Amazing things are happening in the realm of stem cell therapy — especially concerning your stems cells accessible in your very own belly fat…
Mesenchymal cells, as they are known, may be used to deter all sorts of devastating diseases as we discussed in last week’s post. The cells are harvested from your belly fat and reintroduced back into your body to possibly repair your heart… save your joints from arthritis… or to stop multiple sclerosis from ravaging your nervous system.
But before you can take advantage of this amazing medical technology there are a few things you need to know starting with why the FDA feels they have jurisdiction over your fat cells…
Are your cells yours?
Doctors around the world are using stem cell therapy to help patients as we speak. But in the U.S. there is another level of control over therapies and medicines: the FDA.
Here’s the critical point of controversy: the Stromal Vascular Fraction (SVF) of your fat — which contains adult mesenchymal stem cells and growth factors needed to make new healthy tissue grow — has to be processed and prepared before it can be injected back into your body.
If this SVF is changed substantially before it is reintroduced into your body, the FDA then sees this as a drug — not as just your own tissue.
According to the FDA, this processed SVF must be only minimally manipulated 1 in order for it not to be considered a drug. If considered a drug, then it is under the regulation of the FDA and would require approval before it can be used legally in the U.S..
Fortunately, there are physician-research groups working in collaboration with the FDA to develop machines to process the SVF in a way that it is still only minimally manipulated or not manipulated at all. They meet the FDA guidelines by providing same day treatment using your own cells which undergo no manipulation and then is inserted during the same procedure.
Sounds intriguing, right? Let me tell you more about what I found out because it gets better.
For clinical research or disease treatment?
It is true that all stem cell treatments are currently in the investigational stage. But the physician-research groups working in collaboration with the FDA are now providing stem cell therapy to the general public.
How are they doing it? They advertise their therapies as being “for investigational use of Adipose Derived Stem Cells for clinical research and treatment.”
So, if you ask the question, “Are stem cell treatments FDA approved?” the answer is no. However, such surgical procedures fall within the scope of a physician’s professional training. Thus, you and your physician can decide together if such a therapy is safe and will be reasonably effective.
There is an international collaboration of medical doctors who share in more than 10 FDA approved studies that have already started, and some are even registered with Clinicaltrials.Gov. They are called the Cell Surgical Network, acclaimed to be the first multispecialty stem cell center (without walls) in the United States.
The Cell Surgical Network trains affiliate physicians in the proper methodology of harvesting your stem cells from storage fat (SVF), processing it with no manipulation, and then deploying it as treatment for many different health conditions being studied (see my previous article to learn about what it can treat).
As they enroll patients into their studies, they also report their outcomes into a database for all their affiliate doctors regarding thousands of patients who receive these treatments. This is important to be able to establish optimal treatment parameters, evaluate for effectiveness, and monitor adverse effects.
Then by collecting their outcomes data they are poised to present it to the FDA soon for approval. Moreover, they already have shown safety and effectiveness using SVF on 1,524 patients — the largest completed SVF series in the world.
Effectiveness, pricing, and where to find a doctor
How effective can such a procedure be? The first level of effectiveness is already being proven with arthritic joint injections using stem cells as previously described. The Cell Surgical Network claims they are getting consistently around an 85% success rate… as reported by patients. Others report even higher success in orthopedic injections, but success rates for non-orthopedic conditions are not clearly being reported.
When faced with the current standard medicine treatments available for osteoarthritis, for example, steroid injections (which slowly degenerates the joint but often gives more immediate short-lasting effects) or joint replacement surgery (very painful and costly), a one-time injection with your own stem cells resulting in gradual and consistent improvement and healing of your joint becomes an exciting alternative!
How much does it cost? Health insurance does not cover the cost of stem cell therapy. The cost for one treatment (often considered curative) range from $6,000 to as much as $20,000. It takes approximately 4 hours for the entire procedure: mini-liposuction, processing then preparing the SVF (Stromal Vascular Fraction) and deployment (re-injection).
There may be doctors near you who are trained and who offer stem cell therapy. Search online at the Cell Surgival Network or simply search online for “stem cell doctor near me” and learn all you can about their services.
What questions to ask
Just as with any investigative procedure, ask for a detailed description of the treatment and its supporting science. Don’t hesitate to ask any and all questions. Here is a quick list of questions to consider asking:
- Who is the doctor in charge of the treatment and what specialized training does he/she and the support staff have?
- What are all the costs of the treatment? What all does this include?
- Is this part of a clinical trial? Reputable clinical trials are overseen by an independent medical ethics committee to protect your rights such and an Institutional Review Board (IRB); have strong scientific evidence that it will work; comply with the laws and regulations of research using human subjects, and are done in an accredited facility. Its best if it is listed in a recognized clinical trial registry such as clinicaltrials.gov (a service of the U.S. National Institutes of Health) and are being published. Also ask what earlier clinical trials there have been for this treatment.
- What is the expected outcome (success rate)? How many other people have been treated for the same disease at this facility and how many of these got better; how many did not?
- How long until my expected results take effect and how long is it expected to last?
- What are the risks of the therapy?
- What other ways can my condition be treated?
- How is the therapy done? More particularly, what are the source of the stem cells (bone marrow, umbilical cord tissue, or my own fat cells), how are these stem cells prepared to be effective for my condition, and how will they get to and grow in the tissue area I need?
- What does the follow-up treatment consist of and for how long?
- If I am injured from the treatment, what compensation am I entitled to?
The challenge may come when seeking a second opinion because only a small percentage of doctors are educated and trained with stem cell therapy, therefore your untrained doctor will likely dissuade you from it.
After reading this article you know the basics of stem cell therapy. You can go online and find more information regarding stem cell therapy for your condition. But don’t be surprised to find outdated material still posted online. The International Society for Stem Cell Research website is a good place to further your studies on this topic.
To healing and feeling good,
Michael Cutler, M.D.
[1] http://stemcellassays.com/2014/12/fda-clarification-minimal-manipulation/
