7 KEY QUESTIONS TO ASK WHEN CONSIDERING
STEM CELL THERAPY
WHAT IS THE SOURCE OF THE STEM CELLS?
HOW MANY LIVE MESYNCHYMAL STEM CELLS DOES THE END PRODUCT CONTAIN PER 1ML OR 1CC?
WHAT OTHER ESSENTIAL COMPONENTS FOR TISSUE ENGINEERING DOES THE PRODUCT CONTAIN?
IS THE PRODUCT IN FULL COMPLIANCE WITH SECTION 361 HCT/P (Human Cellular Tissues / Products) of the FDA?
HOW DO YOU INJECT THE PRODUCT? WHAT TYPE OF IMAGING DO YOU USE TO DELIVER THE PRODUCT ACCURATELY TO THE DAMAGED AREAS?
DO YOU OPERATE WITHIN THE POLICIES RECOMMENDED BY THE FSMB (FEDERATION OF STATE MEDICAL BOARDS)?
IS YOUR MEDICAL TEAM CERTIFIED IN THESE STEM CELL-BASED PROCEDURES, AND HOW MANY PROCEDURES HAS YOUR COMPANY PERFORMED THUS FAR, AND WHAT IS YOUR SUCCESS RATE?
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 ability 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 (benign tumors) when tested on mice in laboratory settings. Embryonic stem cells are only used in research today and will NEVER be used in the therapeutic applications for humans.
- Adults stem cell therapies (stem cells are derived from bone marrow or adipose tissue of the patient) are considered outdated and have many disadvantages compared to the use of stem cells from birth tissue. Here are the top 5 disadvantages:
- The patient will have the undergo an unnecessary surgical procedure to harvest the stem cells. Surgery not only increases risk, cost and liability but also causes pain and often a long recovery time.
- The other essential components for proper tissue engineering (refer to question 3 in this document for more detail) may be missing and therefore the results may be disappointing. When we harvest stem cells from one area of the body and then relocate them to the injured or damaged area of the body, all we do is relocating but we are not adding anything. Essential components such as growth factors, cytokines, collagen types III and IV, scaffolding etc. may be missing.
- The stem cells harvested from one patient will different in quantity and quality from the stem cells derived from another patient. Therefore, these procedures can NOT be standardized. There is no uniformity and no quality control. Because of the lack of standardization, uniformity and quality control, the FDA has issued a notice to all those practicing adipose tissue derived stem cell-based therapies in November of 2017 stating that they have to discontinue these practices within 36 months.
- Scientists agree that the quantity or amount of stem cells in our body drastically declines with age (refer to graph below). When trying to harvest stem cells from the aging body, often not enough stem cells are obtained. Therefore, the practitioner has to culture (amplify / multiply) these stem cells in a laboratory setting prior to administration. These cultured cells are far less effective than native cells.
- The quality of stem cells in our aging body drastically declines with age Scientists explains this with the fact that the telomeres (telomeres are the end caps of our chromosome that protect our DNA in every cell) shorten as we age. As the telomeres shorten, the quality or the cell’s ability to heal, repair, renew and regenerate drastically declines.
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’s obtained from birth tissue):
- 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 ability to heal, repair and regenerate than our aged body stem cells.
Where do MSC’s from birth tissue come from?
Besides trying to harvest stem cells from the patient’s own body (NOT recommended), stem cells can be obtained from birth tissue: the placenta, umbilical cord blood or umbilical cord matrix (Wharton’s Jelly).
Placental tissue products may contain all the essential components form tissue engineering but lack verification of live MSC’s (refer to question 2 in this document). If we can’t verify live MSC’s, we may be relying on the body’s own stem cells which drastically decline in quantity and quality with age.
Umbilical cord blood contains hematopoietic stem cells but lacks any significant quantity of MSC’s. These products contain blood and blood fractions (increased risk of communicable disease, rejection, and allergies) and are fit to treat blood disorders and pediatric cancer but are not a good choice for soft tissue modulation.
Umbilical cord matrix (Wharton’s Jelly) is by far the best source of MSC’s. This cellular tissue not only contains all essential components for tissue engineering but is a rich source of young MSC’s.
THE YOUNGER THE STEM CELLS,
THE MORE POWERFUL THE STEM CELLS.
Stem cells from birth tissue 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’s (mesynchymal stem cells) that the end-product (the product you will be injected with) contains for each 1cc or 1ml. Why? A product that any significant number of MSC’s or does not contain live cells may NOT produce the result you are looking for.
Not only should you ask for the number of viable MSC’s per cc but you also may ask for verification (third party laboratory test results). Laboratories use flow cytometry to measure the viability and quantity of MSC’s.
Don’t be fooled by NUMBERS!
Patients are easily distracted by big numbers and often fall prey to false advertising and marketing schemes. Here is what you need to know:
- Make sure you compare apples with apples, in this case, MSC’s with MSC’s. Manufacturers and practitioners often use the number of nucleated cells (cells with a nucleus) which includes white blood cells, hematopoietic cells etc. That number will be far greater but does NOT represent the number of MSC’s. To measure the number of MSC’s, a certain combination of markers needs to be tested for.
