Public release date: 26-Jun-2012 [ | E-mail | Share ]

Contact: David Eve celltransplantation@gmail.com Cell Transplantation Center of Excellence for Aging and Brain Repair

Putnam Valley, NY. (June 26 , 2012) Researchers in Japan who evaluated the risks and efficacy of transplanting two varieties of stem cells into mouse cochlea have concluded that both adult-derived induced pluripotent stem (iPS) cells and mouse embryonic stem (ES) cells demonstrate similar survival and neural differentiation capabilities. However, there is a risk of tumor growth associated with transplanting iPS cells into mouse cochleae. Given the potential for tumorigenesis, they concluded that the source of iPS cells is a critical issue for iPS cell-based therapy.

Their study is published in a recent issue of Cell Transplantation (21:4), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/,

"Hearing loss affects millions of people worldwide," said Dr. Takayuki Nakagawa of the Department of Otolaryngology, Graduate School of Medicine, Kyoto University, Japan. "Recent studies have indicated the potential of stem-cell based approaches for the regeneration of hair cells and associated auditory primary neurons. These structures are essential for hearing and defects result in profound hearing loss and deafness."

The authors noted that embryonic stem cells have previously been identified as promising candidates for transplantation, however they have also been associated with immune rejection and ethics issues. Consequently, this study compared the survival and neural differentiation capabilities of ES and three clones of mouse iPS cells.

"Our study examined using induced pluripotent stem cells generated from the patient source to determine if they offer a promising alternative to ES cells," explained Dr. Nakagawa. "In addition, the potential for tumor risk from iPS cells needed clarification."

Four weeks after transplantation, the researchers found that the majority of cochleae that had been transplanted exhibited the settlement of iPS or ES-derived neurons. However, there was a difference in the number of cells present based on cell lines. They noted that the number of cells able to be transplanted into cochleae is limited because of the cochleae's tiny size. Thus, the number of settled cells is low.

They also noted the formation of a teratoma (encapsulated tumor) in some cochlea after transplantation with one group of iPS cells.

"To our knowledge, this is the first documentation of teratoma formation in cochleae after cell transplantation," said Dr. Nakagawa.

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Stem cell transplantation into mouse cochlea may impact future hearing loss therapies

The Sugar Land company involved in Gov. Rick Perry's unlicensed adult stem-cell procedure is rife with basic manufacturing problems, according to the U.S. Food and Drug Administration.

In a report one expert called a blow to the entire adult stem-cell industry, the FDA found that Celltex Therapeutics Corp. cannot guarantee the sterility, uniformity and integrity of stem cells it takes from people and then stores and grows for eventual therapeutic reinjection.

"You have not performed a validation of your banking and thawing process to assure viability" of the stem cells, reads the April 27 report, meaning that the company cannot verify the cells are alive.

The FDA report, which followed an April 16-27 inspection of Celltex, was released under the Freedom of Information Act Monday to the Houston Chronicle and a University of Minnesota bioethicist who complained in February that Celltex is a potential danger to patients and not in compliance with federal law.

The report, partially redacted, was not accompanied by a warning letter.

A former FDA official who asked not to be identified, however, said the deficiencies - 79 in all, from incorrectly labeled products to failed sterility tests - are so serious that Celltex risks being shut down if it does not remedy the problems quickly.

Adult stem cells are cells in the body that multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have shown promise for tissue repair in many other diseases in the last decade, although most scientists in the field consider them not ready for mainstream use.

Rules take effect July 8

Celltex has been in the public eye since it was revealed that Perry's Houston doctor treated him with his own stem cells during back surgery last July and in follow-up appointments. His stem cells were stored and grown at Celltex.

Perry subsequently called for Texas to become the nation's leader of adult stem cell medicine, which he touts as an ethical alternative to embryonic stem cells. Perry worked with his Houston doctor and a state representative to write legislation intended to commercialize the therapy in Texas.

See the article here:
FDA report faults Houston stem-cell company

Optimal stem cell therapy delivery to damaged areas of the heart after myocardial infarction has been hampered by inefficient homing of cells to the damaged site. However, using rat models, researchers in France have used a magnet to guide cells loaded with iron oxide nanoparticles to key sites, enhancing the myocardial retention of intravascularly delivered endothelial progenitor cells.

The study is published in a recent issue of Cell Transplantation (21:4), now freely available online.

"Cell therapy is a promising approach to myocardial regeneration and neovascularization, but currently suffers from the inefficient homing of cells after intracavitary infusion," said Dr. Philippe Menasche of the INSERM U633 Laboratory of Surgical Research in Paris. "Our study was aimed at improving and controlling homing by loading human cord-blood-derived endothelial progenitor cells (EPCs) for transplant with iron oxide nanoparticles in order to better position and retain them in the hearts of myocardial-injured test rats by using a subcutaneously implanted magnet."

The researchers found that the cells were sufficiently magnetic to be able to be remotely manipulated by a magnet subsequent to implantation.

