We know there are many questions about Regenerative Medicine and Stem Cells. We have done our best to put together a group of questions we commonly get and provided answers to these below.
When will I 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 many cells does it take to treat my problem?
Exact numbers for peak efficacy are still not known for many conditions; however, worldwide research for the past 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.
How are the cells injected into patients?
We inject the cells into the desired area the same way as any other injection. Research has shown cells begin to die within minutes of being thawed, so we are expeditious with the injection process.
Will local anesthetics be used?
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.
Why does cell age matter?
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.
How do stem cells 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.
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.
Is it safe to put stem cells 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
How are the Cells Processed and is This Process Safe?
BioGenix’s stem cells are derived exclusively from the umbilical cord, which is the safest and least-invasive method of extraction available. The Umbilical cord is sourced from safe and reliable contracted hospitals, via non-invasive procedure, and transported directly to the lab. Donors are pre-screened through an intensive and complete medical review and pre-natal evaluation.
The umbilical cord is collected, processed in a sterile manner, packaged and cryopreserved, and distributed by our FDA-registered laboratory in accordance all current good practices, state regulations and FDA requirements.
The umbilical-cord-derived stem cells are safe and a reliable source for physicians and patients. All stem cells that come out of our lab are internally tested and third party verified, and are delivered with a certification of analysis of sterility and pathology results.
How does this work?
- Participating hospitals invite mothers expecting normal, healthy births to donate the resulting umbilical cord which is considered to be an excellent source of high-quality stem cells.
- At the time of birth, a specialized nurse enters the delivery room to carry out the extraction procedures.
- With the mother’s informed consent, the umbilical cord is clamped off when the baby is born. This preserves the blood in the cord. There is no harm to the child.
- The cord and taken to our sterile lab, which extracts stem cells for therapeutic use.
- The lab specialists screen the cords under AATB standards and extract the stem cells.
Are there 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.
Do stem cells cause cancer?
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. The laboratory requires any patient going through stem cell therapy be cancer free for 2 years and this must be acknowledged by signing a consent form.
Am I too old for stem cells?
No, there is not an age limit. Patients of all ages can potentially benefit from stem cell 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.
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.
How do we receive the cells from the lab?
The cells are delivered to Rejuvenate 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.
Can I, the patient, use the same vial of cells on different parts of my 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 15 million cells per medium to large sized joint.
Are stem cells obtained from abortions / aborted fetus’?
NO! We only use the donations of umbilical cord blood from a live, healthy baby.
Do you used my own stem cells?
No. Rejuvenate 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.
What’s the downtime following my injection?
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.
Will I need physical therapy?
We provide a very detailed instructions 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.
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 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 insurance cover Regenerative Medicine?
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 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 stem cells for a very specific cancer. Rejuvenate 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 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.