Abstract:
In order to detect the mis-operation of cells or tissues in a culturing step and other working steps to prevent erroneous use in treatment of cultured cell and tissues besides those of the cell donor, a genetic information, held by a cell or tissue, is used as a cell tissue information, which is inseparable from the cell tissue itself and enables individual identification of the cell donor, that is, identification of the origin of the cell or tissue subject to a culture process, and the cell tissue information before and after culturing are compared and collated.

Description:
CLAIM PRIORITY  
       [0001]     The present application claims priority from Japanese Patent Application JP2004-188895, filed on Jun. 25, 2004, the content of which is hereby incorporated by reference into this application.  
       BACKGROUND OF THE INVENTION  
       [0002]     1. Field of the Invention  
         [0003]     This invention relates to a cell tissue culture management method and system for managing the respective steps from receiving to shipment of a cell tissue to be subject to the culture process.  
         [0004]     2. Description of the Prior Art  
         [0005]     In recent years, regenerative medicine techniques, by which a damaged or lost biological tissue or organ is restored utilizing regenerating or reconstructing tissues and cells by the proliferation and differentiation abilities of cells, have come to be noted as new treatment methods. In order to actually perform such treatment, cells or tissues must be sampled from a patient, and after selecting and separating the necessary cells or tissues from the sampled cells or tissues, the cells or tissues must be cultured, and regenerated or proliferated ex vivo the body to the enough amount for the treatment. Extremely troublesome operations, such as exchange of media and transfer of the cells or tissue to a different container, are required not only in the cell or tissue sampling step, separation step, and culturing step but also in a cell or tissue preservation step, transportation step, and inspection step. The troublesomeness of such working steps not only require time for the operations but also increase the possibilities of human errors, such as the mis-operation of the cells or tissues from different patients in a working step, that lead to treatment using amplified cells or tissue originating not from the original patient but from another person and thereby causing serious damage to the patient due to immunological rejection.  
         [0006]     Numerous patents have been applied (since priorly) towards resolving the above issue. For example, among culture management devices for managing cell culture, there is an arrangement system, wherein an identification code is set for each biological sample and the culture records of the biological samples provided with the identification codes are stored to manage culturing while lightening the burden on workers regarding biological sample management in cell culture (see for example, Patent Document 1), and an arrangement system, wherein, in order to accurately and simply manage the association of a cell donor (patient) and cultured cells, cultured from the cells provided, and perform rapid collation of the cultured cells and the patient, containers, which are provided with identification information unique to the sampled cells, are used as carry-in containers, intermediate containers for culturing, and carry-out containers that are used in the cell culture to manage the cell culture by means of the identification information (see for example, Patent Document 2).  
         [0007]     With the arts disclosed in the above-mentioned Patent Document 1 and Patent Document 2, the identification code or identification information for identifying each biological sample is stored in a biological information identification means that comprises a barcode, IC chip, or other non-biological storage medium that is attached to a container for processing or holding the biological sample. However, since such a cell or tissue identification information storage medium, that is formed of non-biological material, is separable from the biological sample itself, the correspondence of the identification code or identification information with the biological sample breaks down when the biological sample becomes mixed up due to human error by a worker or erroneous operation of a device, etc., thus causing the identification code provided on a container to become unmatched with the biological sample that is contained.  
         [0008]     In order to resolve this problem, a method has been proposed wherein a biological information identification means, storing biological substance identification information, is mixed in a biological substance to be identified and the biological substance is identified by reading the information from the coexisting biological information identification means to prevent mixing up of the donor or recipient in the process of performing treatment or inspection using the biological substance (see, for example, Patent Document 3).  
         [0009]     With this method, in comparison to the case where a non-biological matter, such as a barcode or IC chip, etc., is adhered as a storage medium onto a container, since the biological information identification means constantly coexists with the biological sample even though it is separable from the biological sample, the correspondence of the biological information identification means and the biological sample is maintained. Since this correspondence is maintained even upon transfer among containers, the risk of mis-operating biological samples due to human error, etc., can be reduced. However, in using the processed biological sample in treatment, etc., the trouble of separating the biological information identification means, which is a non-biological matter, from the biological sample is required, and the work, of guaranteeing that the biological information identification means has been removed completely, is complex and troublesome.  