- Always compare the number of MSC’s per unit of volume (per 1cc or 1ml).
- Know that cultured stem cells are far less effective than native stem cells. A good guideline is that cultured cells are 1000x less effective than native cells.
Example: if one product contains 1 million native MSC’s/cc and another product lists 100 million MSC’s/cc but these are cultured, then the product containing 1 million MSC’s/cc is considered 10x more effective.
The average amount of viable (live), native MSC’s (mesynchymal stem cells) that are in our product ranges from 1.0 Million to 1.2 Million per 1 cc.
WE CAN VERIFY THAT OUR PRODUCT CONTAINS
1-1.2 MILLION LIVE AND NATIVE MSC’S/CC.
QUESTION 3: WHAT OTHER ESSENTIAL COMPONENTS FOR TISSUE ENGINEERING DOES THE PRODUCT CONTAIN?
In order to effectively repair and renew tissue, we need viable MSC’s but these MSC’s need the support of other essential components in the body to get the job done. These components include but are not limited to: growth factors, bio-active molecules, and scaffolding.
Growth factors (usually a protein or hormone) are important for regulating a variety of cellular processes. Growth factors typically act as signaling molecules between cells. By signaling, these growth factors are believed to activate the MSC’s.
Bio-active molecules such as cytokines, HA (hyaluronic acid), exosomes, collagen types III and IV, etc. are essential for tissue repair and engineering, and carry out their own specialized functions. They are like the framer, painter, plumber, carpenter, roofer etc. in the construction or reconstruction of a home or building.
Scaffolding is the structure or framework from which the MSC’s and bio-active molecules build, rebuild, repair and reengineer.
Remember that live MSC’s are essential, but that without the support of the other essential components for tissue engineering, the results may be disappointing.
OUR PRODUCT CONTAINS NOT ONLY A HIGH QUANTITY AND QAULITY OF LIVE AND NATIVE MSC’S, BUT ALSO CONTAINS THE ESSENTIAL COMPONENTS NECESSARY FOR EFFECTIVE TISSUE ENGINEERING.
QUESTION 4: IS THE PRODUCT IN FULL COMPLIANCE WITH CURRENT FDA GUIDELINES UNDER SECTION 361 HCT/P (Human Cellular Tissues / Products)?
Manufacturers and practitioners alike may be non-compliant with the current FDA regulations and recommendations. They may use a product that is not registered with the FDA or that is proven to be compliant with all current FDA regulations. The practitioner may also treat patients with medical conditions that do not constitute “homologous use” and/or uses the product off-label (for the treatment of conditions considered less efficacious or safe such as cancer etc.) or for unproven stem cell interventions (stem cell therapy that lacks compelling evidence based upon scientific studies to validate treatment efficacy).
These HCT/P’s (Human Cells, Tissues, and Cellular or Tissue-Based Products) are not considered drugs and therefore are not FDA-approved (except for one umbilical cord blood product that obtained approval for pediatric cancer). These products can be registered and can show compliance with the regulations set forth by the Food and Drug Administration (FDA) under 21 CFR Part 1271, section 361
WHERE does the Umbilical Cord Tissue come from?
All birth tissue products are obtained from deliveries from healthy, normal, full-term pregnancies in U.S. Donors that consent to donate their birth tissues is carefully screened prior to the use of their tissues in manufacturing the 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 are minimally manipulated human tissue allografts, regulated by the Food and Drug Administration (FDA) under 21 CFR Part 1271, section 361 as HCT/Ps (Human Cells, Tissues, and Cellular or Tissue-Based Products).
At Neo Matrix Medical, we use these products for homologous use only, for the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues that performs the same basic function or functions in the recipient as in the donor. Recipient cells or tissues may not be identical to the donor’s cells or tissues but must perform one or more of the same basic functions in the recipient as the cells and tissues performed in the donor.
Compliance is important. I’m sure as a patient you do not want to end up at a clinic that is consciously or unconsciously cutting corners, correct? Furthermore, compliance to FDA regulations improves the safety of the product, and therefore mitigates most possible risks associated with the product and procedure.
SAFETY of our product:
Blood typing is not needed, and no rejection or allergic reactions have been reported.
The current safety profile of the product:
The safety of the product we use is extremely high. The manufacturer has sold over 51000 vials for injection and 7 complaints were filed. The risk of any adverse reaction is therefore 0.000137%. To put this is perspective: the risk of any adverse reaction when undergoing a TKA (total knee replacement) is more than 20%.
THE PRODUCT WE USE IS REGISTERED WITH THE FDA AND IS FULLY COMPLIANT WITH ALL REGULATIONS OF SECTION 361 HCT/P’s OF THE FDA
QUESTION 5: 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 Neo Matrix 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 the 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 Neo Matrix Medical.
THE USE OF SAFE MSK (MUSCULOSKELETAL) ULTRASOUND ALLOWS FOR THE ACCURATE PLACEMENT OF THE PRODUCT IN THE DAMAGED OR INJURED AREAS.
QUESTION 6: DO YOU OPERATE WITHIN THE POLICIES RECOMMENDED BY THE FSMB (FEDERATION OF STATE MEDICAL BOARDS)?
