To All: This message is being sent to both the Purdue site and the MUG site. Further messages may not appear at these two locations. Thanks for the response to the inquiry. There are 16 people in this list. None are actually Clinical Sorting at this time. I feel there are others out there that are interested but did not respond. There is some progress happening as we speak. First, Larry Lamb has indicated that there will be a workshop on this at the next ISHAGE. > ---------- > From: Larry Lamb[SMTP:LARRY.LAMB@PALMETTOHEALTH.ORG] > Sent: Friday, December 01, 2000 11:18:31 AM > To: mug@Cytomation.com > Subject: Re: Clinical Sorting > Auto forwarded by a Rule > Just a note to those interested in Jim's idea about a meeting - there will be a workshop on clinical sorting, sponsored in part by Cytomation, at the International Society for Hematotherapy and Graft Engineering (ISHAGE) meeting in Quebec City this June. I have the questionable distinction of chairing this workshop, and we plan to have a good slate of translational/clinical research people who are involved in the development of protocols for this work, a person from the FDA, and at least one applications person from Cytomation. I am not releasing names until the program is finalized, but please send me an email if you wish to be contacted further. The cost of registration will probably be under $50 if anything. Second: Dave Coder has informed me that the FDA has contacted him for more info. <<Let me know what the responses are. I just had a call from the FDA Cell and Gene Therapy division asking about sorting guidelines--I'm the new chair of the ISAC Biosafety committee. Getting an idea of the interest in the flow community would be good in determining how fast to move on making a recommendation. Dave >>>> So from these two events some progress is coming. However as Dave reminded me, it will be slow. I sometimes get impatient. Dave has indicated that the FDA appears to be more interested in what may be carried over from patient to patient than the concern with Operator contamination. These are the areas that I have concerned my project with: 1:Dedicated Instrument. For Human use only. Only use material generated within the lab. All outside material must be tested. This is a requirement for the whole facility. 2:All Tubing, connectors, O-rings etc. that contact the sample must be shown to either be capable for cleaning or be replaced. 3:Have redundant system in case of failure. I keep two lasers in operation. I have many spare parts. I have a duplicate system in research in case I need a board. 4:Detailed setup and cleaning procedures. Detailed procedure for QC and for setting up templates for sorting for specific projects. 5: QC testing on all sorted products (Pre/Post). 6: Good Operator. Someone whom has done Culture work and knows the instrument. We have found that the sorted samples probability of becoming contaminated will originate from the operator not from the environment. There is no substitute for good Culture techniques. 7: Speed is not an issue. I focus on recovery. I vary the speed per the amount of sample that needs to be sorted. Sorts last from 3-12 hrs. By far the most difficult is the cleaning between runs. I figure I can do maybe 2 possibly three per week. As Dave indicated to me, each instrument will have to be setup in different ways. What works for the MoFlo will not work for the Vantage or Coulter instruments. Each user will have to establish their own method in these early years. Hopefully as time progresses a more user friendly sorter for clinical apps will appear. Hopefully more help from the manufacturers. >From what I have experienced at St. Jude, the sorting of the cells and the procedures involved is a small component to the overall project that requires these cells. Please feel free to ask questions if needed. Dave Coder will inform us as he progresses through the process. If you have any thoughts or concerns on this please feel free to contact either he or myself. thanks for the exchange of info and thoughts. Jim Houston Coordinator, Flow Cytometry and Cell Sorting Cell and Gene Therapy, BMT-RES St. Jude Children's Research Hospital Memphis, TN 38105 Ph:901-495-2926 or x4155 E-mail: jim.houston@stjude.org
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