Research Services Neural Stem Cell Study for Spinal Cord Injury Pre-solicitation Notice with Intent to Sole Source

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Summary from the notice

Special Notice Special Notice Page 3 of 3 Special Notice Special Notice Page 1 of 3 Pre-Solicitation Notice for notice of intent to award a sole source contract. This is not a solicitation. The Department of Veterans Affairs intends to negotiate a sole source contract for a one (1) year period with Pharmaron (San Diego) Lab Services LLC, 2820 Loker Ave E, Carlsbad CA 92010 to provide In vivo safety of neural stem cells grafted in rats with spinal cord injury. The vendor will be responsible for all aspects of the rat for the In Vivo GLP study performed in full compliance with FDA 21 CFR Part 58, Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. Rats will be subjected to a spinal cord injury, followed by a neural stem cell or control graft and will be sacrificed at 1, 3, or 9 months post-graft. The Vendor will be responsible for master study protocol, animal procurement, surgical and post-surgical support, animal perfusion and generation of a final GLP study report adhering to FDA 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies guidelines. The facility must be in driving distance to the VA San Diego to maintain scientific integrity of stem cells with time-sensitive transportation (cells that are transplanted into these animals are prepared in house and must be hand-delivered on ice) and to limit long-distance travel. These requirements are critical to support regulatory submission and clinical translation of therapies addressing spin…

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