         [0010]     [Patent Document 1] Japanese Published Unexamined Patent Application No. 2002-269180 (Paragraphs 0007 to 0022, FIG. 1)  
         [0011]     [Patent Document 2] Japanese Published Unexamined Patent Application No. 2004-119 (Paragraphs 0006 to 0041, FIG. 1)  
         [0012]     [Patent Document 3] Japanese Published Unexamined Patent Application No. 2003-180662 (Paragraphs 0011 to 0029, FIG. 1)  
         [0013]     With the above-described conventional arts, since the cell or tissue identification information storage medium, which is formed of non-biological matter, is separable from the biological sample, the possibility of a container and a contained biological sample becoming mixed up due to human error, etc., cannot be eliminated completely and consequently the correspondence between the identification information storage medium and the biological sample cannot be maintained.  
         [0014]     Also, though the making of an identification information storage medium, which is a non-biological matter, coexist with a biological sample by mixing the storage medium in order to maintain the correspondence with the biological sample is effective in terms of keeping the correspondence, this gives rise to the new issue of having, from the standpoint of safety, to completely remove the identification information storage medium, which is a non-biological matter, in using the biological sample for actual treatment.  
         [0015]     This invention has been made in view of the various circumstances described above, and a principal object thereof is to provide a cell tissue culture management method and system by which the mis-operation of cells and tissues in cell culture can be prevented.  
       SUMMARY OF THE INVENTION  
       [0016]     In order to achieve the above object, with the present invention, a genetic information, held in a cell or tissue, is used as a biological sample information (cell culture information), which is inseparable from the biological tissue (cell tissue) and enables individual identification of the cell donor, that is, identification of the origin of the cell or tissue subject to cell culture, and the genetic information before and after the cell culture process are compared and collated.  
         [0017]     By this invention, mixing up of cells or tissues in cell culture can be prevented. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0018]      FIG. 1  is a process sequence diagram of a cell tissue culture management method of a first embodiment;  
         [0019]      FIG. 2  is a block diagram showing the device arrangement of a cell tissue culture management system of the first embodiment;  
         [0020]      FIG. 3  is a diagram showing an example of the data structure of an information storage unit (management DB) of the embodiment;  
         [0021]      FIG. 4  is a diagram illustrating a case of using the information of five SNP positions as genetic information;  
         [0022]      FIG. 5  is a block diagram illustrating, in regard to the first embodiment, the overall flow of information and objects that includes a hospital, the arrangement of a cell processing facility that executes a cell processing step, and the arrangement of the cell tissue culture management system;  
         [0023]      FIG. 6  is a judgment flow in an information collating step of  FIG. 1 ; and  
         [0024]      FIG. 7  is a block diagram illustrating, in regard to a second embodiment, the overall flow of information and objects that includes a hospital, the arrangement of a cell processing facility that executes a cell processing step, and the arrangement of the cell tissue culture management system. 
     
    
     DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS  
       [0025]     First Embodiment  
         [0026]     A first embodiment of a best mode for carrying out this invention&#39;s cell tissue culture management method and system will now be described in detail with reference to the drawings.  
         [0000]     [Process Sequence of a Cell Tissue Culture Management Method] 
         [0027]      FIG. 1  is a process sequence diagram of the first embodiment&#39;s cell tissue culture management method. This process sequence will now be described with reference to  FIG. 1 .  
