What is a stem cell?

A stem cell is any cell that can replicate and differentiate. This means the cell can multiply and it can turn into different types of tissues. There are different kinds of stem cells. Most people are familiar with or have heard the term “embryonic stem cell.” These are cells from the embryonic stage that have yet to differentiate – as such, they can change into any body part at all. These are then called “pluri-potential” cells because they are taken from unborn or unwanted embryos.  While they have been used in some areas of medicine – particularly, outside the United States – they have also been associated with occasional tumor (teratoma) formations. There is work being conducted by several companies to isolate particular lines of embryonic stem cells for future use. [ not surprisingly, there has been considerable controversy surrounding their use]

Another kind of stem cell is the “adult stem cell.” This is a stem cell that already resides in one’s body within different tissues and in after-birth tissues such as the umbilical cord and placenta. In recent times, much work has been done isolating bone-marrow derived stem cells. These are also known as “mesenchymal stem cells” because they come from the mesodermal section of your body. They can differentiate into bone and cartilage, and probably all other mesodermal elements, such as fat, connective tissue, blood vessels, muscle and nerve tissue. Bone marrow stem cells can be extracted however because they are low in numbers, they are usually cultured in order to multiply their numbers for future use. Subcutaneous body fat is also loaded with mesenchymal stem cells. It can have many times more stem cells compared to bone marrow. Most people have adequate fat supplies and the numbers of stem cells are so great so they can be used the same day.

Are stem cell procedure FDA-approved?
No. Bellevue Pain Institute’s surgical procedures fall under the category of physician’s practice of medicine, wherein the physician and patient are free to consider their chosen course of treatment. The FDA does have guidelines about treatment and manipulation of a patient’s own tissues. At BPI we meet these guidelines. The FDA is making determination in 2021 as so much research has now been completed regarding the use of regenerative cells.

Does BPI use any embryonic stem cells?
No. Embryonic stem cells are associated with ethical considerations and limitations.

What is regenerative medicine?
Regenerative Medicine is the process of creating living, functional tissues to repair or replace tissue or organ function lost due to damage, or congenital defects. This field holds the promise of regenerating damaged tissues and organs in the body by stimulating previously irreparable organs to heal them.

What are Non-Embryonic Adult Stem Cells?
Adult Mesenchymal Stem Cells are undifferentiated cells that have the ability to replace dying cells and regenerate damaged tissue. These special cells seek out areas of injury, disease and destruction where they are capable of regenerating healthy cells and enabling a person’s natural healing processes to be accelerated. As we gain a deeper understanding of their biological function and apply this knowledge, we are realizing an enormous therapeutic potential to help the body heal itself. Adult stem cells have been used for a variety of medical treatments to repair and regenerate acute and chronically damaged tissues in humans and animals. Although adult stem cells are found in many organs, they are very accessible in high numbers from fat. If you have been offered amniotic cells, from after birth products, these cells are gamma radiated by the manufacturer and therefore are not live cells. The use of stem cells is not FDA approved for the treatment of any specific disease in the United States at this time and their use is therefore investigational. There are many international medical centers around the world that have been using stem cell therapy to treat various chronic degenerative conditions. Adult stem cells appear to be particularly effective at repairing cartilage in degenerated joints.

How does BPI control sterility in the processing of the stem cells?
Stem cells are harvested under sterile conditions using a special “closed system” technology so that the cells never come into contact with the environment throughout the entire process from removal to deployment. Sterile technique is used to prevent infection.

Does BPI use stem cells from any other animal source or person?
No. Only a person’s own adult autologous cells are used. These are harvested from each individual and deployed back into his or her own body. There is no risk of contamination or risk of introduction of mammalian DNA into the treatments.

Some stem cell treatment centers make extraordinary claims about their success in the treatment of various problems. Why doesn’t BPI?
All investigational data is being collected so that results will be published in peer review literature and ultimately used to promote the advancement of cellular based regenerative medicine. Unless a technology has FDA approval, medical claims and advertising testimonials are not appropriate.

How do adult stem cells heal?
These adult stem cells are known as “progenitor” cells. This means they remain dormant (do nothing) unless they witness some level of tissue injury. It’s the tissue injury that turns them on. So, when a person has a degenerative type problem, the stem cells tend to go to that area of need and stimulate the healing process. We’re still not sure if they simply change into the type of injured tissue needed for repair or if they send out signals that induce the repair by some other mechanism but it is probably a combination of both. Suffice it to say that there are multiple animal models and a plethora of human evidence that indicates these are significant reparative cells.

