Technology
Stemedica has developed proprietary technology to produce “best-in-class” clinical grade, ischemic- tolerant, allogeneic adult progenitor cell products. At every step of the process, our technology allows us to achieve high levels of purity, potency, viability, reproducibility (batch to batch consistency) and safety.
Manufacturing
Our San Diego manufacturing facility is cGMP compliant and is licensed by the State of California to manufacture allogeneic progenitor cells for use in clinical trials.
Advantages
A third party analysis ranked Stemedica’s progenitor cells as best-in-class due to our proprietary manufacturing technologies.
Intellectual Property
Stemedica’s in-house intellectual property counsel has secured a robust patent portfolio for our current and future product candidates to protect our Freedom to Operate.
Manufacturing
Our cell manufacturing facility, located in San Diego, California, offers phase 1/2 clinical grade cell products. Stemedica’s facility is cGMP (Current Good Manufacturing Practices) compliant and licensed by the California State Department of Public Health Food and Drug Branch (FDB) to produce cells for use in human clinical trials. Stemedica follows strict quality control and safety measurement protocols, including FDA guidance for industry to control for infectious diseases, acute and chronic toxicity, and tumorigenicity.
BioSmart Technology™
Our proprietary BioSmart Technology™ secures significant advantages for our progenitor cells:
Stemedica has developed and executed a proprietary platform — BioSmart Technology™— for manufacturing non-embryonic allogeneic progenitor cells. This platform provides a competitive advantage in its ability to manufacture a reproducible and scalable pipeline of new product candidates that address major unmet medical conditions.
Stemedica manufactures its progenitor cells in a low-oxygen, low-tension environment. This type of manufacturing process is responsible for many of the benefits of our progenitor cells, including enhanced proliferation, high migratory ability, insignificant or no HLA-DR antigen expression and engraftment characteristics.
The BioSmart Technology™ manufacturing platform replicates the natural inside-the-body “micro-niche” environment from which cells originate, while the low-oxygen atmosphere further replicates the ischemic clinical conditions under which progenitor cells may be expected to proliferate. This hypoxic manufacturing process has other advantages as well. By keeping the cells in this low oxygen, low tension environment, they are protected from external exposure to normal oxygen and other disruptive and damaging elements.
Stemedica’s proprietary GMP manufacturing technology is not Stemedica’s only competitive advantage. Our cells undergo a battery of tests, monitoring and analysis to ensure the highest-quality cells. Each batch of Stemedica’s progenitor cells is thoroughly analyzed to meet lot release specifications. In addition, representative lots undergo an extensive array of tests designed to ensure the cell’s safety. This includes independent testing for infectious disease, acute and chronic toxicity, and tumorigenicity.
Stemedica’s cell banking processes ensure adequate cryopreservation, thereby enabling us to store cells long term and ship them to approved clinical sites throughout the globe.
Stemedica’s manufacturing technology is not Stemedica’s only advantage. Our cells undergo a battery of tests, monitoring and analysis to ensure the highest-quality cells that will operate predictably under clinical, pre-clinical, or research conditions.
During manufacturing, each of Stemedica’s stem cell products is thoroughly analyzed and both gene and protein profiles are developed. Prior to shipment, Stemedica documents the batch-to-batch consistency and reproducibility of the cells. This documentation is provided with each shipment, to allow for easy traceability from manufacturing to eventual use.
Our cells undergo an extensive array of tests designed to ensure the cell’s safety and potency. This includes testing for infectious disease, acute and chronic toxicity, and tumorigenicity, all performed by independent laboratories. Furthermore, extensive batch testing ensures that there is no variation from product specifications.
Additionally, Stemedica’s proprietary master banking processes ensure cell preservation, thereby enabling us to ship cell products to approved clinical sites throughout the globe.
Our Progenitor Cells
itMSCs (ischemia-tolerant mesenchymal stem cells) are “trophic” cells that circulate throughout the body and release proteins and growth factors into the damaged tissue, rescuing damaged cells from death and creating the right conditions for the newly mobilized cells to proliferate and repair. Stemedica’s itMSCs are extracted from donated bone marrow and then expanded using our proprietary technology.
itNSCs (ischemia-tolerant neural stem cells) are mostly undifferentiated, multipotent cells that generate the main phenotypes of cells in the nervous system. Stemedica’s itNSCs are extracted from donated brain tissue and then expanded using our proprietary technology.
Stemedica manufactures itMSCs and itNSCs for use in FDA-approved clinical trials in the U.S. Additionally, we supply our progenitor cells to geographic distributors to conduct clinical trials that are approved by international regulatory agencies, and for research through our exclusive distribution partner, ThermoFisher Scientific.
The distinctive properties of Stemedica’s itMSCs and itNSCs include the following attributes:
Ischemia tolerant: Stemedica’s progenitor cells are manufactured in hypoxic environment to combat ischemic conditions. For example, itMSCs secrete larger amounts of important cytokines, such as VEGF and SDF-1, that enhance the healing process. VEGF is critical for new blood vessel growth and SDF-1 helps mobilize the patient’s own progenitor cells.
Immune privileged: Stemedica’s progenitor cells do not exhibit HLA-DR antigen proteins which may cause rejection. The lack of HLA-DR expression for each batch is confirmed by flow cytometry analysis. No immunosuppressant agents are required during treatment.
Documented safety: The cells undergo rigorous testing for endogenous viruses, adventitious agents, bacteria, mycoplasma and endotoxin, as well as acute and chronic toxicity and tumorigenicity.