         [0028]     As shown in  FIG. 1 , the process sequence comprises: a first sampling step S 2  of sampling a sample (first cell tissue) for genetic information analysis of a cell or tissue (referred to hereinafter as “cell tissue”), which has been received and is to be subject to a culture process, from the cell tissue; a cell processing step S 3  of subjecting the remaining cell tissue, among the cell tissue from which the sample for genetic information analysis has been sampled in first sampling step S 2 , to the culture process; and a second sampling step S 4  of sampling, after the culture process of the cell tissue in cell processing step S 3 , a sample (second cell tissue) for genetic information analysis of the cell tissue that has been subject to the culture process. The process sequence furthermore comprises: a first inspection step S 5  of performing genetic information analysis on the sample which is sampled in the above-mentioned first sampling step S 2  and thereby obtaining a first cell tissue information J 1 ; a second inspection step S 6  of performing genetic information analysis on the sample which is sampled from the cell tissue after the culture process in the above-mentioned second sampling step S 4  and thereby obtaining a second cell tissue information J 2 ; an information storing step S 7  of storing first cell tissue information J 1 , obtained in first inspection step S 5 , in association with an identification number J 3 ; an information storing step S 8  of storing second cell tissue information J 2 , obtained in second inspection step S 6 , in association with identification number J 3 ; an identification number providing step S 9  of providing identification number J 3  to the received cell tissue to be subject to the culture process; and an information collating step S 20  of collating first cell tissue information J 1 , obtained in first inspection step S 5 , and second cell tissue information J 2 , obtained in second inspection step S 6 , and examining the correspondence of the information.  
         [0029]     In the above-mentioned first sampling step S 2 , an enough amount of the sample to perform genetic information analysis and obtain first cell tissue information J 1  is sampled from the cell tissue to be subject to the culture process. Also, in second sampling step S 4 , an enough amount of the sample to perform genetic information analysis and obtain second cell tissue information J 2  is sampled from the cell tissue that has been subject to the culture process. Also, identification number J 3 , to be provided to the received cell tissue to be subject to the culture process, is stored in association with the first cell tissue information as mentioned above and is stored (written), for example, in a barcode, IC chip, or other tag adhered externally onto a container for containing the cell tissue (see  FIG. 5 ).  
         [0000]     [Device Composition of a Cell Tissue Culture Management System] 
         [0030]      FIG. 2  is a block diagram showing the first embodiment&#39;s device composition of the cell tissue culture management system. The device composition of the cell tissue culture management system of the first embodiment will now be described with reference to  FIG. 2  (and where suitable,  FIG. 1 ). The devices, equipments, etc., that make up cell processing step S 3  of  FIG. 1  are not illustrated in  FIG. 2 .  
         [0031]     As shown in  FIG. 2 , cell tissue culture management system  1  comprises an identification number setting unit  12 , a first genetic information analyzing unit  13 , a second genetic information analyzing unit  14 , an information storage unit  15  (management DB), an information collating unit  16 , and a result display unit  21 . A single genetic information analyzer (not shown), having the function of performing the analysis of genetic information, may be used as first genetic information analyzing unit  13  and second genetic information analyzing unit  14 . Also, a single computer (not shown), having a computing device, a storage device, and a display device, may be used as identification number setting unit  12 , information storage unit  15 , information collating unit  16 , and result display unit  21 . Obviously, these respective units  13  to  16  and  21  may be arranged as individually independent genetic information analyzers or computers. The sending and receiving of information and data among these genetic information analyzers and computers may be carried out online in a wired or wireless manner or offline using an information recording medium. In the description that follows, it will be deemed that the respective units  13  to  16  and  21  are composed as individually independent genetic information analyzers or computers that are connected to each other by a LAN (Local Area Network) (thus forming the cell tissue culture management system) . Though omitted from  FIG. 2 , a tag issuing unit  17 , which issues tags, and other units to be described later (see  FIG. 5 ) are also included in cell tissue culture management system  1  of the first embodiment.  
         [0032]     In  FIG. 2 , first genetic information analyzing unit  13  has a function of obtaining first cell tissue information J 1  by analyzing the genetic information of the cell tissue to be subject to the culture process, second genetic information analyzing unit  14  has a function of obtaining second cell tissue information J 2  by analyzing the genetic information of the cell tissue that has been subject to the culture process, and the results obtained by these analysis units are stored in information storage unit  15 . First cell tissue information J 1  and second cell tissue information J 2  (and furthermore, identification number J 3 ) are stored in information storage unit  15 , and a management DB (database) is constructed with these information.  