Neo Matrix Medical only uses these HCT/P’s for homologous use as per FDA guidelines and as per the document “Regenerative and Stem Cell Therapy Practices – Report and Recommendations of the Workgroup to Study Regenerative and Stem Cell Therapy Practices” adopted as policy by the Federation of State Medical Boards, April 2018.
This policy protects the patient from a growing number of providers and clinics undermining the field of regenerative medicine. Such providers and clinics have been known to apply, prescribe or recommend stem cell-based therapies inappropriately, over-promise without sufficient data to support claims, and exploit patients who are often in desperate circumstances and willing to try any proposed therapy as a last resort, even if there is excessive or scant evidence of efficacy.
At Neo Matrix Medical we proactively protect ourselves and prospective patients by incorporating the following actions:
- We use an informed and shared decision making process
- We discuss the benefits and risks of the treatment accurately, based on scientific evidence.
- We explain alternatives to the treatment
- We explain the right to withdraw from the treatment without denial of the standard of care to the patient
- We give the patient an opportunity to express preferences and values before collaboratively evaluating and arriving at treatment decisions
- We identify physician and physician credentials
- We determine if the diagnosis or condition is appropriate for regenerative and stem cell therapy
- We try to avoid to overemphasize, exaggerate, inflate or misrepresent information provided verbally or in print.
- We try to avoid claims that are deceptive and present information based on scientific evidence
- We do not take advantage of patients that are desperate
- We don’t treat conditions that are not proven effective
- We only treat conditions with regenerative and stem cell therapy when traditional or accepted proven treatment modalities have been exhausted
- We do not charge excessive fees for our treatment
- We practice within FDA guidelines and recommendations
AT NEO MATRIC MEDICAL WE STRIVE TO BE TRANSPARENT AND BE FULL DISCLOSURE.
WE OPERATE WITHIN THE POLICIES SET FORTH BY THE FEDERATION OF STATE MEDICAL BOARDS.
WE COMPASSIONATELY TRY TO HELP OUR PATIENTS WITHOUT TAKING ADVANTAGE OF THEM.
WE DO NOT TREAT CONDITIONS THAT ARE NOT PROVEN TO BE EFFICACIOUS.
WE DO NOT CHARGE EXCESSIVE FEES FOR TREATMENT.
QUESTION 7: IS YOUR MEDICAL TEAM CERTIFIED IN THESE STEM CELL-BASED PROCEDURES, AND HOW MANY PROCEDURES HAS YOUR COMPANY PERFORMED THUS FAR, AND WHAT IS YOUR SUCCESS RATE?
Many physicians or health care professionals offer regenerative and stem cell therapies but have not received targeted training. The health care professionals employed or contracted by Neo Matrix Medical are licensed within the State of Florida and they have experience and received targeted training and/or certification(s) in these regenerative and stem cell-based therapies.
When considering stem cell therapy, ask the provider:
- How long have you been providing stem cell therapy?
- Do you offer other services? What’s your specialty?
- How many patients have you treated?
- How successful are your outcomes?
Neo Matrix Medical & Vitality Health Care (partner of Neo Matrix Medical) have performed tens of thousands of procedures in their clinics across the country over the past 4+ years. At Neo Matrix 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 orthopedic conditions, neuropathy, eye conditions and E.D. (erectile dysfunction).
There are no guarantees in medicine, period. However, our current success rate across our clinics nationwide is VERY HIGH. We contribute our high success rate to:
- Highly professional approach
- Health care professionals trained and certified in these stem cell therapies
- Compliance with FDA regulations
- Proactive incorporation of policy by the Federation of State Medical Boards
- The fact that we specialize in regenerative and stem cell therapy (we do not practice any other type of medicine or offer any other medical services)
- The fact that we only treat conditions proven to be efficacious according to scientific research
- Our vast experience: 1000’s of patients and 4+ years
- Our vast resources, including legal and marketing teams
TOGETHER WITH OUR PARTNER CLINICS WE HAVE PERFORMED TENS OF THOUSANDS OF PROCEDURES AND HAVE A HIGH SUCCESS RATE.
WE CONTRIBUTE OUR HIGH SUCCESS RATE TO OUR VAST EXPERIENCE AND HIGHLY PROFESSIONAL APPROACH.
When researching stem cells or when considering stem cell therapy, one has to be careful with his/her provider selection since not all stem cells are equal and not all providers are compliant with current FDA regulations or adopt policies set forth by the Federation of State Medical Boards. Be aware that some providers take advantage of patients that may be desperate.
At Neo Matrix Medical, we use the most viable source of stem cells available to 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.
Besides a viable source of native and live MSC’s, other essential components for tissue engineering such as growth factors, cytokines, collagens, other bioactive molecules, and scaffolding are crucial to obtaining desired results.
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. Don’t be fooled by the numbers and compare MSC’s with MSC’s. 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 Neo Matrix Medical / Vitaly HealthCare, we have performed tens of thousands of stem cell therapy procedures nationwide over the past 4+ years and we have a high success rate for the conditions that we treat. We contribute our high success rate to our highly professional approach and vast experience.