According to the researchers, an objective assessment of the technique to enhance the homing of circulating stem cells is the ability to track their fate in vivo. This was accomplished by visualization with MRI.

"We found a good correlation between MRI non-invasive follow-up of the injected cells and immunofluoresence or quantitative PCR data," said Dr. Menasche. The researchers concluded that further studies were needed to follow cell homing at later time points. They noted that the magnitude of homing they experienced may have been reduced by the relatively small number of cells used, owing to their large size and the subsequent risk of coronary thrombosis.

"In a rat model of myocardial infarction, this pilot study suggested homing of circulating stem cells can be improved by magnetic targeting and warrants additional benchwork to confirm the validity of concept," said Dr. Menasche. "There is also a need to optimize the parameters of targeting and assess the relevance of this approach in a clinically relevant large animal model."

"This study highlights the use of magnets to target transplanted cells to specific sites which could increase their regenerative impact. Factors to still be extensively tested include confirming the safety of the cells containing the magnetic particles and whether this process alters the cell's abilities" said Dr. Amit N. Patel, director of cardiovascular regenerative medicine at the University of Utah and section editor for Cell Transplantation.

More information: Chaudeurge, A.; Wilhelm, C.; Chen-Tournoux, A.; Farahmand, P.; Bellamy, V.; Autret, G.; Mnager, C.; Hagge, A.; Larghro, J.; Gazeau, F.; Clment, O.; Menasch, P. Can Magnetic Targeting of Magnetically Labeled Circulating Cells Optimize Intramyocardial Cell Retention? Cell Transplant. 21 (4):679-691; 2012.

Journal reference: Cell Transplantation

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Magnet helps target transplanted iron-loaded cells to key areas of heart

COLORADO SPRINGS, Colo.--(BUSINESS WIRE)--

HemoGenix announced today that FDA CBER has given HemoGenix its first Master File Number for an in vitro blood stem cell potency, quality and release assay (HALO-96 PQR) (1)for cellular therapy products(2)used for stem cell transplantation purposes. HALO-96 PQR is the first commercially available stem cell potency assay for cellular therapy products. It incorporates the most sensitive readout available to measure changes in the cells energy source (ATP) as a function of the potential for stem cells to proliferate. Potency and quality of stem cell therapeutic products are required to be measured prior to use to help predict the engraftment of the cells in the patient. At the present time, tests such as cell number, viability and a stem cell marker called CD34 are routinely used. However, none of these tests specifically measure stem cells and none determine the stem cell biological activity required for a potency assay. The only cell functionality test presently used in this field, especially for umbilical cord blood transplantation, is the colony-forming unit (CFU) assay, which is subjective, non-validated and has been used since the early 1970s. HALO-96 PQR changes this paradigm. It is particularly needed in the umbilical cord blood stem cell transplantation field by providing an application-specific test incorporating all of the compliance characteristics required not only by regulatory agencies(3) and standards organizations, but also the cord blood community(4).

Stem cell potency is one of the most important parameters necessary for any therapeutic product, especially stem cells. Without it, the dose cannot be defined and the transplantation physician has no indication as to whether the product will engraft in the patient. The number of cord blood units collected and stored and the number of cord blood stem cell transplantations have increased exponentially over the last 12 years. During this time, significant advancements have been made in pre- and post stem cell transplantation procedures. Yet the tests used during the preparation and processing of the cells have remained unchanged and do not even measure the biological functionality of the stem cells being transplanted. Indeed, the standards organizations responsible for applying regulatory guidance to the community have so far failed to allow any new and alternative assays to be used during cord blood processing. HALO-96 PQR is the first test that actually quantitatively characterizes and defines the stem cells in cord blood, mobilized peripheral blood or bone marrow as high quality and potent active ingredients for release prior to transplantation. Presently, approximately 20% engraftment failure is encountered in cord blood transplantation. HALO-96 PQR could help reduce the risk of engraftment failure by providing valuable and time-sensitive information on the stem cells prior to use. HALO-96 PQR complies with the guidelines not only with the cord blood community, but also with regulatory agencies thereby providing a benefit to both the stem cell transplantation center and the patient, said Ivan Rich, Founder and CEO of HemoGenix (www.hemogenix.com).

About HemoGenix, Inc.

HemoGenix is a privately held Contract Research Service and Assay Development Laboratory based in Colorado Springs, Colorado. Specializing in predictive in vitro stem cell toxicity testing, HemoGenix provides its services to small, medium and many of the largest biopharmaceutical companies. HemoGenix has developed several assays for stem cell therapy and regenerative medicine applications. These and other patented and proprietary assays are manufactured and produced in Colorado Springs and sold worldwide. HemoGenix has been responsible for changing the paradigm and bringing in vitro stem cell hemotoxicity testing into the 21st century. With HALO-96 PQR the company is now also changing the paradigm to become a leader in stem cell therapy assays. To this end, HemoGenix is a member of the Alliance for Regenerative Medicine and working with other companies to decrease risk and improve safety for the patient.

