No doubt some of you who regularly read my posts probably thought that I had lost my mind during the just completed set of three posts on considerations for using IV infusion with autologous BMC to boost up cellularity in a patient’s depleted bone marrow depots. I suspect you couldn’t believe that I would write posts that might be construed to support the contentions of the amniotic fluid product hawkers who tell physicians that their patients could get great benefits from an IV-based therapy with their ever-so precious amniotic fluid. However, I want to set the record straight, since there are a number of important distinctions between the potential utility of IV infusion of BMC versus using amniotic fluid products.
Of course, the most important distinction between BMC therapy and the use of amniotic fluid products is that there are no clinical studies that I could find (yet again) that support any therapeutic benefit for patients receiving amniotic fluid products in treating anything; from non-compliant neurological diseases, like MS, to run-of-the-mill orthopedic conditions, like osteoarthritic knees. So, claims made by hawkers of amniotic fluid products, whispered to their physician targets, about great therapeutic success are all rubbish. Thus, it is completely dishonest to imply that patients could benefit from an IV infusion of a magical amniotic fluid product, since direct site injection of this type of material hasn’t been shown to provide a clinical benefit of any kind for any pathologic condition.
On the other hand, use of BMC to treat orthopedic pathologies goes back more than 30 years courtesy of Dr. Philippe Hernigou (Chief of Orthopedic Surgery at the Henri Mondor Hospital, East University, Créteil, France). For example, he has published numerous clinical studies on using BMC as a treatment of avascular necrotic lesions (e.g., of the femoral head), for treating long bone non-unions, for treating rotator cuff tears as an augmentative therapy following surgical repair, and for treating osteoarthritis in knees of patients who had been treated with corticosteroids and developed avascular necrosis of the knee. Most recently, during a presentation at the MedRebels conference (held at the end of October in Austin, TX), he showed data in which elderly (≥ 80 yo) patients suffering from bilateral knee osteoarthritis for which a single total knee arthroplasty was performed, but who opted to be treated intra-osseously (femoral and tibial plateau) with BMC in the other knee, reported significant pain relief and improvement in their quality of life for the BMC-treated knee comparable to that achieved with their total knee replacement.
In addition to the improved quality of life achieved by the elderly patients following an intra-osseous injection to treat knee osteoarthritis, Dr. Hernigou also presented data at the MedRebels conference that supported a slightly longer life expectancy for patients receiving local BMC therapy. He indicated that patients undergoing an “elective local cell [BMC] therapy” (n = 3435) showed a 5% increase in survival compared to the general population out to 10 years-post treatment. Relative survival of the BMC-treated cohort was statistically significantly improved over survival of the general population, when study subjects were matched for gender and age at treatment. These results were more pronounced for older patients, especially for those being treated for knee osteoarthritis. Patients being treated for avascular necrosis of the femoral head had an even higher relative survival, but those patients being treated for knee osteoarthritis who were less than 50 years old at the time of treatment showed no statistical difference in relative survival. The implication in these extraordinary results is that boosting the cellularity of deficient bone marrow depots, especially in the elderly, provides not only an improvement in their quality of life, but seems to somewhat lengthen their survival.
Now back to the smoke and mirrors of amniotic fluid products. Besides the continuing lack of clinical evidence of efficacy, there are practical problems with commercially available amniotic fluid products. Given the uncontrolled conditions under which vials of frozen amniotic fluid are thawed, recovery of viable cells is low. I know this from being asked by physicians to thaw vials of amniotic product they provided and assess the number and viability of the cells present. Oh, yes, there were cells present, but not very many and with viabilities not exceeding 30% or so. Furthermore, out of four vials from two lots of product, I recall only a single colony growing in the CFU-F assay used to assess the level of MSCs present in the material. Similar observations have been reported by others on their blogs. So, at least with the material I evaluated, there weren’t many cells, their viability was low and there was just one single, rather lonely, CFU-F present in 4 mL of amniotic fluid product. I would hope by now that I don’t need to contrast this sorry situation with the level of progenitor stem cells found in bone marrow, even in the elderly.
I will continue reviewing the significant distinctions between BMC and amniotic fluid products in the next post. These distinctions are more than sufficient to separate the reality of BMC therapy from the fantasy and hype associated with amniotic fluid products.