REGENERATIVE MEDICINE FAQ (FREQUENTLY ASKED QUESTIONS)
WHAT IS REGENERATIVE MEDICINE?
When a baby is conceived, special cells give rise to every cell and tissue in the body. These cells then remain within the body throughout a lifetime and are the basic building blocks of human tissue and have the ability to repair, rebuild, and rejuvenate tissues in the body. When a disease or injury strikes, these cells respond to specific signals and set about to facilitate the healing process by differentiating into specialized cells required for the body’s repair. They release healing growth factors in response to a distress cell signal in an injured or pathologic area of the body.
HOW DO I KNOW IF I AM A CANDIDATE?
Our office will schedule you for an evaluation, consultation, medical records review and radiologic studies review to determine if you are a candidate. We will also determine the likelihood of success for your case.
DOES MY INSURANCE COVER REGENERATIVE MEDICINE?
Unfortunately, no insurance covers regenerative medicine as they are not yet FDA approved, which makes our process and product even more economical and desirable. We anticipate an expedited approval that will happen in 3-5 years but no one knows for sure how long it will take. It will likely come in segmental approvals for certain conditions as the human trial evidence mounts. Currently, the only FDA approved therapy is umbilical cord cells for a very specific cancer. Our Clinic participates in reporting to the national databases that are working toward attaining FDA approval. Currently we follow FDA guidelines and regulations set forth by the American Association of Tissue Banks (AATB) regarding our handling and delivery of regenerative medicine to patients.
HOW MUCH DOES IT COST?
Treatments are condition specific and patient specific. The cost is determined by the amount of regenerative medicine deployed. Most patients are treated for less than the cost of braces for teeth or Lasik surgery for vision.
HOW OFTEN WILL I NEED TREATMENT?
This depends on the area and condition being treated. For many degenerative joint conditions and soft tissue tears, we anticipate needing to treat just once in a patient’s lifetime if no new injury traumatizes the joint following treatment.
WILL I NEED PHYSICAL REHABILITATION?
We provide a very detailed post procedure booklet to help ensure your success. You may request this prior to your procedure. In a nutshell, mobility is a very important part of your recovery and we typically recommend you receive some help from a provider that specializes in physical rehabilitation.
WILL I HAVE TO MISS WORK OR ACTIVITIES?
Most patients experience no downtime whatsoever; however, if your work requires you to do activities that are damaging or traumatic to the tissue that was treated, you may need to refrain from those activities. If you are participating in a sport or activity that is damaging to the tissue being treated, we will likely ask you to refrain for a period of 4-6 weeks. For example, if you are a tennis player and we treat your knee, you would need to refrain from playing tennis for 4-6 weeks.
HOW IS THE REGENERATIVE MEDICINE PROCESSED AND ARE THEY SAFE?
The umbilical cord is processed in the hospital according to the rules and regulations of the American Association of Tissue Banks (AATB). Approximately 4 weeks prior to birth, the mother’s OB/GYN asks her if she would like to keep and store her unborn child’s umbilical cord for future use. If the mother declines, she is asked if she would like to donate the umbilical cord. If she agrees, she undergoes a review of her medical history, social history, and a blood test. If she is deemed an acceptable donor according to prevailing rules of the AATB, then, at the time of birth, an experienced technician will clamp the umbilical cord, take it to a sterile room, and remove the contents of the umbilical cord and place it into a blood bag. The bag of umbilical cord blood is then delivered to the lab for processing. Once at the lab, a sample of the umbilical cord blood is sent to a 3rd party independent FDA registered lab for testing according to United States Pharmacopoeia rule 71 (U.S.P. 71), which is a test for all known communicable diseases. While that test is taking place, the cells are then processed and removed from the red blood cell products. A sample of the finished cell product is then sent to a different 3rd party independent FDA registered lab for sterility testing and for the absence of HLA-DR
markers. Only after both lab reports come back as “clean” and the cells have passed the regulatory requirements, are the processed umbilical cord cells available for distribution.
HOW DO YOU GET THE REGENERATIVE MEDICINE FROM THE LAB IN CALIFORNIA?
The cells are delivered to Our Clinic from the lab via FedEx on dry Ice (-125 C) in a Styrofoam container and an outer cardboard box. The package arrives in less than 24 hours.
WHAT HAPPENS WHEN YOU RECEIVE THE CELLS?
The container with the dry ice is maintained at -125 C for at least 48 hours; however, when the cells arrive at our office, they are immediately transferred to our liquid nitrogen holding tank where we store them in the vapor phase of LNO2 at -180 to -192 Celsius. The cells can be stored for years if necessary because there is little to no cellular metabolism at these extremely cold temperatures.
