WO2010119311A1

WO2010119311A1 - Bag for containing and freezing stem cells

Info

Publication number: WO2010119311A1
Application number: PCT/IB2010/000545
Authority: WO
Inventors: Marco Bertoni
Original assignee: Biomed Device S.R.L.
Priority date: 2009-04-16
Filing date: 2010-03-15
Publication date: 2010-10-21
Also published as: ITMO20090093A1

Abstract

The bag (1) for containing and freezing stem cells comprises an envelope (2) defining a containment chamber (3) for holding the stem cells and associable with introduction/removal means and protection means (7) associated integral with the envelope (2) and suitable for supporting at least an identification label (6) for identifying the characteristics of the stem cells contained in the containment chamber (3).

Description

BAG FOR CONTAINING AND FREEZING STEM CELLS

Technical Field

The present invention relates to a bag for containing and freezing stem cells. Background Art As is known, stem cells are primitive, non-specialised cells having the singular capacity of transforming themselves into any other type of body cell. Stem cells can be of various kinds and are generally classified as cord stem cells, meaning the cells taken from the umbilical cord of a baby, or peripheral cells, meaning the cells taken by selective apheresis from the peripheral venous system or from bone marrow.

The stem cells, after being taken from the umbilical cord or from the donor, undergo a number of treatments and/or additions of adequate additives and solutions (plasma, salt solution, DMSO, etc.) and are then collected in special bags to be cryopreserved, i.e., preserved in liquid nitrogen at a temperature approximately between - 130⁰C and - 190 C.

The bags used comprise an envelope that defines a containment chamber for holding the stem cells and which is associable with introduction and removal means.

According to a recently passed law, called "blood law", on each bag containing stem cells, a label must then be affixed showing a series of indications according to the provisions of the guidelines and applicable laws (identification details of donor and of the cells themselves, bag production lots, sampling date, expiry date, cell production date, etc, etc .). Because it is crucial to preserve the integrity of the stem cells contained in the bags and prevent them from coming into contact with "contaminating" or mutagenous agents that could in some way cause damage, pollution or mutations of the stem cells themselves, all the elements which are used for labelling must be properly selected and certified. To date, some types of paper and ink for certified labels exist on the market, the use of which is safe and in no way affects the "quality" of the cells contained in the bags. In the same way however, no type of certified glue exists that can be safely used for labelling the bags containing stem cells.

In fact, the glues marketed to date contain solvents capable of crossing the wall of the envelope making up the bag and on which the labels are affixed, thereby contaminating the cells contained inside it. Although, despite the above risks, most stem cell production and preservation institutes affix the labels directly on the envelope containing the cells, a number of solutions can be adopted to prevent the risk of damage or mutations or contamination. In particular, the solution most often adopted consists in inserting the bags containing the cells in special removable bag covers, before positioning them in the liquid nitrogen, and in affixing the identification labels on the outside of these bag covers after suitably closing them by means of sealing. Because, before making a transplant of stem cells, it is best to make sure the recipient or receiver is compatible with the cells contained inside a bag, it is crucial to carry out some compatibility tests.

Because these tests must be performed without in any way opening the bag containing the cells, generally, when the stem cells are introduced inside the bag, a number of samples are also added previously separated from the bag itself, which are then frozen inside the same metal container also holding the corresponding bag and relative bag cover. These samples of stem cells are crucial for carrying out the necessary compatibility tests with a possible recipient.

Alternatively, some bags of known type envisage, after their filling, the closing at two points of the filling tube of the bags themselves, in such a way as to isolate a certain quantity of stem cells to carry out tests or compatibility tests. This solution has however a number of drawbacks.

In fact, the labels affixed outside the bag covers can tear, become unthreaded or detach during the handling of the bags and above all during their storage soaked in liquid nitrogen. This can therefore result in the relative bag being without an identification label or in the latter being damaged and therefore not legible. Obviously, a bag without the relative identification label or with the label illegible cannot be used because it is not possible to identify the donor and the properties of the cells contained in it, and it must therefore be destroyed. Another drawback of the bags of known type consists in the fact that the samples held freely inside such metal containers can accidentally come out of these during their handling. This consequently means that the samples are no longer traceable or in any case that they are no longer reliably traceable to the corresponding bag.