Why does BPI take a multispecialty treatment approach to regenerative medicine?
Patients suffer from many varieties of degenerative problems. There may be conditions associated with nearly all aspects of the body. Board certified specialists are ideal to evaluate, recommend and/or treat, and subsequently follow your progress. Together we work to coordinate and provide therapy through regenerative medicine. This could include regenerative cell therapy, conservative physical medicine, connective tissue therapy, Laser therapy, home exercise, supplementation and dietary recommendations.

It should also be noted, that all treatments are currently in the investigational stage. While we recognize our patients are seeking improvement in their condition, each treatment program is part of an ongoing investigation to establish optimal parameters for treatment, to evaluate for effectiveness and for any adverse effects. It is essential that patients understand they are participating in these investigational (research) analyses. Once sufficient information is appropriately documented and statistically significant, then data (validated by the IRB – Institutional Review Board) will be presented to the FDA for consideration of making an actual claim.

Why do patients request cell treatment?
Many have been told that they require surgery or other risky treatments for their ailments and are looking for non-invasive options. Some have heard about the compelling testimonials in the literature and on various websites. Many have read about the results of cell treatments in animal models and in humans. BPI does not believe in claims or testimonials since our work is still investigational but we are a resource for patients who need access to regenerative care. BPI gives a choice to those informed patients who seek modern regenerative therapy but desire convenience, quality and affordability. BPI fills a need at a fraction of the costs for those patients who have been told that they may have to travel to different countries and pay as much as $50,000 to $150,000 dollars for cell treatments off-shore.

Can stem cells treat cancer?
Stem cells have played an important role in cancer therapy for five decades. Hematopoietic stem cells have been used to restore bone marrow and replace blood cell lines after planned ablation of a cancer patient’s bone marrow. This is known as a “bone marrow transplant” and is associated with significant risk to cancer patients. Of course this is different than a regenerative cell therapy to replace or repair damaged tissue. Having said that, new advances in cancer therapy have exploited the stem cell property known as “TROPISM” which is the ability of stem cells to target tumors. This property has been used to help carry cancer-killing agents deep into the cancer where the body’s immune system cannot always operate effectively.

Bellevue Pain Institute is NOT involved in any way with any cancer therapy.

Can stem cells cause cancer?
Adult mesenchymal stem cells are not known to cause cancer. Incidence of cancer caused by stem cells are related to the use of embryonic cells (Not Adult Mesenchymal Cells). These embryonic tumors known as teratomas, are rare but possible occurrences when embryonic cells are used.

How long does it take to see improvement?
Regenerative cell therapy relies on the body’s own regenerative healing to occur. The regenerative process may take time, particularly with orthopedic patients, who may not see results for several months. In some cases, more immediate responses have been seen.

Is everyone a candidate?
No. Only certain orthopedic problems are currently being treated at BPI. Patients need to be medically stable enough to have the treatment in our facility. Some patients may be declined due to the severity of their problem. Other patients may not have conditions appropriate to treat or may not be covered by our specialists or our protocols.

Are any patients automatically excluded?
Yes. Patients with active cancer are excluded. If you have an active infection anywhere in your body you must be treated first. Severely ill patients may require special considerations. Also, anyone with a bleeding disorder requires special evaluation before consideration for therapy.

What is the cost of consultation and treatment?
Patients who are considered to be candidates based on information provided in the candidate application form will be invited for a consultation, which may be associated with a consultation/ examination fee of $150-$250.00 depending on complexity of the case. Consultation with a physician may include office evaluation, physician’s evaluation of X-Rays, review of records, or telephonic consultations. Unfortunately, insurance will not cover the actual cost of regenerative cell treatment in most cases since it is still considered investigational the cost varies depending on the disease state being treated and complexity of stem cell deployment.

Under the guidance, control direction and performance of Dr. Patti Mullen ND, BPI performs one or more stem cell therapies that have not yet been approved by the FDA.  You are encouraged to consult with your primary care provider prior to undergoing a stem cell therapy.

Statement in compliance with Washington State RCW 18.130.180 February 12, 2018