WHAT IS CELL-BASED REGENERATION THERAPY?
The term cell-based regeneration therapy has become interchangeable with Stem Cell Therapy, however we do not inject live nucleated cells into the joint space. We utilize Wharton’s jelly. Our Wharton’s Jelly product is a minimally manipulated flowable tissue transplant that has the highest concentrations of Stem Cells, Hyaluronic Acid, Collagen, Growth Factors and Anti-Inflammatory Cytokines. Cell-based regeneration therapy is simply harnessing the bodies natural capacity to heal itself, super concentrating it and injecting it where we hurt in order to start or accelerate the healing process.
WHAT IS WHARTON’S JELLY?
Found in the Umbilical Cord Wharton’s Jelly (WJ) provides conditioning, support and lubrication for the Cord. That functional purpose in the Cord makes it a perfect product for treating damaged joints whether that damage is caused by arthritis, inflammation or injury. The tissue transplant not only has all the healing and regenerative properties at the highest concentration but also provides relief as it gives the joint space more support, cushioning and lubrication.
WHY DO YOU USE WHARTON’S JELLY?
Wharton’s Jelly has the highest concentration of Mysenchymal Stem Cells (Stem Cells), Growth Factors, Collagen, Hyaluronic Acid and Anti-Inflammatory cytokines. These work to most effectively turn off inflammation and promote regeneration of the tissue. For the patient that simply means much less pain and much more function.
WHAT ARE THE BENEFITS OF WHARTON’S JELLY?
Wharton’s Jelly provides cushioning, support and lubrication in the joint space. It is the only biologic that has the structure for that. Wharton’s Jelly also has the highest concentration of stem cells which are critical for the regenerative process. Wharton’s Jelly also has the highest concentration of Hyaluronic Acid which is important for joint health. Wharton’s Jelly also has the highest concentration of Growth Factors and Anti-inflammatory cytokines.
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. Most patients report reduced pain in four to six weeks. We have follow up consults at three months, six months and a year.
ARE THERE ANY KNOWN SIDE EFFECTS TO THE PROCEDURE?
No long-term negative side effects or risks have been reported with Biologics. Any negative side effects will be in relation to the actual injection itself, as in bleeding and the risk of infection at the injection site. We have not had any infections nor bleeding issues.
ARE THERE SPECIFIC PRODUCT VOLUMES NECESSARY TO TREAT DIFFERENT ISSUES?
We do have dosing protocols that are oriented to the size and condition of the joint treated.
IS THERE A SPECIAL PROTOCOL/METHOD FOR INJECTIONS?
YES. Our staff is trained to use ultrasound guidance in order to get the tissue transplant in exactly the right place.
DO YOU NEED TO MIX/DILUTE THE WHARTON’S JELLY BEFORE INJECTION?
We typically add Normal Saline to the product making it easier to inject into the joint space. Often patients report an immediate benefit. That felt benefit is due to the volume and not the immediate action of the regenerative factors in the Wharton’s Jelly.
DO YOU USE ANESTHETICS?
The injections are relatively painless and do not require the use of anesthetics.
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 15 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. Finally, the young cells have a stimulative effect of the patients older cells causing an increased regenerative impact.
HOW DOES THE TREATMENT WORK?
When the Wharton’s Jelly is placed into an environment of injured tissue, the stem cells, anti-inflammatory cytokines, growth factors, hyaluronic acid, collagen and peptides go to work inhibiting the damaging inflammatory components and modulating the immune system. The cell signaling proteins and growth factors nourish damaged cells back to health and stimulate our own cells to participate in the regenerative process differentiating into the damaged tissue.
WHAT ABOUT STEM CELLS FROM MY OWN BONE MARROW?
Studies report that mesenchymal stem cell products isolated from Umbilical Cord tissue are more effective than those isolated from adults (Bone Marrow).
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.
IS WHARTON’S JELLY THE SAME AS AMNIOTIC FLUID?