Whenever the number of available samples terminates, the relative bag of stem cells must be destroyed inasmuch as no longer usable, due to the complex donation procedure known to technicians in the sector, without having prematurely tested its compatibility with the receiver.

This drawback also concerns the bags with two fastenings along the relative filling tube to isolate a corresponding quantity of stem cells. This type of bag in fact allows performing just one compatibility test, thus restricting the possibility of using its content. Furthermore, the bags of known type can be equipped with an appendix arranged below with respect to the containment chamber of the stem cells, which appendix is suitable for housing a bar code referring to a bag control management system. This appendix however, besides not providing room enough to house the label bearing all the above-indicated data, also increases the external overall dimensions of the bag, thus making its handling and storage more difficult inside the relative metal containers. It obviously follows therefore that the increase in dimensions of such appendix for the affixing of the identification labels would result in an excessive increase in the external overall dimensions of the bag, with inevitable taking up of room and increase in the management and storage costs. Object of the Invention

The main aim of the present invention is to provide a bag for containing and freezing stem cells that allows easily and reliably affixing the identification label to the bag itself, as provided by applicable laws, without this in any way contaminating or damaging the cells contained inside the bag. One object of the present invention is to provide a bag for containing and freezing stem cells that allows reliably affixing the identification label directly to the bag and avoiding this becoming accidentally detached or being damaged during handling of the bag itself or during its preservation in liquid nitrogen. Yet another object of the present invention is to provide a bag that allows using a plurality of samples to perform tests or compatibility tests and which at the same time permits preventing these samples from coming out of the relative container, so that they can be reliably retraced to the relative bag. Yet another object of the present invention is to provide a bag for containing and freezing stem cells which allows affixing the identification label in a reliable way and which at the same time substantially maintains the external overall dimensions of the bags used to date, in such a way as to be able to be cryopreserved inside the same containers in use to date for such purpose. Another object of the present invention is to provide a bag for containing and freezing stem cells, which allows overcoming the mentioned drawbacks of the state of the art within the ambit of a simple, rational, easy, effective to use and low cost solution.

Not the last object of the present invention is to provide a bag for containing and freezing stem cells which, the containment chamber volume being equal, has reduced external overall dimensions with respect to bags of known type, while at the same time satisfying all the requirements of applicable standards and allowing the easy management of the bags themselves.

The above objects are achieved by the present bag for containing and freezing stem cells, comprising an envelope defining a containment chamber for holding the stem cells and associable with introduction/removal means, characterised by the fact that it comprises protection means associated integral with said envelope and suitable for supporting at least an identification label for identifying the characteristics of the stem cells contained in said containment chamber. Brief Description of the Drawings Other characteristics and advantages of the present invention will become more evident from the description of a preferred, but not sole, embodiment of a bag for containing and freezing stem cells, illustrated purely as an example but not limited to the annexed drawings in which: figure 1 is a front view of a bag with the relative bag cover according to the invention; figure 2 is a perspective view of a bag according to the invention according to a first embodiment; figure 3 is a perspective view of a bag according to the invention according to a second embodiment.

Embodiments of the Invention

With particular reference to such figures, globally indicated by 1 is a bag for containing and freezing stem cells.

The bag 1 comprises an envelope 2 defining a containment chamber 3 of the stem cells and associable with introduction/removal means not shown in the illustrations. More in particular, the containment chamber 3 has an inlet gap 4 communicating with a filling tube 20 associable with introduction means not shown in the illustrations and closable, e.g. by sealing, to isolate the containment chamber itself from the outside and not allow the stem cells to come out. Furthermore, the bag 1 has one or more openable connectors 5, e.g., by tearing off, and associable with relative removal or reintroduction means. According to the invention, the bag 1 comprises protection means associated integral with the envelope 2 and suitable for supporting at least a label 6 identifying the characteristics of the stem cells contained in the containment chamber 3. More in particular, the information shown on the label 6 comprises all the details required by applicable regulations, such as, e.g., the name and the surname of the donor, his/her date of birth, the cell collection date and a bar code indicating a management system.

