Category Archives: Stem Cell Human Trials

ALAMEDA, Calif.--(BUSINESS WIRE)-- BioTime, Inc. (NYSE MKT: BTX) announced that the company has amended its license from the University of Utah to expand the field of use for which BioTime is licensed to produce and market products covered by the core patents underlying HyStem technology. Under the amended license, BioTime now is licensed worldwide for all uses, with the exception of veterinary medicine and animal health. The field of use includes, but is not limited to, all human pharmaceutical and medical device applications, all tissue engineering and regenerative medicine uses, and all research applications. Previously, BioTimes license in the United States was not exclusive and the fields of use of the technology permitted by the license were not as broad. We are pleased to have an exclusive license to the full spectrum of human medical products possible with HyStem, said William Tew, Ph.D., Chief Commercial Officer at BioTime. In addition to Renevia which is currently in preclinical studies, we have initiated development programs for additional products that are planned as relatively near-term sources of revenue while strategically laying the foundation for the wide array of cell-based regenerative therapies that may be developed based on stem cell sciences. About BioTime, Inc. … Continue reading →

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT)(ACTC), a leader in the field of regenerative medicine, today issued a statement on the U.S. Appeals Courts ruling, upholding a lower courts dismissal of the case, Sherley v. Sebelius, 11-5241, U.S. Court of Appeals for the District of Columbia Circuit (Washington), on the permissibility of federal funding of embryonic stem cell research. This court ruling should be of considerable benefit to ACT and our embryonic stem cell-based clinical programs, commented Gary Rabin, chairman and CEO. It effectively removes major speed bumps for the National Institutes of Health (NIH) in terms of approving the several stem cell lines that we have submitted for their consideration for funding. With Fridays decisive ruling, we expect that a number of our embryonic stem cell lines will be approved for funding in coming months. Sherley v. Sebelius had sought to block the United States Health and Human Services Department and the NIH from spending federal funds for research with hESCs, contending that doing so would violate the Dickey-Wicker Amendment, a short rider attached to legislation passed in 1996. This ruling removes a great deal of the ambiguity that has hampered legislative attempts to provide an efficient mechanism … Continue reading →

ROUSSAY, FRANCE--(Marketwire -08/21/12)- Successful growth of BioDiem's Virus in VIVALIS EB66() Cell Line Highlights: * BioDiem confirms successful and abundant growth of its virus in VIVALIS' proprietary EB66() cell line in Stage 1 of its collaboration with VIVALIS. * The next stage of the project will use known techniques to demonstrate the creation of new, 'disarmed' viruses (vectors) carrying foreign antigens that can be customized to fight specific diseases. * Both BioDiem's LAIV virus and VIVALIS' EB66 have produced vaccines which have been through Phase II clinical trials, facilitating commercialisation. Melbourne (Australia), Nantes (France), 21 August 2012: Australian infectious disease therapy and vaccine development company BioDiem Ltd (BDM.AX) announced today successful results from two programs of work carried out by French partner VIVALIS (NYSE Euronext: VLS), confirming the ability of BioDiem's Live Attenuated Influenza Virus (LAIV) to grow in VIVALIS' proprietary EB66( )cell line. The next stage of the collaboration between BioDiem and VIVALIS will use known techniques to modify the LAIV virus to demonstrate and optimize the methodology for making a customizable "vector" which could be used by vaccine developers for the development of new vaccines targeting other specific diseases. Priority disease targets include nasopharyngeal carcinoma and respiratory syncytial … Continue reading →

The worlds first clinical safety trial of a human neural stem cell therapy for stroke patients has been given the go-ahead to progress to its next stage. The PISCES trial is being conducted by the University of Glasgow at the citys Southern General Hospital in partnership with pharmaceutical company ReNeuron. The Phase I trial is looking at the safety of injecting expanded neural stem cells, in increasing doses, into the brains of a total of 12 patients left disabled by an ischaemic stroke, the most common form of the condition, and monitoring them over a period of two years. The independent Data Safety Monitoring Board (DSMB) for the clinical trial has recommended the trial advances to the evaluation of a higher dose of stem cells in the third of four dose cohorts to be treated in the study. In arriving at this recommendation, the DSMB reviewed safety data from the first two dose cohorts of six patients treated with ReNeurons ReN001 stem cell therapy. Of these patients, two are through 18 month follow-up, one is through 12 month follow-up, one is through 9 month follow-up, one is through 6 month follow-up and one is through three month follow-up. No cell-related … Continue reading →

EPALINGES, Switzerland, Aug. 14, 2012 (GLOBE NEWSWIRE) -- via PRWEB - Stemedica International, SA (Epalinges, Switzerland), a wholly owned subsidiary of Stemedica Cell Technologies, Inc. ("Stemedica"), a leader in adult stem cell research and manufacturing, announced today that it has been granted a series of licenses by Swissmedic (the Swiss equivalent of the United States Food and Drug Administration). These licenses specifically authorize the Company to import and export its Stemedyne(TM) stem cell products worldwide for human use in approved clinical trials. Granting of the license by Swissmedic marks the culmination of a two-year inspection process of Stemedica's United States and Swiss operations. The Swiss government's rigorous inspection and approval process has included: (1) a comprehensive, in-depth audit of Stemedica's processes and procedures; (2) the examination of Stemedica's quality systems; and (3) interviews with facility management and onsite inspections of the facilities. Stemedica currently produces two lines of ischemia-tolerant adult allogeneic stem cell products. These include Stemedyne(TM)-MSC, bone marrow derived mesenchymal stem cells and Stemedyne(TM)-NSC, neural stem cells. A third product, Stemedyne(TM) Retinal Pigment Epithelium (RPE) stem cells is currently in development. Stemedica now has full regulatory approval from the Swiss government to provide these cells to countries that can … Continue reading →

