Spinal Fusion: Confidence Lost

Clincial studies are untaken to determine patient safety and efficiency of a given device.  Studies published in peer-reviewed journals are considered to be free of biasis and conflict of interest.  Such studies can led to the advancement of medicine.

Unfortunately when money is involved the rules may be overlooked or softened. 

 Medpage Today reports that doctors who received millions of dollars from Medtronic systematically failed to reveal serious complications linked to the company’s lucrative back surgery product: Infuse.  Editors of the Spine Journal found systematic failure to report serious complications and found complication rates that were 10-59 times greater than the estimated complications rates revealed in the medical literature.  The 13 papers reviewed in the Spine Journal were co-authored by doctors who received a median of  $12 million to $16 million per study from Medtronic.

Dr. Centeno has previously blogged about Medtronic’s Infuse product and the high rates of male sterility.

The Centeno-Schultz Clinic has extensive experience and expertise in the treatment of lumbar disc disease. Traditional epidural steroid injections have significant side effects.  Regenexx PL is an alternative to traditional epidurals and offers a different approach in the treatment lumbar degenerative disc disease. 

Testimonials  and MRI pre and post comparisons have been previously discussed.

Discectomy: Nip and Tuck of the Disc

Discectomy is the surgical removal of a portion of the disc that is  thought to be causing pain.  The disc may have a bulge (distention) which presses on a nerve root causing leg pain(sciatica).  Removal of the disc bulge is intended to relieve pain.

Disc bulge with pressure on nerve root

How successful is lumbar discectomy?  Not particularly.  Loupasis examined  long-term outcomes after lumbar discectomy.

The long-term results of standard lumbar discectomy are not very satisfying. More than one-third of the patients had unsatisfactory results and more than one-quarter complained of significant residual pain.  7.3 % of patients required additional lumbar spine surgery frequently due to repeat herniation.  A predisposing factor to poor surgical outcomes was a job requiring significant physical activity.

Surgery weakens the annulus (side wall of the disc) predisposing the disc to re-injury and herniation as illustrated in this video.

At the Centeno-Schultz Clinic  x-ray guided injections of PRP, platelet derived growth factors and mesenchymal stem cells are non-surgical options for debilitating lower back and leg pain.

Stem Cell Therapy for Lumbar Degenerative Disc Disease: Update

Low back pain is a common problem.  Episodic discomfort following purposeful activity is typically self-limited.

The problem is when that knife in your back, that lancinating pain that takes your breath away with minor motion becomes chronic. Physical therapy and myofascial deactivation are often helpful in breaking that cycle.  At the Centeno-Schultz Clinic, when conservative therapies fail, x-ray guided epidural  injections of low dose corticosteroid or platelet derived growth factors are used and can be beneficial.  Unfortunately some patients do not respond to conservative therapy.

NQ is a 39 y/o patient with 3 yr history of lower back pain who failed to respond to conservative and injection therapy.  She declined surgery and opted for the Regenexx procedure which afforded her the opportunity to use her own stem cells.  NQ had her own mesenchymal stem cells injected into the posterior aspect of her L5/S1 disc on .

 NQ returned to clinic today, 4 months post injection reporting  50% improvement in her lower back pain.  She has been able to increase her level of activity and is enjoying the summer with her family.

This corresponds with her postprocedure MRI which is below.  There is a reduction in the size of the disc bulge which is identified by the red arrows.  The diameter of the spinal canal is increased from 0.9cm preprocedure to 1.1cm postprocedure due to a reduction in the size of the disc protrusion.   Stem cell therapy for lumbar degenerative disc disease holds great promise as it eliminates the risks of anesthesia/surgery and the often profound biomechanical changes that occur as a result of cutting through and compromising the integrity of supporting ligaments, muscle and fascia.

Low Back and Leg Pain Successfully Treated with Stem Cells

A disc protrusion can cause severe lower back and leg pain.  Treatment options vary from conservative to surgical.  Conservative therapies often include physical therapy, the use of muscle relaxants, non-steroidal anti-inflammatory medications and narcotics.  Surgical options include trimming the protruding disc through a large incision, a small incision with the assistance of a microscope or laser.  Some studies have demonstrated that surgical repair of a disc protrusion places the patient at increased risk for subsequent back problems in the future.

NQ is a 30+ y/o patient who has a long-standing history of lower back and leg pain.  She had undone conservative therapy in addition to epidural steroid injections with little sustained benefit.  She elected to undergo the Regenexx procedure where she used her own culture expanded cells to treat her back and leg pain.  Her own bone marrow derived stem cells were grown in a state of the art lab and then injected under x-ray into the disc protrusion.  thirty days after injection NQ reports a 90% reduction in her leg back and 40% improvement in her low back pain.   Her lumbar spine MRI shows improvement as illustrated below.    Two matching slices from several months before the procedure (on the left) and two from one month after the procedure (on the right). These are side views of the spine and since MRI’s literally slice across an area, I have included two slices to be as accurate as possible. The images are on an ultra high field magnet (3.0 T) and are also closely matched for imaging parameters (Before=Sag STIR: ET-12, TR-4166.7, TE-37.3; After=ET-12, TR-4166.7, TE-37.3). Note the red arrows in the before images show a large disc bulge that the yellow arrows in the after images show has been reduced.

