FDA Regulated Stem Cell Procedures

5 Rising Regenerative Cell Techniques

By | Regenerative Medicine | No Comments

These 5 regenerative cell techniques used for spine and joint conditions have one thing in common – to encourage the body’s natural healing process to regenerate damaged tissues.They all rely on the fact that the necessary tissue building materials are available for the procedure to be effective.  These cellular materials (if available) actually work  to repair the damage and instigate pain relief.  Stem Cells are only one of the techniques, here’s a run-down of how they all work –

  1. Adult-Derived Stem Cells – This technique extracts and reinjects a patient’s own stem cells to stimulate the body’s healing process.
  2. Prolotherapy – Natural substances  are injected to create inflammation in the area and stimulate the body’s healing process.
  3. Ozone Injections – Using a highly reactive form of oxygen, the cells in the area react and stimulate the body’s healing process.
  4. PRP – This technique extracts and reinjects a concentrated amount of a patient’s blood platelets into the area to stimulate the body’s healing process.
  5. Extracellular Tissue Matrix – Using placental-derived tissue, a high concentration of tissue repair materials are placed in the area. The body’s healing process begins.

For orthopedic applications, these are the types of  conditions regenerative cell therapies are used for:

  • degeneration or arthritis in neck or back
  • herniated (bulged or slipped) disc in neck or back
  • knee, shoulder or hip osteoarthritis
  • chronic pain in the spine or joints
  • pain or tingling from the neck down the arms
  • sciatica or radiating pain from the back into the hip or down the leg

Now that we have a basic understanding of what they are and how they work, let’s focus on just two of them – adult-derived stem cells and the placental-derived tissue matrix.

What are the differences between adult-derived stem cells and an extracellular tissue matrix (placental-derived)?  

One difference is that adult-derived stem cells need to match the tissues of the donor which is why your own stem cells (autologous) are typically used. An extracellular tissue matrix (placental- derived) does not require genetic match as it is considered immune-privileged. Remember what the placenta did during the development of the baby? Let’s think of it as neutral ground when it comes to genetic side-taking.  It provided a safe barrier between separate blood supplies as well as a barrier between two immune systems.

How are these treatments FDA regulated?

When a clinic uses adult-derived stem cells and does anything to add to this tissue in its own lab before re-injecting it into the damaged areas, this is looked upon as a manipulation to the tissue that should be regulated by the FDA.  This is why some clinics are under scrutiny for their techniques.   A donated tissue such as the placental-derived extracellular matrix must be acquired by following strict FDA guidelines and regulations before being provided to a clinic for use in a procedure.  Just to clarify, we are talking about a highly concentrated placental-derived tissue matrix, not the amniotic fluid that surrounds a baby during development.

Here’s a side-by-side comparison  between these two common regenerative options.

Adult-Derived Stem Cells

Extracellular Tissue Matrix (Placental-Derived)

Cells are aged, affected by health of patient, environment and how they are acquired. A matrix of cellular building materials – naive, unaged and viable.  All components needed to build and renew healthy connective tissue are present including growth factors, collagens, proteins and bio-materials.
A patient procedure is required to obtain the cells. Then, a technique is used to isolate or spin out the cells for reinjection.  There is potential damage to the cells during this process and possibility of staff error. Donated tissue is stringently screened and prepared using a patented, FDA approved method. Arrives preserved in a vial until it is needed for a procedure.
Some clinics that are providing stem cell procedures are being reviewed by the FDA for their preparation techniques. FDA regulations and guidelines are in place for donated tissue.  In-house processing or manipulation of the product is not necessary.
Stem cells can be beneficial, but are most effective if  building bio-materials are present in the environment. As the environment is an area in need of repair, that is in indicator that these building materials are needed. The extracellular tissue matrix is the key to an enhanced regenerative environment.  The bio-materials found in the tissue matrix are the necessary parts needed to start the repairing, rebuilding process.

To summarize, we choose the placental-derived tissue matrix over adult-derived stem cells for these reasons:

  • Viable, un-aged cellular building materials.
  • Less invasive procedure for patients.
  • Efficient, uncompromised preparation of cellular tissue.
  • FDA Regulated donated tissue.
  • Tissue Matrix includes collagen, proteins and biomaterials necessary for the body’s natural repair process.

