First Case of Adipose Derived Stem Cells for Repairing Human Skull Defects Reported; Operation with Stem Cells Used in Conjunction with MacroPore Protective Sheet.

SAN DIEGO -- MacroPore Biosurgery, Inc. (Frankfurt: XMP), and The University of Giessen today announced the publication of a case report from Europe using adipose derived stem cells to treat a damaged region in a skull of a seven-year-old girl following a severe head injury that occurred one year earlier. The cells were harvested using a proprietary protocol developed by MacroPore Biosurgery. Three months following the stem cell treatment, CT-scan analysis showed signs of new bone formation and near complete calvarial continuity around the area of the skull trauma. As a result, the patient no longer needs to wear the protective helmet she had worn for the previous year. The operation was performed by Prof. Hans-Peter Howaldt, Head of the Department of Maxillofacial and Facial Plastic Surgery, Justus-Liebig-University Medical School, Giessen, Germany, and was published, together with colleagues from the Neurosurgery Department at the Institute, in the December issue of the Journal of Cranio-Maxillofacial Surgery ((2004) 32, 370-373).

"Due to the limited amount of bone available from the iliac crest in relation to the size of the injury, which was 120 cm2, we needed an alternative method to conventional bone grafting," said Prof. Howaldt. "This was evidenced by unsuccessful treatments that the patient had previously undergone. In response, we hypothesized that adipose derived stem cells might play a role in augmenting the repair process and developed a novel procedure. The result of the case study does not tell us to what extent the osteogenic effect is directly attributable to the combination of techniques using stem cells compared to the effect of the bone grafting alone. However, the outcome provides encouraging anecdotal evidence on the potential application for these cells to treat difficult bone defects, laying the groundwork for future work in this area. After twelve months, subsequent to the submission of our findings, the patient continues to do well and the skull is stable."

"The outcome of this case is consistent with MacroPore Biosurgery's ongoing preclinical research using adipose derived stem cells for orthopedic applications, which could include bone repair, spinal disc regeneration and sports medicine," said Marc H. Hedrick, President of MacroPore Biosurgery. "We also envision these cells being applied toward additional areas of medicine such as cardiovascular disease, which is our most advanced area of research, tissue augmentation and wound healing. For this reason, we are currently designing and developing a system to automate the extraction and processing of these cells in real-time."

For the procedure, stem cells from the patient's adipose tissue were added to grafted bone taken from the patient's iliac crest, which was evenly applied to the skull defect and set in place with two resorbable MacroPore(TM) Protective Sheets. The harvested stem cells were processed in two hours from 42 grams of adipose tissue and suspended in saline. Post operative healing was uneventful and there were no neurological deficits. Clinical follow-up has shown symmetrical calvaria contour while ultrasound examination two and six weeks postoperatively proved the cancellous bone and the MacroPore(TM) Protective Sheets to be in correct and stable position. CT scans four and 12 months after surgery also showed marked ossification of the disseminated calvarian defects.

About MacroPore Biosurgery, Inc.

MacroPore Biosurgery (Frankfurt: XMP) is focused on the discovery and development of regenerative medicine technologies. We have two technology platforms, regenerative cell technology and bioresorbable technology. Within our regenerative cell technology program, we are developing a system to isolate autologous, homologous-use regenerative cells. Simultaneously, we are generating scientific knowledge through internal research to support the clinical use of these cells. Our most advanced research and development program is in the repair of cardiovascular tissues that are damaged after a heart attack. We are also researching applications in bone repair, spinal disc regeneration and, cosmetic and reconstructive surgery. Our surgical implants, derived from our bioresorbable technology, represent one of the latest advancements in spine and orthopedic medicine. For further information please visit our web site http://www.macropore.com.

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