Vitality Healthcare

QUESTION 1: WHAT IS THE SOURCE OF THE STEM CELLS?

Stem cells come from many different sources. Not all sources of stem cells are equal in their capability to repair and re-engineer soft tissue, connective tissue or nerve tissue.

• Adults stem cells (derived from bone marrow or adipose tissue of the patient) have disadvantages compared to MSC (mesenchymal stem cells) derived from the umbilical cord matrix (Wharton’s Jelly) from a healthy live birth where mother and child are well.

RESEARCH clearly shows the benefits of Umbilical Cord/Wharton’s Jelly MSC (mesenchymal stem cells) versus MSC from Bone Marrow or Adipose Tissue:

The number of stem cells in our body dramatically drops as we age:

“Young” stem cells (MSC from the umbilical cord matrix):

• Are obtained from non-invasive procedures unlike liposuction or bone marrow collection, which increase risk, cost and liability.
• Are more robust and therefore are able to replicate at greater and faster rates. The range and level of specific cytokines is greater than those expressed by adult MSC. Sustain less damage from reactive oxygen species (ROS).
• Have a much greater and quicker healing outcome.
• Have a higher proliferative capacity.
• Have a stronger inflammatory protective effect and a strong migratory ability toward the site of inflammation.
• Have many more variety of 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.
• Retain telomere at the highest possible length which protects them from premature loss of viability.
• 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:

How long does it take for a young child to heal from a minor cut or bruise? 24-48 hours, correct? How is the recovery for yourself and other adults? It may take several weeks or even longer in fact. The reason is the healing properties of the young child are at their 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 MESENCHYMAL 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 patient you should ask the exact amount of live MSC (mesenchymal stem cells) that a clinic will use for injection for each 1cc or 1ml. Why? A product that lacks live MSC’s or does not contain live cells will NOT produce the result you want.

The average viable (live) MSC (mesenchymal stem cells) that are in our product ranges from 1.0 Million to 1.2 Million per 1 cc.

CONCLUSION:

THIS PRODUCT CONTAINS 1-1.2 MILLION LIVE MSC’S/CC.

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 preparation of the therapy to be delivered.

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 their 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. These products align directly with the FDA “Homologous Use” definition for structural tissues. The product is fully compliant with all Section 361 regulations of the FDA.

QUESTION 4: HOW DO YOU INJECT THE PRODUCT? WHAT TYPE OF IMAGING DO YOU USE TO DELIVER THE PRODUCT ACCURATELY TO THE DAMAGED AREAS?

Unlike some practitioners who perform ‘blind’ injections and don’t use an imaging modality to accurately identify the damaged areas and place the product accordingly, at Vitality they use a 100% safe imaging modality to optimize their results.

As part of your examination prior to your musculoskeletal or joint injection, a diagnostic musculoskeletal (MSK) ultrasound is 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.

The exam consists of an ultrasound specialist using a water-based gel, as a coupling agent, and an ultrasound probe for imaging the internal structures. The sonographer will place the probe over the injured area to assess for any damage to the musculoskeletal tissue. A specific protocol will be followed for your area of concern. Based on the amount of damage and the locations of the injuries, a detailed plan of action will be designed specifically to fit your needs. After sterilizing the treatment area and using a local anesthetic to provide comfort, the MSK ultrasound is used for the delivery of product to the specific site/sites of trauma.

The use of high-quality musculoskeletal ultrasonography is considered a key part of the process, particularly considering that this modality plays a central role for clinicians to effectively hit the desired targets. Optimal placement correlates with earlier and improved outcomes, making it an essential component of our regenerative therapy applications at Vitality.

CONCLUSION:

THE USE OF 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?

Vitality Health Care has performed tens of thousands of procedures in their clinics across the country over the past 4+ years. At Vitality they specialize in stem cell therapy. Patients are responding very well to pure Wharton’s Jelly MSC’s. Scientific evidence and medical research confirm this finding. This therapy shows positive outcomes for patients with conditions such as neuropathies, a multitude of orthopedic conditions, and auto-immune disorders.

While there are no guarantees in medicine, the current success rate across their clinics nationwide is 94.4%. That is an extremely high success rate which can be attributed to a highly professional, scientific approach.

CONCLUSION:

THEY HAVE PERFORMED TENS OF THOUSANDS OF PROCEDURES AND HAVE A SUCCESS RATE OF 94.4%