"Researchers at Mayo Clinics campus in Florida http have conducted the worlds first prospective blinded and placebocontrolled clinical study to test the benefit of using bone marrow stem cells a regenerative medicine therapy to reduce arthritic pain http and disability in knees. The researchers say such testing is needed because there are at least  stem cell clinics in the U.S. offering one form of stem cell therapy or another to an estimated plus patients who pay thousands of dollars out of pocket for the treatment which has not undergone demanding clinical study. The findings in The American Journal of Sports Medicine  httpajs.sagepub.cominclude an anomalous finding  patients not only had a dramatic improvement in the knee that received stem cells but also in their other knee which also had painful arthritis but received only a saline control injection. Each of the  patients enrolled in the study had two bad knees but did not know which knee received the stem cells. Given that the stem celltreated knee was no better than the controltreated knee  both were significantly better than before the study began  the researchers say the stem cells effectiveness remains somewhat uninterpretable. They are only able to conclude the procedure is safe to undergo as an option for knee pain but they cannot yet recommend it for routine arthritis care. Our findings can be interpreted in ways that we now need to test  one of which is that bone marrow stem cell injection in one ailing knee can relieve pain in both affected knees in a systemic or wholebody fashion says the studys lead author Shane Shapiro M.D. http a Mayo Clinic orthopedic physician. Journalists sound bites with Dr. Shane Shapiro are available in the downloads below. MEDIA CONTACT Kevin Punsky Mayo Clinic Public Affairs  punsky.kevinmayo.edu mailtopunsky.kevinmayo.edu One hypothesis is that the stem cells we tested can home to areas of injury where they are needed which makes sense given that stem cells injected intravenously in cancer treatments end up in the patients bone marrow where they need to go he says. This is just a theory that can explain our results so it needs further testing. Another explanation is that merely injecting any substance into a knee offered relief from pain. That could be but both this idea and the notion that a placebo effect could be involved would be surprising given that some patients are still doing very well years after their study treatment ended says Dr. Shapiro. He adds that these findings are important because while use of a patients own stem cells for regenerative therapy is extraordinarily popular the treatments may be untested and are often poorly regulated. Stem cell clinics often offer expensive treatments for conditions that range from multiple sclerosis lung and heart disease to cosmetic treatments such as facelifts. None of these techniques have been studied because clinics maintain that use of a patients own cells is not a drug. But depending on how they are processed and used stem cells can in fact be regulated by the U.S. Food and Drug Administration as biological products or drugs requiring rigorous safety and efficacy approval processes. In early September the FDA held scientific meetings to clarify how to regulate such practices. Mayo Clinic researchers developed their study with FDA approval. We feel that if we are going to offer any stem cell procedures to our patients the science needs to be worked out Dr. Shapiro says. The study was conducted in Mayos Human Cell Therapy Lab. Researchers extracted  to  milliliters of bone marrow from each patient then filtered it removed all blood cells and concentrated it down to  to  milliliters. The solution which contained tens of thousands of stem cells was injected into a patients knee using ultrasoundguided imagery. We actually counted all of the stem cells with markers that are accepted by the FDA and we made sure they would be able to survive inside the patient Dr. Shapiro says. Counting is expensive. Most clinics just draw the cells from bone marrow or fat and inject them back into the patient without checking for stem cells hoping that patients get better he says. Dr. Shapiro and his colleagues are currently designing new studies that will test whether the stem cells home to distant areas of injuries as well as exploring other implications suggested in their findings. Study investigators include Mayo Clinic in Florida senior author Mary L. OConnor M.D. Shari E. Kazmerchak Michael G. Heckman and Abba C. Zubair M.D. Ph.D. http_ga... Dr. OConnor is now at Yale University. Funding for this study was from Mayo Clinics Center for Regenerative Medicine http_ga...."