US2014032123A1PendingUtilityA1
System for making available individual or pooled, also anonymous patient data on the basis of molecular genome, transcriptome, proteome, epigenome, or metabolome data
Est. expiryFeb 6, 2029(~2.6 yrs left)· nominal 20-yr term from priority
Inventors:Thomas Klein
G16H 50/70G16H 20/40G16H 10/60G06F 19/3418
61
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0
Cited by
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0
Claims
Abstract
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.
Claims
exact text as granted — not AI-modified1 . A system for the allocation and selection of biological cells or tissues, in particular umbilical cord blood preparations, for transplantations, therapies and/or research purposes between at least one collection center and/or storage site and at least one clinic, transplant center and/or research facility, the latter communicating with each other via wired and/or wireless connections on one or more processing units, especially computers, medical systems, storage devices and/or special processors and being connected via a network of said multiple processing units by means of which data are exchanged,
wherein the system comprises
inputting experience data of umbilical cord blood preparations in a computer and storing on a storage medium,
inputting inquiry data of a potential recipient or patient and storing the data on a storage medium,
presetting search criteria, particularly the storage of said search criteria, on a storage medium and/or a processing unit,
search, said search comprising comparing the experience data with the inquiry data, and an automatic evaluation of the search being effected, and/or
order processing and tracking being effected on the basis of this evaluation, and the umbilical cord blood preparation being ordered via the network, wherein
particularly the 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.
2 . The system according to claim 1 ,
wherein in particular umbilical cord blood preparations are acquired 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
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 2 ,
wherein metabolites from tissues, mucous membranes, lungs, liver, blood, intestines, faeces, kidneys and/or urine are determined.
4 . The system according to claim 3 ,
wherein the patient search comprises determining patient-compatible preparations in accordance with the following classification and/or exclusion criteria:
name and identification of clinic or transplantation center,
names of coordinator and attending physician, including contact data,
status of clinic with regard to international certifications (e.g. FACT),
average number of UCB transplantations in the inquiring clinic during the last three years,
name of patient, insurance number and other accounting information,
patient's medical history,
indication and therapy proposal of attending physician,
urgency according to defined classification,
HLA type of patient,
blood group of patient,
weight of patient,
ethnic group of patient,
sex of patient,
age of patient,
known allelic characteristics of patient and/or data of DNA typing, and/or
first treatment or re-treatment,
said classification and/or exclusion criteria being stored on a storage medium and/or processing unit.
5 . The system according to claim 4 ,
wherein the classification of potential umbilical cord preparations is set as follows:
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
4
out
of
6
values
and
blood
group
compatibility
Preparation
not
included
:
other
CF
Prep
=
cell
factor
defines
the
required
number
of
cells
per
kg
of
patient
weight
at
corresponding
match
level
CF
Prep
:=
{
3
×
10
7
:
ML
Prep
=
6
4
×
10
7
:
ML
Prep
=
5
5
×
10
7
:
ML
Prep
=
4
CN
Prep
=
classification
number
of
a
preparation
allowing
arrangement
of
preparations
in
accordance
with
TNC
and
match
level
CN
Prep
=
TNC
Prep
CF
Prep
SL
Single
=
short
list
of
preparations
to
be
considered
for
single
transplants
SL
Single
=
{
p
∈
Prep
CN
p
BW
Pat
≥
1
/
kg
ML
Prep
≥
4
}
and the standard 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
CD
34
+
Prep
=
number
of
CD
34
+
cells
of
a
preparation
ML
Prep
=
match
level
in
accordance
with
HLA
compatibility
between
preparation
and
patient
.
6 . The system according to claim 1 ,
wherein the following classification and/or exclusion criteria are used:
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.
7 . The system according to claim 1 ,
wherein the system is used in the allocation of double or multiple transplantations (multi-cord).
8 . The system according to the preceding claim,
wherein the selection of multi-cord preparations is performed according to the following classification criteria:
ML
P
1
P
2
=
mutual
compatibility
of
2
preparations
:
ML
P
1
P
2
=
{
6
:
HLA
Prep
1
and
HLA
Prep
2
match
in
6
out
of
6
values
and
blood
group
compatibility
5
:
HLA
Prep
1
and
HLA
Prep
2
match
in
5
out
of
6
values
and
blood
group
compatibility
4
:
HLA
Prep
1
and
HLA
Prep
2
match
in
4
out
of
6
values
and
blood
group
compatibility
Preparation
not
included
:
other
BL
Multi
=
basic
list
to
determine
the
selection
list
for
multiple
preparations
:
BL
Multi
:=
{
p
∈
Prep
|
CN
p
BW
Pat
<
1
/
kg
ML
Prep
≥
4
}
SL
Multi
=
short
list
of
preparations
to
be
included
in
multiple
transplants
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
}
.
9 . Use of the system according to claim 1 for the selection of a cell preparation suitable for allogenic transplantation.
10 . The use according to claim 1 ,
wherein the use comprises coordination between hospital, transplant center and attending physician.
11 . The use according to claim 1 ,
wherein the system is used in automatic and full-range selection of single-cord or multi-cord transplants.
12 . The use according to claim 1 ,
wherein the search criteria of the system are adapted to the registered criteria and/or parameters.
13 . The use according to claim 1 ,
wherein the system uses a matrix to display the results obtained using the search criteria and visually displays the results.
14 . The use according to claim 1 ,
wherein the system uses statistics relating to the expected cost and required time to assess the status of the determination of classification criteria.Cited by (0)
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