NIH, National Heart, Lung, & Blood Institute, BDR Contracts Section, Contracts Operations Branch, Rockledge Building (RKL2), Room 6142, 6107 ROCKLEDGE DR MSC 7902, BETHESDA MD 20892-7902

A -- MEDICAL COORDINATING CENTER FOR CLINICAL RESEARCH ON TR ANSPLANTATION OF UMBILICAL CORD STEM AND PROGENITOR CELLS . SOL NHLBI-HB-95-07 POC Joanna B. Magginas, Contract Specialist, (301) 435-0360 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 Medical Coordinating Center include, but are not limited to, the following: 1) coordinate the development, production, and distribution of the protocol, study forms and the manual of operations and arrange, manage and provide minutes for meetings of the Steering Committee and key subcommittees, if any, 2) as soon as possible, but no later than 4 months after the start of the contract, the MCC shall establish a centralized electronic data-base registry of banked cord blood units, beginning with those already in storage at any of the CBBs, 3) train participating center staff in the completion of data forms, 4) perform UCBU searches to find HLA matching units for transplantation at CBTCs, 5) arrange for appropriate UCBUs to be delivered to CBTCs for transplant, 6) perform all activities of a MCC such as collecting, organizing and storing for analysis data from CBBs and CBTCs, 7) assure the quality of the data submitted and stored, and 8) provide monthly reports to the NHLBI concerning the progress of the study. It is anticipated that one award will be made from this solicitation and that the award will be made on or about April 1, 1996. It is anticipated that the award will be a multiple-year cost reimbursement completion contract with a term of five years. RFP NHLBI-HB-95-07 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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