Adult stem cells are much farther ahead in research and clinical applications than embryonic stem cells, an AP writer reports. While embryonic stem cells have been the darling of the media for years and adult stem cells have been the red headed stepchild, this major press coverage is a great advance in notifying the public of this discrepancy.  The bottom line, adult stem cells are being used in early clinical and research work to heal cartilage, bones, multiple sclerosis, heart attacks, diabetes, and other diseases.  This begs the obvious question, do we need embryonic stem cells?

Interesting story out this week on Medtronic’s Bone Morphogenic Protien (BMP) device used to promote spinal fusion-Amplify.  Spinal fusion is when a surgeon does something to cause one vertebra to fuse to the other (grow together).  Lumbar fusions are big surgeries with big risks.  BMP-2 is used by surgeons to stimulate two bones that normally wouldn’t grow together to fuse. We have published with CSU on the use of BMP-2, so we have some knowledge of it’s properties. One of the concerns we’ve seen clinically is that when used in fusions, it seems to really irritate spinal nerves and lead to significant radiculopathy.  Now this article raises concerns about it possibly leading to a higher rate of cancer. This may make some sense and this is one of the reasons we have always avoided using recombinant growth factors with our stem cell procedure. The concern is that these growth factors can be given at doses many, many times their normal physiologic ranges to “whip” cells into doing certain things.  This extra stimulus may promote tumors, as cells are cycling much faster than their design specifications.  As an alternative, we have always used the patient’s own growth factors from blood platelets to grow cells, as the levels of growth factors are more physiologic.  The jury is still out on the cancer risks of this device, so only time will tell.

MF is a young active man from South America who has a L4-L5 disc bulge that causes leg symptoms and back pain.  He wanted to avoid surgery for the disc bulge, so he sought out the Regenexx Disc treatment, where we cultured his own stem cells to get greater numbers and then used imaging guidance to inject these into specific parts of his lumbar disc.  It’s important for any clinic offering investigational care to discuss it’s successes and it’s cases that didn’t quite get there (at least on the first try).  For MF, 4 months out form the procedure he’s only had a small improvement in symptoms and this is consistent with his pre and post MRI’s of the low back.  The images above are side views (sagittals) of his low back, showing some decrease in size of the disc bulge, but only by 20% or so.  The axial images below (top down view) again show a small decrease in size of the disc.  The reason he may not have gotten more relief may be because this L4-L5 disc is bulging both in the middle and out to the side, partially obstructing the foramen (the hole where the nerve exits).  We have recommended a second procedure for MF, as we believe that we have demonstrated some effect based on objective MRI imaging and believe that it may be possible to decrease the size of the bulge in this other sideways direction (into the foramen).

(Please note, this patient was treated with the Regenexx cultured stem cell procedure and not Regenexx-SD.  While Regenexx-SD does rely on the same stem cell type that was used to treat these patients and other clinics have reported good results using similar procedures that don’t rely on stem cell culturing, Regenexx-SD clinical effectiveness has not yet been established.)

The knee ACL is one of the main ligaments in the knee that helps to stabilize it in a front back direction.  When this ligament gets injured, many patients opt to have it replaced.  The logic goes that without a strong ligament, especially when they’re active, the knee may be prone to more damage.  In addition, the wisdom has been that even a partial tear was unlikely to heal.  However a new research study out this week questions that concept.  In this study, athletes with knee ACL tears were randomly assigned to either surgery to replace the ligament or follow a strict physical therapy program.  60% of the athletes that didn’t get the knee surgery never needed to have the ACL replaced.  This brings up an important point.  We have seen more patients getting ACL surgery to replace the ligament, even with partial tears.  We would advocate that these patients wait to see if the ligament heals and if it doesn’t heal, many non-surgical options exist that we believe should be tried before surgical replacement of the ACL.  These include prolotherapy (study by Reeves showing effitiveness) or PRP injections (platelet rich plasma taken from a vein, spun down, and injected into the knee).  We belive these injections should be guided by imaging (x-ray or ultrasound).  We have also helped select patients with full thickness (non-retracted) or partial ACL tears by injecting their own stem cells into the tears.  If all of the less invasive injection options fail, then replacing the ligament may be needed.  However, Frobell’s study shows that for many athletes with ACL tears, just letting it heal over time may be enough.

We were recently happy to show the former president of Argentina our Colorado clinic and give he and his wife a presentation on the use of cultured stem cells to treat orthopedic conditions.  The ex-president and his wife were very interested in the technology we use and in bringing this procedure to Argentina as the practice of medicine.  The president was in town with other Latin American luminaries as part of the Biennial of the Americas celebration in Denver.

