Regenerative Medicine Research
5 KEY QUESTIONS TO ASK
When researching stem cells or when considering stem cell therapy, one has to be careful with his/her selection since not all stem cells are equal and not all providers are compliant with current FDA regulations. At Southern Stem Cell Institute, we have the most viable source of stem cells available to effectively treat our patients. Adult stem cell therapies (stem cells obtained from the aging body) have many disadvantages and the results obtained are far inferior and inconsistent. Stem cells from the Wharton’s Jelly of the umbilical cord of the newborn are high in quantity and quality. They can replicate at much higher rates and therefore heal, repair, modulate and renew soft tissue much better and much faster. Make sure that when you compare stem cell sources and products, you consider the advantages and disadvantages, and verify the amount of live MSC/cc of the end-product. Most providers or manufacturers can NOT verify the amount of live MSC’s in their product.
QUESTION 1: WHAT IS THE SOURCE OF THE STEM CELLS?
Stem cells can be obtained from various sources. Not all sources of stem cells are equal in their capability to repair and re-engineer soft tissue, connective tissue or nerve tissue.
- The use of embryonic stem cells is illegal. In addition to the moral and ethical issues that exist when harvesting stem cells from aborted fetal tissue, embryonic stem cells have been shown to cause teratomas (tumors) in mice. Embryonic stem cells are only used in research and will NEVER be used in the therapeutic applications for humans.
- Adults stem cells (derived from bone marrow or adipose tissue of the patient) have many disadvantages compared to MSC (mesynchymal stem cells) derived from the umbilical cord matrix (Wharton’s Jelly).
Research clearly shows the benefits of Umbilical Cord/Wharton’s Jelly MSC (mesynchymal stem cells) versus MSC from Bone Marrow or Adipose Tissue.
The number of stem cells in our body significantly declines with age:
Benefits of “Young” stem cells (MSC from the umbilical cord matrix):
- Are obtained from non-invasive procedures unlike bone marrow collection, which increase risk, cost and liability.
- Have a far greater ‘fitness’ level and therefore are able to replicate at greater and faster rates.
- Have a much greater and faster healing response.
- Have a higher proliferative capacity.
- Have a stronger inflammatory protective effect and a strong migratory ability toward the site of inflammation.
- Have a larger amount of different growth factors, especially bFGF 20.
- Have the ability to differentiate into adipogenic, osteogenic, chondrogenic, neural cells and Schwann cells; and help organize tendon collagen fibers and induce hepatocyte differentiation.
- Have been shown to differentiate into nervous system cells, liver, pancreas, heart, and other organs of the body.
- Are more robust. The range and level of specific cytokines is greater than those expressed by adult MSC.
- Sustain less damage from reactive oxygen species (ROS).
- Retain telomere at the highest possible length which protects them from premature loss of viability.
- Continue to express molecules with immune-modulating activity after they are extracted from the umbilical cord and able to pass this ability to their progeny. This enables the infused donor cells, whether differentiated or not, to engraft into the diseased target organ and positively modify its microenvironment to promote re-population. The infusion of immunomodulatory MSC provide a significant advantage by better overcoming host responses, providing the needed functional bridging action, and modifying the underlying pathological conditions at the basis of disease.
- Provoke little to no immune response when transplanted; cell rejection is not an issue and human leukocyte antigen (HLA) matching is not necessary (as with adult stem cells).
- Have Immunomodulatory properties: they do not pose risk for metastasis of tumor cells and in fact promote proteins that halt the cell cycle of cancer cells and promote tumor suppressing genes.
All the above research facts (references listed below) are easily illustrated in the following real-life example:
When a young child falls and cuts him/herself, how long does that cut or wound take to heal? 24-48 hours, right? What if you fall and cut yourself? Indeed, several weeks or even longer. That’s because the healing properties of the young child are at its peak. The young MSC (mesynchymal stem cells) have a far greater and faster healing capacity than our aged body stem cells.
Besides the significantly reduced QUANTITY and QUALITY of adult derived MSC, the other essential components for effective tissue repair and tissue engineering are missing with adult stem cell therapies. These other essential components include growth factors, cytokines, HA (hyaluronic acid), and several other bio-active molecules.
CONCLUSION: THE YOUNGER THE STEM CELLS, THE MORE POWERFUL THE STEM CELLS.
Stem cells from the newborn are much higher in quantity and have the ability to replicate much faster. Therefore, young stem cells heal, repair, modulate and renew soft tissue much better and much faster.
QUESTION 2: HOW MANY LIVE MESYNCHYMAL STEM CELLS DOES THE END PRODUCT CONTAIN PER 1ML OR 1CC?
