AmpliCell serves patients and doctors throughout the LA and Orange county area. Our goal is to accelerate and enhance medical research, from basic discovery to improved patient care. If you would like to learn more about uses adipose derived stem cells for deployment & clinical research, please browse our frequently-asked questions listed below
 

1.
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 themselves.
2.
What are the tools of regenerative medicine?
     We have used various medications and hormones 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 injured tissues and reduce inflammation. 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.”
3.
What diseases and problems can be treated?
     This will depend on the type of degenerative condition you have. A specialist 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.
4.
Is our procedure FDA-approved?
    NO. However, the AmpliCell (Cell Surgical Network affiliate) 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 AmpliCell we meet these guidelines by providing same day treatment with the patient’s own cells that undergo no manipulation and are inserted during the same procedure.
5.
Does AmpliCell 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.
6.
What types of specialties are represented at AmpliCell?
     A wide range of medical specialties is represented including allergy and immunology, dermatology, cosmetic surgery, 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.
7.
Why does AmpliCell 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 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. Amplicell uses technology acquired from Asia 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.
8.
How is the fat obtained?
     AmpliCell patients have their fat (usually from lower back "love-handles" area) harvested in our special sterile harvesting technology under a local anesthetic. The “mini liposuction” fat removal procedure lasts approximately twenty 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.

9.
How does AmpliCell 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 oral antibiotics are also used to prevent infection.

10.
Does AmpliCell 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.
11.
Some stem cell treatment centers make extraordinary claims about their success in the treatment of various problems. Why doesn’t AmpliCell?
     AmpliCell and Cell Surgical Network are doing 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.
12.
Can stem cells treat cancer?
     New advances in cancer therapy have exploited 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. Cell Surgical Network is involved in cutting edge clinical trials using stem cells to carry cancer-killing biologic agents deep into cancer tissue that has not responded to conventional therapy. For more information on this study, call 800-231-0407
13.
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.
14.
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. In most cases, stem cells should not be used in patients with known active cancer outside of an active protocol (see “Can stem cells treat cancer”)
15.
Are there reports of autologous adipose derived adult mesenchymal stem cells harming any humans?
     AmpliCell follows all our outcomes and any adverse events and we have had extraordinary safety since we 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 a few reports of serious complications from associated with other technologies. 
16.
What claims are currently made by AmpliCell and CSN 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.

17.
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 (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 AmpliCell we do not add any foreign substances or medications to the stem cells.
18.
Can I be expected to improve after stem cell treatment at AmpliCell?
     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 the physicians at AmpliCell are treating represent pioneering work and there is a lack of data. FDA regulations prevent AmpliCell 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.
19.
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.
20.
Is everyone a candidate?
     No. Only certain medical problems are currently being treated at AmpliCell. Check our list or fill out a candidate application form on the website. All patients need to be medically stable enough to have the treatment in our facility. There may be some exceptional conditions that may eventually be treated in hospitalized patients, but that remains for the future. 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. A waiting list or outside referral (if we know of someone else treating such a problem) might be applicable in such cases.
21.
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
22.
Who decides who is eligible?
     The board certified specialist seeing you at AmpliCell will make a determination based on your history and exam, studies, and current research findings. Any complex cases may be reviewed by CSN ethics advisory committee. Occasionally, we may seek opinions from thought leaders around the world.
23.
Does a candidate have to participate in research to receive treatment at AmpliCell?
     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, AmpliCell, a CSN affiliate, is dedicated to clinical research for the development of stem cell science. AmpliCell and CSN are 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.

24.
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 fee in some cases. 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 which type of stem cell deployment is required. 
25.
What does the cost of procedure include?
     Because of recent innovations in technology, AmpliCell is able to provide outpatient stem cell treatment at a fraction of the cost of that seen in many overseas clinics. Our fees 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.
26.
How many treatments are required for success?
     Most patients, especially those with orthopedic conditions, require only one deployment. Certain types of degenerative conditions, particularly auto-immune disease, 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. Financial consideration is given in these instances.
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