Neural Stem Cell GLP Study for Spinal Cord Injury — VA San Diego

This is a Sources Sought notice and not a request for proposals. This request is solely for the purpose of conducting market research to enhance VHA s understanding of the market s offered products, services and capabilities. The Government will not pay any costs for responses submitted in response to this Sources Sought. This Sources Sought notice provides an opportunity for respondents to submit their notice of ability, and their available products and services in response to the requirement described below. Vendors are invited to submit information relative to their potential of fulfilling the requirement below, in the form of a capability response that addresses the specific requirement identified in this Sources Sought. The Veterans Health Administration (VHA) is seeking a vendor to provide the following products and/or services below. Please see the General Requirements section below for the requested products/services and descriptions. This Sources Sought is to facilitate the Contracting Officer s review of the market base, for acquisition planning, size determination, and procurement strategy. 1. GENERAL REQUIREMENTS The Department of Veterans Affairs Office of Research & Development requires services for a research study in San Diego CA. The San Diego VA Medical Center, Research Service requires In vivo safety of neural stem cells grafted in rats with spinal cord injury. 2. SCOPE OF WORK The vendor will be responsible for all aspects of the rat 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. 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 spinal cord injury in the Veteran population. The study sponsors will perform surgery (lesion and grafting) and product administration at the vendor s facility. At the conclusion of the study, all histological materials from systemic organs will be evaluated by a licensed and independent veterinary pathologist. 3. CONTRACTOR REQUIREMENTS AND TASKS: a. Milestone 1: Completion of study protocol SPECIFIC TASK: Vendor will write a master study protocol to perform spinal cord injuries followed by neural stem cell grafting in rats, post-operative care and euthanasia at specific timepoints post-grafting. Vendor will provide a Quality Assurance (QA) unit to confirm study protocol will be conducted according to U.S. FDA regulations, 21 CFR Part 58, Good Laboratory Practice (GLP) for Nonclinical Laboratory Studies. DELIVERABLE: Signed and executable GLP master study protocol b. Milestone 2 : Purchase and acclimation all study animals SPECIFIC TASK: Vendor will purchase and acclimate all animals enrolled in study protocol. Since animals are athymic rats that are immunocompromised, specialized sterile facilities are required. DELIVERABLE: Report in PDF format detailing acclimation process and results. Report due no later than 15 days after purchase and acclimation. c. Milestone 3: Completion of all lesions and transplant surgeries SPECIFIC TASK: Vendor will provide surgical facilities, as well as surgical and post-operative care support. Vendor will provide a Quality Assurance (QA) unit to confirm study protocol will be conducted according to U.S. FDA regulations, 21 CFR Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies. DELIVERABLE: Report on completion of lesions and transplant surgery to include complications, mortality and/or morbidity, due no later than 15 days after surgery of all animals. d. Milestone 4: Perfusion of all animals scheduled for 1-month time point SPECIFIC TASK: Vendor will compete perfusion and tissue extraction of rats slated for 1-month post-graft timepoint. DELIVERABLE: Animal health and welfare report due no later than 15 days after 1- month timepoint. e. Milestone 5: Perfusion of all animals scheduled for 3-month time point SPECIFIC TASK: Vendor will compete perfusion and tissue extraction of rats slated for 3-month post-graft timepoint. DELIVERABLE: Animal health and welfare report due no later than 15 days after 3- month timepoint. f. Milestone 6: Perfusion of all animals scheduled for 9-month time point SPECIFIC TASK: Vendor will complete perfusion and tissue extraction of rats