by by Dr. Shivinder S. Deol MD, Founder, SanoStem Global LLC
How beneficial are Stemedica’s Unique Patented Adult Hypoxic Allogeneic Immune Privileged Bone Marrow Derived Mesenchymal Stem Cells (BMMSC) in Multiple Diseases & Injuries?
Words: Hypoxic (Low Oxygen), Allogeneic (Donor), Immune Privileged (No immune response, act as Universal Donor Cells), Mesenchymal Stem Cells (MSC)
Tissue oxygen tension (tPO2) varies in different human organs & tissues from 2-7% (Figure 1) while breathing room air, which has 20% FiO2 (Fraction of inspired oxygen). Placenta & embryo tPO2 is 1-2%. This allows 1 human fertilized egg to undergo 41 divisions to become over 2.5 Trillion cells at time of delivery in only 9 months! This is the incredible power of stem cells!
Several studies have confirmed that stem cell (SC) niches in different tissues exist under hypoxic conditions, which promotes the dedifferentiated state (immature stage where the cells can divide & replicate unlimited number of times). Figure 2. Even small amounts of shift in tPO2 stimulates early differentiation, a process by which mature cells specialize in different tissues depending on the location. Early differentiation may have some negative implications.
Most stem cell companies culture the cells at room air. Prolonged exposure outside of body’s normal low oxygen milieu (environment), can potentially lead to smaller cell expansion, as 1 study found that hypoxic BMMSC had 30-fold greater cell growth than regular MSC, lower cytokines & growth factors (different proteins body makes to stimulate or produce response far away),as 1 assay of Vascular Endothelial Growth Factor (VEGF) in hypoxic cultures showed over 50 times higher levels than normoxic MSC, reduced angiogenesis (new blood vessels, essential for repair & regeneration), and eventually compromised or reduced potency and viability (Figure 3).
There are over 300 chemokines, cytokines & growth factors identified from hypoxic MSC and over 37 in substantial amounts to be isolated. These factors are also being studied for multiple conditions, with remarkable efficacy. The low oxygen human stem cell factors will soon be available in liquids, creams, sprays, inhalers, etc. to support multiple conditions.
Stemedica has patented method of culturing cells under hypoxic conditions of 3-5% O2, resulting in much higher efficacy, as seen in several ongoing global clinical trials and numerous case reports.
The hypoxic Stem Cells are fully characterized (Figure 4) with all major biomarkers identified (no CD34 indicating pure MSC cultures, with no hematopoietic or progenitor cells).
The low oxygen MSC are immune privileged (Figure 5) with less than 1% of cells exhibiting HLA-DR (main protein responsible for early rejections), thereby removing any risk of transfusion reactions. Over 10,000 patients have been studied in clinical trials or in case reports & no serious side effects have been observed in any patient so far. Adult Stem Cells do NOT cause teratomas or tumors, as occasionally can be seen with Embryonic Stem Cells.
Stemedica’s Stem Cells are allogeneic, that means these have come from 1 single donor & can be given to over 10 million patients! Every patient gets the same proven effective thoroughly tested safe stem cells. Autologous stem cells on other hand take stem cells typically from bone marrow of the patient, process these and give back in same patient. Unfortunately, there is no way to standardize this process. Results vary considerably for autologous transplantation from no response, to mild response to occasionally good response.
Efficacy has been seen in multiple disease conditions. The US FDA has approved 6 Phase II clinical trials in USA, with 2 completions in heart failure and stroke. Kazakhstan has completed a Phase III clinical trial in myocardial infarction (MI or heart attack) and has received commercialization approval for same in August 2017. A diabetes mellitus clinical trial is being planned in India. MSC have strong anti-inflammatory properties and given intravenous can go to any area in body that is inflamed and produce beneficial response. Stem cells provide multifaceted solutions to heal the body. The body is its best healer, and stem cells may be the most ideal healer.
Stemedica also produces low oxygen foetal neural stem cells (NSC), which can assist in multiple neurological diseases & injuries, in combination with MSC or alone. The more serious or complex the disease, the need for combination treatments.
About Stemedica Cell Technologies Inc.
Stemedica Cell Technologies Inc. is a global biopharmaceutical company that manufactures best-in-class allogeneic adult stem cells and stem cell factors. The company is a government licensed manufacturer of cGMP, clinical-grade stem cells currently used in US-based clinical trials. The Company has FDA Investigational New Drug Approvals for acute myocardial infarction, chronic heart failure, cutaneous photoaging, ischemic stroke, traumatic brain injury and Alzheimer’s disease. Stemedica’s products are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials. Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stems cell under the auspices of the FDA and other international regulatory agencies. The company is headquartered in San Diego, California. Visit the website for more information online at www.stemedica.com.
About SanoStem Global, LLC
SanoStem Global, LLC (SanoGlobal) is a global regenerative company that promotes healthy lifestyles with nutritional support, detoxification, hormonal and neurotransmitter balancing; along with cell-based therapies to promote longevity, quality of life, while reducing disability and diseases especially for diseases that have no cure or good treatment options. SanoGlobal has exclusive distribution rights from Stemedica for its proprietary stem cells products for India and several neighbouring countries. SanoStem India Pvt. Ltd (SanoStem), a subsidiary of SanoGlobal has distribution and manufacturing rights to India. SanoStem seeks to be actively engaged in stem cell clinical trials, treatments, marketing and sublicensing of these stem cells products in India. SanoStem is looking for key partners and allies to assist in clinical trials and developing the regenerative business. The company is headquartered in Bakersfield, California. Visit the website for more information online at www.sanostemglobal.com.
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