The umbilical cord is processed in the hospital according to the rules and regulation of the American Association of Tissue Banks (AATB). Approximately 4 weeks prior to a scheduled caesarean section, the mothers 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 then 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 clean 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 Pharmacopeia rule 71 (U.S.P. 71), which is a test for 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. Only after both lab reports come back as “clean” and have passed the regulatory requirements, are the processed umbilical cord ‘stem cells’ available for distribution.

No, we only use the umbilical cord from a live healthy birth baby.

We use ‘stem cells’ derived from umbilical and placenta cord tissue, which is the safest and least-invasive method of extraction available. These ‘stem cells’ are sourced from umbilical cord and placenta tissue from babies that are born healthy and screened for infectious diseases. These umbilical cords and placentas would otherwise typically just be discarded in the trash. Most everyone considers this use of umbilical/placenta derived ‘stem cells’ to be ethical.

Embryonic tissue: Most embryonic ‘stem cells’ are derived from embryos donated from fertility clinics that perform in vitro fertilization (IVF). Some are ethically opposed to this type of ‘stem cell’ therapy. Bone marrow: Adult ‘stem cells’ can be extracted from bone marrow by aspiration, typically from the superior iliac crest (hip) or the sternum (chest). This process may be painful and extracts adult ‘stem cells’ that are already as old and aged as you currently are. Adipose tissues: Adipose-derived ‘stem cells’ come from a patient’s fat tissue, which is surgically extracted via liposuction under general anesthesia and also extracts adult ‘stem cells’ that are already as old and aged as you currently are.

No, HLA matching is not necessary for the product because HLA-DR, the component responsible for a non-HLA matched negative reaction, is below measurable amounts. Even in the 1990’s when HLA-DR extraction techniques were far less efficient than they are today, negative HLA-DR reactions were not commonly seen.

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 that could 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 act. “Mesenchymal ‘stem cells’ produce huge quantities of bio-molecules, some of which are immunosuppressive; MSC’s put up a curtain of molecules around themselves that allows donor (allogenic) MSC’s 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.

No. Arnold Caplan, PhD. has spoken extensively on the science as to why umbilical cord ‘stem cells’ do not cause a GVH response. It should also be noted that Canada recently approved Umbilical Cord ‘Stem Cells’ for the TREATMENT of GVH.

Yes, you may choose to split the contents of a vial into different regions of your body if it is medically appropriate. For example, if you order the 120 million concentration vial, you 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 size joint.

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.

It is not uncommon to have an inflammatory response after a ‘stem cell’ injection. The reason for the inflammation is the rapid action of the ‘stem cells’ in immunomodulation. An inflammatory response is NOT a negative response, rather it is a positive indication that the cells are working. To counteract the inflammatory response, we may inject into the joint or tissue, 4-10mg of Dexamethasone Sodium Phosphate (not an acetate derivative because of its poor solubility in synovial fluid) to blunt the inflammatory response. The steroid will NOT damage the cells. 4mg for small joints and up to 10mg for large/medium joints. We may also use a homeopathic to decrease the inflammation.

No, an inflammatory response is not necessary. Some people have a response and there is no exact explanation as to why.

It is advised that you NOT increase your activity level above your pre-injection activity level. Give the cells 3 months to modulate inflammation and the immune system and allow the growth factors to begin to stimulate your own cells for regeneration.

Whether to have P.T. after a ‘stem cell’ injection is your choice. If you do participate in P.T., is it recommended that you mainly do Open Kinetic Chain exercises that do NOT put added pressure on the joint.

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 is no longer possible after the 10th week of gestation. Umbilical cord ‘stem cells’ are harvested between weeks 36 and 40.

No, ‘stem cells’ do NOT duplicate themselves in the body. ‘Stem cells’ DO have the ability to duplicate themselves in vitro, in culture in the lab, but they do NOT duplicate themselves in the body. This is a long-held myth that is now disproven.

Research has shown that the vast majority of the function of ‘stem cells’ is for Medicinal Signaling and NOT differentiation. ‘Stem cells’ produce long-term effects by responding to signals from injured tissue. The ‘stem cells’ work by inhibiting the inflammatory components that cause pain and damage to tissue and the mononucleated cells secrete growth factors, proteins, and cytokines that stimulate our own native tissue to repair and regenerate itself.

While there are no large direct studies to show that ‘stem cells’ do not cause cancer, there are studies that whereby ‘stem cells’ are used to treat cancer and the conclusion is that since the cells effectively suppress cancer cells, it is believed that they do not proliferate cancer cells nor cause the formation of cancer cells.