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT, OTCBB: ACTC)(the Company), a leader in the field of regenerative medicine, announced today second quarter financial results for the period ended June 30, 2012. Highlights of the second quarter include: Second Quarter 2012 Financial Results ACT had revenue totaling $218,184 for the 2012 second quarter, compared to revenue of $153,688 in the prior year. Revenue was generated through license fees and royalty payments. Research and Development expenses for the three months ended June 30, 2012 and 2011 were $2,068,098 and $1,532,271 respectively. The Company reported a loss from operations of $(4.5) million in the 2012 second quarter compared to a loss from operations of $(3.6) million in the 2011 second quarter. ACT reported a net loss of $(4.0) million or $(0.00) loss per share in the 2012 second quarter, compared to a net loss in the same period of 2011 of $(4.8) million, or $(0.0) per share. Net cash used in operations for the 2012 second quarter was $2.9 million, compared to net cash used in operations of $3.3 million in the same period in 2011. The net cash used in operations was a result of ongoing clinical activities. The Company ended … Continue reading →

When transplanted into guinea pig hearts, human heart muscle cells (pictured) can beat in time with resident cells. MEDIMAGE / SPL Damaged skin and liver can often repair themselves, but the heart rarely heals well and heart disease is the world's leading cause of death. Research published today raises hopes for cell therapies, showing that heart muscle cells differentiated from human embryonic stem cells can integrate into existing heart muscle[1]. What we have done is prove that these cells do what working heart muscles do, which is beat in sync with the rest of the heart, says Chuck Murry, a cardiovascular biologist at the University of Washington in Seattle, who co-led the research. It has been difficult to assess cell therapies in animal models because human cells cannot keep up with the heart rates of some small rodents. Cardiomyocytes derived from human embryonic stem (ES) cells typically beat fewer than 150 times a minute. External electrical stimulation can increase that rate, but only up to about 240 beats per minute, says Michael LaFlamme, a cardiovascular biologist at the University of Washington and the other co-leader on the project. Rats and mice have heart rates of around 400 and 600 beats … Continue reading →

Public release date: 3-Aug-2012 [ | E-mail | Share ] Contact: Ian Michaels Ian.Michaels@mountsinai.org 212-241-9200 The Mount Sinai Hospital / Mount Sinai School of Medicine Researchers at Mount Sinai School of Medicine, the University of Manchester, and the MD Anderson Cancer Center have found a new role for an oncogenic signaling pathway in embryonic stem cell (ESC) self-renewal and in reprogramming adult cells into an ESC-state, which will aid in the development of future cancer therapies. The findings promote the understanding of the self-renewal mechanism in embryonic stem cells and provide insight into the role of Aurka, an oncoprotein that is amplified in several human cancers. The research is published in the August 3rd issue of the journal Cell Stem Cell. Embryonic stem cells (ESCs) and, more recently, induced pluripotent stem cells (iPSCs) hold great promise for biomedicine as a major source of differentiated cells for developing new ways to study disease etiology, the development of more effective drugs and diagnostic methodologies, and for future transplantation-based therapies. Cancer cells and ESCs can both proliferate indefinitely and show some similarities. The researchers, a team at Mount Sinai School of Medicine led by Ihor Lemischka, PhD, Director of the Black Family Stem … Continue reading →

NEWARK, Calif., Aug. 2, 2012 (GLOBE NEWSWIRE) -- StemCells, Inc. (STEM), a leading stem cell company developing and commercializing novel cell-based therapeutics and tools for use in stem cell-based research and drug discovery, today reported financial results for the second quarter ended June 30, 2012 and provided a business update. "We continue to be encouraged by our progress in developing cell-based therapeutics for a broad array of disorders affecting the central nervous system," said Martin McGlynn, President and CEO of StemCells, Inc. "We have already reported top line results from our Phase I PMD trial and I am pleased to report that the manuscript with the complete PMD trial data is under peer review for publication by a top tier journal. Our other clinical development efforts also continue to advance. We recently reported interim safety data from our chronic spinal cord injury trial, showing that our cells and the procedure have been well tolerated. We have also initiated a Phase I/II trial in dry AMD and look forward to enrolling our first patients in this study soon. Lastly, we recently reported preclinical data showing that our cells restored memory in two animal models relevant to Alzheimer's disease without having to … Continue reading →

MARLBOROUGH, Mass.--(BUSINESS WIRE)-- Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, today announced treatment of the fourth patient, the first in the second patient cohort, in the companys Phase I/II clinical trial for dry age-related macular degeneration (dry AMD) using retinal pigment epithelial (RPE) cells derived from human embryonic stem cells (hESCs). The surgery was performed on Wednesday, Aug. 1 atWills Eye Institutein Philadelphia, by a surgical team lead by Carl D. Regillo, M.D., Chief of the Wills Eye Institute Retina Service, and professor of ophthalmology at Thomas Jefferson University. The patient was injected with 100,000 hESC-derived RPE cells and is recovering uneventfully. We are very pleased to have the second dose cohort in both of our U.S. clinical trials underway, commented Gary Rabin, chairman and CEO of ACT. We are encouraged by our ongoing progress in all three of our clinical trials using our hESC-derived RPE cells to treat forms of macular degeneration. We have not observed any complications or side effects from the stem cell-derived RPE cells, and we will continue to monitor the patients for safety, tolerability and efficacy of this therapy. The dry AMD trial is one of three … Continue reading →