Category Archives: Cell Therapy

SALT LAKE CITY, UT--(Marketwire - Oct 25, 2012) - Q Holdings, Inc., dba Q Therapeutics, Inc., an emerging biotechnology company utilizing its proprietary innovative technology to develop breakthrough cell therapy products for the treatment of debilitating diseases of the central nervous system, today announced that Deborah Eppstein, PhD, President and CEO, will be presenting at the 2012 Stem Cell Meeting on the Mesa's Investor and Partnering Forum -- a premier business development and partnering meeting for regenerative medicine companies.

The Investor and Partnering Forum is being organized by the Alliance for Regenerative Medicine (ARM) and the California Institute for Regenerative Medicine (CIRM) to profile the industry's most exciting technologies.Thirty-five companies and organizations will be presenting over the course of two days, ranging from translational research centers to emerging-growth biotech companies, as well as established, publicly traded industry leaders.

The following are specific details regarding Q Therapeutics' presentation at the conference:

Date: October 29, 2012

Time: 10:15 AM PDT

Location: Sanford Consortium for Regenerative Medicine Building Auditorium, Second Floor Terrace 2880 Torrey Pines Scenic Drive La Jolla, California

The Investor and Partnering Forum was created in 2011 to facilitate translational research, promote engagement between the scientific and business communities and provide opportunities for business, academic research and investor participants to connect in one-on-one strategic partnering meetings.It will be held immediately prior to the Stem Cell Meeting on the Mesa's Scientific Symposium organized by the Sanford Consortium, and the combined meetings are expected to attract over 800 attendees from around the globe. The company presentations will be recorded by ARM and will be made available on ARM's website shortly after the event. To learn more or to register for the 2012 Stem Cell Meeting on the Mesa Symposium and Investor & Partnering Forum, please visit http://www.stemcellmeetingonthemesa.com.Registration is required.

About Q Therapeutics, Inc. Headquartered in Salt Lake City, Utah, Q Holdings, Inc., dba Q Therapeutics, Inc., is a fully reporting, non-trading company, engaged in developing adult stem cell therapies to treat debilitating diseases of the central nervous system.The Company's first product, Q-Cells, is a cell-based therapeutic intended to restore or preserve normal function of neurons by providing essential support functions that occur in healthy central nervous system tissues.Q-Cells may be applicable to a wide range of central nervous system diseases, including demyelinating conditions such as multiple sclerosis, transverse myelitis, cerebral palsy, and stroke, as well as other neurodegenerative diseases and injuries, such as ALS (Lou Gehrig's disease), spinal cord injury, Parkinson's disease and Alzheimer's disease.Q Therapeutics' initial clinical target is ALS, with a first IND filing expected in 2013.For more information, visit http://www.qthera.com.

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 Q Therapeutics' 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 its 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 results and other risks and uncertainties are detailed from time to time in Q Therapeutics' periodic reports, including the quarterly report on Form 10-Q for the period ended June 30, 2012.

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Q Therapeutics CEO to Present at 2012 Stem Cell Meeting on the Mesa

MANILA, Philippines Amid the recent warning issued by the Department of Health (DOH) regarding stem cell therapy, doctors who are offering the treatment in the Philippines clarified that they are not promising a cure.

We are very careful about claiming cure. These days ang dami nagsasalita, nawala ang sakit. All of a sudden siya (stem cell therapy) na yung magic bullet ng buong mundo, like if you get stem cell, you get cured, said Dr. Michelle de Vera, deputy director of the Institute of Personalized Molecular Medicine at The Medical City.

Kapag may narinig na ganyan dapat lalo silang mag-ingat. Cure is zero evidence of disease or kung genetic yung disease dapat napalitan yung genes mo. Hindi mangyayari yun at this point," he stressed.

De Vera, an allergologist and immunologist, does stem cell therapy on her patients at The Medical City but he said he believes that the DOH is right in warning patients on stem cell therapy.