Before a clinic advises you that, “this will work for you,”  there should be a comprehensive review of your condition and current x-rays or MRI’s by a musculoskeletal expert.  We offer a FREE CONSULT with a trained specialist to assess your specific condition and will give you our best recommendations whether or not we offer them at our clinic.  Are you in pain and need to find out what your options are? Schedule a consult to find out if EMTX Renew Treatment is right for you? What can it hurt to find out? Call us at (801)756-7800.  

Phone consults are available for our out-of-town inquiries.

car crash statistics

How many car crashes in Utah per year?

By | Auto Accident Care | No Comments

Statistics from the Utah Car Crash Synopsis 2014

How many car crashes in Utah?   54,036

How many people involved? 134,182

How many deaths?  256

How many lives estimated saved by current seatbelt use? 98

How many estimated additional  lives would be saved if everyone wore a seatbelt? 36

When I was about 14 or 15 years old, I was in a car crash as the passenger of the vehicle (right side).  The driver tried to turn left where she was required to yield to three lanes of oncoming traffic. She did not time it correctly and an oncoming car struck my side of the vehicle going about 25-30 MPH.  As I recall we were able to get out of the car after the incident so if you based my injuries on the damage to the car perhaps I would be okay, right?  Well, my parents were happy I didn’t have any broken bones, bruising or scrapes, but about a week later I woke up with terrible muscle spasms that would not allow me to turn my neck.  I’m a trooper so I went to school the whole day and my mom said to do my best while she tried to get me an appointment with the doctor.  We went to the doctor and he tried some hot packs on my neck and shoulder and since he was an Osteopath, tried to manipulate my neck.  I remember it really didn’t want to move.  So he sent me home and I don’t recall anything more than just rest and hope it gets better. Well, some thirty years later and I’ve been dealing with neck and shoulder issues since that time not really understanding for years that the first car crash whiplash injury I experienced contributed to that.

Of the total persons involved in car crashes (not including those that ended fatally), only about 17% reported that they experienced auto accident related injuries.  Now let me explain why I have a problem with this statistic. Through the experiences of seeing and talking with patients in the clinic, there is something that really bothers me.  It’s the fact that someone who experienced some type of  car accident, didn’t get the care they needed at that time and years later they suffer the consequences.  Now I don’t think anyone does this on purpose.  In most cases they just don’t understand what happens to their ligaments, muscles and spine when they are impacted by forces beyond normal limits.  I’m not talking about broken bones, major cuts, abrasions or losing consciousness, but other injuries that might not be visible at first.  

I am one of the lucky ones, because I’ve been able to get regular chiropractic care, learned what types of exercises I could do on my own and even had a stem cell procedure to help with my chronic neck pain.  I haven’t had to go the route of pain pills and surgery for which I am extremely grateful.  The reason I tell this story is because if I can help someone recognize muscle, ligament or spine injuries caused by an auto collision and get treatment right away, then my experience will be a benefit to someone.  I would not wish anyone to endure suffering or long term consequences years down the road because I did not try to help.  

With the help of the doctors and staff, I designed a short  13 Point Self-Evaluation Guide for those involved in a car crash.  Also, if you’re not sure and you just want to talk to someone, call us for an appointment (801)756-7800.  Don’t wait to find out years later like I did.  Get the care you need now.

– Kristin Lee

Car Crash Blog

The Car is Totaled, What About You?

By | Auto Accident Care | No Comments

When my daughter first started driving, she wrecked the car into a neighbor’s tree and because there was a deep irrigation ditch prior to the tree, there was some pretty obvious damage to the car. One tire was no longer in the vertical position on the axle, but kind of sideways. The car was towed to the body shop and although the damage was bad on the outside, we had hopes that the car would be repairable…

However, as the mechanics dug deeper there was damage to the frame and it was determined that the car would have to be totaled. I was relieved she was okay (meaning no major injuries requiring an ambulance ride to the emergency room). But were there really no major injuries?

Consider the frame of the body – the bones,ligaments, tendons, and muscles.  It would be just as important that these parts were restored to back to pre-injury status to work like they’re supposed to. Did you know that these injuries can have long-lasting effects that cause problems now and later in life?  After all, the damage to our body’s frame after a car wreck isn’t a good thing. When the head is thrust forward and back or side to side,  whiplash injury can affect muscles, ligaments and spinal cord and the damage can be moderate to severe. Did you know that even a 5MPH impact can cause injury? There is real research out there that proves that*.