Headlines this a.m. “Stem cell therapy ‘first’ in trial on arthritic knees” on the BBC wire sounds familiar.  The study seems to be ACI or Autologous Cartilage Implantation surgery where some knee arthritis patients are getting cartilage cells and some cartilage cells mixed with stem cells.  While this may be a first in Great Britan, it’s not close to a worldwide first as a similar study comparing ACI knee surgery to the same surgery performed with cultured stem cells was just published out of Asia a few weeks ago (one that’s long since completed, not planned).  This highlights a huge issue.  Europe and the U.S. are woefully behind Asia when it comes to stem cell therapy.  The reason is the excessively restrictive regulations in the U.S. and Europe that treat the patient’s own stem cells the same as mass produced drugs. In Asia, for the most part, autologous stem cells are treated as body parts to be re-implanted under the practice of medicine.  So while researchers in the U.K. are pretending that what they’re doing is a worldwide first, nearly the same study was done and completed years ago in Asia.  If U.S. and European regulators don’t stop putting the brakes on autologous stem cell therapy by treating it the same as the production of a new antihypertensive or antibiotic, we will soon wake up to an Asia that is far ahead in all aspects of real world stem cell treatment.  I think they say “konnichiha” in Japanese…I better get practicing…

stem cell safety complications

Great study this am out of Japan, where they report on the complications from the longest running surveillance program for a mesenchymal stem cell re-implants in the knee.  They looked at 45 knees in 41 patients for an average of between 5-137 months (11 years plus).  They observed no tumors or other issues with the re-implants.  This is consistent with our own published safety data on 227 patients as well as our recent analysis of 339 patients with about 60 sites tracked by 3.0T MRI (the latter not yet submitted for publication).  The data continues to support the excellent safety record of MSC’s used for orthopedic purposes.

JS is a 43 year old who I have seen for may years to treat low back pain from a car accident about 10 years ago.  We settled into a pattern of treating his low back disc bulge and nerve root irritation (lumbar radiculopathy / sciatica) with steroid epidurals 3-4 times a year.  Using these treatments, he would get temporary relief lasting a few weeks to a few months, but he still needed to take narcotics.  More recently, with the passage of Colorado’s medical marijuana law, he became my only patient (out of about 1,000 active patients) that I trusted enough to fill out his state form.  He thus transitioned from narcotics to medical marijuana, which helped, but left him a bit “unfocused”.  Finally, 9 months ago, he wanted off this treadmill and had seem some of the sucess we were having with implanting the patient’s own stem cells into the low back discs to treat disc bulges.  He signed up for that procedure and was a GOOD-FAIR candidate.  Nine months later, he was seen this morning and has had a dramatic reduction in his pain and increase in his function.  He also dramatically reduced his medical marijuana, which was clear just from speaking with him.  He doesn’t need epidurals at this point and told me he has increased his work hours by 25% as an accountant.  He also just spent his recent vacation jet skiing through 9 foot swells.  I think JS is a good story to tell, because unlike many other patients who we see for stem cell injections into the lumbar discs, I have personally had extensive history with him.  I knew what worked to manage his pain and saw that I could help, but only in short spurts and little bits.  While we able to keep him away from surgery before the stem cells, it was only through repetitive procedures and tons of medication that reduced his ability to earn a living.  After the procedure, he’s a different patient.

(Please note, this patient was treated with the Regenexx cultured stem cell procedure and not Regenexx-SD.  While Regenexx-SD does rely on the same stem cell type that was used to treat these patients and other clinics have reported good results using similar procedures that don’t rely on stem cell culturing, Regenexx-SD clinical effectiveness has not yet been established.)

hip avn osteonecrosis outcomes stem cells stem cell prp

Over this next few months we will be reviewing our large outcomes database and (now about 350 patients and almost 800 procedures) and reporting on the preliminary data in this blog as well as publishing multiple large case series.  Today the focus is on Hip Avascular Necrosis (AVN or osteonecrosis) patients and how they have fared.  This is a select group of 27 patients from a specific time period.  We measured the patient reported results in these patients who were all told they needed a hip replacement.  Instead of the hip replacement surgery, we injected their own mesenchymal stem cells into the bone via x-ray guidance, a procedure with much less downtime than even a surgical CORE decompression and certainly less invasive than a hip replacement surgery.  Of the 27 patients, 4 were lost to follow-up (couldn’t get outcome information), and 3 went on to hip replacements so their data was removed as any results might be due to the hip replacement.  All patients were between 3 months and more than a year out from their stem cell injection.  Of the 20 remaining patients, approximate mean reported improvement was 50%.  While we intend to clean up this data further and report this by disease severity (ARCO grade 1, 2, 3, 4+), I thought this was interesting information to report.

In the meantime, we continue to look at other types of patients such as knee osteoarthritis, hip OA, shoulder, rotator cuff, etc…  Again, this is preliminary data.

(Please note, these patients were treated with the Regenexx cultured stem cell procedure and not Regenexx-SD.  While Regenexx-SD does rely on the same stem cell type that was used to treat these patients and other clinics have reported good results using similar procedures that don’t rely on stem cell culturing, Regenexx-SD clinical effectiveness has not yet been established.)

Images/Data:

3.0 T Coronal PDFS pre and post injection MRI’s of the medial ankle and an OCD in the talardome. The images on the right are 15 months after the injection of adult stem cells into the osteochondraldefect (OCD).

For orientation, the yellow lines point to the dark bony cortex (thick outside of the bone) and the normal grey cartilage.

The white dashed circle is around the OCD and the area of swelling in the bone (marrow edema-the area of light color in the bone). Note that the small white arrow is pointing to a defect in the cartilage (the white horizontal line breaking the grey) that is filled in with grey cartilage again by the time of the post-op images. Note that the dark horizontalbone cortex line is darker, indicating stronger bone under the defect.