         [0033]     Identification number setting unit  12  has a function of providing identification number J 3  to the cell tissue to be subject to the culture process, and in the above-mentioned information storage unit  15 , first cell tissue information J 1  and second cell tissue information J 2  are stored in association with this identification number J 3 .  
         [0034]     Information collating unit  16  has a function of collating first cell tissue information J 1  and second cell tissue information J 2  and thereby detecting matching or non-matching. The detection result is displayed via result display unit  21 . If first cell tissue information J 1  and second cell tissue information J 2  are matched, this means that there has been no mixing up, etc., in cell processing step S 3  and cell culture has been carried out appropriately by the culture process.  
         [0035]     At first genetic information analyzing unit  13 , which performs inspection in first inspection step S 5 , at least one or a plural information among DNA base sequence information, single nucleotide polymorphism (SNP) information, microsatellite polymorphism information, and minisatellite polymorphism information is analyzed and the analysis result is sent to and saved in information storage unit  15  as first cell tissue information J 1 . And from the cell tissue that has been subject to the culture process (culture amplification process) in cell processing step S 3 , a cell tissue portion is sampled as a sample on which inspection in second inspection step S 6  is to be performed using second genetic information analyzing unit  14 . Here also, at least one or a plural information among DNA base sequence information, single nucleotide polymorphism (SNP) information, microsatellite polymorphism information, and minisatellite polymorphism information (that is, the information corresponding to that of first inspection step S 5 ) is analyzed and the analysis result is sent to and saved in information storage unit  15  as second cell tissue information J 2 .  
         [0036]     At information collating unit  16 , first cell tissue information J 1  and second cell tissue information J 2 , which have been saved in information storage unit  15 , are read and collated to confirm, before and after the culture process in cell processing step S 3 , that the cell tissue subject to the process originates from the same cell donor (patient).  
         [0000]     [Data Structure of the Management DB and Cell Tissue Information] 
         [0037]     An example of the data structure of the management DB constructed in information storage unit  15  is shown in  FIG. 3 . Also, a case of using the information on five SNP positions as the genetic information is illustrated in  FIG. 4 . With reference to these FIGURES, an example of using the SNP information as the cell tissue information (first cell tissue information J 1  and second cell tissue information J 2 ) will now be described along with the data structure of the management DB.  
         [0038]     In order to identify the cell tissue to be subject to the culture process, typing of SNPs of arbitrary positions and number is carried out using chromosomal DNA or mitochondrial DNA as the nucleic acid sample. In this process, collation with data in a DNA data bank, such as NCBI (National Center for Biotechnology Information), is carried out to specify the positions of the SNPs to be analyzed. Here a case of using five SNPs will be described. First, the sample that has been sampled from the cell tissue to be subject to the culture process in first sampling step S 2  is inspected and analyzed in first inspection step S 5 . If as a result of analyzing the respective genotypes of the first to the fifth SNP positions in first inspection step S 5 , it is found that the first is A/A, the second is A/A, the third is A/C, the fourth is C/C, and the fifth is C/C, “AAAAACCCCC” is stored as first cell tissue information J 1  in association with identification number J 3 , which is “A-0001,” in the management DB (information storage unit  15 ) by first genetic information analyzing unit  13 . The above-mentioned first, second, and fifth SNPs are homotypes at the alleles and the above-mentioned third and fourth SNPs are heterotypes at the alleles.  
         [0039]     In first inspection step S 5  for obtaining first cell tissue information J 1 , the number of SNPs typing of chromosomal DNA or mitochondrial DNA may be set to any suitable number from 1 to N and is preferably set to 10 or more.  
