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Clinic licensed by controversial stem cell treatment group

The state took action against Dr. Zannos Grekos because of the death of a 69-year-old breast cancer patient April 4, 2010, after undergoing the treatment at his Bonita Springs practice, at 9500 Bonita Beach Road, Suite 310.

BONITA SPRINGS — Dr. Zannos Grekos may not have an attorney representing him at a hearing next month against a state complaint that he performed an unauthorized stem cell procedure on a patient who later died.

Or maybe the Bonita Springs cardiologist will have new counsel for the three-day administrative hearing scheduled to begin March 20.

His original attorney, Greg Chaires of Orlando, withdrew from the case Jan. 24, less than two months before the hearing. He's been Grekos' attorney since the state filed an administrative complaint against the doctor a year ago.

Grekos couldn't be reached for comment at his practice, Regenocyte Therapeutic, 9500 Bonita Beach Road, Suite 310.

Chaires stated in his withdrawal notice to the judge that he had good cause to stop representing him, but didn't elaborate.

Florida health department spokeswoman Jennifer Hirst said this past week that Grekos has two weeks to hire a new attorney “and regardless of whether he does or not, the trial date will not change.”

The case, which stems from events in early 2010, culminated a year later on Feb. 22, 2011, when the health department imposed an emergency restriction against his license. The restriction prohibits him from doing any procedures with bone marrow or stem cells in his practice.

If the administrative law judge sides with the state, Grekos could face sanctions or permanent restriction or revocation of his license.

At issue was Grekos' treatment of a 69-year-old woman who went to him for a consult on Feb. 25, 2010, for numbness and tingling in her arms and legs after chemotherapy.

Grekos ordered imaging of her carotid arteries and her brain and later injected her own aspirated bone marrow into her cerebral circulatory system.

At home that evening, she fell and was hospitalized. She had suffered a severe brain stem injury and was taken off life support on April 2, 2010.

Licensed in Florida since 1992, Grekos' cardiology practice in recent years has focused more on stem cell therapy to repair damaged heart muscle, lungs and other tissue.

He sends a sample of a patient's lung to Israel to cultivate new stem cells and the blood gets sent to a clinic or hospital in the Dominican Republic. The patient travels to the Dominican Republic, where the stem cells are injected into the damaged tissue.

Grekos has established a relationship with doctors and clinicians in the Dominican Republic who do the injections on his behalf; he isn't licensed to practice medicine there.

The case has captured widespread attention among Grekos' supporters who swear their once-chronic illnesses have undergone dramatic improvement since having the therapy through him. Detractors say he is taking advantage of a vulnerable population with congestive heart failure, lung failure and other illnesses for which conventional treatments no longer are effective.

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Stem Cell Treatment Offered At Oceanside Clinic Despite Controversy In Colorado

CLEVELAND, Ohio, Feb. 1, 2012 (GLOBE NEWSWIRE) — Athersys, Inc. (Nasdaq:ATHX – News), a leader in the emerging field of regenerative medicine, announced today grant funding aggregating $3.6 million to further advance its MultiStem(R) product programs and cell therapy platform. Specifically, Athersys was awarded a SBIR Fast-Track grant of up to $1.9 million from the National Institute of Neurological Disorders and Stroke (NINDS) to develop MultiStem for the treatment of traumatic brain injury (TBI). In addition, Athersys' subsidiary based in Belgium, ReGenesys BVBA, was awarded a $1.2 million (EURO0.9 million) grant from the Belgium's Agency for Innovation by Science and Technology (IWT) to further develop cell therapy formulations and manufacturing capabilities. The company has also been awarded funding recently to work in other areas, such as using MultiStem to treat chronic cardiovascular disease.

“These grant awards provide us with additional funding to support further development of MultiStem in specific therapeutic areas, as well as enhance our manufacturing platform,” said Dr. Gil Van Bokkelen, Athersys Chairman & CEO. “Historically, we have been very successful at obtaining this type of funding, which reflects our commitment to outstanding science and technology development, and development of innovative new therapies.”

NINDS TBI Grant

The work under the NINDS grant to develop MultiStem for the treatment of TBI will be conducted in collaboration with researchers at The University of Texas Health Science Center at Houston (UTHealth) Medical School. The research program will include preclinical safety and efficacy studies required to support an Investigational New Drug (IND) application and the clinical investigation of MultiStem treatment of TBI.

TBI is a serious clinical problem that affects young people, members of the armed services and other adults. According to the Centers for Disease Control, there are nearly 1.4 million emergency room visits each year as a result of TBI, resulting in 275,000 hospitalizations and 52,000 deaths annually.

