AN11--Reprogrammed Stem Cells for Osteoarthritis

Atlanta VA Health Care System Research and Development Service (Reprogrammed Stem Cells for Osteoarthritis) STATEMENT OF WORK This Statement of Work, effective as of the start of the contract, is a complete agreement on its terms between the United States Department of Veterans Affairs (VA) and "Service Provider". This document defines the scope, terms, conditions, and mutual responsibilities to which both parties agree. It encompasses all aspects necessary for the services described herein and does not require reference to any external contract or agreement A. GENERAL INFORMATION 1. Title of Project: Reprogrammed Stem Cells for Osteoarthritis 2. Background: The Veteran Health Administration Office of Research and Development has funded a multi-year research project entitled “Stem cell reprogramming for joint preservation to alleviate pain and promote function.” The research project requires unique cell lines derived from inducible pluripotent stem cells (iPSCs) to identify an unlimited source of stem cell line to consistently resolve osteoarthritic inflammation, and pain, and to slow disease progression. The Atlanta VA Health Care System, Research and Development Service, seeks a multi-year (base year plus four option years) contract to provide iPSC lines from various donors and tissue sources to the Atlanta VA Medical Center, 1670 Clairmont Road, Decatur, Georgia, 30033. The vendor will provide iPSC cell lines from various tissue sources including chondrocytes and bone marrow of varying health, and multiple donors. The vendor will provide proof of successful reprogramming of these cell lines and will provide 3–5 clones per line. The vendor’s work, activities and performance will be under the direction of the Atlanta VA research faculty, Dr. Hicham Drissi. These research projects aim to identify and validate a novel cell line to relieve preclinical osteoarthritic pain. 3. Scope of Work: Tissues and donors will be provided by the VA. The vendor will provide inducible pluripotent stem cells (iPSCs) derived from various tissues (including articular chondrocytes and bone marrow) and donors. Demonstration of the successful reprogramming, the vendor, will be provided through standard imaging assays and immunocytochemistry and at least 3 clones per cell line will also be provided. The iPSC reprogramming service price includes the delivery of 3–5 clones per cell line, each with 3 cryopreserved vials. SSEA4 and OCT4 immunocytochemistry are included for one clone of each iPSC line. Cryopreserved vials will be shipped back to the VA. 3.1. Deliverables: The vendor/Contractor agrees to the following deliverable dates: Deliver 18 iPSC lines (3 tissue sources with 6 donors each) over the course of the contract The Atlanta VA will send tissues to Vendor. Vensor will complete re=programing tasks using Sendai virus The iPSC reprogramming service price includes the delivery of 3–5 clones per cell line, each with 3 cryopreserved vials. SSEA4 and OCT4 immunocytochemistry are included for one clone of each iPSC line. Vendor will return items back to Atlanta VA. An invoice will be issued upon completion of each iPSC cell line. 3.2.Description of Tasks and Associated Deliverables: Task One: Deliverable One: One sample set will be sent and returned Delivery Date: The first three months of the contract Task Two: Deliverable Two: Second sample set will be sent and returned Delivery Date: The fourth to sixth months of the contract Task Three: Deliverable Three: Third sample set will be sent and returned Delivery Date: The fourth to sixth months of the contract 4. Contractor Requirements: The source of the iPSCs must be reliable and consistent in their manufacturing of the iPSC lines and must be consistent with our already established cell lines within the lab to provide accurate comparisons with the ongoing work to establish a reliable and consistent cell source to relieve osteoarthritic pain in Veterans. The cells must originate from various donors and from tissues including articular chondrocytes and bone marrow of variable health. The cells must be reprogrammed with a Sendai virus, and returned to the Atlanta VA.. All work must be done in-house without subcontracting the work to a different vendor to provide a consistent and transparent handling pipeline. 7. Type of Contract: Firm-fixed-price Base year plus four option years (if needed) . 8. Place of Performance: The vendor shall complete all work at their site of business. 9. Description: Base Start Date: 8.1.2026 End Date: 7.30.2027 10. Payment Terms: Invoices for services will be through Tungsten 11. Performance and Accuracy / Performance Monitoring: The Research Investigator, will monitor the vendor’s activities and performance, including successful reprogramming of cells (indicated by immunocytochemistry) within the specified timeframe of 4 months. Payment will be approved upon receiving the reprogrammed cells and proof of reprogramming at the Atlanta VAMC. The Research Investigator will meet with the vendor as needed to address any concerns with activities or performance. Any concerns will be addressed and resolved in a timely manner. dor. The Contracting Officer will be contacted as needed. C. CHANGES TO STATEMENT OF WORK Any changes to this SOW shall be authorized and approved only through written correspondence from the Contracting Officer. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the Contracting Officer shall be borne by the contractor. D. CONFIDENTIALITY AND NONDISCLOSURE It is agreed that: 1. The preliminary and final delivera…