Technology

Stemedica has developed proprietary technology to produce “best-in-class” clinical grade, ischemic- tolerant, allogeneic adult stem 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

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Our San Diego manufacturing facility is cGMP compliant and is licensed by the State of California to manufacture allogeneic stem cells for use in clinical trials.

Advantages


A third party analysis ranked Stemedica’s stem 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 stem cell manufacturing facility, located in San Diego, California, offers a manufacturing capacity that is among the largest in the world. Stemedica’s manufacturing is strictly regulated and conforms to the highest standards of safety. Our facility is licensed and certified as Current Good Manufacturing Practices (cGMP) with the State Department of Health and Human Services. Stemedica follows strict quality control and safety measurement protocols, including FDA/cGMP guidelines to control for infectious diseases, acute and chronic toxicity, and tumorigenicity.

BioSmart Technology™

Our proprietary BioSmart Technology™ secures significant advantages for our stem cells:

BA_517Stemedica has developed and executed a proprietary platform —BioSmart Technology— for manufacturing adult allogeneic stem 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 stem cells within a patented low-oxygen, low-tension environment. This unique manufacturing process is responsible for many of the benefits of our stem cell lines, including our stem cells’ enhanced proliferation, high migratory ability, insignificant or no antigen expression and engraftment characteristics.

BA_393 This BioSmart Technology™ manufacturing platform replicates the natural inside-the-body “micro-niche” environment from which the cells originate, while the low-oxygen atmosphere further replicates the ischemic clinical conditions under which stem cells may be expected to proliferate.

This low-oxygen manufacturing process has other advantages, as well. By keeping the cells in this low oxygen/tension environment, they are protected from external exposure to normal oxygen and other disruptive and damaging elements

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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 Stem Cells

itMSCs (ischemia-tolerant mesenchymal stem cells) are “trophic” cells; they work primarily on the environment for healing. Circulating throughout the body and homing to sites of injury, they 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 manufactures itMSCs for use in FDA approved clinical trials in the US. Additionally, we supply our stem cells to geographic distributors to conduct clinical trials that are approved by international regulatory agencies.

itNSCs (ischemia-tolerant neural stem cells) are mostly undifferentiated, multipotent cells that generate the main phenotypes of the nervous system. Stemedica’s itNSCs are extracted from donated brain tissue and then manufactured in a low-oxygen environment, allowing them to display ischemia-tolerant properties. The itNSCs differentiate into neurons and glia cells.

Stemedicas’ ischemia-tolerant Stem Cell Technology Platform isolates, extracts, expands and master banks unique lines of immune-privileged adult stem cells. The distinctive properties of Stemedica’s itMSCs and itNSCs include the following attributes:

Ischemia and toxin tolerant: Stemedica stem cells are manufactured in hypoxic environments and specifically formulated to combat ischemic conditions. For example, itMSCs secrete factors — such as VEGF and SDF-1 — that enhance the healing process. VEGF is critical for new blood vessel growth, and SDF-1 helps prevent cellular death.

Immune privileged: Stemedica’s cells do not exhibit HLADR antigen proteins that cause rejection. Independent biosafety labs test all cell types to confirm the lack of HLADR expression. No immunosuppressant agents are required during transplantation.

Documented safety: All cells undergo rigorous testing for infectious disease, 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 stem cells to be effective in vivo (in the human body), they must secrete the appropriate growth factors, cytokines and hormones. The stem cells must also demonstrate the ability to differentiate into specific types of tissues, i.e. bone, neurons or cartilage. Stemedica stem cells meet these criteria.

Fully characterized: All of Stemedica’s stem-cell products are thoroughly analyzed in terms of gene analysis and protein profile.

Ability to mobilize host progenitor cells: Stemedica’s stem cells help mobilize the body’s resources in the regenerative process.

Stemedica’s Stem Cell Factors

Stemedica’s stem cells come from young, healthy, adult, human, bone marrow-derived mesenchymal stem cell culture media that is well controlled at FDA-approved donor banks. Stem cell factors are released during the expansion of itMSCs and are then purified and verified to be clear of toxins, allergens, bovine serum, insulin, heparin and FGF1. They contain approximately 300 different proteins, 40 of which are well-identified and characterized. Our itMSCs have been shown to secrete a wide variety of cytokines and growth factors that have neuronal protective activities. The itMSC factors are preserved at room temperature using a unique, proprietary foam-drying technique that ensures more than 80-85 percent bioactivity. This extremely attractive delivery form, as well as low cost, allows Stemedica’s stem cell factors to be used as a prevention or maintenance therapies after stem cell treatment.

The Allogeneic Stem-Cell Difference

There are two types of cells currently used for investigating stem cell therapies for degenerative diseases: autologous and allogeneic. Autologous stem cells are derived from the patient being treated. They are retrieved surgically, expanded, and transplanted back into the same patient. Allogeneic stem 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 stem 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

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This photo depicts immature neural cells (green) that express a type VI intermediate filament protein nestin. Glial cells (red) 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.

Intellectual Property Issued:

  • Cellular Scaffold. U.S. Patent: 8,105,380 B2, Issued January 31, 2012
  • Cellular Scaffold. U.S. Patent: 8,709,081 B2, Issued April 29, 2014
  • Culturing Ectodermal Cells Under Reduced Oxygen Tension. U.S. Patent: 8,420,394 B2,
    Issued April 16, 2013. Rights to additional patents filed, to be filed and issued for neurology
    category is also part of this intellectual property (IP) license
  • Methods for Identifying Neuripotent cells. U.S. Patent: 8,642,286 B2, Issued February 4, 2014
  • Stem Cell Therapy for the Treatment of Diabetic Retinopathy and Neuropathy. U.S.
    Patent: 8,318,485 B2, Issued November 27, 2012
  • Compositions of Stem Cells and Stem Cell Factors and Methods for Their Use and
    Manufacture. U.S. Patent: 8,790,638 B2, Issued July 29, 2014
  • Transgenic Therapeutic Stem Cells and Methods for their Use and Manufacture. U.S.
    Patent: 9,080,184 B2, Issued July 14, 2015

Patent Applications Filed with the United States Patent and Trademark Office:

  • Sandwiched Microneedle Array
  • Vaporized Stem Cell Derivatives for Topical and Other Therapeutic Uses
  • Methods for the Use of Stem Cells and Stem Cell Factors in the Treatment of Skin Conditions
  • Stem Cells and Stem Cell Factors for Inhibiting the Progression of Alzheimer’s Disease
  • Stem Cells and Methods Incorporating Environmental Factors as a Means for Enhancing Stem Cell Proliferation and Plasticity
  • Methods for Reducing the Side Effects of Ophthalmic Laser Surgery
  • Stem Cell Therapy for the Treatment of Diabetic Retinopathy and Diabetic Optic Neuropathy
  • Stem Cell Therapy for the Treatment of Central Nervous System Disorders
  • Ischemic Tolerant Cells in Treatment of Acute Coronary Syndrome
  • Chimeric Transplant
  • Energy Assisted Stem Cell Extract
  • Catheter Device with Improved Intra-Body Flow
  • Site-Selected Fibroblasts and Methods for Their Use in the Inhibition of Hair Growth
  • Stem Cell Therapy for the Treatment of Central Nervous System Disorders