What is Our Technology ?

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Early stem cell research has traditionally been associated with the controversial use of embryonic stem cells. The new focus is on non-embryonic adult mesenchymal stem cells which are found in a person’s own blood, bone marrow, and fat. Cell therapy around the world is investigating bone marrow based cells, adipose (fat) derived cells & umbilical cord tissue cells. Methods around obtaining the cells have become minimally invasive and data bases have been collected with varied results around orthopedic, auto-immune and neurological diseases.

One thing that seems to stand out is the treatment with a wholistic approach at the forefront. Support to the cell therapy with an anti-inflammatory diet and positive exercise routine and refraining from unhealthy habits need to considered if you are looking to enhance your own bodies ability to heal and recover from pain and lack of function. Adipose, fat, is an abundant and reliable source of regenerative cells. Autologous cells from a person’s own fat are easy to harvest safely under local anesthesia and are abundant in quantity.

Clinical success and favorable outcomes appear to be related directly to the quantity of regenerative cells deployed. Once these adipose derived stem cells are administered back in to the patient, they have the potential to repair human tissue by influencing healing and also forming new cells of mesenchymal origin, such as cartilage, bone, ligaments, tendons, nerve, fat, muscle and blood vessels. Stem cells’ ability to form cartilage and bone makes them potentially highly effective in the treatment of degenerative orthopedic conditions. Their ability to form new blood vessels and other tissues makes them suitable for mitigating a large number of traumatic and degenerative conditions.

We have initial evidence that cell therapy is effective in healing and regeneration. The bodies regenerative cells seek out damaged tissues in order to repair the body naturally. The literature and internet is full of successful testimonials but we are still awaiting definitive studies demonstrating efficacy of cell therapy. Such data may take five or ten years to accumulate. In an effort to provide relief for patients suffering from certain degenerative diseases that have been resistant to common modalities of treatment, we have initiated pilot studies as investigational tests of treatment effectiveness with very high numbers of adipose derived stem cells obtained from fat.

Current cell harvesting and isolation techniques are based on technologies originally from Switzerland and South Korea. These technological breakthroughs allows patients to safely receive their own autologous regenerative cells in extremely large quantities. The treatments and research is patient funded and we have endeavored successfully to make it affordable. All of our sterile procedures are non-invasive and done under local anesthesia. Patients who are looking for non-surgical alternatives to their degenerative disorders can participate in our trials by filling out our treatment application to determine if they are candidates.

The Bellevue Pain Institute continues to be state of the art in the new field of Regenerative Medicine and conservative Physical Medicine.

 

What is IRB?

IRB stands for Institutional Review Board, also known as an independent ethics committee (IEC), ethical review board (ERB), or research ethics board (REB), is a type of committee used in research in the United States that has been formally designated to approve, monitor, and review biomedical and behavioral research.  This is a process unique to medicine whereby specific protocols, procedures and records of results must be followed, data collected and reviewed by a board of specialist for legitimacy.  The stem cell IRB that BPI is a member of is governed by the branch of the US government known as Health and Human Services (HHS).

 

What is Non-Embryonic Adult Stem Cells?

Adult (not from embryonic source) 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.

 

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 the tools of regenerative medicine?

Traditionally, various medications and hormones have been used to limit disease and help the body repair itself. For example, hormone replacement therapy has shown the ability to more optimally help the immune system and thus help us repair diseased or injured tissues. Genetic research is an evolving area where we will eventually learn and utilize more ways of specifically dealing with gene defects causing degenerative disease. Cell therapy has already shown considerable promise in treating many degenerative conditions. Regenerative cells communicate with our tissues and with each other through a complex system of protein signaling molecules called cytokines or “growth factors.” There are thousands of growth factors and some FDA approved and clinically available such as AQ topical growth factors that are useful for a number of cosmetic and therapeutic purposes. The science of using growth factors is evolving and represents the next main area of growth in regenerative medicine.

 

What is a stem cell?

A stem cell is basically any cell that can replicate and differentiate. This means the cell can only 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, there has been considerable controversy surrounding their use. Also, 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.

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. 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 and because they are low in numbers, they are usually cultured in order to multiply their numbers for future use. Fat is 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.

 

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.

 

What problems can be treated?

This will depend on the type of degenerative condition you have. Our specialists will evaluate you and discuss whether you’re a potential candidate for cell therapy. If after you’ve been recommended for treatment, had an opportunity to understand the potential risks and benefits, and decided on your own that you would like to explore this avenue of treatment, then you can be considered for treatment. Even though this is considered minimally invasive, our doctors will still need to medically clear you for the procedure.

 

Is our 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.

 

Does BPI use any embryonic stem cells?

No. Embryonic stem cells are associated with ethical considerations and limitations.

 

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.

 

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.

 

Can stem cells treat cancer?

Stem cells have played an important role in cancer therapy for five decades. Hematopoetic 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. 

 

Are there reports of autologous adipose derived adult mesenchymal stem cells harming any humans or animals?

All of our outcomes are tracked for 24+ months and we have had extraordinary safety since the network started treating patients in 2010. All of our patients are entered into a database to follow and report even minor adverse reactions. This information is vital to the development of cell science. There have been no reports of serious complications from associated with our technologies.

 

What claims are currently made by BPI about what stem cell therapy can do for you?

None. Our aim is to make cell based medicine available to patients who are interested and to provide ongoing research data under approved Institutional Review Board (IRB) validated studies. We will follow our regenerative cell therapy patients over their lifetimes. This will enable us to accumulate significant data about the various degenerative diseases we treat. Instead of providing simply anecdotal or testimonial information, our goal is to categorize the various conditions and follow the patient’s progress through various objective (e.g. x-ray evidence or video displays) and subjective (e.g. patient and/or doctor surveys) criteria. We are aware of a lot of stories about marked improvement of a variety of conditions, but we make no claims about the intended treatment. Preliminary safety data has been submitted to the FDA as part of an approval application, which is under consideration. Still, these are your own cells and not “medicines” for sale. They are only being used in your own body. Most likely, no claim needs to be made; rather a statistical analysis of our findings would suffice to suggest whether treatments are truly and significantly effective.

 

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.

 

Who decides who is eligible?

The team approach at BPI will make a determination based on your history and exam, studies, and current research findings. The final sign off will be the responsibility of the medical officer provider performing the procedure.

 

Does a candidate have to participate in research to receive treatment at BPI?

YES.  Participation in our IRB protocols is mandatory however there are no incentives, financial or otherwise, to induce patients to enroll in our studies. Each and every case is covered by a 3 million dollar insurance policy to insure your safety and protection, failure to participate in the research would void the insurance policy and BPI would not perform the procedure.  BPI is dedicated to clinical research for the development of stem cell science. BPI is taking an active role in cutting edge clinical research in the new field of regenerative medicine. Research studies will be explained and privacy will be maintained. An Institutional Review Board will regulate formal future research studies, which is an authorized agency that promotes validity, transparency and protection of human study enrollees.

 

What are some diseases that BPI is definitely not treating at this time?

No psychiatric conditions are currently included in our IRB protocols.

 

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.

 

What does the cost of procedure include?

Because of recent innovations in technology, BPI is able to provide outpatient cell treatment at a fraction of the cost of that seen in many overseas clinics. Our fee covers harvesting, preparation, and deployment,

 

How many injections are required for success?

This is determined on a case-by-case basis and full treatment disclosure will be completed prior of scheduling of the procedures.  We have had as few as one and as many as 27 separate injections on one patient on one procedure day, this is entirely based upon the individual needs and condition. There is no increase in cost for multiple site injections.