Congrats to Beike and Medistem for a well done safety study on expanded cord blood treatments in China for neurological disorders. Again, compared to the safety profile of common sledgehammer immune supressant drugs for conditions like Multiple Sclerosis., this therapy seems to be much safer.  While a bigger dataset followed for longer periods would be nice, this paper seems to support the safety profile already published by our group and others showing that cell based therapy complications are generally less than the more traditional therapies they help replace.

This past few months have been interesting for adult stem cell advocates.  The good news is that there have been many news reports showing that these cells are capable of remarkable things, such as helping patients with corneal burns see again.  On the other hand, the entrenched business interests in favor of embryonic cells and IPS cells have been hard at work. Here’s my entry on a scientific evaluation of recent publications of adult stem cell risks.

As of this morning, we will begin offering Regenexx-SD with super platelet mix.  Unlike our cultured stem cell treatment, this is a procedure where stem cells can be re-injected shortly after they are harvested.  One of the difficulties in offering a cultured stem cell therapy is the lag time between the marrow aspirate, culturing, testing, and re-injection-which can often take 6 weeks.  Many patients have requested a stem cell procedure that could be performed over 1-2 days, without big time lag.  Our problem has been how to offer a procedure like this without compromising stem cell yield.  The issue we have had with traditional BMAC (same day marrow draw procedures run in bedside centrifuges) is that they have too few mesenchymal stem cells for many orthopedic applications. One way to increase stem cell number in a same day procedure is to ditch the bedside centrifuge and use a lab that can custom concentrate stem cells to higher numbers.  A second way is to supply growth factors to prompt the smaller number of cells to grow in the body to bigger numbers, essentially replicating what we do in the lab with culturing in the joint (in-vivo culturing).  To try and accomplish this, many clinics use bedside centrifuge concentrated PRP-(Platelet Rich Plasma) added to the stem cells or injected at the same time as the stem cells.  Not satisfied with just adding PRP to isolated bone marrow stem cells, we looked for better solutions.  Since nobody had ever compared different growth factor (platelet) mixes with human mesenchymal stem cells, we did that in 2009.  We compared our usual platelet mix to grow cells in culture (PL-platelet lysate-a growth factor mix where all the growth factors are immediately available), 3X PRP (the usual 3 times concentrated platelet mix provided by bedside centrifuges), blood serum, unconcentrated platelets, a mixture of PRP and platelet lysate, and just basic nutrients (media).  This is what we found:

The graph above plots the numbers of stem cells that grew with the various growth factors we tested, so the higher the bar, the better the result.  The big surprise in this data is the huge number of mesenchymal stem cells that grew with what we now call a “Super Platelet Mix”.  Notice that the “Proprietary Platelet Mix” produced >20 times as many stem cells as just platelets alone, about 11 times as many cells as platelet lysate, and 6 times the number of cells as “3x PRP” (the usual platelet rich plasma used by many physicians).  So the mix of these two platelet mixtures doesn’t produce an “additive effect” (1=1=2) it instead produces a “synergistic effect” (1=1=5).  That’s why we call it a “super platelet mix”.  So finally, we had our answer, here’s a method to get to a quicker turn around procedure that based on the lab data, wouldn’t compromise stem cell number. This is Regenexx-SD, an uncompromising stem cell procedure worthy of carrying the Regenexx name.

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.

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.

Click here to read more information on the Regenexx Knee Procedure

April 11th, 2010, Denver, CO- Rocky Mountain Athletic Trainers’ Association Annual Symposium. Dr. Centeno will be speaking on The Use of Mesenchymal Stem Cells in Orthopedic Injuries. Click here for more information.

April 14th, 2010 5:30 pm- Webinar on The Use of Mesenchymal Stem Cells in Orthopedic Injuries. Click here to sign up.

April 22-25, 2010, Boca Raton, FL- Age Management Medicine Group Conference. Dr. Centeno is speaking on April 22. Click here for more information.

May Events

May 15th, 2010, Denver, CO- American Association of Medical Assistants Colorado State Association Conference. Dr. Centeno will be speaking on Stem Cell Research and Use in Orthopedics. Click here for more information.

May 21-23, 2010, Orlando, FL- Florida Society of Interventional Pain Physicians (FSIPP) Conference. Dr. Centeno will speak on the development of stem cells for pain management. Click here for more information.

June Events

June 25-27, 2010, Salt Lake City, UT- Worldlink Medical. Dr. Centeno will be speaking on Stem Cell Research and the Use of Stem Cells in Orthopedics. Click here for more information.

July Events

July 12-17, 2010, Las Vegas, NV- American Medical Technologist National Meeting. Dr. Schultz will be speaking on Stem Cell Therapy. Click here for more information.

July 16-18 2010, West Palm Beach Florida-Florida Academy of Pain Medicine-Dr. Centeno will be speaking on the Use of Stem Cell Therapy in Pain Medicine. Click here for more information.

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.)

Dr. Centeno’s Analysis:

Wayne is a 60-year-old retired financial planner. He had a multi-year history of bilateral shoulder pain and was told he needed a shoulder replacement. He had tried steroid injections with minimal success. He couldn’t lift his right shoulder, throw a ball or lift heavy objects. Wayne was seen in our Colorado clinic for the RegenexxTM procedure.

Outcome:

Eight months after his stem cell injection into the right shoulder, Wayne reports 75 percent improvement and wants us to inject his other shoulder (which is also a candidate for a joint replacement).

Images/Data:

Below are his pre-stem cell MRI on the left and his five-month post- injection MRI on the right. The biggest change is that the pre-injection MRI shows a dry arthritic joint without fluid, and the post-injection MRI shows a joint with normal joint fluid. This is important, as this synovial fluid lubricates the joint and allows it to move normally while cushioning and protecting the cartilage. We believe the new cartilage cells created by the stem cell injection have now started to produce synovial fluid, where the old cells did not.

For information, please contact us at 303-495-4014 or toll-free at 1-888-525-3005.

Shoulder Arthritis Treatment Image

Mesenchymal stem cells (MSCs) hold great promise as therapeutic agents in regenerative medicine. Numerous animal studies have documented the multipotency of MSCs, showing their capabilities for differentiating into orthopedic tissues such as muscle, bone, cartilage, and tendon. However, the complication rate for autologous MSC therapy is only now beginning to be reported. Methods: Between 2005 and 2009, two groups of patients were treated for various orthopedic conditions with culture-expanded, autologous, bone marrow-derived MSCs (group 1: n=45; group 2: n=182). Cells were cultured in monolayer culture flasks using an autologous platelet lysate technique and re-injected into peripheral joints (n=213) or into intervertebral discs (n=13) with use of c-arm fluoroscopy. While both groups had prospective surveillance for complications, Group 1 additionally underwent 3.0T MRI tracking of the re-implant sites. Results: Mean follow-up from the time of the re-implant procedure was 10.6 +/- 7.3 months. Serial MRI’s at 3 months, 6 months, 1 year and 2 years failed to demonstrate any tumor formation at the re-implant sites. Formal disease surveillance for adverse events based on HHS criteria documented 7 cases of probable procedure-related complications (thought to be associated with the re-implant procedure itself) and three cases of possible stem cell complications, all of which were either self-limited or were remedied with simple therapeutic measures. One patient was diagnosed with cancer; however, this was almost certainly unrelated to the MSC therapy. Conclusions: Using both high field MRI tracking and general surveillance in 227 patients, no neoplastic complications were detected at any stem cell re-implantation site. These findings are consistent with other reports that also show no evidence of malignant transformation in vivo, following implantation of MSCs that were expanded in vitro for limited periods.