She has been able to increase her level of activity and is enjoying this Memorial Day weekend with her family.

Another FDA Recall

Today the FDA recalled Synex II vertebral implants.  The implants were recalled because they pose an imminent  health hazard.  Six adverse event reports have been  filed to date which demonstrated moderate to severe loss of vertebral body replacement height. Other potential complications included neural injury, increased pain and need for reoperation/revision surgery. Synthes had a previous recall in Feb 2009.

In a press release Synthes advised: “that surgeons and hospitals in possession of the subject devices must stop implanting them immediately.”

Vertebral implants are utilized in lumbar spine surgery and were thought to have a potential advantage over conventional fusion techniques.

Vertebral Implant

Surgery is a one way door:  once undertaken one can only move forward.  Complications are part of the risks of surgery. Removal of the disc, which functions as a shock absorber, can result in pressure overload in adjacent levels thereby advancing the degenerative casade.

A non-surgical option for the treatment of lumbar disc disease is the use of your own stem cells.  Utilizing the Regenexx procedure, patients have had reduction in their back and leg pain.

Stem Cell Therapy for Lumbar Disc Protrusions

Lumbar disc protrusions can cause lower back and leg pain which can vary from mild to severe.

Today in clinic, I had the opportunity to followup with a patient who underwent autologous stem cell therapy using the Regenexx procedure.  He has kindly allowed me to share his experience. Patient is a 37-year-old male with longstanding lower back and leg pain.  The back pain was sharp in character, constant in duration, progressive in nature and aggravated by coughing, sneezing and flexion.  He would experience episodic pain which would incapacitate him.  Physical examination was significant for lower back pain aggravated by flexion, extension and straight leg raise.

Micro-discectomy and other surgical treatments were dismissed by the patient and his family.

 4 weeks after having his own stem cells injected into the L5/S1 disc along with platelet derived growth factors, the patient had significant reduction in his back and leg pain.  MRI prior to and after stem cell therapy was significant for a reduction in the L5/S1 protrusion which is illustrated below.

 

 

 

 

 

 

 

 

 

 

 

Let It Grow: The Role of VEGF

 

 

Everyone knows that a seed will not grow without sufficient nutrients and water.

So to with stem cells when implanted in an area that is low or deficient in nutrients.  Blood flow is the key to cellular growth.  No blood flow, no growth.

Lumbar discs have poor blood supply.  One of the growth factors derived from platelets has been utilized to enhance blood flow to lumbar disc and the stem cells which have been implanted in them.  The growth factor is VEGF :Vascular Endothelial Growth Factor.  It has the capacity to create new blood vessels (angiogensis) thereby enhancing nutrient flow.

A case series of patients who underwent implantation of autologous mesenchymal stem cells into the symptomic disc had injections of concentrated VEGF.  66% of patients had a significant reduction in pain.  The before and after stem cell therapy MRI’s clearly demonstrate a reduction in the size of the disc protrusions.

Regenexx.Regeness.MSC.

Results of Stem Cell Therapy Presented at National Meeting

A case series outlining the results of patients who underwent stem cell therapy for symptomic lumbar disc protrusions was recently represented at the National American Society of Interventional Pain Physicians. The abstract is #8. Patients utilized their own stem cells which were expanded and then re-injected into the painful disc. A majority of the patients had a significant reduction in their symptoms as well as changes on MRI.

The Regenexx procedure affords patients an alternative to the risks of surgery and anesthesia. In contrast to conventional surgery, there is no significant down time or need for extensive rehabilitation.

Colorado Stem Cell Therapy Makes News

Colorado based Regenerative Sciences was the focus of a recent New York City news segment.  Dr. Max Gomex discussed the Regenexx procedure where a patient uses their own stem cells to heal a variety of orthopedic conditions.  Examples outlined included non-surgical therapies for rotator cuffs tears, mensical tear, loss of cartilage in the knee and hip as well as degenerative lumbar discs.  Dr. Gomex also discussed the opportunity to bank stem cells for future use.

New treatment opportunites now exist in the Rocky Mountains…..

Stem Cells Can Stop the Progression of Lumbar Degenerative Disc Disease

Degenerative disc disease is a common disease which affects millions of people.  Fan et. al. recently demonstrated that mesenchymal stem cells can stop the progression of lumbar disc degeneration.  Furthermore, the authors demonstrated that injected mesenchymal stem cells led to significant regeneration of the central portion of the disc.  Regenerative Sciences has been utilizing this same cell line in their lumbar disc procedures. Please see MRI of a patient who underwent Regenexx therapy.