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II. Chairman M.C. Ho
III. Business Operations
Collecting and preserving umbilical cord blood (CB) stem cells from newborns at the time of birth, for a predetermined fee, is the key component in private CB banking. Only the original owner or assignee of the original owner, has access to use the banked CB stem cells, should the need for them arise at a future time.
Sino Cell is committed to provide the highest standard of quality and most efficient system of service in delivering collected CB specimens from any delivery room/hospital in Taiwan to its processing laboratory in Hsinchu, within 30 hours after birth. Since its inception in April 2001, Sino Cell has successfully processed and stored over 12,000 CB samples.
In addition to its headquarters in Taipei, Sino Cell also has four fully-staffed branch offices geographically positioned island-wide in the cities of Taipei, Hsinchu, Taichung, and Kaohsiung. SCT’ laboratories for the receiving, processing, testing, and the cryostorage of cord blood stem cell specimens are located in the leading institution of Taiwan’ food industry, Food Industry Research and Development Institute (FIRDI), which is adjacent to the well-known Science and Industry Park in Hsinchu, Taiwan (so-called “Silicon Valley of Taiwan”). Both SCT and FIRDI are ISO-9001 certified institutions.
IV. Cord Blood Processing and Storage Laboratories
Sino Cell Technologies (SCT) has a separate clinical laboratory dedicated to provide the clinical testing and processing services that are essential for the cord blood stem cell specimen acceptance, sample process, and cryostorage. The stem cell processing laboratory is equipped with seven laminar flow hoods that are certified as P-2 units by the Ministry of Health, Republic of China. The cord blood laboratories are staffed by eleven qualified biomedical personnel/certified medical technologists, under the direction of Patrick F. Shen, Ph.D., MT(ASCP), CLS(NCA); Vice President for Research and Development, and Director of Laboratory Operations. Dr. Shen is a senior professor in laboratory medicine with more than twenty years of experience in university teaching, research, and service.
Infectious disease testing is critical in hematopoietic stem cell transplantation. The donor must be screened to minimize the risk of transmission of infectious disease to an already immunocompromised recipient. To verify the acceptability of cord blood stem cell samples for processing and storage, it is imperative that the maternal blood sample must be collected within 48 hours of collection of the cord blood and tested for certain disease markers such as:
- HIV Antibody (antibody to human immunodeficiency virus)
- HBs Antigen (hepatitis B surface antigen)
- HBc Antibody (antibody to hepatitis B core antigen)
- HCV Antibody (antibody to hepatitis C virus)
- HTLV Antibody (antibody to human T-cell leukemia/lymphoma virus)
- Rapid Plasma Reagin (screening test for syphilis)
In each of the key processes for cord blood specimen collection, processing, testing, and cryostorage, SCT’s standard operating procedures (SOPs) are in strict adherence to the AABB guidelines and standards so that each of the precious CB specimens is treated with the utmost care and attention. SCT not only has highly-qualified and skilled laboratory personnel who stringently follow the SOPs for processing and testing cord blood stem cell specimens; but also various advanced laboratory equipments such as B-D FACSCaliber flow cytometer and Wharton-Taylor K-80 cryostorage tanks in assuring the provision of its services. SCT shares the safest cryopreservation facility in Asia, which is located in FIRDI, with Taiwan’s Repository of Cell Lines, National Health Research Institutes (NHRI).
SCT has developed and installed a comprehensive software system called Records Management Program (RMP) that is with the practice of health information privacy protection in mind, to insure an accurate, confidential, and sustainable tracking of data of all cord blood specimens of our customers, from the time of childbirth, CB specimen collection, transportation and receipt of CB specimen from hospital to the SCT laboratory, processing and testing of CB specimen, and cryogenic storage of processed CB specimen in liquid nitrogen storage tank, to the final release of the Report of CB Stem Cell Processing and Storage. A comprehensive barcode identification system has also been incorporated, so that restricted and authorized SCT personnel and regulatory agencies of the government can have instant access to the status of donor and sample information, as well as each and every steps of CB processing and testing. Because of the high-standard performance of its cord blood processing & storage operations throughout the years, SCT is greatly honored to be included in a short list of selected group of biotechnology and therapeutics companies in Taiwan as a recipient of the 2005 National Quality Award.
V. Ongoing R&D Projects
With Sino Cell’s private domain of CB banking business activities, sources that can steadily supply donated CB are readily available. Taking this advantage and realizing the promising potential of adult stem cells, Sino Cell has decided that its research works should focus on the CB stem cells. CB hematopoietic stem cells (HSC) have been shown to be capable of self-renewal and differentiation into different blood cell types in both in vitro and in vivo conditions. The advantages of utilizing CB stem cells for hematopoietic cell transplantation (HCT) include avoiding all the ethical controversies of embryonic stem cells, not having any immunorejections if autologous stem cells are used, and lower incidence of severe graft versus host disease (GVHD), etc.
