutic strategy to achieve efficient cell implantation and improved global and regional cardiac function after myocardial infarction, said Jaconi.

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The full article, Embryonic stem cell-based cardiopatches improve cardiac function in infarcted rats, can be accessed at: http://www.stemcellstm.com/content/early/recent.

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Stem Cell-Seeded Cardiopatch Could Deliver Results for Damaged Hearts

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