Frequently Asked Questions
· 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:
“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.
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.
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: DO YOU KNOW HOW MANY MSCs & OTHER REGENERATIVE FACTORS ARE IN THE END PRODUCT PER CC?
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 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 cells will NOT produce the result you are looking for.
The average viable (live) MSC (mesynchymal stem cells) that are in our product ranges from 1.0 Million to 1.2 Million per 1 cc.
OUR 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 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 DO YOU INJECT THE PRODUCT? WHAT TYPE OF IMAGING DO YOU USE TO DELIVER THE PRODUCT ACCURATELY TO THE DAMAGED AREAS?
Unlike many practitioners who perform ‘blind’ injections and don’t use an imaging modality to accurately identify the damaged areas and place the product accordingly, at Virginia Advanced Medical we use a 100% safe imaging modality to optimize our 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 Virginia Advanced Medical.
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 SATISFACTION RATE?
Virginia Advanced Medical & Vitality Healthcare have performed tens of thousands of procedures in their clinics across the country over the past 4+ years. At Virginia Advanced Medical we specialize in Stem Cell Therapy and stem cell therapy is the only service we offer. 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 neuropathies, a multitude of orthopedic conditions and auto-immune disorders.
There are no guarantees in medicine, period. However, our current satisfaction rate across our clinics nationwide is 94.4%. That is an extremely high satisfaction rate which we contribute to our highly professional approach.
WE HAVE PERFORMED TENS OF THOUSANDS OF PROCEDURES AND HAVE A SATISFACTION RATE OF 94.4%
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 Virginia Advanced Medical / Vitality Healthcare, 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.
For better and faster results, MSK Ultrasound imaging is used to safely diagnose and accurately place the product in the injured areas. Unlike with so-called “blind” injections (absence of an imaging modality), accurate placement allows for optimal results.
At Virginia Advanced Medical / Vitality Healthcare, we have performed tens of thousands of stem cell therapy procedures nationwide over the past 4+ years and we are very proud of our 94.4% satisfaction rate.
It’s time to do what thousands of people have already done – successfully – and that is to take back your life with Stem Cell Therapy!
At Virginia Advanced Medical (the “Company” or “We”), we respect your privacy and are committed to protecting it through our compliance with this policy.
This policy describes the types of information we may collect from you or that you may provide when you visit this website (our “Website”) and our practices for collecting, using, maintaining, protecting and disclosing that information.
This policy applies to information we collect:
- On this Website.
- In e-mail, text and other electronic messages between you and this Website.
- Through mobile and desktop applications you download from this Website, which provide dedicated non-browser-based interaction between you and this Website.
- When you interact with our advertising and applications on third-party websites and services, if those applications or advertising include links to this policy.
It does not apply to information collected by:
- us offline or through any other means, including on any other website operated by Company or any third party (including our affiliates and subsidiaries); or
- any third party (including our affiliates and subsidiaries), including through any application or content (including advertising) that may link to or be accessible from or on the Website.
Children Under the Age of 13
Our Website is not intended for children under 13 years of age. No one under age 13 may provide any personal information to or on the Website. We do not knowingly collect personal information from children under 13. If you are under 13, do not use or provide any information on this Website or on or through any of its features/register on the Website, make any purchases through the Website, use any of the interactive or public comment features of this Website or provide any information about yourself to us, including your name, address, telephone number, e-mail address or any screen name or user name you may use. If we learn we have collected or received personal information from a child under 13 without verification of parental consent, we will delete that information. If you believe we might have any information from or about a child under 13, please contact us via our contact us link.
Information We Collect About You and How We Collect It
We collect several types of information from and about users of our Website, including information:
- by which you may be personally identified, such as name, postal address, e-mail address, telephone number or ANY OTHER INFORMATION THE WEBSITE COLLECTS THAT IS DEFINED AS PERSONAL OR PERSONALLY IDENTIFIABLE INFORMATION UNDER AN APPLICABLE LAW (“personal information”);
- that is about you but individually does not identify you, and/or
- about your internet connection, the equipment you use to access our Website and usage details.
We collect this information:
- Directly from you when you provide it to us.
- Automatically as you navigate through the site. Information collected automatically may include usage details, IP addresses and information collected through cookies, web beacons and other tracking technologies.
- From third parties, for example, our business partners.
Information You Provide to Us.
The information we collect on or through our Website may include:
- Information that you provide by filling in forms on our Website. This includes information provided at the time of registering to use our Website, subscribing to our service, posting material or requesting further services. We may also ask you for information when you report a problem with our Website.
- Records and copies of your correspondence (including e-mail addresses), if you contact us.
- Your responses to surveys that we might ask you to complete for research purposes.
- Details of transactions you carry out through our Website and of the fulfillment of your orders. You may be required to provide financial information before placing an order through our Website.
- Your search queries on the Website.
You also may provide information to be published or displayed (hereinafter, “posted”) on public areas of the Website, or transmitted to other users of the Website or third parties (collectively, “User Contributions”). Your User Contributions are posted on and transmitted to others at your own risk. Although we limit access to certain pages/you may set certain privacy settings for such information by logging into your account profile, please be aware that no security measures are perfect or impenetrable. Additionally, we cannot control the actions of other users of the Website with whom you may choose to share your User Contributions. Therefore, we cannot and do not guarantee that your User Contributions will not be viewed by unauthorized persons.