Advantageously, the protection means comprise at least a protection element 7, substantially plate-shaped, associated integrally with the envelope 2, outside this.

More in particular, the protection element 7 can be superimposed on the envelope 2 in correspondence to the containment chamber 3.

Preferably, the protection element 7 is made of transparent material, so as to also allow reading the label 6 from outside. Possibly, but not necessarily, the material making up the protection element 7 is the same as that making up the envelope 2. An example of material suitable for making the envelope 2 and/or the protection element 7 is ethylene-vinyl acetate (EVA). In a first embodiment, shown in figure 2, the protection means are made up of a single protection element 7 associated with the envelope 2.

In this embodiment, the protection element 7 is associated with the envelope 2 by at least one of its sides 7a. The opposite side 7b can also be associated with the envelope 2 or, in an alternative embodiment, released with respect to the envelope 2 and therefore free to turn, by a restricted angle, around the side 7a sealed on the envelope itself.

The protection element 7 defines two opposite faces 8, one of which is turned outwards and on which is affixed the label 6, and the other turned towards the envelope 2. Suitably, the protection element 7 is associated with the envelope 2 in correspondence to the surrounding edge 9 of the latter.

In the second embodiment, the protection means comprise two protection elements 7 associated the one with the other in correspondence to two connection areas 1 Oa and 10b, of which a first connection area 1 Oa and a second connection area 10b, distinct from one another to define a housing pocket 11 for the label 6.

Advantageously, the protection elements 7 are associated with the envelope 2, by sealing or similar techniques, with at least a connection area 10a and 10b. More in particular, in the embodiment shown in figure 3, the connection elements 7 are associated with the envelope 2 with a connection area 10a, 10b while the other connection area 10b, 10a is free and released with respect to the envelope 2.

The protection elements 7 are therefore free to rotate with respect to the envelope 2, by a restricted rotation angle, around the connection area 10a, 10b sealed on the envelope itself. Preferably, the connection areas 10a and 10b are defined in correspondence to two opposite sides of the protection elements 7. More in particular, the protection elements 7 are associated with the envelope 2 in correspondence to the surrounding edge 9 of the latter. An alternative embodiment cannot however be ruled out envisaging the fixing of both the connection areas 10a and 10b to the envelope 2. Suitably, in this second embodiment, the protection elements 7 can also be associated the one with the other in correspondence to at least a third connection area, not shown in the illustrations and arranged substantially crossways with respect to the connection areas 10a and 10b. More in particular, the third connection area can be defined in correspondence to one of the sides of the protection elements 7 adjacent to the sides in correspondence to which are defined the connection areas 10a and 10b.

Advantageously, the bag 1 comprises at least an auxiliary container 12 for carrying out compatibility tests or analyses, associated integral with the envelope 2 and separable from it. The auxiliary container 12 is separate from the filling tube 20. Preferably, the bag 1 comprises a plurality of auxiliary containers 12, as shown in the illustrations.

The auxiliary containers 12 each define a collection tank 21 communicating with the containment chamber 3 and suitable for being closed, by means of sealing or the like, to isolate a predefined quantity of stem cells contained in the containment chamber itself.

Preferably, the auxiliary containers 12 comprise suction means 13 suitable for varying the volume of the relative collection tank 21 to recall a predefined quantity of stem cells contained in the containment chamber 3. More in particular, the suction means 13 are made up of a compressible wall which delimits at least partially the relative collection tank 21.

