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FREQUENTLY ASKED QUESTIONS
What is 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. 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 compared to bone marrow. Today, we actually have tools that allow us to separate the stem cells from fat. Because most people have adequate fat supplies and the numbers of stem cells are so great, there is no need to culture the cells over a period of days and they can be used right away. Also culturing and expanding stem cell is not currently allowed in the United States.
Adult (NonEmbryonic) 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. Many reputable international centers are not only currently doing stem cell clinical trials but they 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.
Does The iBody 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.
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, trauma or injury. This field holds the promise of regenerating damaged tissues and organs in the body by stimulating previously irreparable organs to heal themselves. (Wikipedia)
What are the tools of Regenerative Medicine?
For the last seven years The iBody has used bioidentical hormone pellet therapy and other holistic supplements and medications to limit disease and help the body repair itself. For example, hormone replacement therapy has, in many cases, shown the ability to more optimally help the immune system and thus help us repair diseased or injured tissues. Stem cell therapy is another rapidly evolving and exciting area that has already shown considerable promise in treating many degenerative conditions.
How do adult stem cells regenerate the body?
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 induces the repair by some other mechanism. Suffice it to say that there are multiple animal models and a plethora of human evidence that indicates these are significant reparative cells.
What diseases and problems can are currently being treated with stem cell at The iBody?
Degenerative diseases such as Osteoarthritis, Fibromyalgia, Rheumatoid Arthritis, Chronic Fatigue Syndrome, Asthma, Emphysema, Chronic Liver Disease, Type I Diabetes, and Crohn’s Disease. Stem cell is also currently being used for anti-aging purposes. Dr. Roberto Tostado 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. 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. The FDA approves drugs or medical devices. Medical treatment in a physicians office is not under FDA Regulation but under the supervision of the Medical Board. The iBody treatments and 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 The iBody we meet these guidelines by providing treatment with the patient’s own cells that undergo very minimal manipulation.
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, trauma or injury. This field holds the promise of regenerating damaged tissues and organs in the body by stimulating previously irreparable organs to heal themselves. (Wikipedia).
What types of specialty is represented at The iBody?
Dr. Roberto Tostado is Board Certified in Family Practice and American Academy of Aesthetic and Antiaging Medicine, Certified by the American Academy of Restorative Medicine and a Fellow of Metabolic and Nutrition Medicine.
Where did Dr. Tostado receive her Stem Cell training and Certification?
Dr. Tostado has been practicing medicine for the last 24 years and has received his training Stem Cell Harvesting and Isolation Techniques from US Stem Cell Institute in Florida. He also received smartlipo and body sculpting training and certification at The Keller Institute in Carmel, CA and has performed advanced body sculpting procedures for the last 12 years .
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. The iBody gives a choice to those informed patients who seek modern regenerative therapy but desire convenience, quality and affordability. The iBody fills a need for those patients who have been told that they have to travel to different countries and pay as much as twenty to one hundred thousand dollars for stem cell treatments off shore.
Once a candidate is selected for treatment, how does The iBody 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 fat harvesting procedure performed by Dr. Tostado. Dr. Tostado has undergone extensive training and certification in liposuction by Keller Institute and Dr. Robert Keller in Carmel, CA. The harvesting procedure generally lasts 30-60 minutes and can be done under local anesthesia. Other candidates may opt for the smartlipo body sculpting procedure to be performed after the fat is harvested to achieve desired body sculpting results.
Why does The iBody use liposuction fat rather than bone marrow as a source of stem cells?
Bone marrow sampling (a somewhat uncomfortable procedure) yields approximately 5,000 – 60,000 cells that are then cultured over several days to yield, 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 cells, which are able to form numerous other tissues from a person’s own liposuction fat.
The iBody uses state of the art stem cell technology to process this fat. Normally, the extraction of 100cc’s of fat will yield 50 million to 1 billion stem cells; therefore, it is possible to obtain enough fat from one liposuction procedure for more than one stem cell treatment. Surplus stem cell-rich fat can thus be safely banked with Celebration Stem Cell Bank, a premier cryobank.
How is the fat obtained?
The iBody patients have their fat (usually abdominal) harvested in our special sterile treatment facility under a local anesthetic. The fat removal procedure lasts approximately 30 minutes. Specially designed equipment is used to harvest the fat cells and less than 100cc of fat is required. Post-operative discomfort is minimal and there is minimal restriction on activity.
How does The iBody 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 and antibiotics are also used to prevent infection.
Does The iBody 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 their 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. The iBody uses adipose derived stem cells that are abundant naturally at approximately 2,500 times levels found in bone marrow (the most common source of mesenchymal stem cells). The iBody 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.
Some stem cell treatment centers make extraordinary claims about their success in the treatment of various problems. Why doesn’t The iBody?
FDA regulations mandate that no advertising medical claims be made. We carefully comply by the FDA’s rules and regulations as to what claims can or can’t be made at this time relevant to Stem Cell Therapy and current research.
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 re-populate their blood and marrow. This is different from the stem cells we deploy to treat noncancerous human diseases at The iBody.
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 where serious harm has resulted.
What claims are currently made by The iBody 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 follow-up with our patients as to their symptoms regarding a degenerative condition and their pain level after the stem cell treatment. We will follow-up with our stem cell patients progress through various means such as lab test, x-rays, CT scans and physical examinations. This will enable us to accumulate significant data about the various degenerative diseases we treat. 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
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. Stem cells injected intravenously are known to “seek out and find” areas of tissue damage and migrate to that location thus potentially providing regenerative healing. Intravenously injected 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 iBody?
Different conditions are treated in different ways and there are different degrees of success. If the goal is regeneration of joint cartilage, one may not see expected results until several months after treatment. Some patients may not experience significant improvement and others may see dramatic regeneration of damaged tissue or resolution of disease. Many of the disorders and problems that Dr. Roberto Tostado is treating represents pioneering work and there is a lack of conclusive medical data. FDA regulations prevent The iBody 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.
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 The iBody. All 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 benefit from stem cell treatment.
Are any patients automatically excluded?
Yes. Patients with 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 stem cells.
Who decides who is eligible?
Dr. Tostado will make a determination based on your history and exam, studies, and current research findings. Dr. Tostado has started treating only her existing patients. Most of these patients have been under her care for an extended period of time using bioidentical hormone pellet therapy, detoxification, nutritional supplementation and other antiaging therapies and protocols developed by Dr. Tostado.
What is the cost of consultation and treatment?
Patients who are considered to be candidates will be invited for a complimentary consultation with Dr. Roberto Tostado.
Will Medical Insurance Cover the Stem Cell Treatment?
Unfortunately, insurance generally will not cover the actual cost of stem cell treatment in most cases since stem cell therapy is still under clinical trials. The cost varies between $10,000.00- $15,000.00 depending on the disease state being treated and the number of treatments required.
What does the cost of procedure include?
The fee covers fat cell harvesting, cell preparation, and stem cell deployment which may include the use of advanced fluoroscopy technique. The fee also covers the follow-up visits with Dr. Sun (approximately 2 visits) 1-3 months apart.
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, this service is outsourced to Celebration, a provider known to have 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 in life as needed.
How many treatments are required?
Most patients, especially those with orthopedic conditions, require only one to two treatments. Certain types of degenerative conditions, particularly auto-immune disease, may respond best to a series of stem cell treatments. The number and necessity of any additional treatments would be decided on a case by case basis. Financial consideration is given in these instances.