Tama naman na magbigay sila ng warning,I think what their trying to do is regulate stem cell therapy, the doctor said.

Public advisory

The DOH recently came out with a public advisory on stem cell therapies saying that there is an "observed proliferation of centers offering stem cell treatments for medical and aesthetic purpose, and although this technology holds promise, stem cell therapy is not yet part of the standard of care and is considered an investigative procedure for compassionate use."

The DOH further stated that "applications of stem cells for the treatment of malignancies, blood disorders, degenerative diseases (e.g. Alzhimer's), metaboloc diseases (eg diabetes), and immune cell therapy are still under clinical evaluation and study."

I did not say it doesn't work but it takes a while, a lot of experiments and clinical studies before it is considered a standard of care in medicine, clarified Health Secretary Enrique T. Ona.

Ona also added in his statement that "the public is strongly advised to avoid stem cell therapies which use the following as sources for stem cells: embryonic stem cells, aborted fetuses, genetically-altered and animal fresh cells." Not from animals

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Doctors don't promise cure with stem cell therapy

PARIS--(BUSINESS WIRE)--

The C4C consortium today announced the implementation of France's first ever dedicated technical facility for the manufacture of cell therapy products. The C4C project (coordinated by CELLforCURE, a subsidiary of the leading French biopharmaceutical company LFB Biotechnologies) brings together the skills of two biotech companies (Celogos and CleanCells) and seven public-sector organizations and university medical centers (the French Blood Agency's [Etablissement Franais du Sang, EFS] directorates in the Aquitaine-Limousin and Pyrnes-Mditerrane regions of France, Bordeaux University Medical Center [CHU de Bordeaux], Lille University Medical Center/University of Lille 2 [CHU de Lille], Nantes University Medical Center, [CHU de Nantes] and the Biological Resource Center at Lyons University Medical Center [Banque de Tissus et de Cellules des Hospices Civils de Lyon]. The first five products are currently being developed, with a view to validating the facility dedicated to the routine production of clinical trial and therapeutic batches. This facility is located on LFB's site in Les Ulis, close to Paris.

C4C is an ambitious project that has attracted 80 million euros in investment from the consortium members and 30 million euros in public-sector financial aid (provided by OSEO, France's state innovation agency). In fact, C4C was selected by OSEO as part of the "Investing in the Future" call for tenders for France's first industry-academic gateway in the field of cell therapy research, development and industrial production. The project has attracted 30 million euros in public-sector financial aid. Thanks to C4C, academic, public- and private-sector stakeholders are provided with an industrial tool for producing both their Phase 3 clinical trial batches and commercial batches.

Lastly, the C4C project corresponds to Europe's first ever modular unit for the large-scale industrial production of novel, cell-based advanced therapy medicinal products.

Cell therapy: definitions and issues

Cell therapy involves the administration of human cells to prevent, treat or alleviate an illness. In some situations, the administered cells repair and/or rebuild damaged tissue. In others, modified cells are used to provide tissue with compounds that it previously lacked. The cell therapy market is set to be worth an estimated 5.2 billion US dollars by 2015 and could double again to reach 10 billion US dollars in 2020.

The five therapeutics currently under development and their target diseases are as follows:

1. The GRAPA Program in Phase I/II development at Bordeaux University Medical Center in collaboration with Frances National Blood Service (EFS). Hematopoietic stem cells are obtained from placental blood and amplified ex vivo prior to use for the treatment of bone marrow or lymph node malignancies (leukemia, lymphoma, myeloma), aplastic anemia, congenital immunodeficiencies and congenital enzyme deficiencies.

2. The CEL-02 cell therapeutic from Celogos, in Phase II clinical development for the treatment of anal incontinence A Phase II clinical trial is currently recruiting at Rouen University Medical Center and the start of the Phase III clinical program (to include investigators across Europe) is scheduled for 2014.

