IE902301A1 - Identification Process And Related Method For Use In¹Preparing A Biological Sample - Google Patents

Abstract

A method for use in preparing a biological sample, ultimately for such purposes as individual identification, research or therapeutic treatment, comprises the steps of (a) upon the birth of an infant, obtaining a segment of the infant's severed umbilical cord, (b) closing both ends of the segment, (c) preserving (e.g., by freezing) the sealed umbilical segment to preserve at least one biological component of the umbilical segment, (d) recording statistics pertaining to the individual and the individual's birth, together with an identification of the preserved umbilical segment, and (e) conveying the preserved umbilical segment to a storage facility. The umbilical cord segments are maintained in a long-term storage facility for an indefinite period. An associated method for confirming the identity of a person comprises the steps of (a) receiving at least a portion of a preserved umbilical cord segment from the storage facility, (b) isolating from the person biological material of a type to be found in umbilical cords and recuding the biological material to values of a plurality of predetermined parameters, and (c) comparing the determined values of the predetermined parameters with the received information to determine whether the person is the same as the individual.

Description

IDENTIFICATION PROCESS AND RELATED METHOD FOR USE IN PREPARING A BIOLOGICAL SAMPLE Background of the Invention This invention relates to a method for use in identifying a person and more particularly in medically identifying a person. This invention also relates to a method for preparing for use a biological sample, for ultimate use in an identification process, medical research, or a therapeutic treatment. The invention also relates to a method for therapeutically treating a patient. More particularly, the instant invention relates to utilization of the umbilical cord in identification, medical research and therapeutic techniques. These therapeutic techniques are specifically applicable in hematopoietic reconstitution and are implemented without the pain generally accompanying the aspiration of bone - 2 marrow from donors in transplantology procedures and without the dangers of the anesthesia used during the extraction process.

The human umbilical cord reaches a length of 35 to 50 cm at term and includes two umbilical artieries and a single umbilical vein. The vein carries oxygenated blood from the placenta to the fetus. The arteries and the vein are embedded in a mucous connective tissue in turn covered by an epithelium which is multilayered at birth. The connective tissue includes interlacing bundles of collagen fibers having intercellular spaces filled with a gelatinous substance known as Wharton's jelly. The cells of the connective tissue are a primitive form of fibroblast, have easily detectable nucleii and are rich in collagen. The umbilical arteries have relatively thick muscular walls containing a diffuse network of elastic fibers.

In many instances, the umbilical cord, like the placenta, is discarded after birth. However, it has been discovered that at least certain constituents of the umbilical cord may have a special usefulness. In a recent advance in the treatment of bone marrow defects in infants, physicians used the blood cells from the umbilical cord of an infant to aid in the regeneration of the stem cells in an older sibling. The blood was separated from the umbilical cord, subsequently frozen, and stored for seven months prior to infusion. Upon thawing, the cells were intravenously infused into the body of the recipient youngster. This technique provides several advantages over conventional marrow transplantation. Using the cord blood in this instance enabled transplant as soon as a compatible sibling was born, while candidates for marrow transplant generally must wait until the newborn is at least six months old. In addition, the procedure eliminates for the donor the pain of marrow extraction.

Other uses for constitutents of the human umbilical cord have been instated. For example, in the article ’’Differential Prostacyclin Production by Human Umbilical Vasculature” by John H. Harold et al., Archive of Pathological Laboratory Medicine. Vol, 112, pp. 43-46 (January 1988), the authors point out that the human umbilical cord provides an - 3 easily accessible source of human vascular tissue.

Conventional methods for identifying or confirming the identities of people are based on such individual indicia as fingerprints and tooth morphology. Newer techniques involve voice prints and retinal structure. All of these conventional methods can provide information about who an individual is. Umbilification technology pursuant to the invention as defined hereinafter can provide information as well as to the biological, histological, and biochemical constituants of a person.

Another recently developed identification technique is based on the composition of genetic material. U.S. Patents Nos. 4,772,549 and 4,861,708 to Philippe M. Frossard, for example, disclose methods for determining the genetic identity of an individual human subject. The former patent in particular describes and claims a method comprising the steps of extracting DNA from the somatic cells of the human subject, digesting the extracted DNA with a selected restriction enzyme, and examining the digested DNA for polymorphisms from a preselected grouping, wherein the polymorphisms are defined by the presence or absence of a DNA fragment of known length which hybridizes to any one of several predetermined probes or their equivalents.

Other methods for genetic typing and identification are known and have been sufficiently developed to enable a determination of parentage from comparison of a child's DNA material with that of possible fathers.

