System for making available individual or pooled, also anonymous patient data on the basis of molecular genome, transcriptome, proteome, epigenome, or metabolome data
The invention relates to a system for automatically, rapidly, and dynamically funding biological cells for transplantion, treatment, or research purposes between collection centers or banks (storage places) and hospitals, transplant centers, or research facilities, monitoring and assisting with processes from the transmission of requests, the delivery of cell preparation suitable for allogeneic transplantation, and the use of the found preparations to the monitoring of the result in the patient, and making said data available for statistical and other purposes, wherein samples are taken before and after the transplantation to analyze genomes, proteomes, transcriptomes, epigenomes, and/or metbolomes.
1. A system for allocating and selecting umbilical cord blood preparations, for transplantations, therapies and/or research purposes, wherein the system comprises data processing equipment including multiple processing units connected via a network of said multiple processing units via which data is exchanged,
wherein
said one or more processing units are configured to:
store experience data of umbilical cord blood preparations imputed into a computer via one or more input devices and storing on a storage medium,
store inquiry data of a potential recipient or patient on a storage medium,
store preset search criteria,
compare the experience data with the inquiry data, and automatically evaluate the search being effected, and/or
effect order processing and tracking on the basis of this evaluation, wherein the umbilical cord blood preparation being ordered via the network, and wherein
the multiple processing units are configured to arrange and select potential umbilical cord blood preparations according to HLA match, patient weight, number of nucleated cells (TNC) and number of hematopoietic cells (CD34+),
metabolites of the umbilical cord blood preparations, of the recipient and/or donor are determined prior to and after said transplantation and/or therapy and are stored by one or more of said processing units, and
genome, proteome, transcriptome and/or epigenome analyses are carried out and are stored by one or more of said processing units, wherein in said allocation and selecting (a) at least one collection center and/or storage site and (b) at least one clinic, transplant center and/or research facility, communicate with each other via wired and/or wireless connections
wherein the one or more processing units are configured to execute
a patient search that comprises determining patient-compatible preparations in accordance with one or more of the following:
name and identification of clinic or transplantation center,
names of coordinator and attending physician, including contact data,
status of clinic with regard to international certifications (e.g. FACT),
average number of UCB transplantations in the inquiring clinic during the last three years,
name of patient, insurance number and other accounting information,
patient's medical history,
indication and therapy proposal of attending physician,
urgency according to defined classification,
HLA type of patient,
blood group of patient,
weight of patient,
ethnic group of patient,
sex of patient,
age of patient,
known allelic characteristics of patient and/or data of DNA typing,
first treatment or re-treatment,
wherein the one or more of said processing units are configured to produce short list(s) of potential umbilical cord preparations using the following settings:
ML
Prep
:
_
=
{
6
:
HLA
Prep
and
HLA
Pat
match
in
6
out
of
6
values
and
blood
group
compatibility
5
:
HLA
Prep
and
HLA
Pat
match
in
5
out
of
6
values
and
blood
group
compatibility
4
:
HLA
Prep
and
HLA
Pat
match
in
5
out
of
6
values
and
blood
group
compatibility
Preparation
not
included
:
other
wherein ML Prep =match level in accordance with HLA compatibility between preparation and patient,
CF
Prep
:=
{
3
×
10
7
:
ML
Prep
=
6
4
×
10
7
:
ML
Prep
=
5
5
×
10
7
:
ML
Prep
=
4
wherein CF Prep =cell factor defining required number of cells per kg of patient weight at corresponding match level,
CN
Prep
:=
TNC
Prep
CF
Prep
wherein CN Prep =classification number of a preparation allowing arrangement of preparations in accordance with TNC and match level, and wherein
