Category Archives: Stem Cell Research

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 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 inspection of Celltex, was released under the Freedom of Information Act on Monday to the Houston Chronicle and a University of Minnesota bioethicist who complained 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, 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.

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.

In April, the Texas Medical Board approved rules regulating the therapy, which isn't approved by the FDA. The rules allow doctors to use stem cells as long as they get the approval of a review board that evaluates clinical research for safety. The board members were all appointed by Perry.

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FDA critical of stem-cell firm

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.

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FDA report faults Houston-area stem-cell company

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.

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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 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.

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FDA report faults Houston 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 ...

Posted at: 06/22/2012 3:10 PM | Updated at: 06/22/2012 5:29 PM By: WNYT Staff

TROY - Stem cells have been heralded as the frontier from which great medical treatments will come. Whether or not that materializes, New York wants to be in on the action.

So Friday, ground was broken on the Rensselaer Center for Stem Cell Research. Located on the RPI campus, the state is providing a grant of almost $2.5 million over four years to get it built.

And through it's funding, the state is very forward looking and it is foster a strong stem cell research community here in New York State, said Shirley Ann Jackson, president of RPI.

RPI has already started working in this area, partnering with Albany Medical College and the University at Albany.

This expands the scope of that work, with the hopes of finding new medicines and cures for a variety of illness and traumatic injuries.

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RPI breaks ground on Rensselaer Center for Stem Cell Research

Public release date: 22-Jun-2012 [ | E-mail | Share ]

Contact: William Gilroy gilroy.6@nd.edu 574-631-4127 University of Notre Dame

Alumnus Michael Gallagher and his wife, Elizabeth, have made a $5 million gift to establish the Elizabeth and Michael Gallagher Family Professorships in Adult Stem Cell Research at the University of Notre Dame.

Their gift, which will fund three new endowed professorships in adult and all forms of non-embryonic stem cell research, will strengthen Notre Dame's leadership in the field of stem cell research and enhance the University's effective dialogue between the biomedical research community and the Catholic Church on matters related to the use and application of stem cells and regenerative medicine.

"As a Catholic university, Notre Dame carries a mantle of responsibility to use our scholarship and resources to help alleviate human suffering, and, in this area of research in particular, to do so with deep respect for the sanctity of all human life," said Rev. John I. Jenkins, C.S.C., the University's president. "These new professorships will enable us to effectively build upon an already strong foundation in this critically important field. We are tremendously grateful to the Gallaghers for making this possible with their transformative gift."

Despite years of research, there are no known cures for a large number of degenerative diseases, such as Type 1 diabetes, Parkinson's disease, cardiovascular disease, macular degeneration and spinal cord injuries. Stem cell research has the potential to contribute to the discovery of new and successful treatments for these and other diseases because it holds the unique promise of regenerating damaged cells and tissues, fully restoring tissues and organs to their normal function.

Although this vital area of research could accelerate the ability to alleviate much human suffering, it has generated extensive ethical debate with the use of embryonic versus non-embryonic stem cells. The Catholic Church affirms the dignity of all human life at every stage and vigorously opposes the destruction of human embryos for the harvesting of stem cells. At the same time, the Church strongly endorses the use of adult and non-embryonic stem cell research as a potential therapy for individuals suffering from these debilitating diseases. Research has demonstrated that adult stem cells, including all forms of non-embryonic stem cells, such as induced pluripotent stem cells and umbilical cord stem cells, can be harvested and programmed to achieve pluripotency the same characteristic that enables embryonic stem cells to differentiate into any type of cell.

An urgent need exists to increase the number of faculty experts performing adult stem cell research at Notre Dame. Doing so will expand upon the strong foundation the College of Science holds in these areas and will help create an environment for excellence in which faculty and students can learn, grow, collaborate and ultimately affect human health.

"We are overwhelmed with gratitude at the generous gift from Mike and Liz Gallagher," said Gregory P. Crawford, dean of the College of Science. "The impact of this gift is truly beyond measure. It will play a crucial role in attracting three more of the best faculty in the field of adult stem cell research to Notre Dame. Furthermore, this gift will equip our existing talented group of adult stem cell researchers at Notre Dame to take the next great leap toward ultimately forming a premier center in adult stem cell research."

Michael Gallagher is a 1991 graduate of Notre Dame, and his wife, Elizabeth, is a 1992 graduate of Saint Mary's College. They have two sons, Brock and Jack, and currently live near Denver.

