NIH, National Heart, Lung, & Blood Institute, BDR Contracts Section Contracts Operations Branch, Rockledge Building (RKL2), Room 6144, 6701 Rockledge Drive, Bethesda, MD 20892-7902

A -- TRANSPLANT CENTERS FOR CLINICAL RESEARCH ON TRANSPLANTATION FOR UM BILICAL CORD STEM AND PROGENITOR CELLS SOL NHLBI-HB-95-06 POC Jack E. Jackson, Contracting Officer, (301) 435-0361. 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. Responsibilities for the transplant centers include, but are not limited to the following: 1) provide as many candidates for cord blood stem and progenitor cell transplant as possible each year of the contract (at least 5 per year, to complete the study, the average number of transplants per transplant center must be 10- 13 per year), 2) participate as member of the Steering Committee in finalizing the details of the protocol and completing the manual of operations, 3) follow the protocol in transplanting patients using umbilical cord blood stem and progenitor cells, 4) provide such data as are required to the medical coordinating center about the patients transplanted, 5) participate in all committee and subcommittee meetings, 6) participate in the discussion, analysis, and interpretation of the data, and 7) prepare scientific reports for publication and presentation. Offerors must provide evidence of certification as an approved allogenic marrow transplant unit by the NMDP-unrelated donors or an NCI Cooperative Chemotherapy Group, or must provide evidence of application to become an approved unit. It anticipated that multiple awards will be made for this solicitation and that the awards will be made on or about March 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-95-06 will be released on or about June 19, 1995. To expedite requests for the solicitation, please furnish three (3) self-addressed labels with your request. (0158)

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