How Successful Is Cellular Treatment and How Long Will It Last?
This is without a doubt one of the most frequent question we are asked in our practice during new patient consultations.
Cellular Treatment is currently elective, meaning not covered by most health insurance plans. Educated patients and consumers like you are smart for wanting to know if it will be successful before investing in the treatment.
They also want to know if successful, how long the positive effects will last. If you are thinking this way, congratulations, as you are really doing your research and not being caught up in the sensationalism and hype being broadcasted on some practice websites.
Both questions are challenging to answer because each patient, and the problem for which they seek treatment, is entirely unique. Each patient must be evaluated thoroughly by a qualified specialist to determine if they are even a candidate for the treatment.
At present, there is no unified patient registry, used by all practices providing Cellular Treatment, for collecting outcomes from patients that have had stem cell procedures within the United States.
Internally, within our multi-practice affiliation we have been collecting data on patient outcomes with Cellular Treatment since early 2010. If we look at the pooled results of all stem cell cases combined (knees, shoulders, hips, etc.) at 6 months post-procedure:
- Greater than 75% of patients – achieve a satisfactory response to treatment with significant (>70%) improvement in pain or function – This means that they respond yes to the question – “Is your pain controlled and has your function improved to a level that no longer impairs your quality of life and allows you to perform activities you want and need to do with minimal modifications?”
- Around 15-20% of patients report – They answer “no” to the above question, but still have had significant improvements in pain and/or function. Many of these patients elect to pursue additional treatments to see if they can achieve an optimal response.
- Less than 10% of patients – Report no measurable improvement with their stem cell procedure. They may then elect for other treatment such as joint replacement surgery.
At present there are reported to be more than 400 active academic institutional studies at universities across the United States evaluating the far-reaching applications of Cellular Treatment. They are not all working on treatment of orthopedic joint and spine conditions but expanding treatment for many other conditions such as diabetes, heart failure, and macular degeneration to name a few.
We have a stem cell research on our website dedicated to taking the very scientific and making it simple to understand. This is where we will continue to curate the highlights of the exciting research as it is published in the scientific literature. I recommend you check back frequently to stay up to date with the body of research as it continues to evolve over the coming years.
According to one of most respected Sports Medicine Orthopedic surgeons in the world:
If Cellular Treatment is So Successful Why Is It Not Covered by Insurance?
This is probably the second most frequently asked question I get asked in my consult room while determining if a patient is a candidate for Cellular Treatment.
To answer this, let us first debunk a few myths and misconceptions.
Regulation and approval are different concepts.
The FDA has strict regulations regarding the use of platelet and Cellular Treatment. FDA-approval means that a device or product is approved for treatment of a specific condition, i.e. osteoarthritis.
According to the FDA Code of Federal Regulations, Title 21, Section 1271.15(b):
“the procedure of Cellular Treatment is compliant when performed as a “same surgical procedure” with “minimal manipulation” of your cells – or what they call a “biologic product”.
Translation: Your stem cells can be harvested from you, “minimally manipulated” by separating the cell types with use of lab equipment such as a centrifuge, and then can be injected back into your body on the same day.
There are other types of stem cell procedures being done in many countries outside the United States, where stem cells can be “more than minimally manipulated”. This can be through addition of growth factors, and/or culturing cells – where the cells are harvested and then are grown for a period of time in a lab in order to expand the quantity of cells available for treatment. According to the FDA, manipulating your cells in this way reclassifies them as a “351 drug”.
[Section 351 of the Public Health Service (PHS) Act defines a biological product as a “virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product, … applicable to the prevention, treatment, or cure of a disease or condition of human beings.”]
You are reading that correct. Although the cells are taken from you and put back into you, once they are manipulated through culturing or addition of growth factors, they become categorized by a drug.
At the time of writing this guide in early 2018, clinics offering Cellular Treatment in the United States are not allowed to bank or culture cells, and they can only perform same day surgical procedures.
Like it or not, this is the letter of the FDA’s “law” right now. It is the opinion of many in the Integrative Orthopedics field that this is holding back the development of the highest-level treatments to harness full potential of Cellular Treatment in the United States.
[*If you would like to blur your vision over a day or two, you can study the full-length version of the above regulations by clicking the links in the reference section at the end of this guide.]
Myth #2 – If the FDA approves a device it should be covered by health insurance companies
As mentioned above, the FDA is responsible for insuring the safety of drugs, surgical and medical procedures, as well as other treatments.
Drugs, medical products or treatments are mandated to be investigational or experimental for a period of time defined by the FDA. They must be put through “bench research” to validate the science in a lab setting.
Then depending on the type of product or treatment, they may also require step-wise human studies before they are given a stamp of approval that they are safe to be delivered to, or performed on, consumers.
