Frequently asked questions
1. What diseases and problems can be treated with Stem cell therapy ?
Clinicians and researchers have used adult autologous adipose-derived stem cells (ADSC’s) to treat a wide variety of health challenges. To determine if you are an appropriate candidate, the medical team at Global StemGenn will evaluate you, review your medical records, 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, 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.
2. Is this procedure FDA approved?
No. The FDA approves drugs (medications) and devices (medical instrumentation). The FDA does not approve medical practices. The therapy at Global StemGenn falls under the category of a 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 and cellular interventions. Global StemGenn follows these FDA guidelines (autologous; homologous; minimal manipulation; same day procedure) by providing same-day treatment with the patient’s own cells, which undergo minimal manipulation and are redeployed during the same procedure.
3. Does your center use any embryonic stem cells?
No. Only adult mesenchymal adult autologous adipose bone marrow – derived stem cells (ADSC’s) 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 moral and ethical considerations and limitations – we do NOT use them.
4. Why does the Global StemGenn Therapy and Research 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. Additionally, most patients are burdened with multiple co-morbidities (multiple co-existing medical conditions). Therefore, we work to coordinate and provide therapy not only with your own stem cells, but also through other avenues of regenerative medicine where indicated. This could include hormone replacement therapy, lifestyle changes, nutritional therapies, or other noninvasive treatments, as deemed appropriate by our physician.
5. What other types of treatments are recommended at the Global StemGenn Therapy and Research Center?
Instruction in diet changes, exercise programs, personalized nutritional supplement programs, and a wide variety of noninvasive regenerative treatments may be recommended at Global StemGenn, depending on each patient’s individual condition and personal desires.
6. 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 Global StemGenn Therapy and Research Center gives a choice to informed patients who seek modern regenerative therapy but desire convenience, quality, and affordability. Global StemGenn Therapy and Research 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.
7. Once a candidate is selected for treatment, how does Global StemGenn Therapy and Research Center obtain a person’s stem cells?
Adult autologous adipose bone marrow-derived stem cells are harvested and deployed during the same procedure, which generally takes less than two hours. Our patients first undergo a minimally invasive liposuction type of harvesting procedure which is performed in our office using a local anesthetic. The actual harvesting procedure generally lasts about 15-20 minutes under local anesthesia. Cells are then processed in our in-house lab and are then ready for deployment. At that time, they are returned to the patient’s body via injection and/or intravenous infusion; the entire procedure takes less than eight hours.
8. How is the fat obtained?
At Global StemGenn Therapy and Research Center patients have their fat harvested, usually from the flank or abdominal area, in our procedure room under sterile conditions using a local anesthetic. The fat removal procedure lasts approximately 15-20 minutes. Specially designed equipment is used to harvest the fat cells, and less than 50 cc’s of fat is required. Post-operative discomfort is minimal, as are the recovery time and the restrictions on activities.
9. How does Global StemGenn Therapy and Research Center control sterility in the processing of the stem cells?
Adult autologous adipose bone marrow-derived 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.
10. Does Global StemGenn Therapy and Research Center use stem cells from any other animal source or person?
No. Only a person’s own adult autologous cells are used. This is consistent with the guidelines promulgated by the FDA for the use of stem cells in humans. These are harvested from each individual and deployed back into his or her own body – only. There is zero risk of contamination, rejection, or introduction of mammalian DNA into the treatments.
11. Can stem cells cause cancer?
Adult autologous 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.
12. What about patients with known cancers?
Stem cell therapy is thought to be safe and to has 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 known active cancer.
13. Are any biological agents added to the stem cells such as medications or mixtures containing platelet-rich plasma?
No. Global StemGenn Therapy and Research Center does not add any drugs or foreign substances to the stem cells. This is strictly prohibited by FDA rules and regulations.. 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 (PRP). Therefore, in some cases administering autologous platelet rich plasma, derived from the patient’s own blood, obtained and deployed during the same procedure, may be indicated. But even in those cases the PRP and the stem cells are not “mixed.”
14. How does the Global Stemgenn Treatment Center control sterility in the processing of the stem cells?
The adult autologous adipose bone marrow – derived 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.
15. 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.
16. 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; typically blood-thinning medication dosage must be either adjusted or temporarily stopped before the stem cell therapy procedure.
17. Who decides who is eligible?
The medical team at Global StemGenn Therapy and Research Center will make a determination based on your consultation, history and examination, studies, and current research findings. Occasionally, we may seek opinions from experts around the nation or around the world.
18. What is the cost of consultation and treatment?
Patients who are considered to be candidates for stem cell therapy, based on information provided in the candidate information form and other materials (e.g., medical records) which they may submit, will be invited for a consultation with our physician staff. There will be no charge for the consultation. Unfortunately, insurance generally will not, in most cases, cover the actual cost of stem cell treatment since it is still considered experimental. The cost is generally the same for each patient and does not depend upon the medical condition; although there may be additional charges if physician interventionists are used for various injections into the lumbar spine or hip. Some financing options may be available.
19. How many treatments are required?
Most patients (approximately 90%) require only one (1) 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. Financial consideration is given in these instances.