We have been working for the past year to get our lab and cell lines (the medical procedure we use in our practice’s lab) certified through the International Cellular Medicine Society (ICMS). ICMS has created guidelines for autologous cell use as well as for labs which function as part of a physician’s medical practice. The Cell Line Advisory and Lab committees have informed us that we passed muster and can now say that we are ICMS certified in these areas. For our lab, this meant multiple visits by third party lab best practices auditing firm Reglera. This is an iterative process where the experts at Reglera helped us improve all aspects of the lab. Next came getting our cell lines certified. ICMS defines a cell line as a medical process used by the physician to process cells as part of a medical practice. This includes cell source (where they come from), the actual processing (grown in culture, how? how long? what safety mechanisms are in place?, etc…), and finally how they will be used. The final step toward full ICMS certification is completing the remaining steps to have the ICMS registry track all of our outcome and complications data. While we have been making this transition for months, ICMS is completing it’s web based capabilities to gather this data. We expect other clinics will follow in our footsteps to get ICMS certified and believe that this third party checks and balances (we had no part in the analysis or decision of ICMS to certify our clinic) makes for safer medical practice using stem cells.
Regenexx Procedure Featured on Singularity Hub
March 10th, 2010Was interviewed by a blogger for Singularity Hub, a futurist web-site I assume named after Ray Kurzweil’s book, “The Singularity is Near”. The Regenexx procedure was featured with an interesting debate on the site about the practice of medicine vs. interstate drug production. Not sure I like the title of the article or everything about it, but the writer ended up I think with with a balanced look at the procedure as well as the regulatory environment. Link is above…
Where you get your Stem Cells Matters
February 16th, 2010I’m often asked by patients and doctors why our stem cell lab doesn’t consider using adipose derived stem cells for orthopedic purposes. After all, it would seem far easier to just take a little fat aspiration in a mini-liposuction procedure rather than performing a bone marrow aspiration (where we derive cells for orthopedic use). The problem is that source of adult stem cells is very important to their function.
Stem cells come in many shapes, sizes, and types. Some are more differentiated than others, while some are less differentiated. Take for example adipose derived mesenchymal stem cells (MSC’s). When these adult stem cells (MSC’s) are compared to bone marrow derived MSC’s for orthopedic uses such as bone or cartilage repair, bone marrow derived MSC’s beat the pants off fat derived stem cells (Vidal et al, Niemeyer et al, Jakobsen et al). The reason is that many adult stem cell types are already pre-differentiated down a certain lineage (in this case bone marrow MSC’s are more differentiated down orthopedic lineages such as cartilage and bone). Fat derived MSC’s are good at becoming more fat, or assisting the repair of wounds to the dermis or subcutaneous tissues. As a result, adipose derived MSC’s are great for cosmetic uses, modulating the inflammatory response, and assisting in the repair of acute nerve injury. Is it possible to select MSC’s out of adipose tissue that might be better for orthopedic applications? It may be, as a recent paper by Jiang discusses. However, you likely still have a fish out of water.
This same rule holds true for many other tissues. As an example, synovium derived MSC’s are about 20% better for orthopedic uses than bone marrow derived MSC’s. This is because, they are simply closer to the area in need of repair (in this case joint cartilage). And so it goes, cardiac muscle derived progenitors are a little better at cardiac muscle repair, etc… The closer the stem cells are to the target tissue in need of repair and the closer their function in the body is to the repair process for that tissue, the better.
One practical caveat to the source rule may be yield. Yield is how many cells you can get from an rea for therapy. As an example, while periosteum stem cells from baby teeth may be very potent, you’re not going to isolate many stem cells from such a diminutive source. As a concrete example, synovial fluid can yield MSC’s for cartilage repair, but the numbers isolated directly from the fluid are usually well below the number needed to repair cartilage (or the cartilage would just repair itself). The same generally holds true for many other cell types derived from the tissues they serve. One way around this issue is culture expansion, or growing cells in culture to bigger numbers. This is how the body handles replacement of stem cells when they are used for daily repair and maintenance, it simply makes more cells. This process can amplify stem cells about 100-1,000 times more than the number harvested.
Here’s a summary of some common stem cell sources (and a few not so common) that seem to be helpful in certain conditions:
- Adipose derived stromal vascular fraction- These are cells that can be obtained by performing an aspiration of fat during liposuction. This adipose tissue is then processed in a simple lab or using a commercially available machine. About 1 in 100 of these cells is a mesenchymal stem cell, so it’s a dilute concentration of stem cells rather than isolated stem cells. These cells appear to be helpful for cosmetic, neural, and anti-inflammatory properties.
- Bone marrow derived cells: These cells can be concentrated in a commercially available centrifuge or by a lab to produce a bone marrow aspirate concentrate (BMAC) or isolated and grown in a more sophisticated lab to bigger numbers. They are appropriate for many uses including cardiac, pancreas, and orthopedic uses (as well as others).
- Cardiac muscle derived progenitors: These are either progenitor cells (stem cells that are more differentiated) or mesenchymal stem cells that are obtained by cardiac muscle biopsy. Since they are cardiac specific, they would be appropriate for cardiac use.
- Synovial derived mesenchymal stem cells- These are orthopedic MSC’s that are specific for cartilage repair and are derived from either a synovial tissue biopsy or a synovial fluid draw.
It’s important to note that almost any tissue can yield stem cells or progenitors. As an example, MSC’s have been obtained from periosteum, cardiac muscle, fat, dermis, blood vessel walls, and marrow, just to name a few. You can even get stem cells from the endometrial tissue obtained from menstrating women. In summary, the closer the stem cell is to its original location or function in the body, the better the stem cell is at repairing that specific area. So in stem cells, source matters.
