For the investigational use of Adipose Derived
Stem Cells (ADSC's) for clinical research and deployment.
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faq's
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The OC Advanced Stem Cell Treatment Center uses adipose- ( fat) derived stem cells for deployment and clinical research. Early stem cell research was 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. Most stem cell treatment centers in the world are currently using stem cells derived from bone marrow.
A recent technological breakthrough enables us to now use adipose-derived stem cells. Autologous stem cells from a person’s own fat are easy to harvest safely under local anesthesia and are thousands of times more abundant than 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 into the patient, they have the potential to repair human tissue by 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 these cell types makes them potentially highly effective in the treatment of musculoskeletal, neurological, cardiovascular, pulmonary, and other conditions, and they are used extensively in Europe and Asia to treat a broad range of disorders.
We have anecdotal and experimental evidence that stem cell therapy is effective in healing and regeneration. Stem cells seek out damaged tissues in order to repair the body naturally. There are many successful testimonials as to their benefits, but we are still awaiting definitive studies demonstrating efficacy of stem cell therapy. Such data may take five to 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 are initiating pilot studies as experimental tests of treatment effectiveness with very high numbers of adipose-derived stem cells obtained from fat. Adipose fat is an abundant and reliable source of stem cells.
The OC Advanced Stem Cell Treatment Center’s cell harvesting and isolation techniques are based on technology from Korea. This new technological breakthrough allows patients to safely receive their own autologous stem cells in extremely large quantities. Our treatments and research are patient funded, and we have endeavored to make it affordable. All our sterile procedures are noninvasive 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. OC Advanced Stem Cell Treatment Center is proud to be state of the art in the new field of Regenerative Medicine. RETURN TO THE TOP
Non-embryonic adult stem cells
Adult (non-embryonic) 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. Once there, they are capable of regenerating healthy cells and accelerating the natural healing process. As we gain a deeper understanding of adult stem cells’ 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 conditions to repair and regenerate acute and chronically damaged tissues in humans and animals.
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 neurological diseases, renal failure, erectile dysfunction, degenerative orthopedic problems, and 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, degeneration, or congenital defects. This field holds the promise of regenerating damaged tissues and organs in the body by stimulating previously irreparable organs to heal themselves.
What are the tools of regenerative medicine?
Medicine has used various medications, hormones, vitamins, minerals, and other therapies to limit disease and help the body repair itself. For example, hormone replacement therapy has a demonstrated ability to increase bone and muscle mass, normalize metabolism, and improve mood and sense of well-being. Genetic research is an advancing field that will eventually provide more methods for dealing with specific gene defects that cause degenerative disease.
Stem cell therapy is another rapidly evolving and exciting area that has already shown considerable promise in treating many degenerative conditions.
What is a stem cell?
A stem cell is basically any cell that can replicate and differentiate. This means the cell can not only multiply, but it can also turn into various tissue types. There are several kinds of stem cells.
Most people are most familiar with embryonic stem cells. These cells from the embryonic stage of development are “pluripotent” because they have yet to differentiate and can change into any body part. Because they are taken from unborn or unwanted embryos, there has been considerable controversy surrounding their use. Furthermore, while they have shown promise in some areas of medicine, they have also been associated with occasional tumor (teratoma) formation. Work is being conducted by several companies, most of them outside the United States, to isolate particular lines of embryonic stem cells for future use.
Another kind of stem cells are adult stem cells, which resides in different tissues in the body. In recent years, much work has been done on bone marrow-derived stem cells. Also known as “mesenchymal stem cells” because they come from the mesodermal areas of the body, they can differentiate into mesodermal cell types such as bone, cartilage, fat, connective tissue, blood vessels, muscles, and nerves. Because bone marrow stem cells are low in numbers, they are usually cultured after extraction in order to multiply their numbers for therapeutic use.
As it turns out, fat is also loaded with mesenchymal stem cells. In fact, it has hundreds if not thousands of times more stem cells than bone marrow–and they are easier to exact. Because most people have adequate fat supplies and the numbers of stem cells are so great–plus we have tools that allow us to separate the stem cells from fat–there is no need to culture the cells over a period of days, so they can be used right away.
How do adult stem cells heal?
Adipose-derived adult stem cells are known as “progenitor” cells. This means they remain dormant (do nothing) until they are signaled by tissue damage. That’s when they get to work. They home in on areas of injury or degeneration and turn on the healing process. They may simply change into the cell type the damaged area needs for repair, and they also appear to reduce inflammation and signal growth factors and other mechanisms of tissue regeneration. Suffice it to say that there are multiple animal models and a plethora of human evidence indicating significant reparative effects of adult stem cells.