3. Autologous islet of Langerhans grafts (Lille University Medical Center/University of Lille 2), in Phase I/II clinical development for the treatment of post-pancreatectomy diabetes The procedure developed by Professor Franois Pattous group in Lille is based on an intramuscular, autologous transplant of islets of Langerhans that makes it possible to obtain long-term insulin independence in the majority of patients.

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The C4C consortium Announces the Implementation of France's First Ever Facility for the Industrialization of Cell ...

WASHINGTON, DC--(Marketwire - Oct 17, 2012) - The Alliance for Regenerative Medicine (ARM), the international organization representing the interests of the regenerative medicine community, announced the publication today of an article on FDA communications to help companies developing cell-based therapies by clarifying the development pathway. The article, entitled "Communications with the FDA on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?" will be published in the journal Stem Cells Translational Medicine. It is co-authored by representatives from ARM, Janssen R&D, GE Healthcare and Life Technologies, with the lead author from the California Institute for Regenerative Medicine (CIRM).

"There are a number of ways cell-based therapy companies can communicate with FDA that will help them navigate the road from the bench to a regulatory submission," said Michael Werner, Executive Director of ARM. "We hope that our combined experience as co-authors, and our attempt to create a single source of guidance on the regulatory process, will help companies bring new cell-based therapies through clinical trials and the regulatory review process more quickly so they can reach patients faster," added Mr. Werner.

Lead author Ellen Feigal, MD, Senior Vice President for Research and Development at the California Institute for Regenerative Medicine (CIRM) commented, "Cell-based therapies represent a fundamentally new way to treat or cure disease, but developing a new therapy is costly, time consuming and fraught with uncertainty. Our paper takes a practical approach to clarifying the path to market."

"Communications with the FDA on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?" provides detailed information on options for communicating with the FDA at different stages; the official communications tied to each stage of development; and the most common reasons regulatory applications are delayed. The article can be accessed at: http://stemcellstm.alphamedpress.org/content/early/recent

About CIRM: CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. A list of grants and loans awarded to date may be seen here: http://www.cirm.ca.gov/for-researchers/researchfunding.

About ARM: The Alliance for Regenerative Medicine is a Washington, DC-based multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, DC to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today ARM has more than 120 members and is the leading global advocacy organization in this field. In March 2012, ARM launched a sister organization in Europe -- the Alliance for Advanced Therapies. For more information go to http://www.alliancerm.org.

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Journal Stem Cell Translational Medicine to Publish Article on FDA Communications and the Regulatory Pathway for Cell ...

NEW YORK, Oct. 17, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), an emerging leader in the fast growing cell therapy market, today announced that it will redeem all outstanding shares of its Series E 7% Senior Convertible Preferred Stock ("Series E Preferred Stock").

On October 10, 2012, the Company gave notice to its Series E Preferred Stockholders that it is redeeming all of the outstanding shares of Series E Preferred Stock for an aggregate redemption price of $3.4 million, $2.5 million of which was funded by money placed into escrow when the Series E Preferred stock was issued in November 2010.

"We are pleased that we have been able to redeem this $10 million investment in full over a two year period. Equal to our focus on cell therapy product development and expanding our PCT contract development and manufacturing operations, we are committed to improving our balance sheet. Through the redemption of the Series E Preferred Stock, we will remove a significant overhang and simplify NeoStem's capital structure. The redemption of the Series E Preferred Stock is another example of a step taken by us to improve Common Stockholder value," said Dr. Robin Smith, Chairman and CEO of NeoStem. "We look forward to continued execution on our near term business strategy, including the forthcoming closing of the divestiture of our Erye China pharmaceutical subsidiary."

About NeoStem, Inc.

NeoStem, Inc. continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy market. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC ("PCT"), with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe this expertise and existing research capabilities and collaborations will enable us to achieve our mission of becoming a premier cell therapy company.

Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed.

For more information on NeoStem, please visit http://www.neostem.com.

