FREQUENTLY ASKED QUESTIONS
What is Stem Cell Therapy?
The main function of stem cells is to maintain and repair tissue. Stem cell therapy enhances this natural function by isolating a large number of highly active stem cells which are directed to an area of need within the body.
How is Stem Cell Therapy performed?
Our outpatient procedures utilize a process in which we isolate a patient’s own stem cells from their adipose or fat tissue. Patients receive a tumescent mini-liposuction procedure under local anesthetic. During the procedure, approximately 60-120 cc’s of fat will be removed. The fat will be broken down through enzymatic digestion followed by a centrifugation process allowing the stem cells to be released. Immediately after processing, stem cells are delivered back to the same patient. The cells may be delivered as a peripheral or vertebral joint injection, intravenously, intrathecally, subcutaneously or intramuscularly.
The entire process typically takes 1.5-2 hours.
Is this procedure FDA compliant?
Yes it is; our procedure falls under the category of physician’s practice of medicine, wherein the physician and patient are free to consider their chosen course of treatment. Our procedure is FDA compliant with the FDA Code of Federal Regulations Title 21 Part 1271. We meet the FDA regulations by providing a same-day procedure done entirely in a medical office with a patient’s own cells, which are then immediately delivered back to that patient.
1271.15(b) of the FDA Code of Federal Regulations states:
“You are not required to comply with the requirements of this part 1271 if you are an establishment that removes HCT/P’s from an individual and implants such HCT/P’s into the same individual during the same surgical procedure.”
How different are stem cell offerings?
Tremendous differences exist. Many clinicians offering “stem cell treatments” are not providing any live stem cells at all!!! This is especially common among placental and amniotic products which according to FDA regulations are not permitted to contain live stem cells due to processing requirements. Assuming the provider is capable of administering live stem cells, Patients should understand how many live stem cells they are likely to receive. The number of cells can vary from less than 100 cells per CC of fat to over 1 million cells per CC of fat. Since the stem cells are responsible for regeneration, the more cells, the better. Our procedures utilize the world class science, methodologies and products. While this doesn’t guaranty optimal results; it certainly enhances the likelihood.
When should patients expect to see results?
It is important to note that we are treating patients with their own adult stem cells; therefore each treatment and response is unique to that patient. As with any medical treatment, no guarantee can be made of precisely what results will be achieved or how soon results can be realized. However, many patients report that they begin to experience results within 4 to 8 weeks. In cases where the condition being treated is more severe, the patient may notice results over a longer time frame, and in some cases may extend to a 6-9 month time frame. It’s not unusual for incremental benefits to extend up to 12 months after initial treatment. Many conditions may require successive treatments depending upon the condition, severity and clinical response; each patient is treated individually with a customized treatment plan.
Does health insurance cover the cost of this procedure?
No, health insurance in the U.S. does not currently cover costs associated with any Stem Cell procedure.
What is the cost?
The cost of autologous stem cell therapy will vary with different types of procedures.
However, pricing is designed to be both fair and competitive with those few providers offering highest quality, state-of-the-art autologous stem cell therapy.
Are there any payment options offered to patients?
Yes, there are many options. These may include interest free loans and repayment terms up to 5 years, depending on credit score, etc.
Are there any moral or ethical issues regarding these treatments?
No. Our Stem Cell procedures use a patient’s own stem cells derived from his or her own fat tissue. We do not perform any procedures or undertake any research using embryonic stem cells.
Is the procedure safe?
Yes. It’s extremely safe and has a superb safety profile. The most common side effect occurs about 3% of the time and is limited to pain or swelling at the injection site.
Does ASC provide patient education, continuity of care and a patient advocate?
Yes. A certified nurse educator is available from beginning to conclusion of treatment. They’re available to educate and answer any questions posed by patients, HCP’s or other authorized parties and they are on call 24 hours per day and 7 days/week.
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