The object of the present invention is therefore also a bag 1 containing stem cells and comprising one or more of the above-described characteristics and at least an auxiliary container 12, distinct from the filling tube 20, which branches from the containment chamber 3 and which has a fastening 22 in correspondence to its connection with the containment chamber itself so as to isolate a predefined quantity of the stem cells collected in the containment chamber 3. Such quantity of stem cells isolated from the auxiliary container 12 is to be used to carry out tests or analyses, and therefore as a sample quantity. The fastening 22 is therefore to be opened to access the contents of the auxiliary container 12. As the expert in the industry will easily appreciate, the auxiliary containers 12 are independent from the presence of other above-mentioned characteristics, such as, e.g., the protection means 7. The auxiliary containers 12 can in fact also be present in bags 1 without the protection means 7 and their presence is particularly advantageous for carrying out tests or analyses without this involving the need to open the containment chamber 3. The operation of the present invention is as follows.

After introducing the stem cells and any additives and/or solutions inside the containment chamber 3 through the inlet gap 4, the filling tube 20 is closed, e.g., by sealing, so as to isolate the containment chamber itself from the outside. In the same way, after suctioning a part of the cellular suspension contained in the containment chamber 3 inside the auxiliary containers 12, by means of the suction means 13, the auxiliary containers themselves are isolated from the containment chamber 3 realising the fastening 22, e.g., by sealing. This way, the auxiliary containers 12 are isolated from the containment chamber 3 and contain a predefined quantity of stem cells usable to carry out tests or analyses. The label 6 can be affixed to the bag 1, exploiting the protection means according to the invention, before or after filling the bag with cellular suspension. Generally speaking, the label 6 is affixed to the bag 1 before introducing the stem cells inside the containment chamber 3. More in particular, in the first embodiment shown in figure 2, the label 6 can be affixed, using any type of glue or adhesive means on the market, on the outer face 8 defined by the protection element 7.

In this way, the glue applied to the label 6 is not at direct contact with the envelope 2 but with the protection element 7, which acts as a barrier between the glue and the envelope 2. Once the label 6 has been affixed, the protection element 7 is made to adhere to the envelope 2 so the bag 1 can be placed inside a bag cover 14, subsequently hermetically sealed and suitable for being placed inside a metal container not shown in the illustrations for preservation in liquid nitrogen. In the second embodiment shown in figure 3, the label 6 can be affixed on one of the outer faces defined by the protection elements 7 or, preferably, positioned inside the housing pocket 1 1, with or without glue or adhesive means. To facilitate introducing the label 6 inside the pocket 1 1, in this case too, it is possible to turn the protection elements 7 around the connection area 10a, 10b associated with the envelope 2, thus facilitating the opening of the pocket itself, and then again have the protection elements 7 adhere to the envelope 2 for subsequent positioning inside the relative bag cover 14. In this second embodiment, therefore, the label 6 is withheld by the protection elements 7, both in the variation which envisages the connection areas 10a and 10b only and in that which also has the third connection area, and which does not therefore require the use of glue or adhesive means to secure the label 6 to the bag 1. Preferably, the opening/s of the pocket 1 1 is/are sealed so as to avoid the label itself accidentally coming out.

Furthermore, in the event of having to perform compatibility tests with a potential receiver, once the bag cover 14 containing the bag 1 has been taken and opened, one of the auxiliary containers 12 will have to be detached by, e.g., cutting it in correspondence to its fastening 22. The separation of the auxiliary containers 12 in any case maintains the integrity of the envelope 2 and therefore keeps the containment chamber 3 hermetically closed.

It has in point of fact been ascertained how the described invention achieves the proposed objects and in particular the fact is underlined that it permits preventing the solvents, the additives, etc.... contained in the means of affixing the identification label to the bag from penetrating inside the containment chamber of the stem cells, thus damaging them, contaminating them or provoking mutations.

The bag according to the invention is therefore considerably safer than the bags currently used to preserve and freeze stem cells inasmuch as it defines a sort of protection barrier between the label and the envelope inside which the stem cells are contained. Furthermore, in the embodiment which envisages the identification label being introduced inside the housing pocket separate from the envelope containing the stem cells, it is even possible to avoid applying glue or adhesive means to the label.

