What is Our Technology ?

The Bellevue Pain Institute is a member of the Cell Surgical Network which has used adipose derived stem cells for deployment & clinical research for 9 years and many 1000’s of patients. 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 shifting its focus from bone marrow based cells to adipose (fat) derived cells since the cells are easy to obtain and generally very robust. Adipose fat is an abundant and reliable source of stem cells. The best quality adipose cells are derived from the enzymatic digestion of liposuctioned fat which can be performed at the bedside in an essentially closed system to protect sterility. Autologous stem cells from a person’s own fat are easy to harvest safely under local anesthesia and are abundant in quantities up to 500 times those seen in bone marrow.

Clinical success and favorable outcomes appear to be related directly to the quantity of stem 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, blood vessels, and certain internal organs. 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 stem cell therapy is effective in healing and regeneration. Stem 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 stem 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.

The Bellevue Pain Institute’s cell harvesting and isolation techniques are based on technology from South Korea. This technological breakthrough allows patients to safely receive their own autologous stem cells in extremely large quantities. Our 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 approved through Cell Surgical Provider Network, credentialed through the International Cellular Surgeons Society (ICSS) and governed by the branch of the US government known as Health and Human Services (HHS).

 

What is Cell Banking?

Cryo-preservation and banking of adipose derived stem cells is possible and can be performed at the same time as your SVF deployment procedure. Our technology partner is US Stem Cell.  Autologous lipo-aspirate can be frozen as SVF Stromal Vascular Fraction (contains mesenchymal and hematopoetic stem cells). SVF can be deployed for repeated treatments and also expanded under Intuitional Review Board (IRB) approval as part of a safety trial providing vast quantities of autologous stem cells that could be used throughout that patient’s life. This will provide patients with their own personal stem cell line that could be used “on demand” for everything from treating stroke, heart attack, serious accident, or even cancer therapy should the need arise. Cell banking and culture expansion is vital since many of the conditions we treat such as neuro-degenerative disorders and auto-immune conditions often require repeat deployments and using banked autologous cells allows this to be done in a convenient and cost effective manner.

 

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 medical function and apply this knowledge, we are realizing their 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. Other sources of stem cells such as “amniotic” products which are commercially available are not from one’s own body and these cells are gamma radiated by the manufacturer and therefore are not live cells. If you have been offered amniotic cells from some source, one should be aware of this fact. 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. Many reputable international centers have been using stem cell therapy to treat various chronic degenerative conditions as diverse as severe neurologic diseases, renal failure, erectile dysfunction, degenerative orthopedic problems, and even cardiac and pulmonary diseases to name a few. 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. Stem cell therapy has already shown considerable promise in treating many degenerative conditions. Stem 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 with stem cells 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 thousands of times more stem cells compared to bone marrow. We now have technology and tools that separate the stem cells from fat. 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 stem 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?

  1. However, the 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 by providing same day treatment with the patient’s own cells that undergo minimal manipulation and are re-deployed during the same day of procedure.

 

Does BPI use any embryonic stem cells?

No. Only adult mesenchymal stem cells are used. These cells are capable of forming bone, cartilage, fat, muscle, ligaments, blood vessels, and certain organs. 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, through the BPI affiliation with Cell Surgical Network, we work to coordinate and provide therapy – mainly with your own stem cells, but also through other avenues of regenerative medicine. This could include 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 through stem cell therapy, each treatment 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.

 

What types of specialties are represented at BPI?

A wide range of medical specialties is represented throughout Cell Surgical network including urology, cosmetic surgery, ear, nose, & throat, sports medicine, functional medicine, orthopedics, internal medicine and cardiology to name a few. Our Network continues to grow and add experts from various other fields. The Bellevue Pain Institute, as an affiliate of Cell Surgical Network, is among the first of the multispecialty stem cell centers in the United States.

 

Why do patients request stem 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 about stem cells in the literature and on various websites. Many have read about the results of stem 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 stem cell treatments off shore.

 

Once a candidate is selected for treatment, how does BPI obtain a person’s stem cells?

Stem cells are harvested and deployed during the same procedure. Our patients undergo a minimally invasive liposuction type of harvesting procedure by a specialist in our customized treatment facility. The harvesting procedure generally lasts about 20-40 minutes and is done under local anesthesia. SVF Stromal Vascular Fraction, which contains mesenchymal stem cells and growth factors, is then processed from 2-8 ounces of fat using a closed sterile system to avoid contact with the environment. SVF is ready for deployment in less than 3 hours.

 

Why does BPI use liposuction fat rather than bone marrow as a source of stem cells?

