Cytori Therapeutics, Inc. ( CYTX ) provided preliminary data from a study evaluating a potential treatment for scleroderma based on the company's cell therapy. The investigator-funded, open-label, pilot study is being conducted on patients with cutaneous systemic scleroderma in France. 12 patients were administered Cytori's cell therapy, injected into their fingers. Safety and hand function improvement are the primary endpoints of the study which were measured by the Cochin hand functional scale at six months. At the end of the two month follow-up period, no infection, ischemic complications or serious adverse events were observed. Moreover, there was a significant improvement in the Cochin hand function disability scale. As far as secondary endpoints are concerned, there was a significant improvement in scleroderma health assessment questionnaire score and in Raynaud's Severity Score. Also, there was a significant improvement in hand pain when measured by the visual analog pain scale. Cytori is focused primarily on the development of treatments for cardiovascular disease and soft tissue injuries and burns based on its proprietary cell therapy formulation. The company's cell therapy is based on the formulation of stem and regenerative cells derived from a patient's own adipose (fat) tissue (ADRCs). The company has also designed … Continue reading →

Dublin, Sept. 23, 2013 (GLOBE NEWSWIRE) -- Research and Markets (http://www.researchandmarkets.com/research/m5gpsl/cellular_therapy) has announced the addition of the "Cellular Therapy and the HSCT/Cord Blood Market Landscape" report to their offering. In this comprehensive market report, the primary focus is on quantitative market metrics in order to characterize the growth and evolution of the cellular therapy field. This report analyzes clinical trial trends and the evolution of several therapeutics areas within cellular therapy [orthopedic, skin/wound care, cardiovascular, and CNS disorders] and presents the current status of every single program within the preclinical through the various clinical trial phases and onto commercialization. Also presented are the breakout of clinical trials in the bona fide cellular therapy sector with respect to geographic breakout, breakout by type of cells utilized, and disease classes interrogated. The authors have also provided a detailed quantitative analysis of the cord blood field as it is rapidly evolving. The report's coverage provides hard numbers on sizes of the various registries, the TNC breakouts of banked units, detailed cost breakouts for banking as well as HSCTs utilizing cord blood. Furthermore, given the author's global footprint, they've been able to compare the EU and US markets side-by-side in this analysis. ATMP regulatory … Continue reading →

Cytori Therapeutics, Inc. (CYTX) provided preliminary data from a study evaluating a potential treatment for scleroderma based on the companys cell therapy. The investigator-funded, open-label, pilot study is being conducted on patients with cutaneous systemic scleroderma in France. 12 patients were administered Cytoris cell therapy, injected into their fingers. Safety and hand function improvement are the primary endpoints of the study which were measured by the Cochin hand functional scale at six months. At the end of the two month follow-up period, no infection, ischemic complications or serious adverse events were observed. Moreover, there was a significant improvement in the Cochin hand function disability scale. As far as secondary endpoints are concerned, there was a significant improvement in scleroderma health assessment questionnaire score and in Raynauds Severity Score. Also, there was a significant improvement in hand pain when measured by the visual analog pain scale. Cytori is focused primarily on the development of treatments for cardiovascular disease and soft tissue injuries and burns based on its proprietary cell therapy formulation. The companys cell therapy is based on the formulation of stem and regenerative cells derived from a patients own adipose (fat) tissue (ADRCs). The company has also designed the Celution … Continue reading →

The Philippine College of Physicians (PCP) asked the Food and Drug Administration (FDA) to issue a cease and desist order with sanctions against all forms of advertisement on stem cell therapy until the government has come up with conclusive studies on its efficacy on diseases. In a media briefing, the doctors said FDAs efforts in governing the use and practice of stem cell treatment in the country is not enough to stop those who offer them despite the absence of clear and conclusive clinical trials on it. The recent guidelines released by the FDA fell short and will not stop the proliferation of storm cell therapy for ailments that were not subjected to scientific study or clinical trials. We will not back down from our earlier call and we will not stop until stem cell therapy undergoes scientific studies to prove its safety, quality and efficacy on the ailments it has been propagated. We will not allow its promotion and use to helpless and unknowing patients and their desperate families, Dr. Prescilla Caguioa, PCP president said. Tony Leachon, PCP Vice President also urged the FDA to stop unaccredited health and commercial facilities to offer the treatment. Recently, the FDA released … Continue reading →

The Philippine College of Physicians urged several hospitals and medical practitioners to adhere to established standards of practice and medical ethics when they perform stem cell therapies (SCT) after they learned that there have been deviations from the three approved uses of stem cells in the country. PCP officials appealed to the Philippines's Food and Drug Administration (FDA) and Professional Regulation Commission on Tuesday to strictly enforce standards of practice involving stem cell cures and probe advertised SCT techniques, adding that the only recognized SCT as of now are: The PCP said all other SCT done in some hospitals and by some doctors that are not FDA-approved and are off-label, including those purported to address diabetes, autism, and HIV-AIDS must meet rigorous clinical standards and peer review. Hematopoietic stem cell transplantation for specific cancers involves the bone marrow, corneal resurfacing with limbal stem cells concerns the eyes, while skin regeneration with epidermal stem cells is used to treat severe burn cases. Dr. Carlos Lasa, a plastic surgeon, said the cosmetic and aesthetic applications of stem cell techniques have been abused and advised that people who are considering stem cell methods to heed the advice of doctors who adhere to FDA-approved … Continue reading →

Metallothioneins and Nanomedicine - Video abstract: 42019 Video abstract of review paper "Clinical Significance of Metallothioneins in Cell Therapy and Nanomedicine" to be published in the open access International ... By: dovepress … Continue reading →

WALTHAM, Mass.--(BUSINESS WIRE)-- Kala Pharmaceuticals, Inc., a leading developer of innovative products that rapidly and effectively penetrate the mucosal barrier to treat ocular diseases, announced today that it has been named by FierceBiotech as one of 2013's Fierce 15 biotechs, designating it as one of the most promising private biotechnology companies in the industry. This is FierceBiotech's eleventh annual Fierce 15 selection. Kala Pharmaceuticals has everything that makes a Robert Langer biotech worth watching: A former grad student championing cool new technology, a batch of close venture backers and an experienced team to make it all work, says John Carroll, the editor of FierceBiotech. Their big idea could change the way eye diseases are treated and has extensive potential in other key areas of the body protected by mucus. They deserve close attention. The Fierce 15 celebrates the spirit of being "fierce" championing innovation and creativity, even in the face of intense competition. Every year, FierceBiotech evaluates hundreds of private companies from around the world for its annual Fierce 15 list, which is based on a variety of factors such as the strength of its technology, partnerships, venture backers and a competitive market position. A complete list of "Fierce 15" … Continue reading →