What diseases and problems can be treated?
Clinicians and researchers have used adult stem cells to treat a wide variety of health challenges. To determine if you are an appropriate candidate, the physician at the OC Advanced Stem Cell Treatment Center will evaluate you and discuss whether stem cell therapy is right for you. 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. Of course, even though it’s a minimally invasive procedure, you will still need to be medically cleared for the procedure.
Is our procedure FDA-approved?
No. However, the OC Advanced Stem Cell Treatment Center’s 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. The OC Advanced Stem Cell Treatment Center follows these guidelines by providing same-day treatment with the patient’s own cells, which undergo minimal manipulation and are redeployed during the same procedure.
Does the OC Advanced Stem Cell Treatment Center use any embryonic stem cells?
No. Only adult mesenchymal adipose-derived stem cells are used. These cells are capable of forming bone, cartilage, fat, muscle, ligaments, blood vessels, and certain other cell types. Embryonic stem cells are associated with ethical considerations and limitations.
Why does the OC Advanced Stem Cell Treatment Center take a multi-modality treatment approach to regenerative medicine?
Patients suffer from many varieties, combinations, and degrees of degenerative illnesses, and they respond differently to various treatment modalities. Therefore, we work to coordinate and provide therapy not only with your own stem cells, but also through other avenues of regenerative medicine. This could include hormone replacement therapy, lifestyle changes, nutritional therapies, or other noninvasive treatments, as deemed appropriate by your physician.
For example, if you have a knee problem, you may also be recommended for further evaluation for an exercise program, targeted nutritional supplements, and therapies such as ultraviolet light, microcurrent, and acupuncture. Nonetheless, we believe stem cell therapy to be the likely foundation of regenerative treatment. It should also be noted, that stem cell treatment is currently in the investigational stage. While we recognize our patients are seeking improvement in their condition through this therapy, each procedure is part of an ongoing investigation to establish optimal parameters for treatment, evaluate effectiveness, and monitor adverse effects, if any. 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 an Institutional Review Board may be presented to the FDA for consideration of making an actual claim.
What other types of treatments are recommended at the OC Advanced Stem Cell Treatment Center?
Instruction in diet changes, exercise programs, personalized nutritional supplement programs, and a wide variety of noninvasive rejuvenative treatments may be recommended at the OC Advanced Stem Cell Treatment Center, depending on each patient’s individual condition and personal desires.
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 seen 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. The OC Advanced Stem Cell Treatment Center gives a choice to informed patients who seek modern regenerative therapy but desire convenience, quality, and affordability. The OC Advanced Stem Cell Treatment Center fills a need for those patients who have been told they would have to travel to different countries and pay as much as $21,000 to $100,000 for stem cell treatments offshore.
Once a candidate is selected for treatment, how does the OC Advanced Stem Cell Treatment Center obtain a person’s stem cells?
Stem cells are harvested and deployed during the same procedure, which takes less than three hours. Our patients first undergo a minimally invasive liposuction type of harvesting procedure by the physician in our specialized, fully accredited treatment facility in San Clemente, California. The harvesting procedure generally lasts about 20 minutes and can be done under local anesthesia. Cells are then processed and are ready for deployment within 90 minutes or less. At that time, they are returned to the patient’s body via injection and/or intravenous infusion.
Why does the OC Advanced Stem Cell Treatment Center use patients’ own fat rather than bone marrow as a source of stem cells?
Removing stem cells from bone marrow is a somewhat uncomfortable procedure that yields approximately 5,000 – 60,000 cells. These cells are then cultured over several days to increase their numbers to perhaps a few million prior to deployment (injection or IV) into the patient. Recent advances in stem cell science have made it possible to obtain high numbers of very high quality pluripotent cells (able to form into numerous cell types) from a person’s own fat, which is removed by liposuction. The OC Advanced Stem Cell Treatment Center uses technology acquired from Asia to process this fat, which yields millions of stem cells per cc of fat. Therefore, it is possible to obtain and deploy several million cells in a single treatment. These-adipose derived stem cells can form many different types of cells when deployed properly, including bone, cartilage, connective tissue, muscle, blood vessels, nerves, and others.
Is there an advantage to using stem cells from fat versus bone marrow?