Established purity: Stemedica maintains rigorous specifications for each of the appropriate biological markers that indicate cell purity. Furthermore, extensive batch testing indicates lot-to-lot reproducibility.
Verified potency: For progenitor cells to be effective in vivo, they must secrete the appropriate growth factors, cytokines and hormones. The progenitor cells must also demonstrate the ability to differentiate into specific types of tissues, such as bone, neurons or cartilage. Stemedica ensures that its progenitor cells meet required criteria prior to release for clinical use.
The Allogeneic Progenitor Cell Difference
There are two types of cells currently used for investigating progenitor cell therapies for degenerative diseases: autologous and allogeneic. Autologous progenitor cells are derived from the patient being treated. They are retrieved surgically, expanded, and transplanted back into the same patient. Allogeneic progenitor cells are derived from healthy volunteers or organ donations. These cells are expanded and stored for future use in multiple medical conditions. Stemedica’s allogeneic progenitor cell products have the following competitive advantages :
Reproducibility: Stemedica can currently produce more than 450,000 doses of itMSCs from an individual donor and 180,000 doses of itNSCs from a different donor, while maintaining strict manufacturing control over cell quality and performance.
Immune Privilege: Autologous cells are considered more immune privileged because they are derived from the same organism which receives the stem cells, thus avoiding the likelihood of an immune response. In contrast, the main cause of rejection and clearance of allogeneic stem cells is from the host expressingHLA-DR receptors on the cell surface, which can lead to an immune response from the host organism. Stemedica is growing itMSCs and itNSCs under low-oxygen conditions; this reduces the presence of HLA-DR to less than 2 percent, therefore reducing the chance of an immune response.
Cost: Autologous stem cell therapy is much more expensive than allogeneic therapy. Allogeneic cells are available off-the-shelf and already tested, but autologous cells must be retrieved from the patient by invasive surgical procedure, tested, expanded individually and, finally, re-introduced into the patient.
Scalability: Stemedica’s itMSCs and itNSCs are highly scalable with hundreds of thousands of treatment doses deriving from a healthy donor sample. Autologous cells are not scalable because they need to be retrieved surgically from each individual patient.
Intellectual Property
This photo depicts immature neural cells (red) that express a type VI intermediate filament protein nestin. Glial cells (green) express glial fibrillary acidic protein (GFAP).
Stemedica has achieved a sustained competitive advantage with its development, registration and management of critical proprietary assets that include: products, processes, know-how, manufacturing, and expertise. Stemedica’s in-house patent department is dedicated to capturing and protecting the Company’s intellectual property.
The patent department executes a comprehensive program aimed at preventing competitors from replicating, designing around, or reverse-engineering its key assets. Two aspects of the Company’s intellectual property program are patents and trade secrets. The published portion of Stemedica’s intellectual property portfolio consists of seven allowed “keystone patents,” and 14 published and pending applications in the Unites States Patent and Trademark Office.
Issued Patents:
- US 8,105,380 for Cellular Scaffold, Issued January 31, 2012
- US 8,709,081 for Cellular Scaffold, Issued April 29, 2014
- US 8,420,394 for Culturing Ectodermal Cells Under Reduced Oxygen Tension, Issued April 16, 2013. Patent family includes a continuation application for treating CNS disorders
- US 8,642,286 for Methods for Identifying Neuripotent cells, Issued February 4, 2014
- US 8,318,485 for Stem Cell Therapy for the Treatment of Diabetic Retinopathy and Optic Neuropathy, Issued November 27, 2012
- US 8,790,638 for Compositions of Stem Cells and Stem Cell Factors and Methods for Their Use and Manufacture, Issued July 29, 2014
- US 9,080,184 for Transgenic Therapeutic Stem Cells and Methods for their Use and Manufacture, Issued July 14, 2015
Published U.S. Patent Applications:
- US 2016/0287668 for Sandwiched Biodegradable Microneedle
- US 2017/0252373 for Combination Therapy for the Treatment of Hair Loss
- US 2012/0141433 for Vaporized Stem Cell Derivatives for Topical and Other Therapeutic Uses
- US 2012/0201786 for Methods for the Use of Stem Cells and Stem Cell Factors in the Treatment of Skin Conditions
- US 2016/0324898 for Compositions and Methods for the Treatment of Alzheimer’s Disease
- US 2016/0222349 for Differentiation of RPE Progenitors Into Neuron-Like Cells
- US 2017/0027990 for Method of Treating Mental State in Patients After Ischemic Brain Injury with Ischemic Tolerant Allogeneic Mesenchymal Bone Marrow Cells
- US 2016/0143950 for Stem Cells and Stem Cell Factors for Inhibiting the Progression of Alzheimer’s Disease
- US 2014/0286910 for Stem Cells and Methods Incorporating Environmental Factors as a Means for Enhancing Stem Cell Proliferation and Plasticity
- US 2013/0177537 for Stem Cell Therapy for the Treatment of Central Nervous System Disorders
- US 2016/0220611 for Ischemic Tolerant Cells in Treatment of Acute Coronary Syndrome
- US 2008/0292598 for Chimeric Transplant
- US 2007/0231307 for Energy Assisted Stem Cell Extract
- US 2013/0085468 for Catheter with Body Wall Separator
U.S. Patent Applications to be Published:
- Stem Cell Factors in the Treatment of the Respiratory System (to be published)
- Antioxidant-Supplemented Serum-Free Growth Medium for Stem Cells (to be published)
- US 2012/0141433 for Vaporized Stem Cell Derivatives for Topical and Other Therapeutic Uses