Category Archives: Stem Cell Human Trials

By Carolyn Y. Johnson, Globe Staff An international stem cell conference scheduled to take place next month at the Vatican has been cancelled, and the Catholic News Agency has reported that the choice of speakers, which included a prominent Boston embryonic stem cell researcher, was a factor. Dr. George Q. Daley, a stem cell researcher at Childrens Hospital Boston, was scheduled to give the opening lecture at the Third International Congress on Responsible Stem Cell Research. Daley said in an interview that he received a brief e-mail late last week announcing that the conference had been cancelled and that an explanation would follow shortly. Unnamed sources told the Catholic News Agency that the event, as planned, would have presented an unacceptably ambivalent stance on embryonic stem cell research. The Catholic Church opposes human embyronic stem cell research because it requires the destruction of embryos. One unnamed member of the Pontifical Academy for Life told the news agency: The news of the cancellation of the Congress is an enormous relief to many members of the Pontifical Academy for Life, who felt that the presence on its program of so many speakers, including the keynote speaker, committed to embryonic stem cell research, … Continue reading →

Nature | Health A Monsignor and Officer for Studies at the Pontifical Academy for Life called the cancellation a "sad event." Attendees are set to receive an official explanation March 26, 2012| By Ewen Callaway of Nature magazine The Vatican has abruptly cancelled a controversial stem-cell conference that was set to be attended by the Pope next month. The Third International Congress on Responsible Stem Cell Research, scheduled for 25-28 April, was to focus on clinical applications of adult and reprogrammed stem cells. But a number of the invited speakers, including Alan Trounson, president of the California Institute for Regenerative Medicine in San Francisco, and keynote speaker George Daley, a stem-cell scientist at Children's Hospital Boston in Massachusetts, are involved in research using human embryonic stem cells, which the Catholic Church considers unethical. The previous two congresses had also included scientists who worked on such cells, without generating much controversy. Father Scott Borgman, secretary of the Church's Pontifical Academy for Life, one of the conference organizers, says that logistical, organizational and financial factors forced the cancellation, which was announced on 23 March. The academy weighs in on bioethical and theological issues that are relevant to Church teachings. The Catholic News … Continue reading →

Scientists in SA have generated non-embryonic stem cells for the first time, the Council for Scientific and Industrial Research (CSIR) announced on Tuesday. These "induced adult pluripotent stem cells" were developed from adult skin cells and can be prompted to grow into any type of adult cell, such as those in the heart or brain. The technology is important for research into regenerative medicine, but is not yet widely used. While the technology is not novel, the development of the capacity to grow these stem cells in SA is important for researchers investigating diseases affecting Africans, said CSIR post-doctoral fellow Janine Scholefield. The CSIR had replicated techniques devised by Japanese researchers in 2007. "Cutting-edge medical research is not useful to Africans if knowledge is being created and applied only in the developed world," said CSIR head of gene expression and biophysics Musa Mhlanga. "Given the high disease burden in Africa, our aim is to become creators of knowledge, as well as innovators and expert practitioners of the newest and best technologies," The CSIR said that adult-generated stem cells were more acceptable to people who objected to using stem cells from embryos. "The other critical thing is the cells (that will … Continue reading →

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE Amex:BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today announced that Chief Executive Officer, Michael D. West, Ph.D., will present a corporate overview of BioTime and its subsidiaries with an update on recent developments at the 2012 Maxim Group Growth Conference on Monday, March 26, 2012, 11:00 a.m. EDT, at the Grand Hyatt in New York City. The presentation will be webcast and available online at the Investors section of the BioTime website at http://www.biotimeinc.com. The 5th annual Maxim Group Growth Conference is designed to provide institutional clients with the opportunity to gain an in-depth perspective on the issues affecting the growth of presenting companies. The one-day event will feature more than 80 company presentations across six designated industry tracks including the healthcare and biotechnology sectors. About BioTime, Inc. BioTime, headquartered in Alameda, California, is a biotechnology company focused on regenerative medicine and blood plasma volume expanders. Its broad platform of stem cell technologies is developed through subsidiaries focused on specific fields of applications. BioTime develops and markets research products in the field of stem cells and regenerative medicine, including a wide array of proprietary ACTCellerate cell … Continue reading →

SOURCE: VistaGen Therapeutics, Inc. Goal to Combine Human Stem Cell-Derived Cardiomyocytes With Novel High-Speed Kinetic Imaging SOUTH SAN FRANCISCO, CA--(Marketwire - Mar 21, 2012) - VistaGen Therapeutics, Inc. (OTCBB: VSTA) (OTCQB: VSTA), a biotechnology company applying stem cell technology for drug rescue and cell therapy, and Vala Sciences, Inc., a biotechnology company developing and selling next-generation cell image-based instruments, reagents and analysis software tools, have entered into a strategic collaboration. Their goal is to advance drug safety screening methodologies in the most clinically relevant human in vitro bioassay systems available to researchers today. Cardiomyocytes are the muscle cells of the heart that provide the force necessary to pump blood throughout the body, and as such are the targets of most of the drug toxicities that directly affect the heart. Many of these drug toxicities result in either arrhythmia (irregular, often fatal, beating of the heart) or reduced ability of the heart to pump the blood necessary to maintain normal health and vigor. "Our collaboration with Vala directly supports the core drug rescue applications of our Human Clinical Trials in a Test Tube platform," said Shawn K. Singh, JD, VistaGen's Chief Executive Officer. "Our high quality human cardiomyocytes combined with Vala's … Continue reading →

