Our Stem Cells
Stemedica’s Stem Cells
itMSCs (ischemia-tolerant mesenchymal stem cells) are the “trophic” cells in stem cell treatment; they work primarily on the environment for healing. Circulating throughout the body and homing to sites of injury, they release 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 Cell Technologies has an inventory of these itMSCs that are being used in clinical trials domestically and internationally under the control of 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. itNSCs primarily differentiate into neurons and glia cells. Stemedica International is currently applying for an IND and seeking FDA approval to conduct clinical trials for the treatment of Alzheimer’s disease.
Stemedica Cell Technologies’ 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 are unsurpassed in the industry and 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 HLA proteins that cause rejection. Independent biosafety labs test all cell types to confirm the lack of HLA 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.
- Validated 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: Each of Stemedica’s stem-cell products is 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 Cell Technologies’ 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. 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 total cost, may allow Stemedica’s stem cell factors to be used as a prevention or maintenance therapy after stem cell treatment.
The Allogeneic Stem-Cell Difference
There are two types of cells currently used for treating degenerative diseases: autologous and allogeneic. Autologous stem cells derive from the patient being treated. They are retrieved surgically, expanded, and transplanted back into the same patient. Allogeneic stem cells derive from healthy volunteers or organ donations. These cells are expanded and stored for future use in many other patients. Leveraging Stemedica Cell Technologies’ allogeneic stem cell technology, Stemedica International delivers the following competitive advantages:
1) 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.
2) Immune Privilege: Autologous cells were considered more immune privileged than allogeneic cells that derive from the same organism, thus not causing immune responses. The main cause of rejection and clearance of allogeneic stem cells from the host is expression of HLA-DR receptor on the surface, which leads to immune responses 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 immune response.
3) 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.
4) 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.