IS HLA MATCHING NECESSARY?
No. HLA matching is not necessary for the cell product because HLA-DR, the component responsible for a negative reaction, is below measurable amounts. Even In the 1990s, when HLA-DR extraction techniques were
far less efficient than they are today, negative HLA-DR reactions were not commonly seen.
CAN YOU SPLIT THE CONTENTS OF THE VIAL ON DIFFERENT PATIENTS?
No. You may NOT split the contents of the vial and use on 2 different patients. For regulatory and tracking purposes, the vials are SINGLE USE and can only be used on a SINGLE PATIENT.
CAN YOU SPREAD THE CONTENTS OF THE VIAL ON THE SAME PATIENT FOR MORE THAN ONE AREA?
Yes. You may split the contents of a vial on the same patient. For example, the doctor may order the 30 million concentration vial and they may split the vial and inject the equally divided contents into 2 or 3 joints for the desired minimum of 7 to 10 million cells per medium to large sized joint.
IS THERE AN AGE LIMIT FOR PATIENTS?
No, there is not an age limit. Patients of all ages can potentially benefit from regenerative medicine.
WHAT IS THE DESIRED LEAD TIME TO SCHEDULE MY INJECTION FOLLOWING A CONSULTATION?
Since our clinic keeps inventory cryopreserved on site, you may receive your injection on the same visit if you wish or you can schedule a time that is most convenient for you in the future.
DO YOU EVER USE AN ABORTED FETUS?
NO. We only use the umbilical cord from a live, healthy baby.
DOES REGENERATIVE MEDICINE DUPLICATE IN THE BODY?
Yes. Regenerative medicine has the ability to duplicate themselves in the body. There is some debate on this topic and this debate is one that is very difficult to prove or disprove, but most medical doctors and scientists agree this action must account for the tremendous regeneration that can follow an injection.
DOES REGENERATIVE MEDICINE CAUSE CANCER OR CAUSE CANCER TO GROW?
No. Many studies have been done to show the long-term safety of regenerative medicine and they are conclusive showing not only does the therapy not proliferate or grow cancer, but it is in fact classified as anti-tumorigenic. Multiple studies are being done around the world showing how regenerative medicine can actually fight cancer and stop the growth of cancer cells. This research is ongoing and the exact effects of regenerative medicine for the treatment of cancer is, as of yet, unknown.
IS DNA TESTING NECESSARY?
No. DNA testing is not necessary because the regenerative medicine and mono-nucleated cells do NOT penetrate the nucleus of the recipients’ cells and thus, do not pass on DNA. The ability of regenerative medicine to pass along DNA matter is a property of a cell when it is in the embryonic stage and this is no longer possible after the 10th week of gestation.
HOW DOES REGENERATIVE MEDICINE DIFFERENTIATE/CHANGE INTO NEW TISSUE IN MY BODY?
Regenerative medicine produces long-term effects by responding to signals from injured tissue. The medicine works by inhibiting the inflammatory components that cause pain and damage to tissue and the mono-nucleated cells secrete growth factors, proteins, and cytokines that stimulate our own native tissue to repair and regenerate itself.
ARE UMBILICAL CORD CELLS FROM ANOTHER PERSON SAFE TO PUT INTO MY BODY?
Yes. Allogeneic (taken from another person of the same species) cells are safe to put into your body. When the umbilical cord is processed, all the red blood cell components with the ability to cause a negative reaction are removed. Also, the umbilical cord cells are naïve/immature and do NOT react the way a mature adult cell would react.
ARE UMBILICAL CORD CELLS THE SAME AS AMNIOTIC FLUID?
No. Umbilical cells are LIVE NUCLEATED CELLS, which will continue to produce anti-inflammatory and immunomodulatory components optimizing the local cellular environment. They also contain mono-nucleated cells, which produce growth factors, proteins, and cytokines, stimulating our own tissue to regenerate itself. Because the cells are LIVE, they can continue to exert the cellular function for weeks and even months in the body. Conversely, amniotic fluid/tissue must be processed in such a way that KILLS the live nucleated cells leaving a product which contains growth factors, proteins, and cytokines that will only have an effect for several hours to a few days.
ARE LIVE NUCLEATED CELLS IMPORTANT?
Yes. The presence of live nucleated cells means the anti-inflammatory and immunomodulatory components from the MSCs will continue to be produced for many weeks and months, optimizing the injured environment. At the same time, the growth factors, proteins, and cytokines produced by the mono-nucleated cells will stimulate our own endogenous tissue to repair and regenerate itself.
