StemProtein manufactures Stem Cell Factors (SCFs) from ischemic-tolerant mesenchymal stem cells and other proprietary and innovative cell lines in a powder form for pharmaceutical use in a wide range of preventative, health-maintenance, and treatment products, including nasal sprays, eye drops, intravenous injections, wound dressings, and creams. It is our mission to improve quality of life for all individuals, young and old, by providing a unique and beneficial clinically-tested product.
StemProtein strives to provide a potent and consistent product for use in a wide variety of known therapeutic applications, and is committed to advancing the efficacy of StemProtein’s product and discovering new and novel uses and applications in the treatment and prevention of disease, and the maintenance of health and wellness.
StemProtein is committed to providing a cGMP-compliant product that meets the highest standards of measurable quality regarding Safety, Potency, Stability, and Flexibility.
- Safety: Stem cell factors (SCF’s) are extracted from human bone marrow-derived mesenchymal stem cells (MSC’s). The cells are manufactured in an FDBlicensed facility that follows cGMP regulations and is authorized by the FDA for clinical trials under a number of Investigational New Drug Applications (INDs). SCF’s are controlled for endotoxin contamination and sterility several times during manufacturing. Nutrient supplements, such as human insulin and bovine serum, are removed from the final stages of manufacturing. The packaged product undergoes terminal sterilization by using a high dose of electron beam radiation (≥25 kGy). SCF’s intended for topical applications are formulated as sterile singleuse vials, which eliminates the need for bacteriostatic agents that may cause skin irritation.
- Potency: The spectrum of bioactive protein secreted by itMSCs is complex. StemProtein quantitatively measured approximately 70 different proteins using multiplex protein arrays. In each gram of dried product, 35 different cell-secreted proteins have been identified in over 0.5 nanogram quantities. The concentrations of VEGF, HGF, IL-6, CCL2, CXCL5, and CXCL8 in our product are routinely monitored, as published literature has identified the important biological activity of these growth factors, cytokines, and chemokines [ref; ref]. Because tissue regeneration critically depends on adequate blood supply, we use in vitro angiogenesis assays to evaluate the therapeutic potency of our stem cell factors.
- Stability: StemProtein obtained an exclusive license to use “Preservation by Vaporization” technology (PBV) for stabilizing macromolecules at ambient temperatures (25°C to 45°C). PBV is a cornerstone to the stabilization and delivery of fragile biologicals such as live vaccines. PBV is a vacuum foam-drying process that immobilizes macromolecules in a hard “glass-like” matrix that protects the molecules from degradation. In tests, concentration of foamdried vascular endothelial growth factor (VEGF-A) showed no signs of decline after 36- month storage at +25°C.
- Flexibility: Preservation technology allows formulation of factors for various applications that are suitable for intravenous, intranasal, and sublingual delivery. Dried SCFs can be ground into a fine powder that can also be incorporated into various topical formulations (cosmetic gels, wound dressings, hydrogels, a needle patch, etc.) as well as eye drops and nasal sprays.