Automated system for the comparison of individual genome, transcriptome, proteome, epigenome, and metabolome data with data from bonemarrow donor registers and blood banks, umbilical cord blood banks and tissue banks

摘要

The invention relates to a system for the automatic, rapid and dynamic allocation of biological cells for transplantation, therapy, or research purposes between collection centers or banks (storage sites) and hospitals, transplant centers or research facilities, and for monitoring and supporting the processes from request transmission up to delivery of a cell preparation suitable for allogeneic transplantation, via the use of allocated preparations up to tracking the results in the patient and providing these data for statistical and other purposes, as well as assigning molecular-diagnostic results of individuals with the aim of verifying options—even in advance—of transplantations among the inventory of registers or banks. Using said system, it is possible for the first time—even in advance and online and with automatic retries—to propose complete solutions in the form of transplantations in specific and individual cases.

主权项

1. A system for allocating and selecting umbilical cord blood preparations, for transplantations, therapies and/or research purposes, wherein the system comprises data processing equipment including one or more processing units connected via a network of said one or more processing units via which data is exchanged,
wherein said one or more processing units are configured to:
store experience data of umbilical cord blood preparations imputed into a computer via one or more input devices,store inquiry data of a potential recipient or patient, said inquiry data comprising genome, transcriptome, proteome, epigenome and/or metabolome data,store preset search criteria,compare the experience data with the inquiry data, and automatically evaluate the search being effected, and/oreffect order processing and tracking on the basis of this evaluation, the umbilical cord blood preparation being ordered via the network, and wherein the one or more processing units are configured to arrange and select potential umbilical cord blood preparations according to HLA match, patient weight, number of nucleated cells (TNC) and number of hematopoietic cells (CD34+) and, in addition, compare them with said genome, transcriptome, proteome, epigenome and/or metabolome data, wherein the one or more processing units are configured to execute a patient search that comprises determining patient-compatible preparations in accordance with the following classification and/or exclusion criteria:
name and identification of clinic or transplantation center,names of coordinator and attending physician, including contact data,status of clinic with regard to international certifications (e.g. FACT),average number of UCB transplantations in the inquiring clinic during the last three years,name of patient, insurance number and other accounting information,patient's medical history,indication and therapy proposal of attending physician,urgency according to defined classification,HLA type of patient,blood group of patient,weight of patient,ethnic group of patient,sex of patient,age of patient,known allelic characteristics of patient and/or data of DNA typing, and/orfirst treatment or re-treatment, said classification and/or exclusion criteria being stored on one of said processing units, andwherein the one or more processing units are configured to produce short list(s) of potential umbilical cord preparations, using the following settings:MLPrep:={6:HLAPrep⁢⁢and⁢⁢HLAPat⁢⁢match⁢⁢in⁢⁢6⁢⁢out⁢⁢of⁢⁢6⁢⁢typing⁢⁢values⁢and⁢⁢blood⁢⁢group⁢⁢compatibility5:HLAPrep⁢⁢and⁢⁢HLAPat⁢⁢match⁢⁢in⁢⁢5⁢⁢out⁢⁢of⁢⁢6⁢⁢typing⁢⁢valuesand⁢⁢blood⁢⁢group⁢⁢compatibility4:HLAPrep⁢⁢and⁢⁢HLAPat⁢⁢match⁢⁢in⁢⁢4⁢⁢out⁢⁢of⁢⁢6⁢⁢typing⁢⁢valuesand⁢⁢blood⁢⁢group⁢⁢compatibilityPreparation not included: other wherein MLPrep=match level in accordance with HLA compatibility between preparation and patient,CFPrep:={3×107:MLPrep=64×107:MLPrep=55×107:MLPrep=4 wherein CFPrep=cell factor defining required number of cells per kg of patient weight at corresponding match level,CNPrep:=TNCPrepCFPrep wherein CNPrep=classification number of a preparation allowing arrangement of preparations in accordance with TNC and match level, and wherein the short list(s) of preparations to be considered for single transplants are produced using the following setting:SLSingle:={p∈Prep|CNpBWPat≥1kg⋀MLPrep≥4} wherein SLSingle=short list of preparations (p) to be considered for single transplants, and wherein standard classifications of preparations in the short list(s) are made according to the following criteria: Classification 1=initial ranking according to match level, followed by classification number, followed by CD34+Classification⁢⁢1⁢⁢(SL):={p⁢⁢1∈SL,p⁢⁢2∈SL|either⁢⁢MLp⁢⁢1>MLp⁢⁢2or⁢⁢MLp⁢⁢1=MLp⁢⁢2⋀CNp⁢⁢1>CNp⁢⁢2or⁢⁢MLp⁢⁢1=MLp⁢⁢2⋀CNp⁢⁢1=CNp⁢⁢2⋀CD⁢⁢34p⁢⁢1≥CD⁢⁢34p⁢⁢2 and/or Classification 2=initial ranking according to classification number, followed by match level, followed by CD34+Classification⁢⁢2⁢⁢(SL):={p⁢⁢1∈SL,p⁢⁢2∈SL|either⁢⁢CNp⁢⁢1>CNp⁢⁢2or⁢⁢CNp⁢⁢1=CNp⁢⁢2⋀MLp⁢⁢1>MLp⁢⁢2or⁢⁢CNp⁢⁢1=CNp⁢⁢2⋀MLp⁢⁢1=MLp⁢⁢2⋀CD⁢⁢34p⁢⁢1+≥CD⁢⁢34p⁢⁢2+ wherein Prep=umbilical cord blood preparation, Pat=patient, HLAPat=HLA values of patient, HLAPrep=HLA values of preparation, TNCPrep=number of nucleated cells of preparation, BWPat=body weight of patient in kg, CD34+Prep=number of CD34+ cells of a preparation, and p1, p2=preparation 1 selected, preparation 2 selected.