Again, the bags for containing and freezing the stem cells according to the invention ensure the traceability and the linking of the bags to the relevant samples for compatibility tests. Such samples in fact, because they are associated integral with the envelope defining the cell containment chamber, cannot accidentally come out of the metal container during the extraction, the handling and the opening of the container itself. Furthermore, the bags according to the invention ensure that the sample content is the same as that of the bag housed in the same container.

This way, the bag according to the invention also permits complying with the requirements of the blood law, according to which the samples used for compatibility tests must be linked in an integral way with the envelope containing the stem cells.

Not least, the bag according to the invention, while complying with all the requirements of the blood law as regards the use and affixing of the identification labels, is also of reduced overall dimensions with respect to the bags of known type, thereby ensuring easier handling and storage in the relative containers.

Claims

1) Bag (1) for containing and freezing stem cells, comprising an envelope (2) defining a containment chamber (3) for holding the stem cells and associable with introduction/removal means, characterised by the fact that it comprises protection means (7) associated integral with said envelope (2) and suitable for supporting at least an identification label (6) for identifying the characteristics of the stem cells contained in said containment chamber (3).

2) Bag (1) according to the claim 1, characterised by the fact that said protection means comprise at least a substantially sheet-shaped protection element (7) associated integral with said envelope (2), outside it.

3) Bag (1) according to the claim 2, characterised by the fact that said protection element (7) is made of transparent material.

4) Bag (1) according to the claim 2 or 3, characterised by the fact that said protection element (7) can be superimposed on said envelope (2) in correspondence to said containment chamber (3).

5) Bag (1) according to one or more of the claims from 2 to 4, characterised by the fact that said protection element (7) has at least one of its sides (7a) which is associated with said envelope.

6) Bag (1) according to one or more of the claims from 2 to 5, characterised by the fact that said protection element (7) is associated with said envelope (2) in correspondence to the surrounding edge (9) of the latter.

7) Bag (1) according to one or more of the claims from 2 to 6, characterised by the fact that said protection means comprise two of said protection elements (7) associated the one with the other in correspondence to at least two distinct connection areas (10a, 10b) to define a housing pocket (1 1) for said label.

8) Bag (1) according to the claim 7, characterised by the fact that said protection elements (7) are associated with said envelope (2) with at least one of said two connection areas (10a, 10b).

9) Bag ( 1 ) according to one or more of the claims from 7 to 8, characterised by the fact that said protection elements (7) are associated with said envelope (2) in correspondence to its surrounding edge (9).

10) Bag (1) according to one or more of the claims from 7 to 9, characterised by the fact that said protection elements (7) are also associated the one with the other in correspondence to a third connection area.

11) Bag (1) according to one or more of the preceding claims, characterised by the fact that it comprises at least an auxiliary container (12) for the performance of the tests or analysis associated with said envelope (2) and separable from it.

12) Bag (1) according to the claim 1 1, characterised by the fact that said auxiliary container (12) defines at least a collection tank (21) of the stem cells communicating with said containment chamber (3) and suitable for being closed to isolate a predefined quantity of the stem cells contained in said containment chamber (3).

13) Bag (1) according to the claim 12, characterised by the fact that it comprises suction means (13) suitable for varying the volume of said collection tank (21) to recall a predefined quantity of stem cells from said containment chamber (3).

14) Bag (1) for containing and freezing stem cells, comprising an envelope (2) defining a containment chamber (3) for holding the stem cells and at least a filling tube (20) for the introduction of the stem cells in said containment chamber (3), characterised by the fact that it comprises at least an auxiliary container (12), distinct from said filling tube (20), which branches from said containment chamber (3) and which has a fastening (22) in correspondence to its connection with the containment chamber itself so as to isolate a predefined quantity of the stem cells collected in said containment chamber (3) for the performance of tests or analysis.