Okay, to introduce her further, she is a Fellow of the American Society of Anesthesiology, she's Professor of Anesthesiology at Duke University, and is in the Department of Population Health Sciences. And so that's something to think about that I've thought about when I was looking at these. fee at all. The 'YY' indicator represents that this procedure is approved to be However, I just would caution that Dr. Gajewski mentioned earlier the possibility of, you know, a little bit more rare, but very, very problematic conditions such as graft versus host. Thank you, Linda, and good afternoon everyone and again, welcome to the Contractor Advisory Committee meeting for Amniotic Product Injections for Musculoskeletal Indications Non-Wound. It's actually quite a good outcome for measuring knee pain and other knee outcomes in osteoarthritis. That makes it an allogeneic product subject to licensure. I don't have a good solution for that. We still don't know. Dr. Barton L. Wise, MD 35 33 It is a randomized, controlled trial. If there are no further comments, then we will proceed to our fourth and final poll. Thanks, Dr. Gajewski, this is Ann Marie Sun again, I actually, the aha moment that I just had was your statement, which is completely true, that there is a possibility that negative studies wouldn't even be published in the first place, right. And the outcomes used were variable within these studies, as well. Benefits. This was Derek Buck. Also, of note, for this particular paper was that the HNP group was on the younger side, 30 years plus minus and that their symptoms, the inclusion criteria required that they have pain for at least three months. The last one, the Farr study, is the best of the group. The AMA does not directly or indirectly practice medicine or dispense medical services. Throughout the call, we ask you to announce yourself prior to speaking, especially if you haven't spoken in some time, so that it's clear for the audience, and for the record, who is providing each comment. It was done by a single physician over 14 months. Yes, good afternoon. Warning: you are accessing an information system that may be a U.S. Government information system. Before sharing sensitive information, make sure you're on a federal government site. But, given what I stated, not homologous use of cells or allogeneic cells are subject to licensure. I also have had strong conversations with FDA, and they agree that the issue of use of a bone marrow asper for joint repairs or fracture repairs, or injection to facilitate, wound repair, that that also is non homologous use, of cells because those cells are for hematopoietic reconstitution hematopoiesis. Other thing and a number 14 with Robert Santrock, Hanselman know essentially the effectiveness is similar to steroid injections. Dr. Padma Gulur We were told we could not look at those separately. They are very heterogeneous in terms of active content. The involvement of a more stringent and standardized process is significantly wanting, before we can truly assess the safety and efficacy of these products in treatment, for low back pain, and cervical facet joint disease. Dalanna S This is Jim Gajewski, I have a question where, where you actually did these injections for the micro fractures? {B$0{@-g;E*m ZhP' 94*_@0C"EXOeB0]:w`;d3Qf)2 }q)e]wNa%FS|C|N/\Z ZLA&0aC`+9MA- 9[cBo}gi;>E\H%2PXus |,"y5q+p^$C-y#]+vJ%@|6 : &TI=C$^';Ez^J=SZ-gZ

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