No. The Wharton’s Jelly matrix contains the highest concentration of live nucleated cells or stem cells. These continue to produce anti-inflammatory and immunomodulatory components optimizing the local cellular environment. The Wharton’s Jelly matrix also contains the highest concentration of mononucleated cells, which produce growth factors, proteins, and cytokines, all of these elements in the matrix 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.
IS WHARTON’S JELLY FROM THE UMBILICAL CORD SAFE TO BE PUT INTO MY BODY?
Yes. Allogeneic (taken from another person of the same species) tissue is safe to put into your body. When the Wharton’s Jelly tissue is processed, all the red blood cell components with the ability to cause a negative reaction are removed so that the patient does not have an immune reaction to the transplant.
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-tumorogenic. 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. All of that being said an active cancer is currently a contraindication for Regenerative Therapy. Our patients must be cancer free for 5 years before we can treat them.
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.
WHAT IS THE DESIRED LEAD TIME TO SCHEDULE MY INJECTION FOLLOWING A CONSULTATION?
We need at least two days lead time for us to order the cells.
IS THERE AN AGE LIMIT FOR PATIENTS?
No, there is not an age limit. Patients of all ages can potentially benefit from Regenerative Treatments.
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.
HOW DO YOU GET THE CELLS FROM THE LAB?
The cells are delivered to Regain/Stem Life 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 -125 C until the time of treatment.
CAN YOU TREAT MORE THAN ONE AREA OF THE BODY FROM A SINGLE VIAL?
Yes. You may split the contents of a vial on the same patient.
DO YOU EVER USE AN ABORTED FETUS?
NO. Umbilical cords are only processed after a caesarian birth and the baby must be healthy.
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, a trained 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 tissue is processed from the cord and all red blood cells are removed. A sample of the harvested tissue 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 tissue has passed the regulatory requirements, are the processed tissues available for distribution.
WILL I HAVE TO MISS WORK OR ACTIVITIES?
No patients experience no downtime whatsoever. We do want to protect the healing cascade in the joint so we counsel our patients in regard to that. 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.
WILL I NEED PHYSICAL THERAPY/ REHABILITATION?
Yes, although it is not mandatory and most clinics don’t have Physical Therapy in their treatment regimen we do. We will write an order for Physical Therapy and it should be covered by your insurance. We have found that patients who have physical therapy improve function much more rapidly.
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.
HOW MUCH DOES IT COST?
Treatments are condition specific and patient specific. The cost is determined by size and damage of the joint which then requires a certain volume of WJ. Most patients are treated for less than the cost of braces for teeth or Lasik surgery for vision. Small joints like ankles or wrists can be treated for as little as $3,500. Larger joints require more tissue volume so the cost increases. The cost of a typical Knee or Shoulder ranges from $5,500.00 to $6,500.00. The cost range for two joints of that size is $7,500.00 to $8,500.00.
DOES INSURANCE PAY FOR THE THERAPY?
Unfortunately, no insurance payers cover 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 years but no one knows for sure how long it will take. It will likely come in segmented 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. Regain 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.
INSTITUTIONAL REVIEW BOARD/ CLINICAL TRIALS
Regain Stem Life are currently involved in a study for osteoarthritic knees. Dr Witte will provide oversight on the Institutional Review Board and Regain/Stem Life will participating in a clinical trial for knee Osteoarthritis. We anticipate further trials for hips and shoulders and we do plan on engaging in these trials as well. We are hopeful that this will have an influence on the FDA’s designation of ‘experimental’ and may help to expedite the process for payers.
HOW DO I KNOW IF I AM A CANDIDATE?
We have a thorough diagnostic process. We utilize ultrasound scans of the joint and are able to determine the amount and extent of soft tissue damage with the goal of determining next steps. If the damage is so extensive we will recommend a surgical repair first and stem cells treatment post surgery.