         [0040]     In likewise manner, in second inspection step S 6 , second genetic information analyzing unit  14  inspects and analyzes the sample obtained in second sampling step S 4  from the cell tissue after the culture process. Second cell tissue information J 2  is thereby obtained. If there was no mixing up of cell tissue or other problems, the analysis results of the respective genotypes of the SNP positions that are obtained should be the same as the results obtained in first inspection step S 5 , that is, the genotype of the first position should be A/A, that of the second position should be A/A, that of the third position should be A/C, that of the fourth position should be C/C, and that of the fifth position should be C/C. Consequently, second genetic information analyzing unit  14  stores “AAAAACCCCC” as second cell tissue information J 2  in association with identification number J 3 , which is “A-0001,” in the management DB. At information collating unit  16 , first cell tissue information J 1 , “AAAAACCCCC,” and second cell tissue information J 2 , “AAAAACCCCC,” which are associated with identification number J 3 , “A-0001,” are collated to compare and collate whether or not these are the same information (detect matching or non-matching).  
         [0000]     [Overall Flow, Etc.] 
         [0041]      FIG. 5  is a block diagram illustrating, in regard to the first embodiment, the overall flow of information and objects that includes a hospital, the arrangement of a cell processing facility that executes the cell processing step, and the composition of the cell tissue culture management system. In  FIG. 5 , cell processing facility  3  is a facility in which cell culture is carried out and has a cell receiving unit  31 , a receiving inspection unit  32 , a cell culture unit  33 , a pre-shipment inspection unit  34 , and a cell shipping unit  35 . The respective units  31  to  35  are equipped with terminals T 31  to T 35  for reading the information in tags adhered onto containers and sending the information to information storage unit  15 . The respective units  31  to  35  are devices or equipments for executing cell processing step S 3  of  FIG. 1 . Terminals T 31  to T 35  are terminals for tracking the respective steps of cell processing step S 3  in which cell culture is carried out. Also, though not illustrated in  FIG. 2 , symbol  17  indicates a tag issuing unit that issues tags (wireless IC tags or barcodes) each of which is adhered onto a container in which a cell tissue is contained and in each of which an identification number J 3  is stored (written). The respective units of symbols  12  to  16  and  21  are as has been described above and redundant description will be omitted.  
         [0042]     The flow of the respective processes of  FIG. 5  will now be described (with reference to  FIG. 1 , etc., where suitable). The cell tissue to be subject to the culture process, which is obtained from a patient at a hospital, is sent from the hospital to cell processing facility  3 . At this cell processing facility  3 , a portion of the cell tissue received at cell receiving unit  31  is sampled for inspection in the above-mentioned first inspection step S 5  (first sampling step S 2 ) and the remaining portion is contained in a container for cell culture. At identification number setting unit  12 , a unique identification number J 3  is issued. Identification number J 3  is stored in a tag by tag issuing unit  17  and is adhered onto the container containing the cell tissue. The information of the tag that is adhered onto this container is read by the respective terminals T 31  to T 35  provided in the respective units  31  to  35 .  
         [0043]     To be more specific, at cell receiving unit  31 , the sampling of the sample for inspection in first inspection step S 5  from the received cell tissue (first sampling step S 2 ), the placing of the remaining cell tissue in the container, the issuing of identification number J 3 , the issuing of the tag in which identification number J 3  is stored, and the adhesion of the tag to the container are carried out. Then from terminal T 31  to information storage unit  15 , an ID unique to terminal T 31 , identification number J 3 , and the time (time of reading) are sent and these are stored in information storage unit  15 . The ID unique to terminal T 31  is information that specifies the step that is carried out on the cell tissue (the same applies hereinafter).  
         [0044]     First cell tissue information J 1 , which is the result of inspection in first inspection step S 5  (first genetic information analyzing unit  13 ), is sent from first genetic information analyzing unit  13  to information storage unit  15  and stored in association with identification number J 3  (information storing step S 7 ; see  FIG. 3 ).  
         [0045]     At receiving inspection unit  32  that follows, a predetermined inspection (inspection of contamination due to viruses, bacteria, etc.) is carried out on the cell tissue by an unillustrated inspection device. Here also, the information in the tag adhered to the container is read by terminal T 32 . Then from terminal T 32  to information storage unit  15 , an ID unique to terminal T 32 , identification number J 3 , and the time (time of reading) are sent and these are stored in information storage unit  15 .  
