Medical Device Daily International Correspondent

LONDON – Scientists in the UK have breached an ethical barrier in embryonic stem cell research, receiving permission to pay women for egg donations for use in therapeutic human cloning. The team from the North East England Stem Cell Institute (Newcastle) received permission to extend an existing egg-sharing scheme, under which women undergoing in vitro fertilization will pay only half the usual cost of treatment if they donate half the eggs produced to cloning research. Currently, the egg donations are reserved for women who cannot produce their own eggs.

Permission to extend the scheme was granted by the Human Fertilisation and Embryology Authority (HFEA), a regulatory agency which also said it will launch a widespread public consultation in September to develop new rules on egg donation for research.

Allowing egg sharing for research is an extension to an existing license granted to Alison Murdoch, professor of reproductive medicine and director of the Newcastle National Health Service Fertility Centre, in 2004. That license permitted researchers to seek patient consent to use eggs that failed to fertilize and those from women undergoing follicle reduction, in research.

One of those eggs produced the only human embryo to date proven to have been cloned. The publication of that advance in May 2005 was overshadowed by the more sensational progress made by Hwang Woo-suk in South Korea. But with the discrediting of his work, the Newcastle clone is acknowledged as a world first.

Following that, in 2005 Murdoch won approval to ask IVF patients to donate two fresh eggs to research if more than 12 had been collected. But the researchers say the number donated is too slow to allow work to progress rapidly, with the existing practice providing only 66 eggs in seven months.

Murdoch called the HFEA's decision a step forward for stem cell research. “This is just another way of engaging volunteers in a research project. Our experience is that these patients understand the benefits of our research, and the majority are very keen to participate.”

No embryonic stem cell lines resulted from the human clone generated in Newcastle, and Murdoch has argued that nuclear transfer is likely to be successful only if the eggs are fresh and used immediately after removal.

“Of course, it is of paramount importance to ensure that all donors are not recruited to participate in this research against their best interest by coercion or excessive financial inducement,” Murdoch said. “We are helping [patients] to have treatment they may not otherwise be able to afford.”

Product Briefs

• Clearant (Los Angeles) reported that it has expanded its product portfolio of allograft implants available through its direct sales force to include Clearant Process sterile soft tissue implants for allograft sport medicine surgeries. Clearant now offers sterile implants for both soft tissue and cervical spinal bone allograft surgeries through direct distribution, saying this increases its addressable market from $100 million annually (for cervical spinal implants) to $350 million or more (for both soft tissue and cervical spinal implants). Clearant's implants are sterilized using the Clearant Process. Clearant develops biological product inactivation technologies.

• Medrad (Indianola, Pennsylvania) and GE Healthcare (Chalfont St. Giles, UK) reported the availability of the first endorectal coil for 3.0T magnetic resonance (MR) prostate imaging. The Medrad 3.0T Prostate eCoil is available for GE Signa HDx 3.0T MR scanners through sales representatives from Medrad and GE Healthcare. The 3.0T Prostate eCoil is designed to produce diagnostic images of the prostate that may enable early diagnosis and staging of prostate cancer in a way that helps physicians localize treatment to only the affected part of the gland. The eCoil balloon conforms to the size and shape of the prostate for consistent contact between the gland and the signal-amplifying elements of the coil, thus producing a small field-of-view (FOV) and high spatial resolution, sensitivity, and specificity that yield clearer pictures of the prostate, according to the company. Medrad is focused on developing medical devices and services that enhance imaging procedures of the human body, including vascular injection systems, MR surface coils and patient care products, and equipment services.

• The Sorin Group (Milan, Italy) has released in the U.S. the successor to its SIII perfusion system, the S5. The Stockert S5 is a fifth-generation heart-lung machine, coming from Stockert and Cobe Cardiovascular (Arvada, Colorado) brand technologies. Sorin said the product is expected to help hospitals achieve new standards for safety, functionality, flexibility and quality. U.S. cardiac surgery teams now have access to the S5 along with the Stockert Heater-Cooler System 3T, used to control patients' temperature during cardiac surgery and also recently cleared for sale in the U.S. The smaller footprint of the S5 allows closer positioning of the unit to the patient, effectively reducing line lengths and the possibility of hemodilution. In addition, acoustically differentiated alarms and information displayed on the high-resolution touch screens clearly describe the status of all monitoring functions of the extracorporeal circuit. With the Stockert S5, there is no boot-up time, so the pumps are operable three seconds after turning the system on, which is important in emergency situations, the company said. During bypass, the Stockert Heater-Cooler System 3T controls the temperature of the patient while separately controlling the temperature of the heart using independent water baths that are controlled by an extremely quiet and effective compressor system.

• Toshiba America Medical Systems (Tustin, California) reported the release of its Version 3.0 software for the Aquilion 64 and 32 computed tomography (CT) systems — the most advanced multislice CT technology available. The new software is designed specifically to improve overall departmental productivity, and features options that further enhance the industry's fast reconstruction kit, up to 28 slices per second, and includes enhanced digital imaging and communications format in medicine (DICOM) data transfer at up to 50 images per second.