The U.S. Food and Drug Administration has received a complaint alleging the Houston company involved in Gov. Rick Perry's unregulated adult stem-cell operation is a potential danger to patients and not in compliance with federal law. In an eight-page letter sent last month, University of Minnesota bioethicist Leigh Turner called on the FDA to investigate Celltex Therapeutics Corp., which banks people's stem cells for future reinjection in the event of disease or injury. Perry was the company's first customer last year. "It appears their business plan involves injecting or infusing on a for-profit, commercial basis non-FDA-approved adult stem cells into paying customers," Turner wrote in the Feb. 21 letter. "This plan conflicts with FDA regulations governing human stem cells." An FDA spokeswoman declined comment, but Turner said an agency official told him the matter has been assigned to an investigator and is being taken seriously. Celltex co-founder David Eller said Tuesday night he is confident the company will "meet all FDA specifications." He emphasized that Celltex doesn't administer stem cells, but stores and processes them at the behest of doctors who later reinject them into patients. Dr. Stanley Jones, a Houston orthopedic surgeon, injected Perry's stem cells during his back … Continue reading →

The Board of Trusties of the Centre for Science and Society at Trinity College of the University of Oxford, England has appointed Nikolai Tankovich, MD, PhD, FASLMS as a Legate of the Centre. Dr. Tankovich is President and Chief Medical officer of Stemedica Cell Technologies, Inc. and Chairman of Stemedica International S.A. a manufacturer of ischemic tolerant adult allogeneic stem cells. (PRWEB) March 15, 2012 Dr. Tankovich has been a frequent lecturer and guest speaker at the Centre for the last several years. The position of Legate recognizes the importance of his continuing role in reporting on the latest worldwide trends in regenerative medicine and biotechnology. Dr Tankovich is a surgical oncologist who holds a Masters Degree in Physics and a PhD in Biophysics. He is a Fellow of the American Society of Laser Medicine and Surgery. Dr. Tankovich is the author of multiple patents in the fields of stem cells and laser science. Dr. Frank C. Schuller, Director of the Centre for Science and Society at Trinity College said, We are pleased to formalize our valued relationship with Dr. Tankovich by naming him a Legate of the Center. This honor is in recognition of his extensive contributions to advancing … Continue reading →

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE Amex: BTX), a biotechnology company that develops and markets products in the field of regenerative medicine, today reported financial results for the fourth quarter and year ended December 31, 2011 and highlighted recent corporate accomplishments. At the forefront of our corporate strategy is a plan to develop and acquire novel technologies in the stem cell field and to establish one of the broadest sets of capabilities in the industry. We made significant strides towards the accomplishment of that goal through further development of our products and through key strategic acquisitions in 2011. We are now positioned to focus on commercializing these emerging technologies, said Michael D. West, Ph.D., BioTime's President and CEO. We are on track to begin human clinical trials in 2012 for HyStem-Rx as a medical device for the delivery of adipose stem cells for reconstructive surgery and transplantation, and we look forward to providing updates on our progress of this and other important product development programs during 2012, including the PanC-DxTM cancer diagnostic development program. Financial Results Revenue For the quarter ended December 31, 2011, on a consolidated basis, total revenue was $1.6 million, up $0.2 million or 15% from $1.4 … Continue reading →

The U.S. Food and Drug Administration has received a complaint alleging the Houston company involved in Gov. Rick Perry's unregulated adult stem-cell operation is a potential danger to patients and not in compliance with federal law. In an eight-page letter sent last month, University of Minnesota bioethicist Leigh Turner called on the FDA to investigate Celltex Therapeutics Corp., which banks people's stem cells for future reinjection in the event of disease or injury. Perry was the company's first customer last year. "It appears their business plan involves injecting or infusing on a for-profit, commercial basis non-FDA-approved adult stem cells into paying customers," Turner wrote in the Feb. 21 letter. "This plan conflicts with FDA regulations governing human stem cells." An FDA spokeswoman declined comment, but Turner said an agency official told him the matter has been assigned to an investigator and is being taken seriously. Celltex co-founder David Eller said Tuesday night he is confident the company will "meet all FDA specifications." He emphasized that Celltex doesn't administer stem cells, but stores and processes them at the behest of doctors who later reinject them into patients. Dr. Stanley Jones, a Houston orthopedic surgeon, injected Perry's stem cells during his back … Continue reading →

NEW YORK & PETACH TIKVAH, ISRAEL--(BUSINESS WIRE)-- BrainStorm Cell Therapeutics Inc. (OTCBB: BCLI.OB - News), a developer of adult stem cell technologies and CNS therapeutics, announces plans to initiate a preclinical study assessing the efficacy of its NurOwn stem cell technology in patients with Multiple Sclerosis (MS). Positive proof-of-concept results for MS have been confirmed in a set of in-vitro and in-vivo experiments, and the Company is working to advance MS into preclinical development in Q2 2012. Based on initial promising pre-clinical data published by the Company's Chief Scientist, Prof. Daniel Offen of Tel Aviv University, BrainStorm has decided to explore MS as an additional indication for its NurOwn technology. The Company will draw plans to initiate pre-clinical safety trials, after which it will seek a leading medical center specializing in MS for clinical trials. We have been focused on growing our pipeline of indications using our NurOwn stem-cell technology, commented Dr. Adrian Harel, Acting CEO of BrainStorm Cell Therapeutics. As we continue our ongoing trials to evaluate the safety, tolerability and therapeutic effects of NurOwn in ALS patients, we have determined through positive preliminary animal data that MS will be the next indication to pursue using our technology. About … Continue reading →