Comments on: Cord Banking and Cerebral Palsy http://www.traumaticbraininjurycenters.com/2009/07/cord-banking-and-cerebral-palsy/ Function, Education and Research Wed, 09 Jun 2010 13:45:16 +0000 http://wordpress.org/?v=2.9.2 hourly 1 By: admin http://www.traumaticbraininjurycenters.com/2009/07/cord-banking-and-cerebral-palsy/comment-page-1/#comment-94 admin Wed, 23 Dec 2009 14:41:15 +0000 http://empower2go.wordpress.com/2009/07/12/cord-banking-and-cerebral-palsy/#comment-94 Talked to the FDA about stemcells and asked them about storage. This page is very helpful in regards to regulations. Storage seems OK but apparently growing out cells has been regulated since 1995 and their proceedings on this are available online. The regulation 1271 link here http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271 For safety reasons things like direct transfer of cells and atificial insemination are considered safe practice of medicine whereas growing out these cells whether in a fertility clinic or Drs office is regulated although any dr or organization can apply on an individual basis for a compassionate exception. Talked to the FDA about stemcells and asked them about storage. This page is very helpful in regards to regulations. Storage seems OK but apparently growing out cells has been regulated since 1995 and their proceedings on this are available online. The regulation 1271 link here http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271 For safety reasons things like direct transfer of cells and atificial insemination are considered safe practice of medicine whereas growing out these cells whether in a fertility clinic or Drs office is regulated although any dr or organization can apply on an individual basis for a compassionate exception.

]]> By: admin http://www.traumaticbraininjurycenters.com/2009/07/cord-banking-and-cerebral-palsy/comment-page-1/#comment-93 admin Fri, 18 Dec 2009 19:36:43 +0000 http://empower2go.wordpress.com/2009/07/12/cord-banking-and-cerebral-palsy/#comment-93 Hi Matt, I was told this numerous times by a stem cell company based in Colorado. From my contact with universities active in bone marrow and skin stem cell research I am not sure the information is accurate. I will call the FDA and ask them. It seems to me there would be no way to match organ recipients, blood types or marrow for other needs if this was the case. Perhaps the issue was them growing stem cells out in various culture media and then reinserting as the harvesting of the cells at safe times and the media even if media separately met FDA safety standards, the concern that the interaction may be unpredictable may be the issue...it seems to me that there are some restrictions even for fertility clinics on how the embryos are grown as this can alter the DNA, since about 98% of DNA is not fully coded and research is pointing to this being the part of the DNA that is involved with regulation and growth which may be the cause for concern with grown out stem cells ...If the FDA says something different I will post what I learn...Thanks for bringing this to my attention Hi Matt,
I was told this numerous times by a stem cell company based in Colorado. From my contact with universities active in bone marrow and skin stem cell research I am not sure the information is accurate. I will call the FDA and ask them. It seems to me there would be no way to match organ recipients, blood types or marrow for other needs if this was the case.

Perhaps the issue was them growing stem cells out in various culture media and then reinserting as the harvesting of the cells at safe times and the media even if media separately met FDA safety standards, the concern that the interaction may be unpredictable may be the issue…it seems to me that there are some restrictions even for fertility clinics on how the embryos are grown as this can alter the DNA, since about 98% of DNA is not fully coded and research is pointing to this being the part of the DNA that is involved with regulation and growth which may be the cause for concern with grown out stem cells …If the FDA says something different I will post what I learn…Thanks for bringing this to my attention

]]> By: Matt http://www.traumaticbraininjurycenters.com/2009/07/cord-banking-and-cerebral-palsy/comment-page-1/#comment-92 Matt Fri, 18 Dec 2009 03:16:26 +0000 http://empower2go.wordpress.com/2009/07/12/cord-banking-and-cerebral-palsy/#comment-92 I was wondering if you could elaborate on legal issues pertaining to transport across state lines? I hadn't heard of this being an issue before, and it was my understanding that a large number of private banks often store in states other than where their offices are located and/or cord blood collected. Are there particular states which have particular prohibitions on exporting? Thanks for any further information. I was wondering if you could elaborate on legal issues pertaining to transport across state lines? I hadn’t heard of this being an issue before, and it was my understanding that a large number of private banks often store in states other than where their offices are located and/or cord blood collected. Are there particular states which have particular prohibitions on exporting?

Thanks for any further information.

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