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For more information about Scleroderma Stem Cell Treatment, please visit worldstemcells.com 2012 World Stem Cells LLCFrom:WorldStem CellsViews:2 0ratingsTime:07:56More inScience Technology

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East Asia faces unique challenges, opportunities for stem cell innovation

ScienceDaily (Nov. 27, 2012) Tension is the theme running through the new consensus statement issued by the Hinxton Group, an international working group on stem cell research and regulation. Specifically, tension between intellectual property policies and scientific norms of free exchange, but also between eastern and western cultures, national and international interests, and privatized vs. nationalized health care systems.

The consensus, titled Statement on Data and Materials Sharing and Intellectual Property in Pluripotent Stem Cell Science in Japan and China, was released on the Hinxton Group's website on November 19, 2012.

"China and Japan are among the world's leading nations in stem cell research, but because of challenges distinct from western nations, they are dramatically underrepresented in terms of patents and licensing," says Debra Mathews, PhD, MA, assistant director of Science Programs at the Johns Hopkins Berman Institute of Bioethics and a founding member of the Hinxton Group. Mathews was one of 22 co-signers of the consensus statement.

"We thought it was crucial, with the science advancing incredibly rapidly, and as intellectual property policies evolve in East Asia, to examine our 2010 global recommendations for proprietary issues in stem cell research in that regional context," Mathews says.

Strengthening national stem cell innovation was the top goal articulated in Kobe, the statement says. Whereas in the West there is a robust and mature infrastructure for encouraging and supporting the development of intellectual property rights such as patents, East Asian nations like China and Japan have comparatively less well-developed, younger systems, the group observes. While this can make it more difficult to bring new inventions to international markets, the statement says, the opportunities created by the regional environment in Japan and China provide valuable lessons for the global development of this field.

"For example, as noted in the statement, Japan and China each have a large and highly qualified scientific workforce, paired with substantial national investment in stem cell research," says Mathews. "This combination of factors means that both countries are well-situated to take the kinds of collective action that will be required to move the field forward efficiently and translate basic science discoveries into products and therapies."

An area where Japan and China exercise strong state control to the possible benefit of stem cell-based invention is their national health care systems, the statement notes. In the West, strong intellectual property rights have encouraged the "development of stand-alone blockbuster products," the group says, whereas the national health systems in East Asia may allow patients access to more individualized, innovative treatments. This, the group posits, could be a model for stem cell-based therapies.

"Innovation in China and Japan occurs in the context of national commitments to public health, and as a practical matter that should make access to cell-based therapies more equitable," Mathews says.

The statement also notes the significant cultural differences that contribute to challenges -- and opportunities -- with intellectual property policy, practice and stem cell research in the region. The group notes that Japan and China are "markedly less litigious" than western nations, and recognition for scientific work and publication priority are highly valued. "Secrecy appears to be a relatively more common mode of protecting researchers' raw [intellectual property rights], as opposed to more formalized legal systems of protection, such as patenting," the statement says. In light of this, an appropriate incentive to sharing data and materials among scientists in the region would be the protection of their interests and rights, perhaps through a grace or priority period, the group says, during which the data is public but the original scientists have exclusive rights to publish.

The statement also discusses the challenges of sharing data and materials internationally, noting an "underlying tension between national and international interests." In China, for example, samples donated by citizens are considered intellectual property of the state and are governed by strict polices that create roadblocks to international sharing and access. Such policies, varying country by country, may present significant challenges to the Hinxton Group's goal of creating an internationally coordinated stem cell bank, the statement says.

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East Asia faces unique challenges, opportunities for stem cell innovation

Study suggests different organ-derived stem cell injections improve heart function

Public release date: 27-Nov-2012 [ | E-mail | Share ]

Contact: Robert Miranda cogcomm@aol.com Cell Transplantation Center of Excellence for Aging and Brain Repair

Putnam Valley, NY. (Nov. 27, 2012) A study published in the current issue of Cell Transplantation (21:8), now freely available on-line at http://www.ingentaconnect.com/content/cog/ct/, has found that when mesenchymal cells derived from skeletal muscle (SM-MSCs) or adipose tissue (ADSCs) were injected into the heart muscle (myocardium) of separate groups of laboratory rats that had suffered a myocardial infarction, rats in both groups experienced significantly improved left ventricle function and smaller infarct size after cell therapy.

The study, carried out by researchers at Oslo University Hospital and the Norwegian Center for Stem cell Research, Oslo University, sought to determine if MSCs from different organs would result in different functional outcomes.