The FDA does not determine whether or not a third-party insurance company is obligated to cover the product or treatment once it is deemed safe. It is generally a step in that direction, but whether or not these treatments are covered is entirely up to the insurance company.
When you purchase health insurance you are buying a product, i.e. health insurance plan. The product has a scope that is covered and others that are elective and not covered by these products. This is entirely determined by each insurance company.
Cellular Treatment and other Integrative Orthopedics procedures at this time are categorized as elective. They are not experimental.
Myth #3 – Insurance companies/plans (including Medicare) do not want this to be covered because of “deals” with pharmaceutical and medical device companies
I predict otherwise, and maybe as soon as the next 3-5 years.
The purpose of this guide is to bring you up to speed with the current state of the science with Cellular Treatment, not float conspiracy theories about why these treatments seemingly are being held back from widespread adoption in the conventional medical system.
If we look at the current state of affairs being written about in scientific journals as well as lay publications, there is some positive movement in the right direction. What is going on right now at the state level in some states here in the U.S. is very encouraging. They are actively involved in implementation (not just regulation) of Cellular Treatment and other Integrative Orthopedics procedures at the government level.
See the following headline from an article:
Pilot Study will allow Regenerative Injection Therapies to be covered on State Employee and Teacher health plans
LITTLE ROCK, Ark., April 12, 2017 (Source: PRNewswire) – The Emerging Therapies Act of 2017 was signed into law by Governor Asa Hutchinson today, granting pilot access to State Employees and Teachers for Regenerative Injection Therapies as a treatment of orthopedic conditions on their health care plans. Arkansas now leads the country as the first state to adopt a policy to include these emerging therapies in state employee health insurance.
How did this come to be? In short, through a cost-analysis they discovered:
“This could potentially save the state of Arkansas $100 Million using Integrative Orthopedics as an alternative to surgery or pharmaceuticals for orthopedic conditions.”
“Regenerative Injection Therapies like Platelet Rich Plasma (PRP) and Bone Marrow Aspirate Concentrate (BMAC) have been shown to be effective treatments with up to an 80% savings of surgical costs while virtually absent of complications.”
Their words, not mine.
It is encouraging to see government-sponsored pilot studies happening that will certainly shift the landscape for qualified coverage of Integrative Orthopedics treatments hopefully in the not so distant future.
In the meantime, think about your current treatment as an investment in your future self, and then if and when you need more treatment, your next round of treatment may be covered. That is truly exciting to think about.
The other encouraging piece in the Arkansas pilot study is that they are also actively working on what necessary infrastructure needs to be place for widespread adoption into the conventional medical model. This will be essential for patients to know they are being treated by certified providers or practices, using approved technology – and would then be available for reimbursement through plans electing to cover these services.
Currently, the FDA lacks the manpower to police the exploding numbers of clinics offering Cellular Treatment and other Integrative Orthopedics procedures. This is an area that could probably benefit from additional regulations to protect consumers.
Dr. David L. Harshfield, Jr. is a pioneer in Integrative Orthopedics and cellular therapy and had this to say about the developments out of Arkansas:
“Integrative Orthopedics moves away from the allopathic medicine (M.D.) model, where a physician matches a diagnosis to only a binary, pharmaceutical or surgical solution, and focuses instead on the “correction of medicine”. The State of Arkansas will now give patients a choice beyond drugs or surgery. “We are not man-made, and no ‘man’ can heal us. Physicians must admit to patients that we only ‘men’ and as such, we can only help patients heal themselves. With Integrative Orthopedics, physicians can help patients restore their health by utilizing the natural healing responses found within the body.”
I agree with his statement and know many of my colleagues also echo these sentiments.
Cellular Treatment and Integrative Orthopedics procedures offer patients additional choices about how to treat and heal their body.
What we now would like to see is that all patients, rather than a select group, are given the ability to choose a treatment that aligns with their view of how they would like to treat their body.
This is at stark contrast to standard non-surgical treatment, or the typical pain-pill-pain cycle, that I was witness to for so many patients I saw during my training and early years of practice.
If you would like to break this cycle for yourself, and many other patients who suffer in pain but have been given few options beyond pain pills, steroid shots, or surgery – I would encourage you to seek out a qualified provider to start a conversation about whether these treatments are right for your condition.
If you would like to see Cellular Treatment more available in healthcare, similar to Arkansas, start writing your state representatives and senators! You can make a difference.
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Rejuv Medical Southwest is located in Southwest Arizona and provides clinical services to the surrounding cities: Tucson, Oro Valley, Catalina, Saddlebrooke, Oracle, Marana, Casa Grande, Green Valley, Nogales, Vail, Sahuarita, Phoenix, Gilbert, Chandler, Mesa, Tempe, Scottsdale, Glendale.
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