Cryogenic preservation techniques have advanced sufficiently to enable the long term storage of genetic materials. Vivigen, Inc., a company in Santa Fe, New Mexico, has announced that it is commencing the cryogenic storage of DNA and RNA for medical and research purposes. This firm, along with other companies currently storing DNA are currently sotring diseased cells only.

Objectives of the Invention An object of the present invention is to provide a method for use in identification procedures.

Another object of the present invention is to provide a method for obtaining medical identification information - 4 for individuals upon birth and, additionally, for medically identifying individuals at birth.

Another, more particular, object of the present invention is to provide such a method wherein the medical identification information is biological or biochemical in nature.

Another object of the present invention is to provide a method for obtaining medical identification information and aiding in medical research and therapeutic treatment, by a noninvasive procedure which is less painful than other methods.

Yet another object of the present invention is to provide a method for obtaining medical identification information and aiding in medical research and therapeutic treatment which is less expensive than other methods.

An additional object of the present invention is to provide a method for preparing for use a biological sample.

The sample can be ultimately used in an identification process, medical research or a therapeutic treatment.

Yet another object of the present invention is to provide a method for therapeutically treating a patient.

Another, more particular, object of the present invention is to provide a method utilizing the umbilical cord in identification, medical research and therapeutic techniques.

Yet another particular object of the present invention is to provide a method for use in typing the contents of the umbilical cord.

A further particular object of the present invention is to provide a method for gathering and storing the contents of umbilical cords in each typed category.

Summary of the Invention This invention pertains to the typing of the contents of umbilical cords (umbilityping) and to using specific values of umbilical cord parameters (umbilification) for medical identification and/or research information. Umbilification technology entails the preservation and storage of umbilical cords of the world's newborn population for purposes of identification and enhancement of their medical well - 5 being.

A method for preparing for use a biological sample, ultimately for such purposes as individual medical identification, research or therapeutic treatment of a patient, comprises, in accordance with the present invention, the steps of (a) upon the birth of an infant, obtaining at least a segment of the infant's severed umbilical cord, (b) preserving at least a portion of the obtained umbilical segment, (c) recording statistics pertaining to the individual and the individual's birth, together with an identification of the preserved umbilical segment, and (d) conveying the umbilical segment to a storage facility. The recorded statistics include, for example, the infant's name and weight and his or her genetic heritage, including genetic predispositions to certain diseases.

Pursuant to another feature of the present invention, the step of preserving includes the step of closing opposite ends of the umbilical segment. The closing is preferably accomplished by tying off both ends of the segment. However, other technigues may be more advantageous, depending on the individual circumstances. The segment may be placed in a respective container or receptacle, such as a box, bag or ampule, which may carry on an external surface a bar code readable by a laser or other type scanner. If the umbilical cord segment is not stored in a respective container, the opposite ends of the severed segment may, for example, be covered with respective end caps made of a material suitable for the use of a bar code and laser scanner.

Pursuant to another feature of the present invention, the step of preserving may include the step of cooling the umbilical segment. Preferably, the umbilical segment is frozen and preserved cryogenically. In that event, the storage facility is a cryogenic storage facility. The preservation may be accomplished by immersion of the segments in a bath of liquid nitrogen or supercooled carbon dioxide, or by placing the segments in respective thin-walled containers and placing the containers in contact with a chlorofluorocarbon mixture.

It is to be noted that the invention contemplates - 6 utilization of the preservation technique best suited to minimize destruction of the cellular contents of the umbilical cord.

The umbilification storage facility can be centrally located and serve, for example, several hospitals all in the same city, county or state. In some instances, however, the storage facility may be a small unit, perhaps even portable, located on the hospital premises.

In accordance with another aspect of the present invention, the recorded statistics are transmitted to an information storage facility. Preferably, that storage facility is at the same location as the cryogenic storage apparatus.

In one possible embodiment of the invention, the personal history information is not transferred or stored.

The stored umbilical cord segments may in that case nevertheless be used for research wherein the identity of the infant is immaterial.

Pursuant to further features of the present invention, the umbilical cord may be severed into a multiplicity of segments, each of the segments is closed at opposite ends thereof, for example, by tying or otherwise clamping, and then the closed or sealed segments are separately preserved, for example, by freezing. The segments may be of various sizes.