“Based on the results from studies conducted with our collaborators, we believe MultiStem could have a significant impact in treating damage from acute neurological injury, such as TBI, ischemic stroke and other indications,” said Dr. Van Bokkelen.

Dr. Charles Cox, Jr., who directs the multi-disciplinary effort at UTHealth Medical School that is focused on stem cell therapy for traumatic brain injury and related neurological injuries, will lead the collaboration with Athersys. “Our prior work with Athersys has demonstrated that MultiStem modulates the inflammatory component of secondary brain injury in preclinical models of TBI,” said Dr. Cox, professor of pediatric surgery at UTHealth and director of the pediatric trauma program at Children's Memorial Hermann Hospital in Houston. “This is an area of tremendous unmet medical need, which carries both a high cost burden, as well as impacting patient and family quality of life. We will build on this promising work to advance the application of this cell therapy into clinical studies.”

IWT Grant

The IWT grant will fund a product and process development program undertaken in Belgium by ReGenesys, Athersys' affiliate. A principal focus of these efforts will be the continued development of serum-free formulations for the manufacture of MultiStem and related cell therapy products. ReGenesys researchers will collaborate with researchers from the Katholieke Universiteit of Leuven, as well as certain corporate partners to complete the program.

“Our ReGenesys affiliate plays a significant role in the development of improved process and manufacturing approaches for cell therapy products,” said William Lehmann, President and COO of Athersys, and Manager of ReGenesys. “We expect this grant-funded work to have substantial impact on product manufacturing and clinical development in Europe and globally.”

About MultiStem

MultiStem(R) cell therapy is a patented product that has shown the ability to promote tissue repair and healing in a variety of ways, such as through the production of multiple therapeutic factors produced in response to signals of inflammation and tissue damage. MultiStem has demonstrated therapeutic potential for the treatment of inflammatory and immune disorders, neurological conditions, and cardiovascular disease, as well as other areas, and represents a unique “off-the-shelf” stem cell product that can be manufactured in a scalable manner, may be stored for years in frozen form, and is administered without tissue matching or the need for immune suppression. The product is extensively characterized for safety, consistency and potency. Athersys has forged strategic partnerships with Pfizer Inc. to develop MultiStem for inflammatory bowel disease and with RTI Biologics, Inc. to develop cell therapy for use with a bone allograft product in the orthopedic market.

About Athersys

Athersys is a clinical stage biotechnology company engaged in the discovery and development of therapeutic product candidates designed to extend and enhance the quality of human life. The Company is developing its MultiStem(R) cell therapy product, a patented, adult-derived “off-the-shelf” stem cell product platform for disease indications in the cardiovascular, neurological, inflammatory and immune disease areas. The Company currently has several clinical stage programs involving MultiStem, including for treating inflammatory bowel disease, ischemic stroke, damage caused by myocardial infarction, and for the prevention of graft versus host disease. Athersys has also developed a diverse portfolio that includes other technologies and product development opportunities, and has forged strategic partnerships and collaborations with leading pharmaceutical and biotechnology companies, as well as world-renowned research institutions in the United States and Europe to further develop its platform and products. More information is available at www.athersys.com.

The Athersys, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=4548

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. These forward-looking statements relate to, among other things, the expected timetable for development of our product candidates, our growth strategy, and our future financial performance, including our operations, economic performance, financial condition, prospects, and other future events. We have attempted to identify forward-looking statements by using such words as “anticipates,” “believes,” “can,” “continue,” “could,” “estimates,” “expects,” “intends,” “may,” “plans,” “potential,” “should,” “suggest,” “will,” or other similar expressions. These forward-looking statements are only predictions and are largely based on our current expectations. A number of known and unknown risks, uncertainties, and other factors could affect the accuracy of these statements. Some of the more significant known risks that we face that could cause actual results to differ materially from those implied by forward-looking statements are the risks and uncertainties inherent in the process of discovering, developing, and commercializing products that are safe and effective for use as human therapeutics, such as the uncertainty regarding market acceptance of our product candidates and our ability to generate revenues, including MultiStem for the treatment of inflammatory bowel disease, acute myocardial infarction, stroke and other disease indications, and the prevention of graft-versus-host disease. These risks may cause our actual results, levels of activity, performance, or achievements to differ materially from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements. Other important factors to consider in evaluating our forward-looking statements include: our ability to raise additional capital; final results from our MultiStem clinical trials; the possibility of delays in, adverse results of, and excessive costs of the development process; our ability to successfully initiate and complete clinical trials; changes in external market factors; changes in our industry's overall performance; changes in our business strategy; our ability to protect our intellectual property portfolio; our possible inability to realize commercially valuable discoveries in our collaborations with pharmaceutical and other biotechnology companies; our ability to meet milestones under our collaboration agreements; our collaborators' ability to continue to fulfill their obligations under the terms of our collaboration agreements; our possible inability to execute our strategy due to changes in our industry or the economy generally; changes in productivity and reliability of suppliers; and the success of our competitors and the emergence of new competitors. You should not place undue reliance on forward-looking statements contained in this press release, and we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.