the short list(s) of preparations to be considered for single transplants are produced using the following setting:
SL
Single
:=
{
p
∈
Prep
❘
CN
p
BW
Pat
≥
1
/
kg
⋀
ML
Prep
≥
4
}
wherein SL Single =short list of preparations to be considered for single transplants,
and wherein the classifications of preparations in the short list are made according to the following criteria:
Classification
1
=
initial
ranking
according
to
match
level
,
followed
by
classification
number
,
followed
by
CD
34
+
Classification
1
(
SL
)
:=
{
p
1
∈
SL
,
p
2
∈
SL
❘
either
ML
p
1
>
ML
p
2
or
ML
p
1
=
ML
p
2
⋀
CN
p
1
>
CN
p
2
or
ML
p
1
=
ML
p
2
⋀
CN
p
1
=
CN
p
2
⋀
CD
34
p
1
≥
CD
34
p
2
and
Classification
2
=
initial
ranking
according
to
classification
number
,
followed
by
match
level
,
followed
by
CD
34
+
Classification
2
(
SL
)
:=
{
p
1
∈
SL
,
p
2
∈
SL
❘
either
CN
p
1
>
CN
p
2
or
CN
p
1
=
CN
p
2
⋀
ML
p
1
>
ML
p
2
or
CN
p
1
=
CN
p
2
⋀
ML
p
1
=
ML
p
2
⋀
CD
34
p
1
+
≥
CD
34
p
2
+
wherein
Prep=umbilical cord blood preparation
Pat=patient
HLA Pat =HLA values of patient
HLA Prep =HLA values of preparation
TNC Prep =number of nucleated cells of preparation
BW Pat =body weight of patient in kg
CD34+ Prep =number of CD34+ cells of a preparation
P1, P2=preparation 1 selected, preparation 2 selected.
2. The system according to claim 1 ,
wherein the one or more of said processing units are configured to acquire data regarding
umbilical cord blood preparations with a data set during data processing, which data set comprises the following parameters:
name and identification of the UCB storage bank (UCB bank),
status of the UCB storage bank with regard to international certifications, preferably FACT,
process reliability of the UCB bank according to classification,
contact in the respective bank, including contact data,
identification number of preparation,
medical history of mother, child and family according to anamnesis form of the maternity clinic,
ethnic group of mother, father and/or child,
sex of child,
date of initial storage of preparation,
details of preparation processing,
blood group of preparation,
HLA type of preparation,
cell count (TNC) of preparation,
cell count (CD34+) of preparation,
viral status of preparation,
allelic characteristics of preparation, and/or
parameters of molecular diagnoses and analyses of genome, transcriptome, proteome, epigenome and/or metabolome,
said data set being stored on a storage medium and/or processing unit.
3. The system according to claim 1 , wherein metabolites from tissues, mucous membranes, lungs, liver, blood, intestines, faeces, kidneys and/or urine are determined.
4. The system according to claim 1 ,
Wherein the one or more processing units are configured to execute a patient search that determines patient-compatible preparations in accordance with the following classification and/or exclusion criteria:
HLA type of patient, and
weight of patient.
5. The system according to claim 1 ,
wherein
the following further classification and/or exclusion criteria are implemented:
preparations having a CD34+ cell count above 10% of the TNC count,
exclusion of preparations wherein less than 75% of the CD34+ cells survived and/or were activated in a CA (colony assay),
blood group identity,
ethnic identity,
gender,
age of preparation,
accreditation standard and/or
ranking of the UCB bank.
6. The system according to claim 1 ,
wherein one or more of said processing units are configured to allocate double or multiple transplantations.
7. The system according to claim 6 ,
wherein one or more of said processing units are configured to perform the selection of multi-cord preparations according to the following classification criteria:
ML
P
1
P
2
:=
{
6
:
H
L
A
Prep
1
and
H
L
A
Prep
2
match
in
6
out
of
6
values
and
blood
group
compatibility
5
:
H
L
A
Prep
1
and
H
L
A
Prep
2
match
in
5
out
of
6
values
and
blood
group
compatibility
4
:
H
L
A
Prep
1
and
H
L
A
Prep
2
match
in
4
out
of
6
values
and
blood
group
compatibility
Preparation
not
included
:
other
wherein ML P1P2 =mutual compatibility of 2 preparations, and
BL
Multi
:=
{
p
∈
Prep
❘
CN
p
BW
Pat
<
1
/
kg
⋀
ML
Prep
≥
4
}
wherein BL Multi =basic list to determine the selection list for multiple preparations, and wherein said one or more processing units are configured to prepare a short list of preparations to be included in multiple transplants according to the following formula:
SL
Multi
:=
{
p
1
∈
BL
Multi
,
p
2
∈
BL
Multi
❘
ML
p
1
p
2
≥
4
⋀
CN
p
1
+
CN
p
2
BW
Pat
≥
1
}
.