Thus, in a particular embodiment of the present invention, a method for preparing for use a biological sample, ultimately for such purposes as individual identification, research or therapeutic treatment, comprises the steps of (a) upon the birth of an infant, obtaining a segment of the infant's umbilical cord, (b) closing both ends of the segment in preparation for its preservation, (c) preserving (e.g., by freezing or freeze-drying) the segmented umbilical cord so that its biological components can be utilized for medical identification, research and/or therapeutic treatment of patients, and (d) recording statistics pertaining to the individual and the individual's birth, as well as pertinent family information, together with an identification of the preserved umbilical segment. The preserved umbilical segment is in most cases stored for possible future use of its biological, - 7 histological, cellular and biochemical components.

Preferably, a method in accordance with the present invention, including the steps of severing, closing, freezing, and recording, is performed for each individual infant born in a health care institution and preferably in an entire state or country. If a replication (e.g., in vitro replication) technology is utilized, the preserved and stored umbilical cords can be of great medical benefit to the respective individuals. For example, with the utilization of a replication technology, autologous hematopoietic reconstitution can be effectuated in an adult patient, using umbilical cord blood cells stored in the preserved umbilical cord at the time the patient was an infant. As the numbers of stored umbilical cords increase and the typing of the umbilical cords into categories proceeds, the value of umbilification technology accordingly increases. Because of the vast numbers of umbilical cords stored then in each typed classification, allogeneic hematopoietic reconstitution may be implemented, without the utilization of replication technology.

With umbilical cords of twins, triplets, quadruplets, etc., umbilityped into categories, the stored materials can be retrieved and expanded and used in syngeneic transplants without a need for aspirating marrow from donating siblings. All of these procedures in hematopoietic reconstitution can be implemented without pain or with less pain than is currently experienced in transplantology.

Embodiments of the instant invention contemplate the monitoring of incoming requests for preserved and stored materials. Upon a request for a stored cellular material, the identified umbilical cord segment can be retrieved from the storage apparatus and can be conveyed to the appropriate location.

In another method in accordance with the present invention, for use in individual identification, at least a portion of a preserved umbilical cord segment is received and treated to isolate a kind of biological material. The biological material is analyzed to determine values of a plurality of predetermined biochemical parameters. In another step, information recorded at the birth of an individual - 8 attached to an umbilical cord from which the umbilical cord segment was severed and subsequently preserved is received.

The information includes statistics pertaining to the individual and the individual's birth, together with an identification of the preserved umbilical cord segment. The received recorded information and the determined values of the predetermined biochemical parameters are then stored for future reference. The umbilical parameters for which specific values (the umbilitype) are determined may include, for example, blood type, tissue type or composition of genetic materials or any other materials contianed within the umbilical cord.

Pursuant to yet another feature of the present invention, the step of isolating includes the steps of separating out genetic material from cells of the person, the step of analyzing including the step of comparing the composition of the separated genetic material with known genetic compositions to determine at least in part a genetic structure of the individual.

A method for therapeutically treating a patient comprises, in accordance with the present invention, the steps of (a) receiving at least a portion of a preserved umbilical cord segment from a storage facility, (b) isolating a biological component of the portion of the umbilical cord segment, and (c) using the isolated component to treat the patient.

The umbilical cord segment is preferably cryopreserved, the storage facility being a cryogenic storage facility. Then, a further step includes wanning the portion of the umbilical cord segment.

Where the isolated umbilical segment component is a cell, the step of using the isolated component to treat the patient includes the step of infusing the cellular material into the patient. The cell may exemplarily take the form of a stem cell from the blood of the preserved umbilical cord segment and is infused intraveously into a patient suffering from a blood or blood marrow disorder.

In accordance with a particularly feature of the present invention, prior to infusion into the patient, an appropriate isolated umbilical cord blood cell will have been - 9 replicated in vitro by others.

The preservation of umbilical cords in accordance with the present invention serves as a universal procedure for obtaining information for purposes of medical identification.

In addition, as umbilical cord segments are stored in greater numbers and are typed for their tissue, cellular and biochemical characteristics ('’umbilityping) , a valuable bank is created which stores: (1) blood cells, for example, stem cells and progenitor cells for hematopoietic reconstitution, both autologous and major histocompatibility complex-matched; (2) human vascular tissue; and (3) genetic information, not only for identification purposes, but for research and proliferation extending over generations of individuals and across large geographical areas.

This bank of medical information and materials for therapeutic treatment is collected in a noninvasive manner without pain to the individual. Moreover, the information and biological materials are collected by a method which is less expensive than other methods, for example, extracting blood from newborn babies, which requires a medical examination of the infant to determine whether it can safely withstand the extraction procedure.

