- Product Overview
Chronic and degenerative diseases such as cerebral palsy, Autism, cardiovascular diseases, spinal cord injury, autoimmune diseases, and many others are major threats to public health and the solvency of health systems worldwide. Current treatments for these diseases cannot meet medical needs. Cell therapy is a new technology that has the potential to alleviate much of the burden of these chronic and degenerative diseases in a cost-effective manner.
The number of cell therapy companies that are currently in Phase 2 and Phase 3 trials has been gathering momentum, and we anticipate that new cellular therapy products will begin to appear on the market within the next several years.
CBMG is developing our business in cell therapeutics and capitalizing on the increasing importance and promise that adult stem cells have in regenerative medicine.
Knee osteoarthritis (KOA) is one of the most common types of osteoarthritis, caused by regular “wear and tear” degradation accumulated over time. This leads to swelling, stiffness and pain caused by the localized immune response in the knee.
Of the 57 million people suffering from osteoarthritis in China, 53% with knee osteoarthritis will degenerate to the point of requiring artificial joint replacement surgery every year. However, only forty thousand will actually be able to undergo replacement surgery, leaving the majority of patients to suffer from a lifelong disability due to lack of effective treatment.
Human adipose-derived mesenchymal progenitor cells are currently being considered as a new and effective treatment for osteoarthritis, with a huge potential market. In 2009, the worldwide market for orthopedic, tissue repair and cell therapy related products reached $3.6 billion, and sales are expected to reach $5.5 billion in 2014.
Independent research and development work can be done with CBMG’s cell isolation and culture kit, which has the added benefit of standardizing technical training, ensuring the scalability and quality of our KOA cell therapy technology.
CBMG’s proprietary haMPC proliferation and processing knowhow enable haMPC therapy to be a low cost, safe, and effective treatment for KOA. Additionally, banked haMPCs can continue to be stored for additional use in the future.
- HCC (Liver Cancer)
Recent scientific findings have demonstrated the presence of special cells in tumors that are responsible for cancer metastases and relapse. Named "cancer stem cells", these cells make up only a small portion of the tumor mass. The central concept behind Tumor Stem Cell Specific Dendritic Cell (TC-DC) therapy is to immunize against these cells. TC-DC therapy takes a sample of the patient's own purified and irradiated cancer cells and combines them with specialized immune cells, educating the immune cells to destroy the cancer stem cells from which tumors arise. The selective targeting of cells that drive tumor growth allows for effective cancer treatment without the risks and side effects of current therapies that also destroy healthy cells in the body.
CBMG has partnered with California Stem Cell Inc. (CSC) to utilize this new cancer immunotherapy to tackle late stage hepatocellular carcinoma (liver cancer). CBMG’s joint venture with CSC grants CBMG an exclusive license from CSC to develop and market CSC’s cancer (TC-DC) technology in Greater China. As of January 2013, our liver cancer therapy has officially begun a Phase I clinical trial.
One of the primary difficulties in administering effective cancer therapy is in the uniqueness of the disease – no two cancers are the same. Importantly, CBMG sources both immune and cancer cells directly from the patient, and our completely autologous approach to cancer therapy means that each dose is specific to each individual.
In simplified terms, TC-DC therapy takes a sample of the patient's own dendritic, or immune cells and a sample of the patient's tumor stem cells and places them together in the lab. The dendritic cell will learn the characteristics of the tumor stem cells, and is reintroduced to the patient's body, where it can "train" the immune system to fight and destroy the tumor stem cells, which are the root cause of tumor recurrence and metastasis.
- T Cell Cancer Immunotherapy
CellecTTM Autologous T Cells-Based Immunotherapy
CELL TYPE: Tcm - T Central Memory Cell
China has numerous AAA hospitals for in-patient cancer treatment and the number of cancer patients in China is growing rapidly. There are 3,120,000 new cancer patients in China annually, or 8,550 new patients per day.
Tcm cells are the subpopulation of T lymphocytes with key characteristics including high potency and long-term memory of specific immunity; and they are the key element of immunocellular fortification against tumors, infections and immune disorders.
Currently under China’s regulation, cancer patients treated with T-cell technology are entitled to medical insurance coverage in approximately ten provinces
- Adipose Derived Stem Cells
Fat tissue contains a dense population of cells known as mesenchymal stem cells which are capable of undifferentiated replication, or becoming bone, cartilage, fat, muscle, tendon or marrow. The advantages in using adipose tissue are that it is one of the richest sources of mesenchymal stem cells in the body, are very easy to obtain via liposuction, and the initial cell isolation procedures that can begin immediately on-site with minor equipment needs.
As such, human adipose-derived Mesenchymal Progenitor Cells (haMPC’s) are one of the main focuses of the next generation of medical research and clinical development. Numerous studies have provided preclinical data that support the safety and efficacy of allogeneic and autologously derived cells, offering a choice for those where factors such as donor age and health are an issue.
Additionally, certain disease treatment plans call for an initial infusion of these cells in the form of Stromal Vascular Fraction (SVF). The therapeutic potential conferred by the cocktail of ingredients present in the SVF is evident, as it is a rich source for preadipocytes, mesenchymal stem cells, endothelial progenitor cells, T regulatory cells and anti-inflammatory macrophages.
- Cartilage Defect
Cartilage Defect resulting from osteoarthritis (OA) or sports injury
CELL TYPE: haMPC - Human Adipose-Derived Mesenchymal Progenitor Cells (fat tissue)
CELL SOURCE: Autologous (patient’s own)
PHASE: Clinical Study
The incidence of cartilage defect in routine knee arthroscopies in China has been reported to be almost 300,000 per year. With the rapid change of life style resulting in increasing sports injuries, CD is an unmet orthopedic medical need.
The repair of cartilage defect would greatly improve life quality of CD patients, allowing for greater mobility, flexibility and less pain.
The clinical study evaluates the safety and efficacy of haMPCs combined with lavage, and/or debridement, and/or microfracture under arthroscopy treatment for cartilage defect. In addition, this study shall serve as a supporting study of ReJoinTM for Knee Osteoarthritis (KOA) so as to bring additional clinical data to the protocol of future KOA trials.
- Other Products
CBMG has fully licensed and transferred technology from California Stem Cell to produce clinical-quality motor neuron and neuronal progenitor cells from human embryonic stem cells (hESC). These stem cell-derived motor neurons have potential applications in treating a plethora of different neurodegenerative diseases, such as Lou Gehrig’s disease and Spinal Muscular Atrophy. Both of these diseases have no known cure, and are extremely debilitating.
CBMG has developed a stem cell line called human umbilical cord derived mesenchymal progenitor cells (huMPC). These cells have tremendous capacity for self-renewal whilst also maintaining their multipotent ability to differentiate into osteoblasts, adipocytes, and chondrocytes as well as myocytes and neurons. Our umbilical cord cell line has a high safety profile and preliminary evidence suggests therapeutic use in treating lupus and cerebral palsy.