Hospital in Bangkok, Thailand is the first accredited center in Asia for Functional Medicine, providing customized supportive therapies for each patient’s unique condition including: Physiotherapy, Aquatherapy, Occupational Therapy, Hyperbaric Oxygen Therapy, Transcranial Magnetic Stimulation, Acupuncture, and Nutrition Therapy.
The hospital is based on the principles of Functional Medicine which guides the treatment of each and every chronic illness patient. It is designed as an Integrative Center, where many different treatment modalities can be provided under one roof, aiming at therapeutic lifestyle changes to heal the causes of chronic illness alongside advanced stem cell therapy.
Umbilical Cord Collection and Initial Testings
It is a common practice in China for mothers to voluntarily donate the umbilical cord blood from the birth of their healthy full-term children. Every mother who enters a hospital in China to give birth is automatically tested for all major diseases. Detailed family histories are also collected from each mother prior to donation. Only women who have been fully screened and found to be completely healthy are allowed to donate their umbilical cord and umbilical cord blood.
Second Round of Testing
The collected sample starts a second round of testing and while following donor’s requirement from the USFDA and AABB, also carries out testing for cytomegalovirus, exogenous virus (human T-cell leukemia virus, HTLV), micro-organisms (aerobic bacteria, anaerobic bacteria, fungi, etc), survival rate, stem cell surface markers and stem cell biological characteristics (colony forming ability, differential capacity…) in each step to ensure the highest quality to its cell products.
Obtaining the cord blood serum and preparing the stem cells for culturing is accomplished by separating the desired components from the cord blood. The blood cells need to be removed from the blood serum and stem cells so as to not interfere with future injections. A centrifuge is used to separate the serum and stem cells from the red cells and platelets. This is highly refined and specialized separation process. After separation has been completed, the stem cells are removed for culture.
The stem cells derived from each umbilical cord are seeded into a flask filled with culture medium. This medium does not contain any animal products (such as fetal calf serum) but it is enhanced with cell growth factors. The flasks are placed in a sterilized, temperature and humidity controlled incubator. The stem cells are expanded in the culture medium. Once the culturing is complete, the culture medium is washed away and are harvested.
The cell products are then cryo-preserved and stored at a consistent -196 degree Celsius temperature with automatic supplement of liquid nitrogen using the highly advanced Thermogenesis BioArchive system. This technology allows for integrated control rate of freezing that totally avoids sudden drops in temperature. Cryo-preservation storage equipment is also equipped with 24h real-time control system and in any case of power-failure or other emergency, a redundant fail-safe power supply ensures that normal operation is carried out. Vacuum protection system can maintain proper temperature for 20 days without supplement of liquid nitrogen.
Packing and Transport
All batches of stem cells undergo final testing. During this process they are also checked for quantity and quality. Once the stem cells are deemed safe, each unit is placed into either a sterile vial or a sterile IV bag for future transplantation. All products are individually cataloged and tracked while in transit. Cell transplants take place two to three days a week. All of cells are processed on an as-needed basis. All of cell products are processed and kept fresh, giving us the highest stem cell viability count and the maximum potency.
Quality is a top priority.
Beike has an extensive ‘start-to-finish’ quality control protocol in place that starts from the selection of stem cell donors all the way to the delivery of stem cells to the treatment centers.
Strict Quality Control Systems
Has established more than 20 adult stem cell processing laboratories, in accordance with GMP standards, and has been awarded ISO9001 and ISO17025 certificates. Inspection center was accredited by the China National Accreditation Service for Conformity Assessment (CNAS) in 2011, and it is the first adult stem cell processing laboratory accredited by CNAS. Successfully completed on-site evaluation for AABB (American Association of Blood Bank) accreditation in September 2011.
GMP Standard Laboratory
Has more than 20 GMP standard laboratories across the country with class-100 clean rooms outfitted with hi-tech equipment, including BD high-speed sorting flow cytometry (8 colors), Olympus fluorescence microscopes, Chart MVE gas storage systems, ABI fluorescence quantitative PCR devices, and automated stem cell separation and storage systems.
China’s First and Most Integrated Stem Cell Quality Control System
Adheres to a strict biological quality management system and established the earliest and most complete quality standard system for adult stem cells.
- Laboratory standards for clinical-grade adult stem cell processing
- Safety and quality control system for clinical-grade adult stem cells
- Research and management system for clinical-grade adult stem cells
- Disease-specific translation protocols for clinical-grade adult stem cells
Quality management system is based on the following regulations and standards for cell therapy products:
- FDA-CBER*, OCTGT**, CDRH***
- Good Tissue Practices (GTPs)
- Good Manufacturing Practices (GMPs)
- Good Clinical Practices (GCPs)
- Institutional Review Board, Biosafety Committee
- Foundation for cellular Therapy (FACT)
- American Association of Blood Banks (AABB)
- American Association of Tissue Banking (AATB)
- United States Pharmacopeia (USP)
- College of American Pathologists (CAP)
- Clinical Laboratory Improvement Amendments (CLIA)