Pursuant to the invention, the individual umbilical cords are typed into categories. As the members of typed cellular material in each category increases, it will eventually be possible to utilize the accumulated cellular materials in each category for allogeneic hematopoietic reconstitution. This is important insofar as it permits therapeutic treatment of adults without the need for replication technology.

In contrast to existing or proposed repositories of genetic materials, a bank of biological, histological and biochemical materials formed in accordance with the present invention may include both diseased cells and healthy cells. Although the storage of healthy cells is the primary purpose and effect of the invention, on those occasions where diseasedcells are stored, the diseased cells may be useful for research purIE 902301 poses. In addition, in the event that the diseased cells are undesirable for any particular application, it is possible to cull out the diseased cells (e.g., leukemia cells) through the use of known magnetic, photochemical and/or chemical techniques. Detailed Description In a general embodiment of a method in accordance with the invention, umbilical cords from infants born within a prescribed territory (a city, county, state or an entire country) are sectioned, preserved and stored . Also stored is information pertaining to each individual such as the infant's name, birth statistics and any pertinent information as to genetic predisposition to certain diseases. The preserved umbilical cords or portions thereof are subsequently made available for medical identification, research purposes or therapeutic treatment upon proper request.

Specifically, upon the birth of an infant, its umbilical cord is severed into one or more segments. The severing may be accomplished by any known technique. See, for example, U.S. Patent No. 4,648,401 to Philip D. Mattson, the disclosure of which is incorporated by reference herein.

Upon severing of an umbilical cord segment, the ends of the segment are closed to retain all biological materials ontained within the umbilical cord. The closure may be accomplished by tying or with synthetic resin end caps or other clamps, or otherwise sealed. The closure procedure is implemented on a free end of the umbilical cord segment while that end is clamped by a hemostat or other instrument. In an alternative procedure, the ends of an umbilical cord are dipped into a cryogenic bath to close the ends by freezing.

The umbilical cord segments may be washed, preferably prior to sectioning of the cord to minimize the loss of umbilical cord blood. Alternatively, each segment may be washed subsequently to the sealing of the ends.

Upon the sectioning of an umbilical cord and the closing of the segment ends, each segment is then preserved preferably by immersion in a cryogenic coolant such as liquified nitrogen. Alternatively, a sealed umbilical cord section is first placed in a suitable thin walled container such as a polyethylene bag or vial. The container is then immersed in a - 11 low-temperature fluid. Such a fluid may take the form of liquid nitrogen, liquid carbon dioxide or a chlorofluorocarbon mixture such as those described in U.S. Patent No. 4,803,842 to Coehlo, the disclosure of which is incorporated by reference herein.

The umbilical cord segments may also be preserved by other techniques, such as freeze drying. Freeze-drying is generally not preferred because of the effects of the freezedrying process on structures of various biological components such as cell membranes. However, inasmuch as certain biochemical components such as DNA, RNA and various proteins may be stored intact by a freeze-drying technique, preservation of at least one segment of each umbilical cord by freeze-drying may be useful.

A particular technique for preserving liposomes is disclosed in published PCT Application No. PCT/US85/01502, Publication No. WO 86/01103. Liposome preparations are dehydrated under reduced pressure in the presence of one or more sugars, preferably the disaccharides trehalose and sucrose. The amounts of the sugars used depends on the type of sugar and on the characteristics of the liposomes to be protected. Freezing of the lipopsomes prior to dehydration is optional.

In an additional series of steps in a procedure in accordance with the invention, various constitutents, for example, blood and endothelial vein cells, of an umbilical cord are isolated from an umbilical cord sample at the birth of an infant. The constituents are analyzed and typed according to known methods. For example, the blood type, the blood protein concentrations, the karyotype, the HLA and other factors are all determined and recorded. These umbilical cord parameters are included in the general statistical information pertaining to the personal history of the individual, including his or her name, parentage, birth date, weight, sex, etc., which is generally collected by a health care institution such as a hospital.

Upon the umbilityping of the contents of the umbilical cord of a new-born infant, as described hereinabove, the umbilification information is transmitted, together with the personal history statistics, to an information storage facility.

The information is preferably encoded in digital form and is transmitted via a communications link (telephone, wireless, satellite) to the storage facility, which is preferably a general - 12 purpose computer.

The computer is an information repository containing all the umbilification and personal history information for all individuals born after a certain date in the prescribed area (a hospital, a city, a county, several counties, a state, several states or an entire country). The stored information includes, for each parcel of umbilification and personal history information, the location of the individual's umbilical cord segment or segments.