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Athersys Awarded $3.6 Million in Grant Funding for Stem Cell Product Development

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Calif. clinic licensed by controversial stem cell treatment group

NEW YORK & PETACH TIKVAH, Israel–(BUSINESS WIRE)– BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI.OB – News), a leading developer of adult stem cell technologies and therapeutics, announced today that the prestigious Experimental Neurology Journal, published an article indicating that preclinical studies using cells that underwent treatment with Brainstorm’s NurOwn™ technology show promise in an animal model of Huntington’s disease. The article was published by leading scientists including Professor Melamed and Professor Offen of the Tel Aviv University.

In these studies, bone marrow derived mesenchymal stem cells secreting neurotrophic factors (MSC-NTF), from patients with Huntington’s disease, were transplanted into the animal model of this disease and showed therapeutic improvement.

“The findings from this study demonstrate that stem cells derived from patients with a neurodegenerative disease, which are processed using BrainStorm’s NurOwn™ technology, may alleviate neurotoxic signs, in a similar way to cells derived from healthy donors. This is an important development for the company, as it confirms that autologous transplantation may be beneficial for such additional therapeutic indications,” said Dr. Adrian Harel, BrainStorm’s CEO.

“These findings provide support once again that BrainStorm’s MSC-NTF secreting cells have the potential to become a platform that in the future will provide treatment for various neuro-degenerative diseases,” says Chaim Lebovits, President of BrainStorm. “This study follows previously published pre-clinical studies that demonstrated improvement in animal models of neurodegenerative diseases such as Parkinson’s, Multiple Sclerosis (MS) and neural damage such as optic nerve transection and sciatic nerve injury. Therefore, BrainStorm will consider focusing on a new indication in the near future, in addition to the ongoing Clinical Trials in ALS.”

BrainStrom is currently conducting a Phase I/II Human Clinical Trial for Amyotrophic Lateral Sclerosis (ALS) also known as Lou Gehrig’s disease at the Hadassah Medical center. Initial results from the clinical trial (which is designed mainly to test the safety of the treatment), that were announced last week, have shown that the Brainstorm’s NurOwn™ therapy is safe and does not show any significant treatment-related adverse events and have also shown certain signs of beneficial clinical effects.

To read the Article entitled ‘Mesenchymal stem cells induced to secrete neurotrophic factors attenuate quinolinic acid toxicity: A potential therapy for Huntington's disease’ by Sadan et al. please go to:

http://www.sciencedirect.com/science/article/pii/S0014488612000295

About BrainStorm Cell Therapeutics, Inc.

BrainStorm Cell Therapeutics Inc. is a biotech company developing adult stem cell therapeutic products, derived from autologous (self) bone marrow cells, for the treatment of neurodegenerative diseases. The company, through its wholly owned subsidiary Brainstorm Cell Therapeutics Ltd., holds rights to develop and commercialize the technology through an exclusive, worldwide licensing agreement with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel-Aviv University. The technology is currently in a Phase I/II clinical trials for ALS in Israel.

Safe Harbor Statement

Statements in this announcement other than historical data and information constitute “forward-looking statements” and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements, including, inter alia, regarding safety and efficacy in its human clinical trials and thereafter; the Company's ability to progress any product candidates in pre-clinical or clinical trials; the scope, rate and progress of its pre-clinical trials and other research and development activities; the scope, rate and progress of clinical trials we commence; clinical trial results; safety and efficacy of the product even if the data from pre-clinical or clinical trials is positive; uncertainties relating to clinical trials; risks relating to the commercialization, if any, of our proposed product candidates; dependence on the efforts of third parties; failure by us to secure and maintain relationships with collaborators; dependence on intellectual property; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility, and risks that we may lack the financial resources and access to capital to fund our operations. The potential risks and uncertainties include risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect its technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. The Company does not undertake any obligation to update forward-looking statements made by us.