MOST COMPANIES OR MANUFACTURERS DO NOT HAVE THE FINANCIAL RESOURCES TO HAVE THEIR PRODUCTS TESTED BY A THIRD PARTY, OR THEY WISH NOT TO HAVE THEM TESTED SINCE THE TEST RESULTS MAY BE DISAPPOINTING.
Regardless, as a consumer you must ask the exact amount of the live MSC (Mesynchymal Stem Cells) that the end-product (the product you will be injected with) contains for each 1cc or 1ml. Why? A product that lacks live MSC’s or does not contain live stem cells will not produce the result you are looking for.
Our Stem Cell injections have a counted number of cells. The relationship between CCs and cells includes:
- 1.0 CC – 1.1 Million Cells
- 2.0 CC – 2.2 Million Cells
- 4.0 CC – 4.4 Million Cells
CONCLUSION: The average viable (live) MSC (Mesynchymal Stem Cells) that are in our product ranges for 1.1 million to 4.4 million cells.
QUESTION 3: IS THE PRODUCT IN FULL COMPLIANCE WITH THE FDA GUIDELINES UNDER SECTION 361 HCT/P (HUMAN CELLULAR TISSUES / PRODUCTS)?
Where does umbilical cord tissue come from?
All birth tissue products are obtained from c-section deliveries from normal, full-term pregnancies in u.s. donors that consent to use of their birth tissues are carefully screened prior to the use of their tissues in manufacturing our products.
Comprehensive medical and social histories of the donors are obtained and tissues are procured, processed, and tested in accordance with standards established by the aatb (american association of tissue banks) and fda requirements to minimize potential risks of disease transmission to recipients. infectious disease testing is performed at a certified laboratory in accordance with the clinical laboratory improvement amendments of 1988 (clia) and 42 cfr part 493.
Each donor is tested for HBSAG (hepatitis b surface antigen), HBCAB (hepatitis b core antibody), HCV (hepatitis c antibody), HIV I/II-AB (antibody to human immunodeficiency virus types 1 and syphilis detection test, HIV NAT (hiv nucleic acid test), and HCV NAT (hcv nucleic acid test).
All products are tested post-sterilization to demonstrate the absence of bacterial and fungal pathogens and are non-pyrogenic. all testing results are reviewed by the medical director of predictive biotech (2749 e. parleys way, suite 101, salt lake city, ut 84109) prior to the release of the product.
The FDA identified “umbilical cord tissue” as a “structural tissue” and states that structural tissue, in addition to cytokines and other factors, can and may have live cells present. the products we use align directly with the fda “homologous use” definition for structural tissues. the product we use is fully compliant with all section 361 regulations of the FDA.
QUESTION 4: HOW IS THE PRODUCT INTRODUCED TO THE BODY?
Stem cells can be injected into any joint or introduced through IV. The injection of the stem cells and the IV of the stem cells only takes a few minutes. As part of your examination prior to your musculoskeletal or joint injection, a diagnostic musculoskeletal (MSK) ultrasound can be performed to determine the current state of the injured area and to identify the specific location of the injury. The ultrasound exam provides real-time imaging that can evaluate the health/injury of tendons, muscle, ligaments, bone, cartilage, and bursa. After your treatment, we advise our patients to do a hyperbaric chamber session. The hyperbaric oxygen therapy (HBOT) has been shown to significantly increase the concentration of circulation stem/progenitor cells within the peripheral circulation system.
CONCLUSION: At Southern Stem Cell Institute we have the ability to use safe msk (musculoskeletal) ultrasound allows for the accurate placement of the product in the damaged or injured areas.
QUESTION 5: HOW MANY PROCEDURES HAS YOUR COMPANY PERFORMED THUS FAR, AND WHAT IS YOUR SUCCESS RATE?
Southern Stem Cell Institute has performed thousands of procedures. At Southern Stem Cell Institute, we specialize in stem cell therapy. We treat patients with conditions that recent literature and published research, along with our vast experience show to be responding very well to our pure Wharton’s Jelly MSC’s. These conditions include neuropathy, a multitude of orthopedic conditions and auto-immune disorders. There are no guarantees in medicine. However, our current success rate across our clinics nationwide is 94.4%. That is an extremely high success rate which we contribute to our highly professional approach.
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When you contact us for a free consultation with SSCI, we will:
- Set aside dedicated time with one of our world-class, professionally trained stem cell specialists so that you can ask any questions.
- Give you a very in-depth overview on how stem cell therapy works.
- Examine your past medical history and conduct a thorough case review to determine if you may be a candidate for stem cell therapy.
Again, our consultations are completely free/at no cost to you. And we have the availability for either in person or over the phone consultations.