I had whiplash injuries that had gone untreated for years before I started to have bigger problems. I didn’t like sitting down to read because of pain in my neck.  It was hard for me to work on the computer because of the pain in my neck and shoulders.  I also avoided certain types of exercise.   Because I learned about these types of injuries and their affect on my life, I made sure my daughter received chiropractic care right away for her injuries. Waiting until it becomes bigger problem later in life can really impact being able to do the things you love to do.  It can even affect your ability to manage daily duties such as work or family.

It doesn’t hurt anything to find out right away about injuries from a car crash and doesn’t cost you anything either**.  But it does hurt to wait and develop bigger (more painful and costly) problems later.

To be assessed by a Spine Injury Specialist for auto collision injuries, give our Care Team a call (801)756-7800.  

*To request the research for the 5MPH impact, please send an email to careteam@vistamedicalcenters.com.

**In the State of Utah, every auto insurance policy has minimum coverage for injuries, whether or not the accident is your fault.

To Read more about my car crash experience (click here).


Vista Medical Centers – 3 Keys to Optimal Auto-Injury Care

  1. Proper Diagnostics for Complete Assessment of Damage
  2. Medical Evaluation and Treatment for Pain and Repair
  3. Chiropractic and Physical Therapy for Injured Areas

 

Stockholm

Recent Car Crash? Free Injury Guide.

By | Auto Accident Care | No Comments

Here are a some easy questions to ask after a car crash, whether you were able to walk away or had an ambulance ride to the emergency room.  When asking these questions think about normal everyday activities that may be more difficult than usual.

  1. Is there pain or stiffness when I try to turn my neck?
  2.  Are my shoulders, arms or wrists sore and hurting beyond my normal everyday aches and pains?
  3. Do I have pain where the seatbelt restrained me?
  4. Did I receive impact to my body when the airbag deployed?
  5. Was I looking the opposite direction when the car I was in received impact?
  6. Can I bend forward and back without stiffness or pain?
  7. Do I have pain or discomfort  in other areas that normally don’t bother me?
  8. Did I feel my head fly forward and back or side to side during the collision?
  9. Was I released from the emergency room with pain killers and/or muscle relaxers? a neck support?
  10. Did the staff in the emergency room take X-rays, MRI’s or CT Scans?
  11. It’s been a couple of weeks and I still don’t feel like myself, is this normal?
  12. Am I having difficulty concentrating or performing my regular everyday tasks or work since the accident?
  13. It’s been a couple of weeks and I do not feel like I can function without pain medications, what should I do now?

If any of these questions applied to you during your self-evaluation, then it is likely that you have soft tissue injuries or other conditions that should be evaluated and treated by a licensed professional.

If you have any other questions or concerns about what happens to your body when you are in a car crash, please come in for a complimentary consult. As Spine and Joint specialists, we are able to assess your overall biomechanics and how your muscles, ligaments, spine and extremities have been affected. We offer a comprehensive approach to recovery by coordinating medical and rehabilitative protocols for your injuries.

Just a reminder, this information does not constitute a professional relationship  between a patient and provider and is not a substitute for actual assessment by a provider.  If you are in pain, then please seek help right away.

Vista Medical Centers, Why a Cost Effective Multi-Disciplinary Approach? Why Regenerative Medicine?

By | General | No Comments

We’ve met  with thousands of patients through the years providing conventional and alternative treatment options including medical procedures, physical therapy,  and chiropractic for a broad spectrum of conditions such as headaches, neck pain caused by ligament laxity,  sprain or strain to joints, degeneration or herniation in the spine, and osteoarthritis affecting spine and joints. We’ve also consulted with them regarding their insurance coverage for procedures that included medical exams & procedures including pain management injections, diagnostics such as biopsies, NCV/EMG, x-rays & MRIs,  physical therapy, chiropractic and durable medical equipment (DME).

Over the past seven years, we recognized the changing dynamics of  health insurance coverage which were creating greater out-of-pocket costs for a majority of our patients with each passing year. Even if a patient was double-covered or purchased a plan through the Health Insurance Marketplace, the premiums to have these coverages were increasing and many of our patients complained that there were still high out-of-pocket costs associated with the care they would like to choose or lots of limitations.  Also, over the last several years, the insurance industry (federal and commercial) has made an effort to reduce their payment of claims in the rehabilitative medicine area and certain medical injections by increasing policy restrictions, bundling  or reducing the amount payable to providers and increasing the patient’s out-of-pocket amounts such as copays.  There have also been heightened efforts  to go back to the doctors and recover monies previously paid for services (which has been extended to 5 years via the middle-class relief act).  Basically, these changes, limitations and costs have created several problems:

1) Difficulty for the patient to receive the care without significant costs.