No, umbilical cells are LIVE NUCLEATED CELLS that contain ‘stem cells’ that will continue to produce anti-inflammatory and immunomodulatory components that optimize the local cellular environment. They also contain mononucleated cells that produce growth factors, proteins, and cytokines that 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 that contains growth factors, proteins, and cytokines that will have an effect for, at most, several hours to a few days.

Yes, the presence of live nucleated cells means that the anti-inflammatory and immunomodulatory components from the MSC’s will continue to be produced for many weeks and possibly months, optimizing the injured environment. At the same time, the growth factors, proteins, and cytokines produced by the mononucleated cells will stimulate our own tissue to repair and regenerate itself.

Yes, bone marrow aspirate and adipose derived ‘stem cells’ also contain live nucleated cells, though the age and health of the patient from which the cells are taken directly affect the activity level and function of the cells.

No, live nucleated cells from umbilical cord blood are young, vibrant cells that have not been effected by age or disease whereas bone marrow aspirate and adipose derived ‘stem cells’ are significantly older and potentially damaged by disease.

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 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.

Int. J. Mol. Sci. 2013, 14, 17986-18001; doi:10.3390/ijms140917986. International Journal of Molecular Sciences ISSN 1422-0067 www.mdpi.com/journal/ijms

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. Studies have shown that even if you have an abundant amount of growth factors, they are unable to stimulate regeneration in the presence of high concentrations of inflammatory components, specifically TNF-a (tumor necrosis factor-alpha) so the components work together first by inhibiting inflammation and secondly by stimulation of our own tissue with the growth factors, proteins, and cytokines.

Yes, Worldwide research and experience since the 1990’s has given us some effective parameters.

Large to Medium Joints: (Shoulder, hip, knee, ankle) 10 million cell preparation miminum.

Small Joints: (Elbow, 1st MCP/MTP, etc.) 2.5 to 5 million cells/joint (It should be noted that when injecting smaller joints, it is very important to NOT damage the cartilage upon entry into the joint. Many clinicians will place the cells peri-articular, around the small joint, to avoid cartilage damage inside the joint. The cells will migrate into the joint)
Soft Tissue: (epicondyles, tendonitis/tendinosis, partial tendon/ligament tears etc.) 5 million cells minimum.

(When injecting for a damaged ligament or tendon, it is most effective to inject around the site and not actually into the damaged tendon or ligament to avoid further needling damage and inflammatory response)

Intra-Disc: 15 million cells/disc
Clinical trials have shown 14 million cells to be effective, so typically, when doing a single level disc injection, you will also inject the corresponding
Facet Joints along with 1 level above and 1 level below. Example: Use ½ of the 30 million cell vial (15 million cells) to inject into the desired disc. (you can add PRP for some volume and ½ to 1cc of hyaluronic acid for viscosity) Using the other ½ of the vial, add enough PRP or saline to inject 1cc of ‘stem cell’/PRP solution into each of the 6 corresponding facet joints. IF you are injecting 2 discs, then you will split the 30 million cell preparation evenly between each disc and if you desire to inject the corresponding facet joints along with 1 level above and below, (8 facets) you would add 7 cc’s of PRP or saline to a 1 cc vial of the 10 million cell concentration and inject 1cc into each facet. It should be noted that if the facet joint is collapsed, peri-articular injection is quite effective for the desired peripheral anti-inflammatory effect.

Ideally, it is best if the patient can refrain from taking NSAIDS (anti-inflammatories such as aspirin, Advil, Aleve, ibuprofen, naproxen, Excedrin, Celebrex, or Mobic for 3 days before the injection to up to 4 weeks after the injection. Part of the function of the cells is a prostaglandin response and the NSAIDS will inhibit that. Recognize that NSAIDS will NOT destroy the cells but potentially lessen the effects. It is understood that not taking NSAIDS is to optimize the process.

Since Biologics typically inhibit the immune system and ‘stem cells’ activate and modulate the immune system, the use of Biologics could diminish the overall effect of the ‘stem cells’ in the body.

No. Umbilical cord ‘stem cells’ are NOT FDA approved and are considered experimental. FDA approval is not required if the ‘stem cells’ are labeled and advertised by the manufacturer for treatments that will not have a systemic effect.

Initially yes. VEGF, FGF-2, and SCF are initially more concentrated in PRP but since there are no live cells in PRP the Growth Factors will only function for the half-life of that Growth Factor which is approximately 12 to 72 hours vs. Live Nucleated Cells in Umbilical Cord Cells which will continue to produce those very same Growth Factors for weeks and possibly even months.