Upon freezing of an umbilical cord segment, the segment is conveyed to a cryogenic storage facility. Analogous to the information storage facility, the cryogenic storage facility is a repository containing umbilical cord segments for all individuals born after the prescribed date in the prescribed locale. The computer and the cryogenic storage facility may be in the same location, the computer serving in part to monitor and memorize the locations of the cryopreserved umbilical cord segments in the cryogenic storage facility. The cryogenic storage facility advantageously takes the form of the apparatus disclosed and claimed in copending U.S. Patent Application Serial No. 389,543 filed August 4, 1989 by Hermann Knippscheer and Daniel D.

Richard, the disclosure of which is hereby incorporated by reference.

It is contemplated that several umbilical cord segments for each newborn individual are prepared and transferred to the cryogenic repository for future utilization under different circumstances. As a precaution, it is recommended that one or more segments for each individual are sent to a second, back-up facility essentially duplicating the umbilical cord and information contents of the first cryogenic/information storage facility.

Umbilical cord segments are maintained in a cryopreserved or freeze-dried state at a cryogenic storage facility for an indefinite period. The facility receives requests for items stored at the facility. Upon receiving a request for a deposited stored umbilical cord segment, that segment is retrieved from storage and conveyed at least in part to another location.

Several uses of consitutent parts of umbilical cords - 13 are already known. It is known, for example, that umbilical cord blood includes hematopoietic stem and multipotential (CFU-GEMM), erythroid (BFU-E), and granulocyte-macrophage (CFU-GM) progenitor cells utilizable in hematopoietic reconsitution as an alternative to bone marrow transplantation. See, e.g., Human umbilical cord blood as a Potential Source of Transplantable Hematopoietic Stem/Progenitor Cells by Hal E. Broxmeyer et al., Proceedings. National Academy of Sciences, Vol. 86, pp. 3828-32 (1989), which is incorporated by reference herein, and references cited in the article. Broxmeyer et al. noted that umbilical cord blood contains numbers of CFU-GM cells well within the range of bone marrow CFU-GM cells that have been associated with successful autologous and major histocompatibility complex-matched allogenic bone marrow transplantation. The conclusion to be drawn from that study is that cells from human umbilical cord blood from a single individual are sufficient for autologous reconstitution and for major histocompatibility complex-matched allogenic hematopoietic reconstitution.

In a recent clinical study described in the article, incorporated by reference herein, Hematopoietic Reconstitution in a Patient With Fanconi's Anemia by Means of umbilical cord blood From an HLA-Identical Sibling, by Elaine Gluckman et al., New England Journal of Medicine. Vol. 321, No. 17, pp. 1174-78 (Oct. 26, 1989), a five year-old boy having classic symptoms and malformations of Fanconi's anemia received cryopreserved umbilical cord blood, isolated from the umbilical cord prior to freezing, from a sister shown to be unaffected by the disorder, to have a normal karyotype, and to be HLA-identical to the patient. After a pretreatment including the oral administration nonabsorbable antibiotics and of cyclophosphamide for pretransplantation conditioning and further including the application of irradiation to the thoracoabdominal region by a linear accelerator, cryopreserved umbilical cord blood was thawed and infused into the patient without further processing. The blood had been obtained from the sister's umbilical cord and the placenta and transported at ambient temperature by overnight courier to a laboratory for analysis, cryopreservation and storage. The blood was frozen in dimethyl sulfide at a final concentration of 10 percent. Upon thawing of the umbilical cord blood, it was found - 14 that eighty-two percent of the nucleated cells were viable. As suggested by the Gluckman et al. article, other conditions for which bone marrow transplant is indicated may be treated with the use of cord blood.

Accordingly, blood from cyropreserved umbilical cord segments may be used, in accordance with the invention, in bone marrow reconstitution. Upon a blood typing of the patient, in which specific values of umbilityping parameters are determined for that individual, the determined umbilification information is transmitted to the information repository, where it is compared with the digitally stored blood type and other information pertinent to stored umbilical cord segments. Upon detecting a match, the corresponding umbilical cord segment is transferred in a cryopreserved state to the requesting health care institution.

In a method for therapeutically treating a patient, at least a portion of a preserved umbilical cord segment is received from a storage facility upon following the procedure set forth above. A biological sample or component is then isolated from the umbilical cord segment and is used to treat the patient. The umbilical cord segment is warmed prior to the isolation or extraction of the desired molecule, cell, tissue or organ portion.