         [0046]     At cell culture unit  33  that follows, cell culture (amplification) is carried out by an unillustrated cell culture device. Here also, the information in the tag adhered to the container is read by terminal T 33 . Then from terminal T 33  to information storage unit  15 , an ID unique to terminal T 33 , identification number J 3 , and the time (time of reading) are sent and these are stored in information storage unit  15 .  
         [0047]     At pre-shipment inspection unit  34  that follows, a predetermined inspection (quality inspection) is carried out on the cultured cell tissue by an unillustrated inspection device. Here also, the information in the tag adhered to the container is read by terminal T 34 . Then from terminal T 34  to information storage unit  15 , an ID unique to terminal T 34 , identification number J 3 , and the time (time of reading) are sent and these are stored in information storage unit  15 .  
         [0048]     At cell shipping unit  35  that follows, the shipment of the cultured cell tissue (regenerated tissue) is carried out by an unillustrated shipping device. In the process of shipping, a sample for inspection in second inspection step S 6  is sampled from the cell tissue (second sampling step S 4 ). The sampled cell tissue is then inspected in second inspection step S 6 . Second cell tissue information J 2 , which is the result of inspection in second inspection step S 6  (second genetic information analyzing unit  14 ), is sent from second genetic information analyzing unit  14  to information storage unit  15  and stored in association with identification number J 3  (information storing step S 8 ; see  FIG. 3 ).  
         [0049]     Information collation step S 20  is then carried out by information collating unit  16 .  
         [0000]     [Flow of Judgment in the Information Collating Step] 
         [0050]     Information collation step S 20 , which is executed by information collating unit  16 , will now be described with reference to a flowchart.  FIG. 6  shows the judgment flow in the information collating step. In  FIG. 6 , information collating unit  16  first determines the identification number J 3  of the cell tissue on which collation is to be performed. That is, the identification number J 3  to be collated is determined (S 41 ). This determination of identification number J 3  may be carried out by reading the information in the tag adhered to a container that is waiting for shipment at cell shipping unit  35  by terminal T 35 . Identification number J 3  may also be determined by manual input from an unillustrated keyboard, or identification number J 3  may be acquired via a LAN or a communication line. First cell tissue information J 1  and second cell tissue information J 2  that are associated with identification number J 3  (for example, “A- 0001 ”), for which it has been determined that collation is to be performed, are then read from information storage unit  15  (S 42 ). Whether or not the read first cell tissue information J 1  and second cell tissue information J 2  match is then judged by comparison and collation (matching or non-matching is detected) (S 43 ).  
         [0051]     If there has not been a mixing up of cell tissues due to human error, erroneous operation of a device, etc., in cell processing step S 3 , first cell tissue information J 1  and second cell tissue information J 2 , which are collated here, should match.  
         [0052]     If first cell tissue information J 1  and second cell tissue information J 2  match, an “OK” display is displayed on an unillustrated monitor via result display unit  21  (S 44 ). If first cell tissue information J 1  and second cell tissue information J 2  do not match, since it can then be assumed that mixing up of cell tissues, etc., occurred due to some cause in the cell processing step, an error display is displayed via result display unit  21  to prevent use of the processed cell tissue in subsequent treatment, etc., (S 45 ). It can thus be confirmed before and after the culture process that the cell tissue subject to the culture process in cell processing step S 3  originates from the same cell tissue donor (patient) and the problem of mixing up of cell tissues can be resolved. The result of collation by information collating unit  16  is arranged so that it can be viewed at the hospital via the communication line.  
         [0053]     With the above-described first embodiment, since collation is carried out using genetic information (first cell tissue information J 1  and second cell tissue information J 2 ) unique to the cell tissue, the mis-operation of cell tissue can be discovered and prevented without fail. Also, since a unique identification number J 3  is provided to the received cell tissue and reading and storage of identification number J 3  are carried out in the respective steps, the processing record of the cell tissue can be left without fail and processing record management can be carried out without fail.  
