WHAT ARE STEM CELLS?
When a baby is conceived, stem cells give rise to every cell and tissue in the body. These cells then remain within the body throughout a lifetime. Stem cells 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, stem 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 UMBILICAL CORD STEM CELLS ACTUALLY WORK?
When umbilical cord cells are placed into an environment of injured tissue, the stem cells go to work inhibiting the damaging inflammatory components and modulating the immune system. At the same time, the mononucleated cells produce growth factors that nourish damaged cells back to health and stimulate our own cells to regenerate themselves.
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.
IS THERE AN AGE LIMIT FOR PATIENTS?
No, there is not an age limit. Patients of all ages can potentially benefit from stem cell treatments.
HOW MUCH DOES IT COST?
Treatments are condition specific and patient specific. The cost is determined by the number of stem cells deployed. Most patients are treated for less than the cost of braces for teeth or Lasik surgery for vision. Treatments for small joints like ankles or wrists can be treated for as little as $3,500. Larger joints require more cells so the cost increases.
DOES MY INSURANCE COVER STEM CELL THERAPY?
Unfortunately, no insurances cover stem cell therapy as they are not yet FDA approved, which makes our process and the stem cell product even more economical and desirable. We anticipate an expedited approval that will happen in 3-5 year, 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 stem cells for a very specific cancer. Redefine Stem Cell 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 stem cells to patients
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.
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.
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 stem 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.
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.
ARE THERE SPECIFIC NUMBERS OF CELLS NECESSARY TO TREAT DIFFERENT PROBLEMS?
Exact numbers for peak efficacy are 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.
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.
CAN I USE 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 intradiscally (injection inside the intervertebral disc) we typically give a mild sedative prior to the procedure.
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 stem cells can duplicate themselves every 22-28 hours, for up to 65 generations or more, 50+ year old bone marrow aspirate and adipose derived stem 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.
ARE THERE OTHER STEM CELL PRODUCTS THAT CONTAIN LIVE NUCLEATED CELLS?
Yes, bone marrow aspirate and adipose derived stem cells also contain live nucleated cells.
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 mononucleated cells will stimulate our own endogenous tissue to repair and regenerate itself.
ARE UMBILICAL CORD CELLS THE SAME AS AMNIOTIC FLUID?
No. Umbilical cells are LIVE NUCLEATED CELLS containing stem cells, which will continue to produce anti-inflammatory and immunomodulatory components optimizing the local cellular environment. They also contain mononucleated cells, which produce growth factors, proteins, and cytokines, which stimulate 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 have an effect for several hours to a few days.
ARE UMBILICAL CORD STEM CELLS FROM ANOTHER PERSON SAFE TO BE 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. “Mesenchymal stem cells produce huge quantities of bio-molecules, some of which are immunosuppressive; MSCs put up a curtain of molecules around themselves that allows donor (allogenic) MSCs to be transplanted into a recipient, free from an immune response. (Immune privileged/Immune Masked)” Arnold Caplan, PhD. Case Western Reserve University. Experimental and Molecular Medicine (2013) 45 Mesenchymal stem cells: environmentally responsive therapeutics for regenerative medicine
DO STEM CELLS CAUSE CANCER OR CAUSE CANCER TO GROW?
No. Many studies have been done to show the long-term safety of stem cells and they are conclusive showing not only do stem cells not proliferate or grow cancer, but stem cells are in fact classified as anti-tumorigenic. Multiple studies are being done around the world showing stem cells can actually fight cancer and stop the growth of cancer cells. This research is ongoing and the exact effects of stem cells for the treatment of cancer is, as of yet, unknown.
IS DNA TESTING NECESSARY?
No. DNA testing is not necessary because the stem cells and mononucleated cells do NOT penetrate the nucleus of the recipients’ cells and thus, do not pass on DNA. The ability of a stem cell to pass along DNA matter is a property of a stem cell when it is in the embryonic stage and this is no longer possible after the 10th week of gestation.
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.
IS HLA MATCHING NECESSARY?
No. HLA matching is not necessary for the stem cells we use 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 SPREAD CONTENTS OF THE VIAL ON THE SAME PATIENT FOR MORE THAN ONE AREA OF THE BODY?
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.
DO YOU EVER USE AN ABORTED FETUS?
NO. We only use the umbilical cord from a live, healthy baby.
HOW ARE THE CELLS 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 a scheduled caesarean section, 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 her caesarean section, 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 stem cells are then processed and removed from the red blood cell products. A sample of the finished stem 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 stem cells have passed the regulatory requirements, are the processed umbilical cord stem cells available for distribution.
DO YOU USE MY OWN STEM CELLS?
No. Redefine Stem Cell Clinic utilizes human umbilical cord stem cells, which is the most advanced stem cell product available. Published research reveals stem cells from the umbilical cord replicate faster and replicate for many more generations than other types of stem cells. Umbilical cord stem cells also have a higher level of pluripotency than mature adult stem cells helping the body regenerate lost tissue like cartilage, muscle and soft tissue faster and more effectively.
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.