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Experimental Neurology Journal: BrainStorm's NurOwn™ Stem Cell Technology Shows Promise for Treating Huntington's …

Pro/Am ballroom dancer and orthodontist, Dr. Janet Vaughan, is once again slated to compete on the professional dance circuit with her current professional partner, Mr. Eddie Stutts (Professional 10-Dance World Champion) following a successful stem cell procedure on her knee in Panama.

Corpus Christi, TX (PRWEB) February 01, 2012

Pro/Am ballroom dancer and orthodontist, Dr. Janet Vaughan, is once again slated to compete on the professional dance circuit with her current professional partner, Mr. Eddie Stutts (Professional 10-Dance World Champion) following a successful stem cell procedure on her knee in Panama.

From 2007-2009, Dr. Vaughan partnered with World Champion Tony Dovolani and competed extensively in the U.S., winning a National Reserve Pro/Am Rhythm title. Tony Dovolani is best known for his appearances on ABC's hit reality series, “Dancing with the Stars”, and has teamed up with Chynna Phillips, Wendy Williams, Audrina Partridge, Kate Gosselin, Kathy Ireland, Susan Lucci, Jane Seymour and other celebrities on the show.

Dr. Vaughan and Mr. Stutts are slated to compete in the Heritage Classic Dancesport Championships in Asheville, North Carolina next month. This will be the first time Dr. Vaughan has been able to compete since 2010 when she sustained a dancing related knee injury.

Dr. Vaughan also suffered from chronic neck pain resulting from injuries sustained in a car crash twenty years ago. Her neck injury culminated in a natural fusion of the c5-c6 vertebrae, scoliosis and extreme pain when her neck slipped out of alignment.

In an attempt to repair her knee and get her dancing career back on track, Dr. Vaughan decided to undergo stem cell therapy at the Stem Cell Institute in Panama City, Panama. “I was basically removed from competitive dance work because I could not rise or squat without extreme pain. I had also resigned myself to enduring chronic neck pain from my past accident and painful hand joints due to generalized arthritis,” said Dr. Vaughan.

Dr. Vaughan 's knee was treated with stem cells that were harvested from her own adipose (fat) tissue.

The fat tissue sample is collected via mini-liposuction, which is performed by a certified plastic surgeon under light, general anesthesia. Mesenchymal stem cells and T regulatory cells reside within this tissue.

Adipose-derived cells are then separated from the fat at Medistem Panama’s state-of-the-art laboratory at the prestigious City of Knowledge. This entire process is subjected to stringent quality control. Before they can be administered back into the patient, these adipose-derived stem cells are tested for quality, bacterial contamination (aerobic and anaerobic) and endotoxin.

All patients treated with adipose stem cells at the Stem Cell Institute wait about one week before the stem cells can be re-implanted to minimize the probability of the cells migrating back to the liposuction injury site. This essential procedural step separates treatment in Panama from “same-day” protocols offered elsewhere.

The adipose-derived stem cells are administered by a highly-qualified physician into the affected joint(s) (intra-articular injection) and intravenously (IV).

“It's taken about 6 months but I am amazed at the results I've gotten with my knee. Even my neck is better. I used to spend almost $1,000 per month on a neuromuscular massage therapist but I haven't needed any neuromuscular massages for the past 6 months. I wasn't counting on that. Even my doctors say that the dense scar tissue in my neck has changed in texture from grizzly to smooth, supple tissue,” exclaimed Dr. Vaughan.

She continued, “I just danced 6 hours in Houston preparing for the upcoming competition in Asheville and my knee isn't even sore.”

Dr. Vaughan is planning to return to Panama for a follow-up treatment this summer.

About the Stem Cell Institute

Founded in 2006 on the principles of providing unbiased, scientifically-sound treatment options, the Stem Cell Institute has matured into the world’s leading adult stem cell therapy and research center. In close collaboration with universities and physicians world-wide, the institute’s doctors treat carefully selected patients with spinal cord injury, osteoarthritis, heart disease, multiple sclerosis, rheumatoid arthritis, and other autoimmune diseases. Doctors at The Stem Cell Institute have treated over 1000 patients to-date.

About Medistem Panama Inc.

Medistem performs all stem cell processing for the Stem Cell Institute. It operates an 8000 sq. ft. cGMP and cGMP compliant laboratory that features 3 class 10000 clean rooms, 8 class 100 laminar flow hoods, and 12 class 100 incubators.