Forward-Looking Statements for NeoStem, Inc.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's or its partners' successful development of AMR-001 and other cell therapeutics, the size of the market for such products, its competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its contract development and manufacturing ("CDMO") business, and the efficacy of protection from its patent portfolio, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. Forward looking statements also include statements with respect to satisfying all conditions to closing the disposition of Erye, including receipt of all necessary regulatory approvals in the PRC. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including but not limited to matters described under the "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update its forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

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NeoStem, Inc. Announces the Redemption of the Outstanding 7% Series E Preferred Stock

The Grekos hearing is scheduled to resume today. The location is the Collier County Courthouse in room 4-D, according to a case filing Monday.

The hearing before J. Lawrence Johnson, an administrative law judge from Tallahassee, is scheduled to last four days. The Collier County Courthouse is located at 3315 U.S. 41 E.

Photo by Allie Garza

Zannos Grekos

EAST NAPLES The patient was friends with the mother of Dr. Zannos Grekos, a Bonita Springs cardiologist who performed stem cell therapy on people with debilitating illnesses.

Chemotherapy for breast cancer several years earlier had left the 69-year-old patient, Domenica Fitzgerald, with numbness in her legs. She was unable to walk for more than 10 minutes. She hoped Grekos and his stem cell treatment could help.

"She was looking for a cure. She wanted to get well," her husband, John "Jack" Fitzgerald, testified Tuesday.

A four-day administrative hearing started Tuesday in a Collier County courtroom for a state Department of Health complaint against Grekos. The state says he committed medical malpractice and violated other standards of care when he performed a stem cell treatment on the patient on March 24, 2010. The patient suffered brain damage.

The state is only identifying the patient in its complaint by her initials, D.F. The Daily News learned of her identity by a public records request to the Collier County Medical Examiner's Office of all people who died on April 4, 2010, in the county. That was the day that Fitzgerald died after being taken off life support.

The state last year restricted Grekos' license after her death and ordered him not to do anything with stem cells with other patients. His license was fully suspended earlier this year when the state said he violated the order by treating another patient who also died.

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Husband testifies wife 'was looking for a cure' and found Bonita stem-cell doctor

NOKOMIS, Fla.--(BUSINESS WIRE)--

Rainbow Coral Corp. (RBCC) subsidiary Rainbow BioSciences will keep a close eye on a new study that could potentially lead to stem cell therapies for children with autism.

Researchers have been given the go-ahead by the FDA to launch a small study evaluating the effectiveness of autism treatments using patients own umbilical cord blood. Thirty children, aged two to seven, will receive injections of their own stem cells from the cord blood banked by their parents at birth.

Scientists will evaluate whether the stem cell therapy helps improve language and behavior in the children. Although the cause of autism is unknown and there is no cure for the disorder, one theory suggests that autism occurs because cell in the brain, known as neurons, are not connecting normally. Its possible that stem cells may address this problem.

RBCC is working to capitalize on the rising demand for effective new stem cell treatments by bringing a potentially game-changing stem cell technology to market. The company is close to a deal with Regenetech to acquire a license to perform cell expansion using that companys Rotary Cell Culture SystemTM, a rotating-wall bioreactor originally developed by NASA.

The rotating-wall bioreactor is capable of multiplying functional, 3-D stem cells for use in a variety of research projects, said RBCC CEO Patrick Brown. Stem cells carry tremendous potential to help researchers develop new treatments and cures for devastating diseases from Parkinsons to Alzheimers and even autism, but much research must be done first. Consequently, were very optimistic about the market potential for this revolutionary bioreactor technology.

RBCC plans to offer the new technology to help kickstart billions of dollars worth of research in an industry currently dominated by Amgen, Inc. (AMGN), Celgene Corporation (CELG), Genzyme Corp. (NASDAQ:GENZ) and Gilead Sciences Inc. (GILD).

For more information on Rainbow BioSciences, please visit http://www.rainbowbiosciences.com/investors.html.