"Despite advances in revascularization and medical therapy, acute myocardial infarction (AMI) and heart failure are still important causes of morbidity and mortality in industrialized countries," said study co-author Dr. Jan E. Brinchmann of the Norwegian center for Stem Cell Research at Oslo University Hospital, Oslo. "AMI leads to a permanent loss of contractile elements in the heart and the formation of fibrous scarring. Regeneration of contractile myocardium has been a target of cell therapy for more than a decade."

According to Dr. Brinchmann, MSCs tolerate hypoxia, secrete angiogenic factors and have been shown to improve vascularization; thus, they have properties suggesting that they may beneficially impact AMI, chronic heart failure and angina pectoris after cell transplantation. Following injection into the "border zone" and infarct area of immunodeficient rats one week after induced myocardial infarction, the researchers used echocardiography to measure myocardial function and other analyses to measure the size of scaring, density of blood vessels in the scar, and the health of myocardial tissues.

"Our results showed that intramyocardial injection of both ADSCs and SM-MSCs one week after AMI led to a substantial decrease in infarct size and a significant improvement in left ventricle function when compared with injections of cell culture medium alone," concluded the authors. "There was a trend toward better functional improvement in the SM-MSC group when compared to the ADSC group, but this did not reach significance."

They concluded that many questions remain unanswered, including the question of whether MSCs isolated from different organisms could result in different functional outcomes. Other unanswered questions relate to the optimal time delay between the onset of myocardial infarction and injection of MSCs. These cells do, however, still appear to be "a potentially interesting adjuvant treatment modality for selected patients following acute myocardial infarction," they concluded.

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Contact: Dr. Jan E. Brinchmann, Norwegian Center for Stem Cell Research, Institute of Basic Medical Sciences, Oslo University Hospital Rikshospitalet and University of Oslo, PO Box 1121 Blindern 0317 Oslo, Norway. Tel. +42-22-84-04-89 Fax. +42-22- 85-10-58 Email: jan.brinchmann@rr.research.no

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Study suggests different organ-derived stem cell injections improve heart function

Fate Therapeutics Initiates Phase 2 Clinical Study of ProHema for the Treatment of Hematologic Malignancies

SAN DIEGO, Nov. 27, 2012 /PRNewswire/ -- Fate Therapeutics, Inc., a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators, announced today the initiation of a randomized, controlled, Phase 2 multi-center study of its investigational hematopoietic stem cell therapy, ProHema, in adult patients undergoing double umbilical cord blood transplantation (dUCBT) for hematologic malignancy. The advancement of ProHema into later-stage development builds upon positive results from a Phase 1b single-center study, interactions with the U.S. Food and Drug Administration and refinements to the product manufacturing process. The previously completed Phase 1b study achieved its primary objective of demonstrating safety and tolerability. The study also established early clinical proof-of-concept trends of accelerated neutrophil recovery, improved 100-day survival and low rates of graft-versus-host disease were evident, and durable and preferential reconstitution with ProHema occurred in 10 of 12 evaluable patients. ProHema is produced through a proprietary, two-hour, ex vivo modulation process, which has been shown to significantly activate key biological pathways involved in hematopoietic stem cell homing, proliferation and survival in preclinical models.

"Allogeneic umbilical cord blood transplantation holds great promise as a potentially curative treatment for children and adults with hematologic malignancies and many other life-threatening, non-malignant disorders," said Christian Weyer, M.D., M.A.S., President and Chief Executive Officer of Fate Therapeutics. "ProHema is being developed with the intent to improve outcomes in patients undergoing cord blood transplantation by facilitating both accelerated engraftment and durable reconstitution using a simple, point-of-care, ex vivo modulation process. The initiation of Phase 2 marks an important milestone for the company and brings us one step closer towards achieving this objective."

The Phase 2 study is expected to enroll at least 45 adult patients undergoing dUCBT for the treatment of hematologic malignancies. Patients will be randomized, with a ratio of 2:1, to receive either ProHema plus an unmanipulated cord blood unit or two unmanipulated cord blood units. The study will evaluate time to neutrophil and platelet recovery, incidence of serious infections and graft-versus-host disease, 100-day mortality and relative dominance of ProHema over the unmanipulated cord in contributing to reconstitution. Results are expected in 2013.

"The preclinical and clinical data obtained to date suggest that ProHema may address several of the unmet medical needs in the evolving field of hematopoietic stem cell transplantation," said Steven Devine, M.D., Professor of Medicine and Program Director of the Blood and Marrow Transplant Program at the Ohio State University and a principal investigator of the Phase 2 clinical study. "While further investigation is required, an intervention that enables early and durable reconstitution of the best-HLA-matched cord blood unit has the potential to improve patient outcomes and substantially enhance the therapeutic value proposition of cord blood transplant."

