SituGen Ltd. Completes Clinical Trials Of Novel Device For Umbilical Cord Blood Collection

Main Category: Stem Cell Research
Also Included In: Medical Devices / Diagnostics
Article Date: 11 Sep 2008 - 5:00 PDT

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SituGen Ltd. announced the completion of clinical trials of its innovative patent-pending device for the collection of umbilical cord blood. The trials show that the revolutionary device increases the number of stem cells collected by an average of 81%, to 1.51 billion Total Nucleated Cells (TNC), compared to the world average of 0.83 billion TNC. This significantly increases the quantity of stem cells that can be transplanted into adults.

TNC is the main indicator for the quality of cord blood collected. The number of nucleated cells is a significant factor in transplantation success and is a major predictor of recovery speed after transplant.

FDA approval of the new device is expected later this year, with European approval (CE) shortly to follow.

"The results of the clinical trials are a global breakthrough in cord blood collection," says Miki Shacham, SituGen's CEO. "The increase in cord blood quantity and quality collected will now enable transplants of these quality stem cells in adults with an average body weight of 65 kg. Adults comprise the majority of patients who need stem cell transplants, and today they are mostly dependent on bone marrow stem cell donations or on umbilical cord stem cells originating from several donors."

SituGen's revolutionary device is disposable and needle-free, relieving the "bottleneck" effect created by applying a needle to collect the blood from the cord's vein. Situgen's device is in full accordance with all the requirements set for all umbilical cord blood collection devices. It is also suitable for operating rooms and caesarean sections.

SituGen's device is easy to operate, requiring only minimal training of delivery and operating room staff members.

Following successful completion of clinical trials, SituGen is preparing to manufacture and market the device to cord blood banks worldwide. In addition, SituGen will continue research and development in the stem cell and cord blood fields, focusing on blood coagulation aspects in the umbilical cord and the placenta, in pregnancy and birth.

Stem cells are the progenitors of all cells in the human body and umbilical cord blood is one of the richest sources of stem cells available. Stem cells extracted from cord blood are currently used not only to treat blood and immune system-related genetic diseases, cancers, and disorders, but also to treat additional diseases, such as rehabilitation after heart attack, diabetes and Alzheimer's. The usage of stem cells extracted from cord blood in these diseases has already been successfully tested in humans. Cord blood includes unique stem cells, which are genetically suitable, with high probability, for transplantation in immediate family members. This resulted in an increase in the number of families in recent years that have been collecting and keeping their newborn's cord blood for possible future use. Additionally, government budgets are being granted to public cord blood banks to increase their capacity in realizing this critical need.

Stem cell treatment is accomplished through transplants. Among other things, these cells help rehabilitate the blood system after chemotherapy or radiation treatments. Chemotherapy and radiation treatments are known to destroy malignant cells, but also have an adverse effect on stem cells. Therefore, after such treatments, a transfusion or transplantation of stem cells is required. These transplanted cells then duplicate to rebuild the cell blood reservoir and the immune system cells.

About SituGen Ltd.

Founded in 2003, SituGen is a sister company of BioCord, an Israeli private cord blood bank, which will soon start conducting national, multi-center trials of the SituGen device in Israel. SituGen was founded and is managed by Mr. Miki Shacham. In 2006, RAD BioMed technological incubator, of the RAD Bynet Group of multi-national high-tech companies, joined SituGen as an investor and partner. The RAD BioMed incubator supports and nourishes numerous technological startups in the biomedical field from seed to product, and is supported by the Chief Scientist of the Israeli Ministry of Industry, Trade and Labor. The head of SituGen's scientific advisory board is Professor Arnon Nagler, Director of Hematology Division, the Bone Marrow Transplantation Department and the public cord blood bank at Israel's Sheba Medical Center.

SituGen Ltd.