Whether your adult mesenchymal stem cells come from bone marrow or from fat probably does not make a difference in terms of clinical results. Although some centers claim that bone marrow-derived cells are superior to fat-derived cells, there is no evidence to substantiate that. The fact that there are many more studies on bone marrow cells does not prove clinical superiority but merely supports the obvious fact that fat-derived cells are based on more recent discoveries, and although evidence is accumulating, there are far fewer studies using these cells. It is important understand that although “bone marrow” may suggest that this source is superior for treating orthopedic conditions such as cartilage degeneration, this is not the case.
All types of adult mesenchymal stem cells have the potential to differentiate into various mature functional tissues. For many conditions, including cardiovascular disorders, adipose-derived cells appear to be superior to bone marrow-derived cells. This may be related to the well-documented decline in quantity and quality of bone marrow-derived stem cell, related to age and chronic illness. Such changes in number and viability have not been seen in fat-derived stem cells.
How is the fat obtained?
OC Advanced Stem Cell Treatment Center patients have their fat harvested, usually from the abdominal area, in our special, sterile, accredited treatment facility under a local anesthetic. The fat removal procedure lasts approximately 20 minutes. Specially designed equipment is used to harvest the fat cells, and less than 100 cc of fat is required. Post-operative discomfort is minimal, as are recovery time and restrictions on activities.
How does the OC Advanced Stem Cell Treatment Center control sterility in the processing of the stem cells?
Stem cells are harvested under sterile conditions using a special “closed system” technology so the cells never come into contact with the environment throughout the entire process, from removal to deployment. Advanced sterile techniques are also used to prevent infection.
Does the OC Advanced Stem Cell Treatment Center 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 zero risk of contamination or 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, where they are available only in relatively small quantities. They are then required to culture, or grow, the cells in order to obtain adequate quantities for therapeutic purposes. Research appears to indicate that success of treatment is directly related to the quantity of cells injected. The OC Advanced Stem Cell Treatment Center uses adipose-derived stem cells, which are approximately 2,500 times more abundant than those found in bone marrow. Our Center 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 90 minutes of harvesting.
Can stem cells treat cancer?
No. Many are confused by this because they have heard of cancer patients receiving “stem cell transplants.” These patients had ablative bone marrow therapy and need stem cells to repopulate their bone marrow and blood. This is different from the stem cells we deploy to treat noncancerous human diseases at the OC Advanced Stem Cell Treatment Center.
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 probably 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.
What about patients with a history of cancer?
Stem cell therapy is thought to be safe and to have no effect on dormant cancers. If a patient has had cancer that was treated and responded successfully, there is no reason to withhold stem cell deployment. In most cases, stem cells should not be used in patients with active cancer.
Are there reports of autologous adipose-derived adult mesenchymal stem cells harming any humans or animals?
We know of no documented cases personally or in the literature that have resulted in serious harm. All our patients will be entered into a database to follow and report any adverse reactions. This information is vital to the development of stem cell science. There have been a few reports of serious complications from overseas, and these are being thoroughly evaluated by epidemiologists to ascertain the facts. The International Cell Surgical Society (ICSS) has more than 1,000 cases currently, and only two percent of the treatments were associated with any complications, none of which were considered “serious adverse events.”
What claims are currently made by the OC Advanced Stem Cell Treatment Center 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 simply providing anecdotal or testimonial information, our goal is to categorize the various conditions and follow patients’ progress through various objective (e.g., X-rays or lab tests) and subjective (patient and/or doctor surveys) criteria.
We are aware of stories about marked improvements in a variety of conditions, but we make no claims about the treatment. Once adequate amounts of data are accumulated, it might be appropriate to submit the information to the FDA, at which point actual claims may be substantiated and recognized. In any case, statistical analysis of our findings would suffice to suggest whether treatments are truly and significantly effective. We also hope to submit our patients’ data to an approved International Cell Surgical Society (ICSS) , further fostering large collections of data to help identify both positive and negative trends.
Some stem cell treatment centers make extraordinary claims about their success in the treatment of various problems. Why doesn’t the OC Advanced Stem Cell Treatment Center?
The OC Advanced Stem Cell Treatment Center is participating in pioneering research and treatment of many health challenges. All investigational data is being collected so results will be compiled, analyzed, and published in peer-review medical literature to ultimately promote the advancement of cellular-based regenerative medicine. FDA regulations mandate that no advertising of medical claims be made and that website testimonials are prohibited.
Are any biological agents added to the stem cells such as medications or mixtures containing platelet rich plasma?