Induced Pluripotent Stem (IPS) Cells Show Problems
February 14th, 2010In a recent study, adult skin cells that were turned into embryonic like stem cells showed problems with advanced aging IPS cells are created from normal adult cells, usually by exposing them to some chemicals or inserting new genes. If you know a basic amount about stem cell science, this story has to fall into the “duh” category. Adult cells are not made to be immortalized (faked out so that they can be grown forever). The only immortalized cells we encounter on a day to day basis are cancer cells. So until we understand all there is to know about how a human cell works at a genetic machinery level (maybe 20-50 years from now?), trying to trick skin cells into becoming immortal stem cells is like juggling with hand grenades, it’s possible, just not smart. Since these adult cells tricked into thinking they are stem cells at some level still know they are normal adult skin cells, they age like normal adult skin cells. As I have posted before, there is no logical reason we are considering embryonic and IPS cells for drug candidates, as both have severe downsides compared to the patent’s own adult pluipotent stem cells (like the mesenchymal stem cells we use or other adult stem cell types). In fact, I can think of only one reason why one would consider using these stem cell types at this early juncture, big pharma. The only big advantage these cells have (other than the rare cases where the patient;s own cells might not work) would be that they can be grown in bio reactors, placed in vials, and sold as drugs. Since the patent’s own adult stem cells were built for repair and maintenance, other than the problems with business plan, they would be the best candidate for safe stem cell therapy now. This is consistent with the adult stem cell safety study we just published.
Regenexx Featured in the Broomfield Enterprise
February 9th, 2010Knee Meniscus Tear treated without Surgery
January 27th, 2010
Greg is a 51 year old who fell from a ladder and tore the back part of his medial meniscus (radial tear of the posterior horn of the medial meniscus). Greg limped around for three months and then decided he didn’t want surgery. Instead, he presented to our clinic and we determined on exam that this was likely the cause of his pain. As you know, research now shows that knee meniscus tears are not always the cause of pain, so a good exam is now needed to make sure. He decided to avoid surgery and have his own stem cells harvested, grown in culture, then injected under imaging guidance into the tear. He was seen for a series of injections, and 6 months out from these, he reported this week 100% improvement in his knee pain symptoms and a significant improvement in function. As a another discussion, a different patient seen yesterday in clinic needed adjustments in his treatment plan beyond the meniscus. This patient also had a significant meniscus problem, which was treated during his first two procedures. This area significantly improved. However, it was detected on his exam that he has ongoing instability in this knee due to a lax ACL (anterior cruciate ligament) and tendinitis in his patella, which left him with continued anterior (front) knee pain. As a result, we needed to change the placement of cells from the meniscus to the ACL and patellar tendon to treat these secondary issues. So while the first case was smooth sailing from the start, the second patient had knee instability that needed treatment in addition to the meniscus. This brings up the importance of specific targeting of certain knee structures versus just blind injections in the joint. The research in this area supports that specific placement of cells would be more effective than just blindly injecting cells into the joint. This second patient also brings up the ortho 2.0 concepts I have blogged on in the past.
Stem cells injected to treat thumb arthritis
January 25th, 2010Larry is a 60 year old male with severe arthritis in his CMC joint (base of thumb). He was unable to button his own shirt due to pain. I think this patient update is a good follow-up to the last blog, which discussed surgically removing a wrist bone to treat thumb arthritis (the space fills in with scar tissue). He was offered surgical options, but chose to have his own adult stem cells injected into the joint rather than surgery. This morning he reported 90% improvement at 6 months after his procedure, and the ability to button his shirt again. We had Larry at a FAIR candidate for the procedure (we use GOOD, FAIR, POOR for patients who are considering the procedure), which to us means that while the procedure may be successful, there is a significant chance of failure. We continue to grade patients for the procedure more pessimistically than is likely necessary, because we believe that until we have more data analyzed, it’s better to stay conservative. Also realize that Larry had no surgery, only an x-ray guided injection pre-injection and then injection of his own stem cells, with limited downtime. He wore a splint for a week after the injection, but had no prolonged immobilization. We will continue to track Larry’s outcomes, but his results are consistent with other patients we have treated for thumb arthritis.
Removing the Trapezium Bone to Help Thumb Arthritis?
January 19th, 2010In the truth is stranger than fiction category this morning is a patient who discussed that her surgeon was planning on taking out an important wrist bone to solve her thumb CMC arthritis problem. Arthritis at the base of the thumb (black berry or texting thumb) is a common problem these days. The trapezium bone is in the yellow dashed circle above (‘E”) in the diagram above, and lives at the base of the thumb joint (CMC). The theory is that yanking this bone out will remove 1/2 of the painful joint and the area will fill in with scar tissue. This surgery can be done in such a way as to spare the surrounding ligaments. The problem is that the carpal bones are needed to help coordinate proper hand function and the wrist joint is one of the body’s most complex areas. Yanking out an important piece of the wrist may help with a short term reduction in pain, but will permanently alter the biomechanics of the wrist and likely lead to more arthritis in more of the wrist. In addition, once the bone is removed, there is no going back. While this surgery may help reduce pain, I’d have to put it in the same category as many surgeries that try to improve upon the body’s function by removing critical parts, a bad idea. Think about if your mechanic came to you with an extra part in his hand after “fixing” your car. He tells you that you really don’t need this part and that you can get an extra 1,000 trouble free miles out of it as a result of him removing the part. You ask him what happens after that? He tells you that he’s not exactly sure, but he thinks that as a result of removing the part, he’ll have to perform a major rebuild of your engine. I think it’s clear that most of us wouldn’t take the trade off.
Hip AVN / ON (Avascular Necrosis – Osteonecrosis) Outcomes
January 15th, 2010Over 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.




