Literature Cited

Read more here:
HemoGenix® FDA Master File to Measure Blood Stem Cell Potency for Cellular Therapy Products:

The Sugar Land company involved in Gov. Rick Perry's unlicensed adult stem-cell procedure is rife with basic manufacturing problems, according to the U.S. Food and Drug Administration.

In a report one expert called a blow to the entire adult stem-cell industry, the FDA found that Celltex Therapeutics Corp. cannot guarantee the sterility, uniformity and integrity of stem cells it takes from people and then stores and grows for eventual therapeutic reinjection.

"You have not performed a validation of your banking and thawing process to assure viability" of the stem cells, reads the April 27 report, meaning that the company cannot verify the cells are alive.

The FDA report, which followed an April 16-27 inspection of Celltex, was released under the Freedom of Information Act Monday to the Houston Chronicle and a University of Minnesota bioethicist who complained in February that Celltex is a potential danger to patients and not in compliance with federal law.

The report, partially redacted, was not accompanied by a warning letter.

A former FDA official who read it, however, said the deficiencies - 79 in all, from incorrectly labeled products to failed sterility tests - are so serious that Celltex risks being shut down if it does not remedy the problems quickly. The former official asked not to be identified.

Adult stem cells are cells in the body that multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have shown promise for tissue repair in many other diseases in the last decade, although most scientists in the field consider them not ready for mainstream use.

Rules take effect Friday

Celltex has been in the public eye since it was revealed that Perry's Houston doctor treated him with his own stem cells during back surgery last July and in follow-up appointments. His stem cells were stored and grown at Celltex.

Perry subsequently called for Texas to become the nation's leader of adult stem cell medicine, which he touts as an ethical alternative to embryonic stem cells. Perry worked with his Houston doctor and a state representative to write legislation intended to commercialize the therapy in Texas.

Read more:
FDA report faults Houston-area stem-cell company

SUNRISE, Fla., June 25, 2012 (GLOBE NEWSWIRE) -- Bioheart, Inc. (BHRT.OB) announced today that Kristin Comella, the company's Chief Science Officer presented at the 10th Annual Meeting of the International Society for Stem Cell Research (ISSCR) in Yokohama, Japan June 13 - 16, 2012. One of the world's premier stem cell research events, the ISSCR format includes international research and poster presentations from invited speakers, exceptional peer-to-peer learning and unparalleled networking opportunities.

Comella presented a poster on clinical applications of adipose or fat derived stem cells (ADSCs).

The ISSCR annual meeting serves as the largest forum for stem cell and regenerative medicine professionals from around the world. Through lectures, symposia, workshops, and events attendees experience innovative stem cell and regenerative medicine research, advances and what's on the horizon. The meeting features more than 1,000 abstracts, nearly 150 speakers and provides numerous networking and professional development opportunities and social events. For additional information, visit http://www.isscr.org.

Kristin Comella has over 14 years experience in corporate entities with expertise in regenerative medicine, training and education, research, product development and senior management including more than 10 years of cell culturing experience. She has made a significant contribution to Bioheart's product development, manufacturing and quality systems since she joined the company in September 2004.

About Bioheart, Inc.

Bioheart is committed to maintaining its leading position within the cardiovascular sector of the cell technology industry delivering cell therapies and biologics that help address congestive heart failure, lower limb ischemia, chronic heart ischemia, acute myocardial infarctions and other issues. Bioheart's goals are to cause damaged tissue to be regenerated, when possible, and to improve a patient's quality of life and reduce health care costs and hospitalizations.

Specific to biotechnology, Bioheart is focused on the discovery, development and, subject to regulatory approval, commercialization of autologous cell therapies for the treatment of chronic and acute heart damage and peripheral vascular disease. Its leading product, MyoCell, is a clinical muscle-derived cell therapy designed to populate regions of scar tissue within a patient's heart with new living cells for the purpose of improving cardiac function in chronic heart failure patients. For more information on Bioheart, visit http://www.bioheartinc.com, or visit us on Facebook: Bioheart and Twitter @BioheartInc.

Forward-Looking Statements: Except for historical matters contained herein, statements made in this press release are forward-looking statements. Without limiting the generality of the foregoing, words such as "may," "will," "to," "plan," "expect," "believe," "anticipate," "intend," "could," "would," "estimate," or "continue" or the negative other variations thereof or comparable terminology are intended to identify forward-looking statements.

Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Also, forward-looking statements represent our management's beliefs and assumptions only as of the date hereof. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.

The Company is subject to the risks and uncertainties described in its filings with the Securities and Exchange Commission, including the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2011, and its Quarterly Report on Form 10-Q for the quarter ended March 30, 2012.

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Bioheart's Chief Science Officer Kristin Comella Presents at 10th Annual Meeting of International Society for Stem ...