ARE ALL LIVE NUCLEATED CELLS CREATED EQUAL?
No. Live nucleated cells from umbilical cord blood are young, vibrant cells that have not been affected by age or disease. Whereas bone marrow aspirate and adipose derived different cells that are significantly older and potentially damaged by disease, a high number replications throughout a lifetime, toxins like sunlight, alcohol, medications and smoking.
ARE THERE OTHER CELL PRODUCTS THAT CONTAIN LIVE NUCLEATED CELLS?
Yes, bone marrow aspirate and adipose derived cells also contain live nucleated cells.
HOW DO UMBILICAL CORD CELLS ACTUALLY WORK?
When umbilical cord cells are placed into an environment of injured tissue, the cells go to work inhibiting the damaging inflammatory components and modulating the immune system. At the same time, the mono-nucleated cells produce growth factors that nourish damaged cells back to health and stimulate our own cells to regenerate themselves.
DOES CELL AGE MATTER?
Yes, age definitely matters. In Vitro research by the International Journal of Molecular Sciences has shown that while young, vibrant umbilical cord cells can duplicate themselves every 22-28 hours, for up to 65 generations or more, 50+ year old bone marrow aspirate and adipose derived cells duplicate at a much slower rate of 3 to 5 days for an average of only 11 to 13 generations. Also of note is that older cells undergo senescence (aging) at a much faster rate than young, vibrant umbilical cord cells and older senescent cells produce less quantities and less effective growth factors, proteins, and cytokines. (Int. J. Mol. Sci. 2013, 14, 1798618001; doi: 10.3390 ijms140917986. International Journal of Molecular Sciences ISSN 1422-0067 www.mdpi.com/journal/ijms)
CAN I USE A LOCAL ANESTHETIC?
Local anesthetics may be used to numb the needle pathway; however, we do NOT want to infuse large amounts of any local anesthetic into the joint or area being treated. We rarely use local anesthetics because the pinch of the anesthetic stick is very similar to the pinch associated with the actual injection. Most people have little to no issue with the actual procedure without anesthetic. When we treat intra-discally
(injection inside the inter-vertebral disc) we typically give a mild sedative prior to the procedure.
ARE ANY ANESTHETICS BETTER TO USE THAN OTHERS?
Yes. There is some research showing that ‘sodium channel blockers’ (lidocaine, carbocaine, etc.) have a damaging effect on the nucleated cells whereas the ‘amide group’ of local anesthetics (Marcaine, bupivacaine, ropivacaine) does not have the same damaging effect.
ARE THERE SPECIFIC NUMBERS OF CELLS NECESSARY TO TREAT DIFFERENT PROBLEMS?
Exact numbers for peak efficacy is still not known for many conditions; however, worldwide research over almost 20 years has given us some effective parameters. Most research supports the notion that more cells are often better and the body may utilize the extras in other ways that can be beneficial.
IS THERE A SPECIAL PROTOCOL/METHOD FOR INJECTING REGENERATIVE MEDICINE INTO THE PATIENT?
Yes. We inject the cells into the desired area the same way as any other injection. The only difference is in the preparation and our use of precision guided ultrasound, which allows us to inject precisely into the affected tissues. Research has shown cells begin to die within minutes of being thawed, so we are expeditious with the injection process.
DO YOU NEED TO MIX/DILUTE THE UMBILICAL CORD CELLS BEFORE INJECTION?
The cells may be injected directly into the desired area without any dilution or we may choose to add Hyalgan if the cells are being deployed into a weight bearing joint. Hyalgan does not negatively effect the viability of regenerative medicine.
WHAT IS THE BEST METHOD FOR THAWING THE CELLS?
Multiple methods of thawing, at the clinical level, have been studied. The easiest most effective method is by placing the vial in the palm of your hand (or the patient’s hand) for 3 to 4 minutes. This should only be done once the patient is ready to be prepped for the procedure.
ARE THERE ANY KNOWN SIDE EFFECTS TO THE PROCEDURE?
No long-term negative side effects or risks have been reported. The side effects of umbilical cord derived cell therapies are rare and may include but are not limited to: infection, minor bleeding at the treatment site, and localized pain. These side effects typically last no longer than 24 hours.
HOW LONG WILL IT TAKE TO SEE RESULTS?
Since each condition and patient is unique, there is no guarantee of how fast the results will be achieved. According to patient feedback, most patients report results within a few days; however, it may take as long as six to nine months.