Bone marrow sampling (an uncomfortable procedure) yields approximately 5,000 – 60,000 cells that are then cultured over several days to perhaps a few million cells prior to deployment (injection into the patient). Recent advances in stem cell science have made it possible to obtain high numbers of very excellent quality multi-potent (able to form numerous other tissues) cells from a person’s own liposuction fat. BPI uses technology to process this fat to yield approximately five hundred thousand to one million stem cells per cc of fat, and therefore, it is possible to obtain as many as 10 to 40 million cells from a single treatment. These adipose derived stem cells can form many different types of cells when deployed properly including bone, cartilage, tendon (connective tissue), muscle, blood vessels, nerve tissue and others.

 

How is the fat obtained?

BPI patients have their fat (usually abdominal or lateral back) harvested in our special sterile harvesting technology under a local anesthetic. The “mini liposuction” fat removal procedure lasts approximately 20-40 minutes. Specially designed equipment is used to harvest the fat cells and less than 10 ounces of fat is required. Post-operative discomfort is minimal and there is minimal restriction on activity.

 

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.

 

Why do some stem cell facilities around the world require days to weeks before removal of mesenchymal stem cells until reinsertion into the patient?

These facilities are obtaining stem cells from bone marrow or blood in relatively small quantities and they are then culturing (growing) the cells to create adequate quantities. Research seems to indicate that success of treatment is directly related to the quantity of cells injected. BPI uses adipose derived stem cells that are abundant naturally at approximately 500 times levels found in bone marrow (the most common source of mesenchymal stem cells). BPI uses technology that isolates adipose stem cells in vast numbers in a short time span so that prolonged culturing is unnecessary and cells can be deployed into a patient within  hours of harvesting.

 

Some stem cell treatment centers make extraordinary claims about their success in the treatment of various problems. Why doesn’t BPI?

BPI is participating within the Cell Surgical Network in doing the pioneer research and treatment of many diseases. 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 (similar to mesenchymal stem cells and also found in stromal vascular fraction) 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 therapy using stem cells 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 cancer therapy.

 

Can stem cells cause cancer?

Adult mesenchymal stem cells are not known to cause cancer. Some patients have heard of stories of cancer caused by stem cells, but these 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.  In nearly 10,000 cases within the Cell Surgical Network we have never had a single case of abnormal cell growth.

 

What about patients with known cancers?

Stem cell therapy is thought to be safe and not affect dormant cancers. If someone has had cancer that was treated and responded successfully, there is no reason to withhold stem cell deployment. At Bellevue Pain Institute ALL active cancer patients are NOT taken as candidates for the therapy.

 

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

Bellevue Pain Institute and the rest of the Cell Surgical Network follows all our outcomes and any adverse events 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 stem 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 stem cell treatment 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. We have submitted preliminary safety data 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.

 

Are any biological agents added to the stem cells such as medications or mixtures containing Plasma Enriched Platelets?

Our adipose derived stem cell harvesting and isolation technique yields extremely high numbers of stem cells. In reviewing outcomes data, treatment cell numbers appear to correlate with treatment success. Our cells are actually in a type of “soup” called Stromal Vascular Fraction SVF which is stem cells bathed in a rich mixture of natural growth factors this not the same as human growth factor hormone which is only one type of growth factor. Some types of orthopedic and urologic diseases appear to respond better to stem cells that are super enriched with growth factors created by administering Platelet Rich Plasma to the patient. Autologous Platelet Rich Plasma is derived from a patient’s own blood drawn at the time of deployment. At BPI we do not add any foreign substances or medications to the stem cells.

 

Can I be expected to improve after stem cell treatment at BPI?

Different conditions are treated in different ways and there are different degrees of success. If the goal is regeneration of joint cartilage, one may expect to notice results in just a few months after cell deployment treatment. Some patients may not experience significant improvement and others may see dramatic regeneration of damaged tissue or resolution of disease. FDA regulations prevent BPI from making any claims about expectations for success, however, if you are chosen for treatment, it will be explained that we believe stem cell therapy may be beneficial or in some cases that we are unsure and treatment would be considered investigational.

 

How long does it take to see improvement?

Stem 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 diseases, more immediate responses are possible.

 

Is everyone a candidate?

No. Only certain medical 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 stem cells.

 

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 provider performing the procedure. Our ethics advisory committee may review any complex cases.

 

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 generally will not cover the actual cost of stem cell treatment in most cases since stem cell therapy is still considered investigational the cost varies depending on the disease state being treated and complexity of stem cell deployment as well as the desire for Stem Cell banking.

 

What does the cost of procedure include?

Because of recent innovations in technology, BPI is able to provide outpatient stem cell treatment at a fraction of the cost of that seen in many overseas clinics. Our fee covers Stromal Vascular Fraction (SVF) harvesting, preparation, and deployment, which may include the use of advanced interventional radiology and fluoroscopy techniques. Total costs will be determined after a medical evaluation and will range from $5,000 to $25,000.

 

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.