If the isolated or extracted component takes the form, for example, of a stem cell from the umbilical cord blood, the cell is then infused into the body of the patient with other stem cells and possibly progenitor cells from the same umbilical cord segment and from other umbilical cord segments whose specific unbilification parameters match the umbilification parameters determined for the patient. Such an allogeneic hematopoietic reconstitution can be implemented after the preservation, umbilityping and storage of several millions of umbilical cord segments.

In an alternative procedure for an allogeneic hematopoietic reconstitution, the stem cells from one matched umbilical cord segment are replicated in vitro and subsequently injected into the patient. A method for replicating bone marrow samples is described in U.S. Patent No. 4,721,096 to Naughton et al., pertinent portions of which are hereby incorporated by reference herein. In that patent, the bone marrow sample is - 15 obtained from a bone or bones of a donor. Pursuant to the invention, bone marrow cells (stem cells, progenitor cells) are obtained from one or more preserved umbilical cord segments.

It is also within the contemplation of the instant invention that an autologous hematopoietic reconstitution can be effectuated upon in vitro replication of stem cells obtained from a preserved specimen of the patient's own umbilical cord. Of course, in any hematopoietic reconstitution technique involving replication of the required cells, only a small segment of a single umbilical cord is needed.

It is to be noted that a program of storing umbilical cord segments for all individuals born after a prescribed date within a predetermined geographical area provides a bank or repository of human molecular, cellular, tissue and organic components for research and therapeutic purposes. This repository shall become increasingly valuable as more techniques are developed for isolation and use of various umbilical cord components. In addition, a store of biological and personal history information is provided for use with the preserved umbilical cord segments.

Umbilification technology in accordance with the present invention shall provide a repository of raw material for research into diseases affecting entire groups of people, for example, sickle-cell anemia or Tay-Sachs disease. This technology will also enable the tracing of changes in genetic compositions of families giving rise to a predisposition to such afflications as cancer. In addition, changes in genetic make-up due, for example, to radioactive fall-out from a nuclear catastrophe or accident can be traced from umbilical cord segments and associated information for all the people born in the area of the accident.

It is to be noted that the bank or repository of human molecular, cellular, tissue and organic components for research and therapeutic purposes is built from material (umbilical cord segments) which could otherwise be discarded after the infants' births. The bank or repository is thus implemented without any invasive surgery or other invasive extraction techniques.

A method in which, umbilical cord sections are cryopreserved in accordance with the present invention would have - 16 ~ utility even if the various cells in the umbilical cord, including blood cells and endothelial vein cells, were not found in a particular instance to be viable in sufficient numbers. It is known that DNA may be cryopreserved for a significant period. As mentioned above, Vivigen, Inc., a company in Santa Fe, New Mexico, has announced its readiness to cryogenically store DNA and RNA for medical and research purposes. Pursuant to the present invention, the DNA and/or RNA in a cryopreserved umbilical cord section may be used to identify or confirm the identity of an individual who is, for example, unconscious from an accident or a disease or who refuses to provide proof of his identity.

The comparative analysis of the individual's genetic material with the genetic material of an umbilical cord section, performed by known techniques, such as those disclosed in U.S. Patents Nos. 4,772,549 and 4,861,708 to Philippe M. Frossard, the disclosures of which are incorporated by reference herein, may be supplemented by blood typing and other histological, cellular and molecular assay techniques.

Accordingly, in a method for identifying a person, a preserved umbilical cord segment is received from a storage facility, while information recorded at the birth of an infant attached to an umbilical cord from which said umbilical cord segment was severed and subsequently preserved is also received.

The recorded information includes statistics pertaining to the newborn and his or her birth, together with an identification of the preserved umbilical cord segment. In a further step, biological material of a type to be found in umbilical cords (genetic material, blood including stem cells, etc.) is isolated and extracted from an individual to be identified and analyzed to determine a plurality of predetermined umbilification parameters. The determined values of the predetermined parameters are then compared with the received information to determine whether the individual to be identified is the same person as the infant from which the preserved umbilical cord was obtained. As described hereinabove, the parameters used for the identification process may include blood type and composition of genetic materials.

More specifically, in the latter instance, the step of isolating includes the steps of separating out and determining the composition of genetic material from cells of the idividual to be - 17 identified, the step of comparing including the comparison of that separated-out genetic material with material from cellular bodies in an frozen umbilical cord segment. This method is essentially set forth in the aforementioned U.S. Patents Nos. 4,772,549 and 4,861,708 to Philippe M. Frossard.