About ProHema

ProHema is an innovative cord blood-derived cell therapy containing pharmacologically-modulated hematopoietic stem cells (HSCs). ProHema is produced through a proprietary, two-hour, ex vivo cell modulation process that results in rapid activation of key biological pathways involved in homing, proliferation and survival of HSCs. In preclinical testing, ProHema has demonstrated the potential to accelerate engraftment and to drive durable hematopoietic reconstitution, without the need for multi-week expansion protocols. In an initial Phase 1b study in adult patients with hematologic malignancies undergoing double umbilical cord blood transplant (dUCBT), the median time to neutrophil recovery (> 500 cells/microliter) with ProHema was 17.5 days, which compares favorably to historical norms for patients undergoing dUCBT. In that study, ProHema provided the dominant source of hematopoiesis in 10 of 12 evaluable subjects, suggesting that treatment with ProHema may accelerate engraftment and drive durable and preferential reconstitution.

About Fate Therapeutics, Inc.

Fate Therapeutics is a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators. The Company's first clinical program, ProHema, is an innovative cord blood-derived cell therapy containing ex vivo pharmacologically-modulated hematopoietic stem cells and is being developed to improve hematopoietic reconstitution in patients undergoing stem cell transplant. In addition, Fate Therapeutics has preclinical programs of novel in vivo stem cell modulators for skeletal muscle regeneration and hearing restoration. To advance its discovery and development efforts, the Company applies its award-winning, proprietary, induced pluripotent stem cell technology to generate rare cell populations and model disease. Fate Therapeutics is headquartered in San Diego, CA, with a subsidiary in Ottawa, Canada. For more information, please visit http://www.fatetherapeutics.com.

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Fate Therapeutics Initiates Phase 2 Clinical Study of ProHema for the Treatment of Hematologic Malignancies

Stem cell treatment in Germany’s Villa Medica

Published on 27 November 2012 Hits: 257 Written by JESS G. DUREZA CHAIRMAN, ADVOCACY MINDANOW FOUNDATION INC.

DAY ONE (Thursday): It was about 6 a.m. when Cathay Pacific (CX) Flight 0289 docked at the Frankfurt International Airport Bay no. 2.

Beth was nursing some stiff neck and the usual neck pains when we unbuckled to disembark. It was an 11-hour flight from Hong Kong and like all previous foreign trips, Beth never had some good sleep, despite the comfortable and totally reclinable CX modernized seats in the Business Class section.

From the glass windows at the tube, we saw the heavy fog outside. After gathering our luggage, Villa Medica (VM) representative (named Sammy, an Iranian) was flashing the VM sign at the arrival gate for us. We were the only passengers in his van for the 140-kilometer trip to Edenkoben. Sammy said that there were about eight guests from Thailand and Vietnam in our batch but they were arriving later in the day. (Times Editors note: Edenkoben is a town in the Sdliche Weinstrasse district of Rhineland-Palatinate, Germany.)

Sammy was a good source of information. I was curious and I could not wait for the briefing by the VM doctors. He said that the fresh cells are taken from Black Mountain sheeps, specially raised in a farm and transported to VM laboratories for tests and procedures before they are slaughtered while 18-week pregnant. The mother sheep is slaughtered on the day of the injection on the client (they dont use the word patients). The unborn fetus, about 18 weeks old, is still alive when the fresh cells are taken and within two hours, the harvested cells must be injected on the guest. He gave a few prominent names in the Philippines who have come to VM. And many kept coming back, he said.

We arrived at Villa Medica after an hour-and-a-half of travel, passing grape vineyards that have started to wilt and darken with the onset of winter. Villa Medica looked like a mansion house in the middle of the forest.

When we disembarked, we were met by the VM head staff named Joyce, a Malaysian, who turned out to be Sammys wife.

Before being conducted to our room upstairs, we were told: Please proceed to Praxis [name of the room] on the ground floor for the first infusion.

We entered a room with about 12 reclined seats facing a drapeless window looking out into the forests. The first infusion meant being linked to an oxygen aerator attached to your nose and getting an intravenous flow of some pinkish-looking fluid containing concentrates of Vitamin C, B12 and Glutathione combined. The procedure was over in about 45 minutes.

When I asked the German lady nurse what the infusion was for, she explained that it was to loosen up the body in preparation for the next days fresh cell injections.

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Stem cell treatment in Germany’s Villa Medica