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Notre Dame establishes professorships in adult stem cell research

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Some of the automated sampling equipment in the Rensselaer Stem Cell Research Center in Troy. Some of the automated sampling equipment in the Rensselaer Stem Cell Research Center in Troy. (Mike McMahon / The Record)

By Danielle Sanzone dsanzone@troyrecord.com Twitter.com/DanielleSanzone

State Department of Health Commissioner Nirav Shah, left, and Rensselaer Polytechnic Institute President Dr. Shirley Ann Jackson, right, announce the opening of the Rensselaer Center for Stem Cell Research during a forum at the colleges Troy campus Friday. (Mike McMahon / The Record)

TROY During a Rensselaer Polytechnic Institute forum on Friday, dozens were able to see their first baby picture: a single cell that eventually multiplied, in part due to stem cells, into an organism with trillions of cells.

That, to me, is the most amazing thing in the study of biology, said Glenn Monastersky, director of the Rensselaer Center for Stem Cell Research.

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VIDEO: Stem cell research facility to open at Rensselaer Polytechnic Institute

Newswise Troy, N.Y. Ground-breaking research to advance the application of stem cells to address critical injuries and diseases will be taking place at Rensselaer Polytechnic Institute, in a new center funded by New York state and opened today (June 22, 2012).

The Rensselaer Center for Stem Cell Research was launched officially by Rensselaer President Shirley Ann Jackson, New York State Department of Health Commissioner Nirav Shah, and Jonathan Dordick, director of the Rensselaer Center for Biotechnology and Interdisciplinary Studies (CBIS) and the Howard P. Isermann 42 Professor of Chemical and Biological Engineering. They were joined at the ribbon cutting by Glenn Monastersky, CBIS operations director and biomedical engineering professor of practice. Monastersky is also principal investigator under the $2.45 million grant awarded to fund the new center, from the New York State Stem Cell Science Program (NYSTEM).

The opening of the Rensselaer Center for Stem Cell Research marks a milestone on the path toward this important area of exploration, which promises so much in terms of alleviating disease and improving health, said Jackson. At the center we will work at the frontiers of this promising discipline in collaboration with New York state and investigators from across the region.

This research complements stem cell research, sponsored by New York and the National Institutes of Health, that is already in progress at Rensselaer, Jackson added. Due to our commitment to biotechnology that began over 10 years ago under The Rensselaer Plan, we are able to link engineering with the life and physical sciences in ways that allow us to explore new possibilities. We are grateful to Dr. Shah and the state of New York for their leadership in this important research area, and for providing the funding to launch this center.

Governor Cuomo recognizes that stem cell research is a vital and growing industry that helps create jobs here in the Capital Region and around the state, said Nirav R. Shah, M.D., M.P.H., New York State Commissioner of Health. Targeting our investment in results-oriented research enterprises like this center will lead to medical advances as well as expand our economy and make New York the place to be for 21st century health and science research.

According to Dordick, the new center continues to place CBIS and the research conducted there on the leading edge of efforts to harness advances in biotechnology to address 21st century health challenges.

Ranging from our work on the blood anti-coagulant drug heparin to solutions to fighting some of todays super bugs to important advances in understanding Alzheimers disease, we are focusing our efforts on scientific advances that will ultimately open the doors to new cures for traumatic injuries or treatments for long-term conditions and diseases, Dordick said. Now, working with our partners at New York state and other researchers in the region, we will expand our work on stem cells to help the medical and scientific research communities advance efforts to better understand those cells and how they can be used in medicine.

Research on stem cells offers promise in an array of health areas, ranging from trying to regenerate damaged nerve cells following spinal cord injuries to offering potential cures for autoimmune diseases such as multiple sclerosis, lupus, rheumatoid arthritis, and Type 1 diabetes. According to the National Institutes of Health (NIH), stem cells are important because unlike other cells in the human body they are capable of dividing and renewing themselves for long periods. In addition, because stem cells are unspecialized meaning that they are not associated with any tissue-specific functions early research has shown that under the right circumstances these cells can give rise to cells associated with specific functions, under a process called differentiation. Today, according to NIH, scientists are just beginning to understand the so-called triggers that can start stem cell differentiation into, for example, nerve, muscle, or bone cells.