It is contemplated in accordance with the present invention that as further techniques become developed and known techniques perfected for isolating, identifying and replicating molecular, cellular and other components of umbilical cords, the preserved umbilical cord segments may be taken out of storage and analyzed by the new techniques. Upon determination of the values of a plurality of such biochemical or histological parameters, those values, properly encoded, are stored in a computer together with the personal history and other information recorded at the birth of the respective individual from which the umbilical cord segment was severed and subsequently preserved. As stated above, the personal history information includes statistics pertaining to the individual and the individual's birth, together with an identification of the preserved umbilical cord segment.

Although the invention has been described in terms of particular embodiments and applications, one of ordinary skill in the art, in light of this teaching, can generate additional embodiments and modifications without departing from the spirit of or exceeding the scope of the claimed invention. Accordingly, it is to be understood that the drawings and descriptions herein are proferred by way of example to facilitate comprehension of the invention and should not be construed to limit the scope thereof.

Claims (51)

WHAT IS CLAIMED IS:

1. A method for use in preparing a biological sample, comprising the steps of: upon the birth of an individual, obtaining a segment of a severed umbilical cord which extended from said individual to a respective placenta; closing both ends of said segment; freezing the umbilical segment to preserve at least one biological component of the umbilical segment; recording statistics pertaining to said individual and said individual's birth, together with an identification of the umbilical segment; and conveying the umbilical segment to a cryogenic storage facility.

2. The method recited in claim 1 wherein said step of closing is performed prior to said step of freezing.

3. The method recited in claim 1 wherein said step of conveying is performed subsequently to said step of freezing.

4. The method recited in claim 1, further comprising the step of transmitting the recorded statistics to an information storage facility.

5. The method recited in claim 4 wherein said cryogenic storage facility and said information storage facility are at the same location.

6. The method recited in claim 1 wherein said steps of obtaining, closing, freezing, recording and conveying are performed for each individual infant born in a health care institution.

7. The method recited in claim 1, further comprising the steps of severing the umbilical cord segment into a multiplicity of sections, closing each of said sections at opposite ends thereof and freezing all of the closed segments. - 19

8. The method recited in claim 7, further comprising the step of conveying at least two of the umbilical sections to separate cryogenic storage facilities.

9. The method recited in claim 8, further comprising the step of transmitting the recorded statistics, necessarily pertaining to all of the umbilical sections, to two separate information storage facilities.

10. A method for use in preparing a biological sample for a therapeutic treatment, comprising the steps of: providing a preserved umbilical cord segment closed at opposite ends; depositing the preserved umbilical cord segment in a long-term storage apparatus; maintaining the deposited umbilical cord segment in a preserved state in said storage apparatus for an indefinite period; receiving incoming requests for materials stored in said storage apparatus; upon receiving a request for a biological component of the deposited umbilical cord segment, retrieving the deposited umbilical cord segment from said storage apparatus; and conveying at least a portion of the deposited umbilical cord segment to another location.

11. The method recited in claim 10, further comprising the step of recording the location of the deposited umbilical cord segment in said storage apparatus.

12. A method for identifying or confirming the identity of a person, comprising the steps of: receiving at least a portion of a preserved umbilical cord segment from a storage facility; isolating from said person biological material of a type to be found in umbilical cords and reducing said biological material to values of a plurality of predetermined parameters; and comparing the determined values of said predetermined - 20 parameters with the received information to determine whether said person is the same as said individual.

13. The method recited in claim 12, further comprising the step of receiving information recorded at the birth of an individual attached to an umbilical cord from which said umbilical cord segment was severed and subsequently preserved, said information including statistics pertaining to said individual and said individual's birth, together with an identification of the preserved umbilical cord segment.

14. The method recited in claim 12 wherein said parameters include blood type.

15. The method recited in claim 12 wherein said parameters include composition of genetic materials.

16. The method recited in claim 12 wherein said step of isolating includes the steps of separating out and analyzing genetic material from cells of said person, said step of comparing including the comparison of said genetic material with material from cellular bodies in said frozen umbilical cord segment.

17. The method recited in claim 12 wherein said umbilical cord segment is preserved by cooling.

18. The method recited in claim 12 wherein said umbilical cord segment is preserved by freezing.

19. A method for use in identification, comprising the steps of: receiving at least a portion of a preserved umbilical cord segment; isolating from said portion of said preserved umbilical cord segment biological material; analyzing said biological material to determine values of a plurality of predetermined biochemical or histological parameters ; - 21 receiving information recorded at the birth of an individual attached to an umbilical cord from which said umbilical cord segment was severed and subsequently preserved, said information including statistics pertaining to said individual and said individual's birth, together with an identification of the preserved umbilical cord segment; and storing the received recorded information and the determined values of said predetermined biochemical or histological parameters.

