Histostem awarded U.S. patent for isolation of mesenchymal stem cells

Oct 13 2009

Stem Cell Therapy International, Inc. (OTCBB: SCII) announced that its soon to be subsidiary, Histostem Ltd. of South Korea ("Histostem"), has been awarded U.S. Patent Number 7,582,477 B2, entitled "Method of Isolating and Culturing Mesenchymal Stem Cell Derived from Cryopreserved Umbilical Cord Blood." This patented method is utilized across the company for research, clinical and cosmetic applications. The method is central to obtaining the primary ingredients in the development and manufacturing of the Company's Stem Cell Facial Cream, as well as for previous and anticipated future clinical trials.

David Stark, Stem Cell Therapy's President and CEO, stated, "Amstem, which will be the new merged company, has a unique three pronged platform in the regenerative market with the world's largest fully accredited public cord blood bank, a lab dedicated to clinical development of stem cell therapies for unmet medical needs, as well as compelling consumer products preparing for international distribution. Of particular relevance is its use in the development and manufacturing of our Stem Cell Facial Cream, which is used to rejuvenate the skin. The cream's active ingredients include Human Stem Cell Conditioned Media (HSCM), which are proteins created during the culture of stem cells using Histostem's patented method. The Stem Cell Cream helps to recover the function of the skin's own stem cells, thereby vitalizing the natural fibroblasts of the skin."

Dr. Hoon Han, President and Founder of Histostem Ltd. and the holder of the patent, commented, "This product has been used in Korea and throughout Asia for over 2 years, with documented safety and positive results. We are pleased to receive this patent award as a testament to all our years of work on this project. We are now ready to offer this product to the rest of the world, through AmStem Corporation."

The patent, issued on September 1, 2009, included this description in its abstract: "The present invention relates to a method of isolating and culturing mesenchymal stem cells using cryopreserved umbilical cord blood that is the most ideal for cell therapy." Dr. Han explains, "This method provides our stem cell cream with a very robust active ingredient, and also bodes well for our many clinical trials regarding incurable diseases."

"We are actively exploring partnering opportunities with U.S. and E.U. distribution partners. Given our proven market presence in Asia, proprietary supply chain, GMP-approved manufacturing facility, and promising study results, the response has been extremely positive," stated Mr. Stark.

With this patent added to Histostem's stable of proprietary technology, clinical trials will be upgraded immediately, leveraged by the vast experience of Mr. Stark and his colleagues, who have a combined 30 years experience in international regulatory affairs. New and improved trials will be run in South Korea by AmStem; under strict guidance of the KFDA, and in adherence to ICH guidelines, as part of a 2-year plan to validate earlier, successful outcomes in Histostem trials.

Additional development of Histostem technology by AmStem will include ensuring that their vast stockpile of cord blood units (CBUs) (and therapeutic stem cells derived from them using the newly-patented technique) will be available to researchers and patients in need around the world. "We will be making inroads to pool our accredited cord blood bank with other international repositories to facilitate the use of the CBU's by patients in the fastest, most accurate way possible," Mr. Stark announces.

Andrew Norstrud, CFO of SCII, adds, "We believe that we are well positioned in the market to quickly increase our combined world-wide revenue with the new, improved stem cell based cosmetic products and the supply of stem cells for research. With the appropriate level of capital, we expect to make significant progress on our research and development objectives for future stem cell applications."