Medical Device Daily Contributing Writer

LONDON – The Roslin Institute (Midlothian, Scotland) is setting up a facility to provide clinical-grade embryonic stem cell lines with no intellectual property rights attached. The not-for-profit center aims to speed the process of translating stem cell research into treatments, and the cell lines will be available to both companies and academic researchers.

Roslin Cell Center (RCC) will be an important element of Scotland's attempt to build a stem cell hub in the country. It is focused around a £600 million ($1.1 billion) translational research institute currently under construction in Edinburgh. RCC will be the first link in the supply chain, producing GMP-grade cells for clinical use.

Initial funding for the RCC of £2 million has come from the development agency Scottish Enterprise. The Roslin Institute, birthplace of Dolly the sheep, has set up Roslin Cells to run the RCC and consolidate its expertise in stem cell research.

There are expected to be opportunities to spin technologies out of the RCC and a seed fund, the Genomia Fund has partnered with Roslin to provide initial finance for technology commercialisation.

The RCC – to be run by Paul De Sousa, one of the leading stem cell researchers in the country – will create stem cell lines from donated eggs and embryos. De Sousa has established several new embryonic stem cells lines previously as well as being involved in setting up a program in which women having elective sterilization procedures are asked to donate eggs.

"The RCC will make clinically usable stem cell lines available under a range of negotiated terms," De Sousa said. "[That] includes one-off payments without reach through rights.

"This approach will provide huge benefits to academics and companies already working in the field or seeking to enter it."

The Scottish National Blood Transfusion Service (Edinburgh) will be involved in the project to ensure the cell lines are produced to GMP standards.

St. Jude wins Atlas CE marking

St. Jude Medical (St. Paul, Minnesota) yesterday reported CE marking of its newest high-powered devices for treatment of patients with potentially lethal heart arrhythmias and heart failure (HF).

The Atlas II implantable cardioverter defibrillator (ICD) and the Atlas II HF cardiac resynchronization therapy defibrillator (CRT-D) devices include features providing more tailored therapy and speed follow-up visits for physicians and patients.

The Atlas II devices also take advantage of the company's newly released QuickOpt feature, which helps physicians improve patient outcomes by providing programmer-based optimization in less than two minutes. The QuickOpt feature electrically characterizes the conduction properties of the heart and uses an exclusive algorithm to calculate the optimal timing values, allowing for efficient and frequent optimization during routine device follow-up visits. QuickOpt, the company said, "has proven comparable to a traditional echocardiography (echo) procedure for determining optimal device settings; however, echo optimization can be costly and time-consuming and typically takes between 30 and 120 minutes.

In addition, the Atlas II devices offer enhanced telemetry speed for faster communications – up to five times faster than predecessor devices – which results in quicker, more convenient follow-up visits for patients and physicians. Additionally, a "patient notifier" gently vibrates to alert patients, including those who have difficulty hearing, of critical changes in device function so they know to contact their physicians.

Christian Lampersberger, MD, who implanted an Atlas II+ DR ICD at Landesklinikum St. Pölten, Austria, said, "The DeFT Response feature is very beneficial in that it provides a way to non-invasively manage those who may experience high defibrillation thresholds," said Lampersberger. "Also, the QuickOpt optimization feature is exciting new technology, as it will help to provide more tailored therapy for patients and save clinic time."

Luigi Padeletti, MD, implanted an Atlas II HF CRT-D at Careggi Hospital (Florence, Italy).

The Atlas II ICD and Atlas II HF CRT-D devices are two of more than 20 new cardiac rhythm management products that St. Jude Medical plans to introduce this year, it said.

University of Twente gains SCI license

Stem Cell Innovations (SCI; Houston) reported that it has launched a collaboration with the University of Twente (Enschede, the Netherlands) to explore the bone forming properties of PluriCells.

Dr. James Kelly, CEO of SCI, said, "This former IsoTis in-house orthobiology research group has developed a comprehensive set of robust in vitro and in vivo models in which the PluriCells will be tested. SCI is impressed that their science is very application driven … "

Under the agreement, the university gains access to SCI's proprietary human pluripotent stem cell technology and know-how. In return SCI will receive a non-exclusive license to intellectual property generated with the PluriCells.

Stem Cell Innovations recently disclosed it has produced multiple lines of human pluripotent stem cells. These PluriCell lines can be efficiently cultured in tissue culture plates without the use of feeder layers and can be efficiently differentiated into multiple cell-types, having the potential to aid in drug discovery and development.

PluriCells are a type of pluripotent stem cell isolated from fetal tissue that has the ability to become all cell types of the body. Because they are developed from fetal germ cells, not viable embryos, they are eligible to be used in any National Institutes of Health -funded laboratory. Stem cells derived from fetal germ cells were explicitly excluded from the Presidential ban by the Department of Health and Human Services guidance document that laid out what type of stem cells could and could not be used in federally funded research.

The University of Twente describes itself as "an entrepreneurial research university" that was founded in 1961 and offering education and research in ranging from public policy studies and applied physics to biomedical technology.