20. The method recited in claim 19 wherein said parameters include blood type.

21. The method recited in claim 19 wherein said parameters include composition of genetic material.

22. The method recited in claim 19 wherein said step of isolating includes the steps of separating out genetic material from cells of said person, said step of analyzing including the step of comparing said genetic material with known genetic compositions to determine at least in part a genetic structure of said individual.

23. A method for therapeutically treating a patient, comprising the steps of: receiving at least a portion of a preserved umbilical cord segment from a storage facility; isolating a biological or biochemical component of said portion of said umbilical cord segment; and using the isolated component to treat the patient.

24. The method recited in claim 23 wherein said portion of said umbilical cord segment is frozen and said storage facility is a cryogenic storage facility, further comprising the step of warming said portion of said umbilical cord segment.

25. The method recited in claim 23 wherein said component is a cell, said step of using the isolated component to treat the patient including the step of infusing said cell into - 22 the patient.

26. The method recited in claim 25 wherein said cell is a blood cell and is infused intraveously into the patient.

27. The method recited in claim 26 wherein said step of using the isolated component to treat the patient includes the steps of replicating said cell and infusing the replicated cells into the patient.

28. The method recited in claim 27 wherein the infusion comprises an autologous hematopoietic reconstitution.

29. The method recited in claim 27 wherein the infusion comprises an allogeneic hematopoietic reconstitution.

30. The method recited in claim 24, further comprising the steps of isolating blood cells from several umbilical cord segments from said storage facility, said umbilical cord segments all having a common umbilitype, and infusing said blood cells into the patient.

31. The method recited in claim 30 wherein the infusion comprises an allogeneic hematopoietic reconstitution.

32. The method recited in claim 23 wherein said step of isolating is performed subsequently to said step of warming.

33. A method for use in preparing a biological sample, comprising the steps of: upon the birth of an individual, obtaining a segment of a severed umbilical cord which extended from said individual to a respective placenta; preserving the umbilical segment; recording statistics pertaining to said individual and said individual's birth, together with an identification of the umbilical segment; and conveying the umbilical segment to a storage facility. - 23

34. The method recited in claim 33 wherein said step of preserving is performed prior to said step of conveying.

35. The method recited in claim 33 wherein said step of preserving includes the step of closing opposite ends of said umbilical segment.

36. The method recited in claim 35 wherein said step of closing includes the step of tying off both ends of said segment.

37. The method recited in claim 35 wherein said step of closing includes the step of covering said ends of said segment with respective caps.

38. The method recited in claim 33 wherein said step of preserving includes the step of cooling said umbilical segment.

39. The method recited in claim 38 wherein said step of cooling includes the step of freezing said umbilical segment.

40. The method recited in claim 39 wherein said storage facility is a cryogenic storage facility.

41. The method recited in claim 38 wherein said step of cooling includes the step of freeze-drying said umbilical segment.

42. The method recited in claim 33, further comprising the step of storing said umbilical segment.

43. The method recited in claim 42, further comprising the steps of maintaining the stored umbilical cord segment in a preserved state in said storage facility for an indefinite period; receiving incoming requests for materials stored in said storage facility; upon receiving a request for a biological component of the deposited umbilical cord segment, retrieving the deposited umbilical cord segment from said storage apparatus. - 24

44. The method recited in claim 33, further comprising the step of transmitting the recorded statistics to an information storage facility.

45. The method recited in claim 44 wherein the storage facility for said umbilical segment and said information storage facility are at the same location.

46. The method recited in claim 33 wherein said steps of obtaining, preserving, recording and conveying are performed for each individual infant born in a health care institution.

47. The method recited in claim 33, further comprising the steps of severing said umbilical segment into a multiplicity of sections, closing each of said sections at opposite ends thereof and cooling all of the closed segments.

48. The method recited in claim 47, further comprising the step of conveying at least two of the cooled umbilical segments to separate storage facilities.

49. The method recited in claim 48, further comprising the step of transmitting the recorded statistics, necessarily pertaining to all of the cooled umbilical segments, to at least two separate information storage facilities.

50. A method substantially as hereinbefore described with reference to the Examples.

51. A biological sample whenever prepared by a method as claimed in any preceding claim.