Here’s a roundup of recent clinical trial news:
- Harvard expands DAPT study Down Under
The Harvard Clinical Research Institute announced that the DAPT Study has expanded into Australia and New Zealand. Professor Ian Meredith, MBBS, Ph.D., interventional cardiologist at MonashHeart in Melbourne, Australia and National Coordinating Investigator for the DAPT Study in Australia, was the first Pacific Rim investigator to enroll patients into the study. Enrollment into the DAPT Study was initiated in the United States in October 2009 and in the European Union in May 2010.
- Tengion presents large animal data on kidney regeneration, announces first implantation of neo-urinary conduit
Tengion Inc. (NSDQ:TNGN) presented new data at the American Society for Transplantation’s Annual Scientific Exchange in Orlando, Fla., highlighting new early data from Tengion’s Neo-Kidney Augment development program demonstrating promising improvements in kidney function with an autologous cellular therapy approach to kidney regeneration in a canine model of chronic kidney disease. The company also announced that surgeons at the University of Chicago implanted its Neo-Urinary Conduit in the first patient as part of the ongoing clinical trial evaluating its lead product candidate in bladder cancer patients requiring a urinary diversion following bladder removal.
- EDAP successfully completes preliminary trial of HIFU in liver cancer
EDAP TMS SA (NSDQ:EDAP) reported successful completion of the first phase of the clinical protocol aimed at evaluating High Intensity Focused Ultrasound (HIFU) technology in patients with metastatic liver cancer.
- 2nd total artificial heart patient in U.S. history discharged using the Freedom portable driver
On Oct. 18, 45-year-old Troy Golden became the second patient in the U.S. to leave the hospital using the Freedom portable driver to power his SynCardia temporary Total Artificial Heart. The pastor from Geary, Okla., was discharged from INTEGRIS Baptist Medical Center to wait for a matching donor heart at home with his family and friends.
- Combining stem cell and gene therapy techniques to tackle a deadly blood disease
The National Institutes of Health have awarded a three-year, $3.9 million grant to Children’s Hospital Boston researchers and their colleagues to develop a therapy to treat Fanconi anemia, a fatal genetic blood disease. The researchers will investigate new ways to create induced pluripotent stem (iPS) cells from a patient’s skin or other tissue and transform them into genetically repaired hematopoietic stem cells that can make normal blood cells.
- Implantable vestibular prosthesis study begins
Physicians and engineers at the University of Washington will begin a study of an implantable vestibular prosthesis in 10 patients today by surgically inserting the first one into a patient with persistent Ménière’s disease, according to MedGadget.com.
- Cardica announces peer-reviewed publication of positive results from 5-year clinical study of PAS-Port proximal anastomosis system
Cardica Inc. (NSDQ:CRDC) announced the publication of a 5-year study demonstrating the safety and efficacy of its PAS-Port proximal anastomosis system in the November 2010 issue of the Annals of Thoracic Surgery, evaluated the frequency of major adverse events five years after undergoing coronary artery bypass graft (CABG) surgery using the PAS-Port system and patency (openness) of the grafted vessels six months following the procedure.
- Aethlon Medical initiates patient enrollment of Hepatitis-C Virus clinical studies
Aethlon Medical Inc. (OTC:AEMD) announced it has established primary clinical endpoints and clarified efficacy assessments related to a study that will evaluate the use of the Aethlon Hemopurifier in combination with standard of care (SOC) HCV drug therapy.As a result, Aethlon will now initiate the recruitment of candidate patients and begin exporting its Hemopurifier for clinical purposes.
- Improvements in DNA yield from forensic samples reported with pressure cycling technology
Pressure BioSciences Inc. (NSDQ:PBIO) announced that two scientific presentations at the 21st International Symposium on Human Identification have provided further evidence that pressure cycling technology offers an improved method for the extraction of DNA in the analysis of forensic evidentiary samples.
- Independent Clinical Results Demonstrate Outstanding Effectiveness of INVOcell Process
INVO Bioscience Inc. (OTC:IVOB) announced that Dr. Elkin Lucena of the Columbian Fertility and Sterility Center in Bogota, Colombia, presented the results of the center’s first 95 fertility treatment cycles utilizing INVO Bioscience’s INVOcell for couples with fertility issues at the 66th Annual Meeting of the American Society of Reproductive Medicine in Denver.
- Calypso Medical initiates first clinical study using real-time tracking during lung cancer radiotherapy
Calypso Medical Technologies Inc. announced the initiation of the first clinical study to evaluate the use of the Calypso System for tracking lung cancer tumors during radiation delivery, including a new design of the company’s implantable Beacon transponder.
- 20 new clinical studies on Masimo non-invasive patient monitoring technologies
Masimo (NSDQ:MASI) announced that more than 20 new clinical studies showcasing Masimo noninvasive patient monitoring technologies were presented last week at the American Society of Anesthesiologists annual meeting in San Diego.