NIH, National Heart, Lung, & Blood Institute, BDR Contracts Section, Contracts Operations Branch, Rockledge Building (RKL2), Room 6134, 6107 ROCKLEDGE DR MSC 7902, BETHESDA MD 20892-7902

A -- COLLECTION AND STORAGE CENTERS FOR CLINICAL RESEARCH ON TR ANSPLANTATION OF UMBILICAL CORD STEM AND PROGENITOR CELLS SOL NHLBI-HB-95-05 POC Lynda A. Bindseil, Contracting Officer, (301) 435-0356. This study is designed to determine if stem and progenitor cells from umbilical cord blood units (UCBUs) are a clinically acceptable alternative to those from marrow or peripheral blood for unrelated-donor allogeneic transplantation. It is anticipated that at least 300 patients will be transplanted to answer important questions about UCBU transplantation. This project will require establishing: a) two to four collection and storage centers (Cord Blood Banks - CBBs) to provide the necessary resource by collecting, processing, cryopreserving and distributing human umbilical cord blood for transplantation to unrelated recipients, b) six to eight Cord Blood Transplant Centers (CBTCs) to follow common protocols for the transplantation of cord blood stem and progenitor cells, and c) a Medical Coordinating Center (MCC) to manage donor searches, facilitate the provision of cord blood units for transplants and collect and analyze data from these transplants. Responsiblilities for the Cord Blood Banks include, but are not limited to, the following: 1) participate as a member of the Steering Committee in finalizing details of the collection and storage protocol, study forms, and in completing the manual of operations, 2) collect, process, test and store UCBUs at a rate of 2,000 to 4,000 units per year for 3 years and 125-250 units per year for the remaining 18 months, with a varied racial-ethnic mix. The goal for the number of cord blood units to be stored in multiple participating banks is 20,000 within 3-4 years, with an additional 1,000 collected over each of the last 1-2 years of the program (total, 21,000 - 22,000), 3) develop and maintain a tracking system, linking confidentially each unit to the infant- donor and mother pair, taking all necessary precautions to protect the confidentiality of both mother and infant-donor, 4) HLA-type (HLA class I and II), or arrange to have HLA typed, all UCBUs and be prepared to so type mother's blood samples (before or after storage). HLA class I typing may be performed initially employing serological techniques, but as soon as possible, molecular-based techniques shall be used. Laboratories shall be prepared to type for HLA-A, -B, and -C. All class II typing shall use high resolution DNA-based technology. Laboratories performing these tests shall be CLIA certified, and 5) collaborate with investigators from other CBBs, the MCC, CBTCs and the NHLBI program office on developing and writing scientific presentations and manuscripts for publication. It is anticipated that multiple awards will be made from this solicitation and that awards will be made on or about April 1, 1996. It is anticipated that the awards will be multiple-year cost reimbursement completion contracts with a term of five years. RFP NHLBI-HB-95-05 will be released on or about June 19, 1995. To expedite requests for solicitation, please furnish three (3) self-addressed labels with your request. (0153)

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