Like any procedure, the Regenexx-C procedure works better in some patients than in others. We have always provided prospective grading of candidacy. What does this mean? It means that we obtain basic information about the patient and ask to review films to determine the severity of their disease. We compare that severity to our clinical experience with that specific procedure and place the patient in a GOOD, FAIR, or POOR category. We believe this is an important part of any stem cell based procedure. What this means practically is that about 1/4 of the patients get put into the GOOD category, 1/2 in the FAIR category, and about 1/4 in the POOR category. In addition, this stem cell procedure grading is different for each procedure. As examples:
-For peripheral joints (knee, hip, shoulder, ankle, etc…) the grading depends on severity of the arthritis. We feel GOOD candidates have a limited amount of cartilage loss or an “OCD”. FAIR candidates have one compartment cartilage loss (like medial or lateral side) without major bony structural changes and POOR candidates generally have significant structural changes in the bone (huge bone spurs) that cause significant loss of range of motion.
-For ligaments and tendons the grading depends on the integrity of the structure. GOOD candidates have a partial thickness tear or a small full thickness tear where the tendon or ligament is still intact. At this point we can’t treat full thickness and retracted tears in ligaments or tendons, so these are placed in a “we can’t treat you” category. This is because the ends of the tears need to be surgically brought back together before any injection based therapy is likely to help.
-For bone problems (fracture non-union and AVN) our grading is based on the amount of damage. AVN is graded on a scale (we use ARCO) and stage 1-2 (without structural collapse of the bone) are GOOD candidates, yet stages 3 and above are considered FAIR-POOR candidates (we discourage these patients from trying our non-surgical stem cell treatment). For fracture non-unions, the fracture site must be stable for the patient to be a GOOD candidate, the fracture site should have all areas in relatively close approximation (we have filled in up to a 1 cm gap), and the fracture within 1-2 yerars old. Large areas of loss of bone may place you in the FAIR or POOR categories. In addition, if the fracture has been there many years (more than 1-2), this may also make the procedure much less effective. The good news is that we have seen healing in smokers and patients that have failed a bone stimulator, patients who are usually notoriously difficult to heal.
-Low back discs are graded on their severity and degree of collapse. GOOD candidates are patients with at least 75% of disc height preserved, can have a dark disc, have a contained disc bulge or subligamentous herniation (herniated disc where the herniated material hasn’t pushed past the posterior longitudinal ligament). If the disc is collapsed and has lost most of it’s disc height, our procedure is unlikely to help.
There are also other factors outside of disease severity that make up our grading. These include age vs. sex (male vs. female), number and type of prescription medications, activity level, body mass index, overall physical health, etc… Even though we prospectively grade candidates for the Regenexx-C procedure, we have been surprised. Despite our grading system we have had poor candidates show up from time to time and do well with treatment (the vast majority of these are knee arthritis patients). In summary, we believe that any valid medical or surgical procedure needs to grade patients up front to let them know their basic candidacy. In addition, whether or not they are allowed to try to the procedure despite being warned of being a POOR candidate should be directly related to the degree of complications associated with the procedure. Since we have had no significant stem cell related complications in about 450 patients in the last 4 years and have been surprised in knees, we do allow primarily knee patients to try the procedure even if they are not ideal candidates. However, we will not see late stage AVN patients, disc patients whose disc has already collapsed, unstable fractures, etc…