About Rainbow BioSciences

Rainbow BioSciences, LLC, is a wholly owned subsidiary of Rainbow Coral Corp. (OTCBB:RBCC). The company continually seeks out new partnerships with biotechnology developers to deliver profitable new medical technologies and innovations. For more information on our growth-oriented business initiatives, please visit our website at [http://www.RainbowBioSciences.com]. For investment information and performance data on the company, please visit http://www.RainbowBioSciences.com/investors.html.

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RBCC: Could Stem Cells Be Key to Promising Autism Therapy?

The Grekos hearing is scheduled to begin at 9 a.m. Tuesday in the Martin Luther King, Jr. Administration Building, room 1-140A, 5775 Osceola Trail, Naples. It is scheduled for four days.

Photo by Allie Garza

Zannos Grekos

BONITA SPRINGS Bonita Springs physician Zannos Grekos, whose license is in jeopardy for controversial stem cell therapy, is getting his day before a judge.

Barring a last-minute delay or settlement, an administrative hearing is scheduled to begin Tuesday in Naples for the 47-year-old. He is fighting to get his license back in good standing from a suspension order, while the state Department of Health is pursuing more discipline and potentially revocation of his license.

Trained as a cardiologist, he's been licensed in Florida since 1996.

The trial-like proceeding, without a jury, is scheduled for four days before an administrative law judge. The proceeding is open to the public. The case against Grekos has garnered considerable media attention, including CNN and inquiries from European media.

A Texas father, Jimmy Bell, will be tracking what happens. Last year, he paid $57,000 upfront for his 5-year-old son, Jason, to undergo stem cell therapy to fight pulmonary hypertension. Despite pleas that his boy was weakening by the day, the treatment was never scheduled and Jason died. Bell received a $10,000 refund.

"He's taking advantage of people and it's more for personal gain," Bell said. "I'd like to see that stopped."

The hearing has been rescheduled numerous times since the state issued an emergency restriction against Grekos in February 2011. Authorities restricted his license and told him not to do any treatment with patients which involve bone marrow or stem cells.

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State licensing hearing for Bonita Springs stem cell doctor to begin Tuesday

Hanggang ngayon ay usap-usapan pa rin ang Fresh Cell Therapy (FCT) o mas kilala natin bilang stem cell therapy lalo nat marami nang celebrities ang nahihikayat na sumailalim sa naturang medical procedure na nagpo-promote ng anti-aging at nakatutulong para labanan ang ilang serious health conditions.

Isa na nga rito ang sikat na hairstylist, beauty expert, philanthropist, businessman, at TV host na si Ricky Reyes o mas kilala bilang si Mother Ricky.

Sumailalim si Mother Ricky sa FCT noong Hunyo ng taong ito at ngayon nga ay ine-enjoy niya ang benepisyo nito sa kanyang kalusugan.

The fact that my arthritis is gone, Im very, very happy and Im thankful to Bobby [Kittichaiwong, Villa Medica CEO). And its just a two-shot on my back, gone instantly. You know, yung quality of life mo na hindi ka aray-aray-aray?

Tapos nagpunta ako sa Germany last June and its such a beautiful place. We even had meron ka pang tour sa Paris [France]. Very nice place, sabi ni Mother Ricky.

Nakausap ng PEP.ph (Philippine Entertainment Portal) si Mother Ricky sa presscon ng Villa Medica tungkol sa FCT na ginanap kaninang tanghali, Oktubre 13, sa Crowne Plaza sa Ortigas, Pasig City.

Hindi rin daw niya maitatanggi ang kabutihang naidulot ng FCT sa kanyang ina, na sumailalim din sa naturang therapy.

Oo naman, with my experience with my mom. Dati nakatungo na, ngayon nakataas na yung leeg na ganyan, paglalarawan pa ni Mother Ricky tungkol sa nagawa ng FCT sa kanyang ina.

Nai-stretch na yung mga kamay. Isang malaking utang na loob ko yun kay Bobby. It is a Christmas gift of Bobby to me to cure my mom.

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Ricky Reyes to help set up Fresh Cell Therapy clinic in the Philippines