SL Muiti =short list of preparations to be included in multiple transplants,
wherein
P1=preparation 1 selected,
P2=preparation 2 selected, and
Multi=multiple transplants.
8. A method for selecting a cell preparation suitable for allogenic transplantation comprising
providing a system wherein said system allocates and selects umbilical cord blood preparations, for transplantations, therapies and/or research purposes between (a) at least one collection center and/or storage site and (b) at least one clinic, transplant center and/or research facility, (a) and (b) communicating with each other via wired and/or wireless connections on multiple processing units and being connected via a network of said multiple processing units via which data are exchanged,
and wherein the method further comprises
inputting experience data of umbilical cord blood preparations in a computer and storing said data on a first storage medium,
inputting inquiry data of a potential recipient or patient and storing the data on said first or a second storage medium,
presetting search criteria on said first, second or a further storage medium and/or one of said processing units,
conducting a search, said search comprising comparing the experience data with the inquiry data, and an automatic evaluation of the search being effected, and/or
effecting order processing and tracking on the basis of this evaluation, and the umbilical cord blood preparation being ordered via the network,
wherein
potential umbilical cord blood preparations are arranged and selected according to HLA match, patient weight, number of nucleated cells (TNC) and number of hematopoietic cells (CD34+) and, in addition,
metabolites of the umbilical cord blood preparations, of the recipient and/or donor are determined prior to and after transplantation and/or therapy of biological cells and/or tissues, and genome, proteome, transcriptome and/or epigenome analyses are carried out and executing
a patient search comprising:
determining patient-compatible preparations in accordance with one or more of the following:
name and identification of clinic or transplantation center,
names of coordinator and attending physician, including contact data,
status of clinic with regard to international certifications (e.g. FACT),
average number of UCB transplantations in the inquiring clinic during the last three years,
name of patient, insurance number and other accounting information,
patient's medical history,
indication and therapy proposal of attending physician,
urgency according to defined classification,
HLA type of patient,
blood group of patient,
weight of patient,
ethnic group of patient,
sex of patient,
age of patient,
known allelic characteristics of patient and/or data of DNA typing,
first treatment or re-treatment,
wherein the one or more processing units are configured to produce short list(s) of potential umbilical cord preparations using the following settings:
ML
Prep
:=
{
6
:
H
L
A
Prep
and
H
L
A
Pat
match
in
6
out
of
6
values
and
blood
group
compatibility
5
:
H
L
A
Prep
and
H
L
A
Pat
match
in
5
out
of
6
values
and
blood
group
compatibility
4
:
H
L
A
Prep
and
H
L
A
Pat
match
in
4
out
of
6
values
and
blood
group
compatibility
Preparation
not
included
:
other
wherein ML Prep =match level in accordance with HLA compatibility between preparation and patient,
CF
Prep
:=
{
3
×
10
7
:
ML
Prep
=
6
4
×
10
7
:
ML
Prep
=
5
5
×
10
7
:
ML
Prep
=
4
wherein CF Prep =cell factor defining required number of cells per kg of patient weight at corresponding match level,
CN
Prep
:=
T
N
C
Prep
CF
Prep