Sources of hematopoietic stem cells (HSC) are bone marrow, mobilized peripheral blood, embryo, and cord blood. Among these sources for obtaining HSC, cord blood offers the most natural, absolutely safe, and relatively abundant stem cells. Compared to marrow and peripheral blood, cord blood contains plenty of HSC, neural stem cells (NSC) and mesenchymal stem cells (MSC) that can give rise to not only all the cell types in both blood and immune systems (erythrocytes, platelets, granulocytes, lymphocytes, monocytes, macrophages, and dendritic cells); but also can differentiate into astrocytes, neurons, and oligodendrocytes; and give rise to adipocytes, chondroblasts, fibroblasts, and osteoblasts. Thus, CB has become an increasingly important alternative therapeutic tool for HSC transplantation to cure life-threatening solid tumor, metabolic disorders, genetic disorders, hematological malignancies, and severe immunodeficiency syndromes.
The incredible plasticity and trans-differentiation potential of stem cells has drawn a lot of efforts and resources into SC research during last decade. Following the passage of Proposition 71 on November 2nd, 2004, California will provide $3 billion US dollars over next 10 years to fund stem cell research activities. Proposition 71 will establish an independent California Institute for Regenerative Medicine authorized to disburse $300 million annually over the next decade. In addition to HSC, identification of NSC and MSC may at some day lead to stem cell-based therapies for diseases that affect the central nervous system (CNS), such as Parkinson’s disease, Alzheimer’s disease, stroke, and spinal cord injuries; or organs such as liver (hepatitis, liver cirrhosis, hepatocellular carcinoma); heart (myocardial infarction and other cardiovascular diseases); and pancreas (diabetes mellitus), etc. It is with high hope that one day stem cells-based therapies represent powerful tools and hold promise to combat and eradicate those aforementioned debilitating diseases.
Due to the fact that mouse cells used to sustain the existing lines of human embryonic stem cells approved for US government funded research, could trigger an immunological response and rendered unusable for human therapeutics; scientists believe that none of these existing cell lines could be used to derive US FDA-approved therapies.
In an attempt to realize the full therapeutic potential of stem cells, the enthusiastic and devoted scientists at SCT R&D Division are working hard trying to elucidate the basic problems of stem cells biology. It is with high hope that some of our studies will lead to a better understanding of stem cells and to more practical and efficient cellular therapies. Some of our specific ongoing R&D projects include:
A. Ex vivo expansion of HSC
One drawback of using UCB in current medical treatment is the limited volume of UCB per sample. With limited number of HSC available, recipients of UCB transplantation, in general, have to have a body weight less than 20 kg. To tackle this obstacle, Sino Cell Technology, in collaboration with Dr. Huang of FIRDI, has successfully developed a serum-free stem cell culture medium and a technique for ex vivo expansion of stem cells, which allow cord blood HSC to expand their number by 30-fold in 5 days and 7000-fold in 6 weeks. This exciting breakthrough is the first of its kind in Taiwan, and SCT has proudly hosted a news conference last August in Taipei to share this noteworthy achievement to our costumers and colleagues in science community. We are currently conducting animal study of the ex vivo expanded HSC by using NOD/SCID mouse model. This project is supported by the funding of the Ministry of Economic Affairs (MOEA) of the Republic of China, for Small Business Innovation Research (SBIR) grant.
B. Directed differentiation of MSC
Sino Cell Technologies is developing the key technologies for isolation/purification and expansion of MSC from UCB, in attempt to conducting induced-differentiation of these MSC ex vivo into various tissue-specific cells that are valuable in regenerative medicine, such as adipocytes, osteocytes, hepatocytes, osteoclasts, chondrocytes, endothelial cells, cardiomyocytes, and neural cells, etc. In the near future, the trans-differentiation technology will be used together with regenerative medicine and tissue engineering to develop novel, integrated therapeutic protocol. The target diseases include liver diseases, strokes, spinal cord injuries, Alzheimer disease, cardiovascular disease, diabetes, etc.One of our projects titled “Ex Vivo Expansion and Differentiation of Cord Blood-Derived MSC with Serum-Free Media”, in collaboration with Dr. M C Wu of the University of North Texas at Fort Worth, USA, has been funded by MOEA in August 2002.
C. cGMP compliance cell therapy
In order to be able to apply the laboratory findings to the bed side, an advanced manufacturing technology and facilities with cGMP compliance plays an essential role. Sino Cell is planning to work with its domestic and international strategic alliance partners such as Stem Cell Institute of Tokyo, Japan, to establish a state-of-the-art facility that is under cGMP guidelines for production of FDA-approved therapeutic-grade byproducts from stem cells.
D. HLA typing and miscellaneous activities
In addition to FIRDI, Sino Cell has established long-term research collaborations and interactions with some of the foremost players in biomedical research in Taiwan such as National Defense Medical Center (NDMC), Tri-Service General Hospital (TSGH), and Kaohsiung Medical University (KMU). Sino Cell applies molecular biology methods of polymerase chain reaction-sequence specific primers (PCR-SSP) and DNA sequencing for human leukocyte antigen (HLA) typing. Sino Cell has close contact with experienced immunogeneticists, who formerly worked for the HLA typing reference laboratory of the American Red Cross for more than 25 years, to interpretation HLA-matching results accurately for potential allogeneic cord blood transplantation between siblings.
In summary, stem cell researchers of Sino Cell have made progress on several fronts. The utmost goal of our research team is to elucidate the basic problems that control the mechanisms of plasticity and regenerative potential of stem cells, and to overcome hurdles of clinical applications of stem cell therapies that will ultimately pave the way to full-blown applications of stem cell-based/derived therapies to successful treatment of many devastating and not curable diseases to benefit all human beings.
(Updated by PFS. June, 2006) |