For more information on stem cell therapy:

Stem Cell Institute Website: http://www.cellmedicine.com

Stem Cell Institute

Via Israel & Calle 66

Pacifica Plaza Office #2A

San Francisco, Panama

Republic of Panama

Phone: +1 800 980-STEM (7836) (USA Toll-free) +1 954 636-3390 (from outside USA)

Fax:    +1 866 775-3951 (USA Toll-free)    +1 775 887-1194 (from outside USA)

###

Jay Lenner
jdlenner@cellmedicine.com
1-800-980-7836
Email Information

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Pro/Am Dancer is "Dancing with the Stars" Again After Stem Cell Therapy in Panama

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Skin cells turned into neural precusors, bypassing stem-cell stage

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Stanford scientists turn skin cells into neural precusors, bypassing stem-cell stage

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ScienceDaily (Jan. 27, 2012) — A
collaborative anti-cancer research jointly conducted by The
Hong Kong Polytechnic University (PolyU), Peking University
Shenzhen Graduate School and Nevada Cancer Institute has led to
the development of a novel class of chemical inhibitors that
specifically target cancer cells with pluripotency.

This cutting-edge research has combined the effort of three
research teams including one led by Dr Tao Ye (??), Associate
Professor of PolyU's Department of Applied Biology and Chemical
Technology. This breakthrough may help the selective removal of
cancer stem cells and potentially provide a novel strategy to
eradicate cancers.

Cancer is a major cause of human death in China and all around
the world. It is difficult to treat cause of the existence of
cancer initiating cells/cancer stem cells. Although they exist
in very few in numbers, cancer stem cells (CSCs) can
proliferate and self-renew, and are pluripotent and
multipotent, which have the capability to differentiate into
various more heterogeneous cancer cells that constitute the
entire tumor mass. As stem cells, they are more resistant to
most conventional cancer therapies such as chemotherapy or
radiotherapy due to their differences in the cell cycle
regulation and DNA repair processes. They also act as the
source for metastasis and recurring drug resistant cancers
after conventional cancer therapy. Currently, there are no
chemical inhibitors or other agents that can specifically and
selectively target cancer stem cells. The development of
compounds that target cancer stem cells is an unmet medical
demand for the eradication of malignant cancers.

According to Dr Ye, the potential clinical applications of new
LSD1 inhibitors include the following:

(1) They can be used to treat malignant germ cell tumors such
as teratoma/teratocarcinomas, embryonic carcinomas, seminomas,
choriocarcinomas, and tumors of yolk sac. These tumors are
usually treated by surgery or cis-platinum, but after initial
treatment, these tumors always become resistant to platinum
drugs. So far, the LSD1 inhibitors are highly effective towards
these pluriptont cancers with stem cell properties.

(2) The LSD1 inhibitors may also be used to remove
teratomas/embryonic carcinomas during stem cell-based therapy.
One major problem in stem/iPS cell-based therapy is the
formation of embryonic carcinomas, teratomas, or
teratocarcinomas by incomplete differentiation of ES/iPS cells
in the organs of recipients.  Because LSD1 selectively
inhibit these pluripotent embryonic carcinomas, teratomas, or
teratocarcinomas, LSD1 inhibitors may help ensure the
successful application of stem cell-based therapy.

(3) More importantly, since teratomas/embryonic carcinomas are
pluripotent cancer stem cells, researchers will probe whether
cancer stem cells of other types of major organ-specific
cancers such as breast, ovarian, lung, and brain cancers are
sensitive to these LSD1 inhibitors. Further studies indicated
that LSD1 inhibitors can also be used to inhibit many cancer
stem cell-like cells such as breast and ovarian cancers.

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Story Source:

The above story is reprinted from materials provided by The Hong Kong Polytechnic
University, via ResearchSEA.

Note: Materials may be edited for content and length. For
further information, please contact the source cited
above.

Journal References:

Felix Cheung. Cancer biology: Ridding the seeds of
evil. Nature China, 2012; DOI: 10.1038/nchina.2012.1

J. Wang, F. Lu, Q. Ren, H. Sun, Z. Xu, R. Lan, Y. Liu, D.
Ward, J. Quan, T. Ye, H. Zhang. Novel Histone
Demethylase LSD1 Inhibitors Selectively Target Cancer Cells
with Pluripotent Stem Cell Properties. Cancer
Research, 2011; 71 (23): 7238 DOI: 10.1158/0008-5472.CAN-11-0896

Note: If no author is given, the source is cited
instead.

Disclaimer: This article is not intended
to provide medical advice, diagnosis or treatment. Views
expressed here do not necessarily reflect those of ScienceDaily
or its staff.

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Collaborative research sheds light on new cancer stem cell therapies

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