wherein CN Prep =classification number of a preparation allowing arrangement of preparations in accordance with TNC and match level, and wherein
the short list(s) of preparations to be considered for single transplants are produced using the following setting:
SL
Single
:=
{
p
∈
Prep
❘
CN
p
BW
Pat
≥
1
/
kg
⋀
ML
Prep
≥
4
}
wherein SL Single =short list of preparations to be considered for single transplants,
and wherein the classifications of preparations in the short list are made according to the following criteria:
Classification
1
=
initial
ranking
according
to
match
level
,
followed
by
classification
number
,
followed
by
CD
34
+
Classification
1
(
SL
)
:=
{
p
1
∈
SL
,
p
2
∈
SL
❘
either
ML
p
1
>
ML
p
2
or
ML
p
1
=
ML
p
2
⋀
CN
p
1
>
CN
p
2
or
ML
p
1
=
ML
p
2
⋀
CN
p
1
=
CN
p
2
⋀
CD
34
p
1
≥
CD
34
p
2
Classification
2
=
initial
ranking
according
to
classification
number
,
followed
by
match
level
,
followed
by
CD
34
+
Classification
2
(
SL
)
:=
{
p
1
∈
SL
,
p
2
∈
SL
❘
either
CN
p
1
>
CN
p
2
or
CN
p
1
=
CN
p
2
⋀
ML
p
1
>
ML
p
2
or
CN
p
1
=
CN
p
2
⋀
ML
p
1
=
ML
p
2
⋀
CD
34
p
1
+
≥
CD
34
p
2
+
wherein
Prep=umbilical cord blood preparation
Pat=patient
HLA Pat =HLA values of patient
HLA Prep =HLA values of preparation
TNC Prep =number of nucleated cells of preparation
BW Pat =body weight of patient in kg
CD34+ Prep =number of CD34+ cells of a preparation
P1, P2=preparation 1 selected, preparation 2 selected.
9. The method according to claim 8 ,
further comprising coordinating between hospital, transplant center and attending physician.
10. The method according to claim 8 ,
wherein the system is used in automatic and full-range selection of single-cord or multi-cord transplants.
11. The method according to claim 8 ,
wherein
the search criteria of the system are adapted to the registered criteria and/or parameters.
12. The method according to claim 8 ,
wherein
the system uses a matrix to display the results obtained using the search criteria and visually displays the results.
13. The method according to claim 8 ,
wherein
the system uses statistics relating to the expected cost and required time to assess the status of the determination of classification criteria.
14. The method according to claim 8 ,
further comprising a patient search comprising:
determining patient-compatible preparations in accordance with the following classification and/or exclusion criteria:
HLA type of patient, and
weight of patient.
15. The method of claim 8 ,
wherein the system is used in the allocation of double or multiple transplantations.
16. The method of claim 15 ,
wherein the selection of multi-cord preparations is performed according to the following classification criteria:
ML
P
1
P
2
:=
{
6
:
H
L
A
Prep
1
and
H
L
A
Prep
2
match
in
6
out
of
6
values
and
blood
group
compatibility
5
:
H
L
A
Prep
1
and
H
L
A
Prep
2
match
in
5
out
of
6
values
and
blood
group
compatibility
4
:
H
L
A
Prep
1
and
H
L
A
Prep
2
match
in
4
out
of
6
values
and
blood
group
compatibility
Preparation
not
included
:
other
ML P1P2 =mutual compatibility of 2 preparations, and
BL
Multi
:=
{
p
∈
Prep
❘
CN
p
BW
Pat
<
1
/
kg
⋀
ML
Prep
≥
4
}
wherein BL Multi =basic list to determine the selection list for multiple preparations, and wherein said one or more processing units are configured to prepare a short list of preparations to be included in multiple transplants according to the following formula:
SL
Multi
:=
{
p
1
∈
BL
Multi
,
p
2
∈
BL
Multi
❘
ML
p
1
p
2
≥
4
⋀
CN
p
1
+
CN
p
2
BW
Pat
≥
1
}
.
SL Multi =short list of preparations to be included in multiple transplants,
wherein
P1=preparation 1 selected,
P2=preparation 2 selected, and
Multi=multiple transplants.