The new state-of-the-art center is housed on the ground floor of the Rensselaer biotechnology center. In addition to advanced cell biology research equipment, new lab equipment acquired with funding from New York state includes an Olympus VivaView microscopy/incubation system and a Thermo Fisher Arrayscan cell-imaging system that utilizes advanced optics and analytical software to guide the analysis of stem cell development.

The Rensselaer Center for Stem Cell Research and its associated scientific staff, will enable collaborations with several New York partners including the New York Neural Stem Cell Institute, Albany Medical College, the University at Albany, the University of Rochester Medical School, and the Trudeau Institute. The main focus of the center is the basic science critical to development of stem cell-based therapies for human diseases and traumatic injuries.

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Rensselaer and New York State Launch New Stem Cell Research Center

SAN BRUNO, Calif., June 20, 2012 /PRNewswire/ -- Twenty years ago this month, CBR (Cord Blood Registry) in partnership with the University of Arizona, processed the first cord blood stem cell sample in the world to be stored specifically for family use. Since 1992, the number of conditions treated with cord blood stem cells has greatly expanded, and so has CBR. Today, CBR is the largest family cord blood bank in the world with more than 425,000 samples in storage a population the size of a major city like Miami. What distinguishes the "city of individuals" with newborn stem cells banked at CBR is the exclusive opportunity to participate in a growing number of ground-breaking clinical trials.

(Photo: http://photos.prnewswire.com/prnh/20120620/SF27549-INFO)

(Logo: http://photos.prnewswire.com/prnh/20120216/AQ54476LOGO)

"As the leader and innovator in family banking, we believe every newborn deserves a healthy future and that we have a responsibility to lead the way," said Heather Brown, vice president of scientific & medical affairs at CBR. "Looking back, the creation of our bank allowed families for the first time to preserve a genetically-related source of newborn stem cells, ready and available if needed for a lifesaving transplant to regenerate a person's immune system after radiation or chemotherapy. As we look to the future, we are helping shape new areas of regenerative medicine. We are the only family bank actively pioneering clinical trials evaluating new therapeutic uses of cord blood stem cells for unexpected injuries and conditions with no current cure."

Expanding Areas of Clinical Research: Helping the Body Heal Injured Nerves Until very recently, the prevailing medical opinion in neurology has been that damage to the central nervous system caused by injuries like birth trauma, accidents or stroke is often permanent. Currently, intervention after injury focuses on stabilizing the patient to minimize damage. However, data from animal research in recent years has challenged this assumption, leading to cord blood stem cell clinical research to study whether these cells may stimulate neural cell and tissue repair to restore function and alleviate neurological impairments.

CBR is taking the lead in moving animal research rapidly into the clinic to investigate the ability for cord blood stem cells to trigger the body's own mechanisms to initiate nerve repair by establishing specific clinical trials at leading medical institutions across the country. By pairing researchers with children who have been diagnosed with chronic conditions like cerebral palsy, traumatic brain injury or hearing loss-- and who also have access to their own cord blood stem cells -- CBR is helping physicians move beyond surgery and drugs to evaluate how newborn stem cells may help the body repair itself.

Celebrating a History of Firsts Throughout its history, CBR has taken many of the first steps to create and advance the notion of preserving and ensuring access to high quality newborn stem cells that are viable for use. Among the company's contributions to stem cell medicine and science, CBR was:

"CBR continuously improves our systems and technology to maintain the highest published cell recovery rate in the industry of 99%, every single time. We treat every sample as if it belongs to our own child or grandchild," says Tom Moore, CEO and founder of CBR. "That care and precision is what we offer clinical researchers, who are partnering exclusively with CBR to evaluate the use of a child's own cord blood stem cells to help treat chronic diseases like cerebral palsy, hearing loss and traumatic brain injury."

About Cord Blood RegistryCBR (Cord Blood Registry) is the world's largest and most experienced cord blood bank.The company has consistently led the industry in technical innovations and safeguards more than 425,000 cord blood collections for individuals and their families. CBR was the first family bank accredited by AABB and the company's quality standards have been recognized through ISO 9001:2008 certificationthe global business standard for quality. CBR has also released more client cord blood units for specific therapeutic use than any other family cord blood bank. Our research and development efforts are focused on helping the world's leading clinical researchers advance regenerative medical therapies.For more information, visit http://www.cordblood.com.

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CBR - World's Largest Stem Cell Bank - Applies Two Decades of Experience to Advance Regenerative Medicine