         [0054]     Second Embodiment  
         [0055]     A second embodiment of the best mode for carrying out this invention&#39;s cell tissue culture management method and system will now be described in detail with reference to  FIG. 7  (and with reference to  FIG. 1  where suitable).  FIG. 7  is a block diagram illustrating, in regard to the second embodiment, the overall flow of information and objects that includes a hospital, the arrangement of a cell processing facility that executes the cell processing step, and the composition of the cell tissue culture management system. Blocks provided with the same numbers as the blocks in  FIG. 5  are the same as those shown in  FIG. 5  and description thereof will be omitted.  
         [0056]     This second embodiment differs from the first embodiment in that the setting of identification number J 3  is carried out in the hospital or other medical agency  30  in which the cell tissue is sampled from the cell donor (and thus identification number setting unit  12  is unnecessary), the analysis of cell tissue information (third cell tissue information J 4 ) on the cell tissue is also carried out at medical agency  30 , and collation is performed with the incorporation of third cell tissue information J 4 , etc.  
         [0057]     In  FIG. 7 , in the process of sending the cell tissue to cell processing facility  3 , medical agency  30  analyzes third cell tissue information J 4  separately from cell processing facility  3  (analyzes using a separate sample) and also sets identification number J 3 . The cell tissue is then transported, with identification number J 3  being indicated, etc., to cell processing facility  3 . In conjunction, the pair of identification number J 3  and third cell tissue information J 4  are sent via the communication line.  
         [0058]     By the above, cell processing facility  3  (cell tissue culture management system  1 ) can perform, in addition to the collation of the first embodiment, a collation that incorporates third cell tissue information J 4 , provided from medical agency  30 , at collating unit  16 . That is, third cell tissue information J 4 , which has been obtained separately, can be acquired to detect the matching or non-matching of cell tissue by performing at least one of either of the collation of first cell tissue information J 1  with third cell tissue information J 4  and the collation of second cell tissue information J 2  with third cell tissue information J 4 . Thus in addition to the prevention of mis-operation in cell processing facility  3 , the prevention of mis-operation, etc., during transport of the cell tissue from medical agency  30  to cell processing facility  3  is also enabled.  
         [0059]     Furthermore, in the process of shipping the cell tissue (regenerated tissue) after the culture process to medical agency  30 , by sending, etc., via the communication line, at least one of either of first cell tissue information J 1  and second cell tissue information J 2  along with identification number J 3  to medical agency  30 , the validity of the regenerated tissue can be verified at medical agency  30  to further prevent mis-operation. As the sample for obtaining third cell tissue information J 4 , a cell tissue, etc., of any portion of the patient may be used.  
         [0060]     Other Embodiments  
         [0061]     This invention, which has been described above, is not limited to the above-described embodiments and can be modified widely within the scope of the spirit of the art thereof.  
         [0062]     For example, though first inspection step S 5  is performed at the point of receiving and second inspection step S 6  is performed at the point of shipping in the embodiments described above, this invention is not limited thereto and inspections may be carried out at intermediate stages. Also (see  FIG. 5 ), for example, the contents (culturing temperature, culturing time, etc.) of the processes carried out in cell culture unit  33  may be associated with identification number J 3  and stored in information storage unit  15  via terminal T 33 . That is, a procedure of associating identification number J 3  with the information on the steps carried out on the cell tissue in cell processing step S 3  and storing this information in information storage unit  15  may be carried out.  
         [0063]     Also for example, in the first embodiment, first cell tissue information J 1  may serve in common as identification number J 3 . That is, first cell tissue information J 1  may be used as identification number J 3 . In this case, there is no need to provide identification number setting unit  12  in particular. Also, the genetic information used for identification is not limited to any specific information. Also, the collation in information collating step S 20  (information collating unit  16 ) is not limited to any specific form in particular and, for example, the collation may be performed in the form of performing image analysis, etc., and performing pattern matching.  
         [0064]     Also for example, in the process of acquiring first cell tissue information J 1  and second cell tissue information J 2 , an SNP search may carried out using a marker (for example, a telomere or a microsatellite, etc.) on DNA as a starting point.  
         [0065]     Also with the second embodiment, third cell tissue information J 3  may be obtained by genetic analysis at a third party agency that is neither medical agency  30 , which is to perform transplantation, nor cell processing facility  3 , which is to perform culturing.