The OC Advanced Stem Cell Treatment Center does not add any drugs or foreign substances to the stem cells. However, in reviewing outcomes data, some conditions, including orthopedic injuries and degeneration, appear to respond better to stem cells that are super-enriched with growth factors such as those from platelet rich plasma. Therefore, in some cases administering autologous platelet rich plasma–derived from the patients’s own blood, obtained and deployed during the same procedure–may be indicated.
How are the cells deployed into a patient?
Depending on the type of treatment required, stem cells can be injected through veins, arteries, into spinal fluid, subcutaneously, or directly into joints or organs. All of these are considered minimally invasive methods of introducing the stem cells. At the OC Advanced Stem Cell Treatment Center, stem cells are most often injected intravenously. That’s because they are known to seek out and find areas of tissue damage and migrate to those location, thus potentially providing regenerative healing. Intravenously infused stem cells have been shown to have the capability of crossing the blood-brain barrier to enter the central nervous system, and they can be identified in the patient’s body many months after deployment.
Can I be expected to improve after stem cell treatment at the OC Advanced Stem Cell Treatment Center?
Different conditions are treated in different ways, and there are different degrees of success. If the goal is regeneration of joint cartilage, you may not see expected results until several months after treatment. Some patients may not experience significant improvement while others may see dramatic regeneration of damaged tissue or resolution of disease. Many of the disorders and problems that the physicians at the OC Advanced Stem Cell Treatment Center are treating represent pioneering work, so there is a lack of conclusive data. FDA regulations prevent the OC Advanced Stem Cell Treatment Center from making any claims about expectations for success. However, if you are deemed appropriate 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 conditions, more immediate responses are possible.
Is everyone a candidate?
No. Only certain medical problems are currently being treated at the OC Advanced Stem Cell Treatment Center. Check our list on this website. All patients need to be medically stable 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 protocols.
Are any patients automatically excluded?
Patients with active, uncontrolled cancer are excluded. If you have an active infection anywhere in your body, you must be treated first. Severely ill patients may require special consideration. Also, anyone with a bleeding disorder or who takes blood-thinning medications requires special evaluation before consideration for treatment.
Who decides who is eligible?
The physician at the OC Advanced Stem Cell Treatment Center will make a determination based on your history and exam, studies, and current research findings. Occasionally, we may also seek opinions from other experts.
Does a candidate have to participate in research to receive treatment at the OC Advanced Stem Cell Treatment Center?
No. Participation in any of our protocols is not mandatory, and there are no incentives, financial or otherwise, to induce patients to enroll in our studies. However, the OC Advanced Stem Cell Treatment Center is dedicated to clinical research for the development of stem cell science. Our Center 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. Formal future research studies will be regulated by an Institutional Review Board, which is an authorized agency that promotes validity, transparency, and protection of human study enrollees.
What are some diseases that the OC Advanced Stem Cell Treatment Center is definitely not treating at this time?
At this time, we are not treating autism, spinal cord injuries, and some advanced diseases.
What are the costs of consultation and treatment?
Patients who are considered to be candidates will be invited for a physician consultation. A non-refundable fee is charged for this consultation, which includes office evaluation and/or physician review of X-rays, medical records, and telephone consultations. The OC Advanced Stem Cell Treatment Center will apply this towards the cost of the procedure. Unfortunately, insurance generally will not in most cases cover the actual cost of stem cell treatment since it is still considered experimental. The cost varies depending on the condition being treated and which type of stem cell deployment is required. Financing is available through a credit vendor.
What does the cost of procedure include?
Because of recent innovations in technology, the OC Advanced Stem Cell Treatment Center is able to provide outpatient stem cell treatment at a fraction of the cost of that seen in many overseas clinics. The fee covers fat cell harvesting, cell preparation, and stem cell deployment.
Can extra stem cells be saved for future use should an immediate need arise?
Stem cells can be cryopreserved in the form of liposuction fat for prolonged periods of time. Currently, we are able to send your cells to a company with a great reputation for excellent quality control. Many patients have been inquiring about banking cells while they are still young, since stem cell numbers drop naturally with each decade of life and some advocate obtaining and saving cells to be used later as needed.
How many treatments are required?
Most patients, especially those with orthopedic conditions, require only one treatment. Certain types of degenerative conditions, particularly autoimmune disorders, may respond best to a series of stem cell deployments. The number and necessity of any additional treatments would be decided on a case-by-case basis.
Where can I get more information on stem cells?
A good resource is the International Cell Surgical Society (ICSS) . Stem Cells 101