2) Difficulty for the provider to give the care and be paid for it.

3) Difficulty of meeting restrictive policy limitations and guidelines.

Our best patient outcomes have been achieved by combining medical procedures such as injections with physical therapy or otherwise known as a multimodal approach.   For example, as a fully accredited Osteoarthritis Facility, we introduced a Knee Osteoarthritis 8-Week Knee Protocol (USPTO 9,226,938) to Utah in 2009 using visco-supplementation injections with physical therapy. We were included in a study published in October 2013 reporting positive outcomes that included 66 treatment facilities in the U.S.  The study can be found here.  We introduced a multimodal Neuropathy Protocol in 2012 and a multimodal Headache Protocol in 2013.

During the time we offered these treatments we would get these kinds of questions from our patients:

  1. Can I have access to an exercise plan that I can do at home or at my gym on my own time without the additional costs of a visit to the clinic?
  2. Isn’t there something that can regenerate the cartilage in my knees?
  3. What can I do to avoid surgery in my…neck, back, knees, hip, etc.?
  4. What can I do to be able to continue to work?
  5. Do I really have to pay for another doctor visit, to have this test, this MRI, etc?

This small shift in thinking lends itself to the thought, how much more cost effective would healthcare be if our patients  who desired to maintain and manage their own health had access to simple tools to do so?  How much money could they save by having access to wellness care rather than sick care?  If instead of waiting for the next time their back gave out, they were actively participating in exercises, quality diet and regular chiropractic care to maintain their health?  Perhaps the changes in a government mandated healthcare are just what we need to help us make that shift in thought process.

We heard our patients’ desires for more affordability and accessibility to the kind of healthcare designed to improve the quality of life and we determined to find solutions.  We also wanted to continue to do what we enjoy which is to help them feel better and have access to a better quality of life.

Here are the solutions we provide –

We offer physical therapy specific to a patient’s condition via computer, tablet,  or smartphone (printed hard copy available as well)  that can be performed at home or at a gym.

For maintenance care, we offer affordable monthly plans for chiropractic, nutritional and supplementation guidelines, and weightloss solutions. 60% of us over the age of 40 already have some degeneration in our backs.  This means we need to take an active-care approach which should include chiropractic, regular stretching/exercise and evaluated nutritional support for our condition.

Personal injury coverage or med-pay benefits are available in Utah to patients who have been in an auto accident (there is a minimum of  $3000.00 no fault injury coverage on Utah car insurance policies). Our auto injury patients experience coordinated care in our facility with access to medical and rehabilitative care.We have a secure platform with virtual access to medical providers to oversee the entire case as well as provide medical procedures in the facility. Through our affiliation with IASIS we can easily coordinate with a network of providers for additional services.

Regenerative medicine is here to stay and whether it’s PRP, prolotherapy, ozone therapy, autologous stem cell therapy or placenta-derived allograft, these procedures are being sought after by individuals who would like pain relief and to avoid the possible complications of surgery.   We’ve had a few years to research and learn of various regenerative options and we offer a placenta-derived allograft.  It does not require a “donor” match, is delivered by following FDA regulations for donated tissue, and has an extra-cellular matrix with stem cells which is like a “power-pack” for healing and regenerating tissues.   We have had positive clinical outcomes for knee osteoarthritis, degenerative neck/back, ligament laxity, shoulder osteoarthritis, plantar fasciitis, severe ankle sprain and other conditions.

With the exception of personal injury insurance, we are a cash only practice.  This keeps our administration costs down, and allows us to provide services to our patients that we consider the most effective and not dependant on “what the insurance will cover.”  We do work with medical providers who accept insurance and for certain services as we recognize this may be the best option for our patients.  We also have relationships with providers who have affordable cash prices for their services.  We are an IASIS affiliated clinic which means we have access to a network of medical professionals to provide care and treatment that we do not provide.

This explains a little bit about why we do what we do, how we see the world of healthcare evolving, and where we find we best serve our patients and community.