Information We Collect Through Automatic Data Collection Technologies.
As you navigate through and interact with our Website, we may use automatic data collection technologies to collect certain information about your equipment, browsing actions and patterns, including:
- Details of your visits to our Website, including traffic data, location data, and other communication data and the resources that you access and use on the Website.
- Information about your computer and internet connection, including your IP address, operating system and browser type.
We also may use these technologies to collect information about your online activities over time and across third-party websites or other online services (behavioral tracking). The information we collect automatically is statistical data and does not include personal information, but we may maintain it or associate it with personal information we collect in other ways or receive from third parties. It helps us to improve our Website and to deliver a better and more personalized service, including by enabling us to:
- Estimate our audience size and usage patterns.
- Store information about your preferences, allowing us to customize our Website according to your individual interests.
- Speed up your searches.
- Recognize you when you return to our Website.
The technologies we use for this automatic data collection may include:
- Flash Cookies. Certain features of our Website may use local stored objects (or Flash cookies) to collect and store information about your preferences and navigation to, from and on our Website. Flash cookies are not managed by the same browser settings as are used for browser cookies.
- Web Beacons. Pages of our the Website may contain small electronic files known as web beacons (also referred to as clear gifs. pixel tags and single-pixel gifs) that permit the Company, for example, to count users who have visited those pages or opened an e-mail and for other related website statistics (for example, recording the popularity of certain website content and verifying system and server integrity).
We do not collect personal Information automatically, but we may tie this information to personal information about you that we collect from other sources or you provide to us.
We do not control these third parties’ tracking technologies or how they may be used. If you have any questions about an advertisement or other targeted content, you should contact the responsible provider directly.
How We Use Your Information
We use information that we collect about you or that you provide to us, including any personal information:
- To present our Website and its contents to you.
- To provide you with information, products or services that you request from us.
- To provide you with information about our services
- To provide you with notices about your account/subscription, including expiration and renewal notices.
- To carry out our obligations and enforce our rights arising from any contracts entered into between you and us, including for billing and collection.
- To notify you about changes to our Website or any products or services we offer or provide though it.
- To allow you to participate in interactive features on our Website.
- In any other way we may describe when you provide the information.
- To fulfill any purpose for which you provide it.
- For any other purpose with your consent.
We may use the information we have collected from you to enable us to display advertisements to our advertisers’ target audiences. Even though we do not disclose your personal information for these purposes without your consent, if you click on or otherwise interact with an advertisement, the advertiser may assume that you meet its target criteria.
Disclosure of Your Information
We may disclose aggregated information about our users, and information that does not identify any individual, without restriction.
- To our subsidiaries and affiliates.
- To contractors, service providers and other third parties we use to support our business and who are bound by contractual obligations to keep personal information confidential and use it only for the purposes for which we disclose it to them.
- To a buyer or other successor in the event of a merger, divestiture, restructuring, reorganization, dissolution or other sale or transfer of some or all of the Company’s assets, whether as a going concern or as part of bankruptcy, liquidation or similar proceeding, in which personal information held by the Company about our Website users is among the assets transferred.
- To third parties to market their products or services to you if you have consented to these disclosures. We contractually require these third parties to keep personal information confidential and use it only for the purposes for which we disclose it to them.
- To fulfill the purpose for which you provide it. For example, if you give us an e-mail address to use the “e-mail a friend” feature of our Website, we will transmit the contents of that e-mail and your e-mail address to the recipients.
- For any other purpose disclosed by us when you provide the information.
- With your consent.
We may also disclose your personal information:
- To comply with any court order, law or legal process, including to respond to any government or regulatory request.
- If we believe disclosure is necessary or appropriate to protect the rights, property, or safety of the Company, our customers or others. This includes exchanging information with other companies and organizations for the purposes of fraud protection and credit risk reduction.
Choices About How We Use and Disclose Your Information
We strive to provide you with choices regarding the personal information you provide to us. We have created mechanisms to provide you with the following control over your information:
- We do not control third parties’ collection or use of your information to serve interest-based advertising. However these third parties may provide you with ways to choose not to have your information collected or used in this way. You can opt out of receiving targeted ads from members of the Network Advertising Initiative (“NAI”) on the NAI’s website.
Accessing and Correcting Your Information
You may send us an e-mail via our contact link to request access to, correct or delete any personal information that you have provided to us. We cannot delete your personal information except by also deleting your user account. We may not accommodate a request to change information if we believe the change would violate any law or legal requirement or cause the information to be incorrect.
Your California Privacy Rights
California Civil Code Section § 1798.83 permits users of our Website that are California residents to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes. To make such a request, please contact us via the Contact Us link.
We have implemented measures designed to secure your personal information from accidental loss and from unauthorized access, use, alteration and disclosure
The safety and security of your information also depends on you. Where we have given you (or where you have chosen) a password for access to certain parts of our Website, you are responsible for keeping this password confidential. We ask you not to share your password with anyone.
Unfortunately, the transmission of information via the internet is not completely secure. Although we do our best to protect your personal information, we cannot guarantee the security of your personal information transmitted to our Website. Any transmission of personal information is at your own risk. We are not responsible for circumvention of any privacy settings or security measures contained on the Website.
Thank You for Visiting the Website.