3. Calcein AM solution 4 mM in DMSO, 100 μL, sterile.
4. Collagenase from Clostridium histolyticum Type IA, sterile.
5. Dulbecco’s phosphate-buffered saline (DPBS) solution, CTS
grade, sterile.
6. Eppendorf reaction tubes, 1.5 mL, sterile.
2.5 Requirements
of an Ovarian Tissue
Bank for Preparation,
Cryopreservation,
and Storage of Ovarian
Tissue
The following list summarizes the requirements:
1. The tissue establishment must ensure that the entire procedure
chain, including preparation, cryopreservation, storage, and
quality testing of transported and prepared tissue, is carried out
in accordance with the state of the art in science and technology.
2. Processing must be carried out in a sterile class II laminar
airflow [1, 3, 23]. The laminar airflow should be placed in a
cleanroom (ISO class 7/GMP Grade B “in operation”/Grade
C “at rest” B/C”) [24] (see Note 1).
3. According to “Good Manufacturing Practice (GMP)” criteria,
it must be ensured that the patient’s infection status is negative
(proof of GMP) before ovarian tissue removal: anti-HIV 1/2
p24 antigen, HBs-Ag, anti-HBc; in case of positivity
HBV-PCR; as well as anti-HCV-IgG and Treponema
pallidum TP.
4. The additional serological determination of the current antiMu ¨llerian hormone (AMH) value in the serum before the start
of cytotoxic therapy, in combination with the size of the ovaries, the corresponding antral follicle counts (AFCs), and the
age and determination of the primordial and primary follicle
density, serves to specify the fertility reserve and to determine
later the number of pieces for transplantation [1, 3, 23].
5. The establishment of the method for determining the primordial and primary follicle density also serves to ensure that
sampling, transport from the sampling institution to the cooperating cryobank, processing, and also cryopreservation or the
subsequent thawing of the tissue have not led to any relevant
damage to follicles and their host oocytes [1, 3, 23].
6. Ovarian tissue material should not be released for therapeutic
use/storage until the quality has been assessed as satisfactory
and can be demonstrated in writing. Tissue collection must
therefore always be accompanied by a small tissue sample for
histopathological examination, in order to exclude infections
and the presence of malignant/transformed cells (metastases)
[3, 23].
7. A verifiable quality management system should be implemented and demonstrate all these principles and working methods
of good professional practice for all responsible and executing
persons.
488
Jana Liebenthron and Markus Montag
4. Collagenase from Clostridium histolyticum Type IA, sterile.
5. Dulbecco’s phosphate-buffered saline (DPBS) solution, CTS
grade, sterile.
6. Eppendorf reaction tubes, 1.5 mL, sterile.
2.5 Requirements
of an Ovarian Tissue
Bank for Preparation,
Cryopreservation,
and Storage of Ovarian
Tissue
The following list summarizes the requirements:
1. The tissue establishment must ensure that the entire procedure
chain, including preparation, cryopreservation, storage, and
quality testing of transported and prepared tissue, is carried out
in accordance with the state of the art in science and technology.
2. Processing must be carried out in a sterile class II laminar
airflow [1, 3, 23]. The laminar airflow should be placed in a
cleanroom (ISO class 7/GMP Grade B “in operation”/Grade
C “at rest” B/C”) [24] (see Note 1).
3. According to “Good Manufacturing Practice (GMP)” criteria,
it must be ensured that the patient’s infection status is negative
(proof of GMP) before ovarian tissue removal: anti-HIV 1/2
p24 antigen, HBs-Ag, anti-HBc; in case of positivity
HBV-PCR; as well as anti-HCV-IgG and Treponema
pallidum TP.
4. The additional serological determination of the current antiMu ¨llerian hormone (AMH) value in the serum before the start
of cytotoxic therapy, in combination with the size of the ovaries, the corresponding antral follicle counts (AFCs), and the
age and determination of the primordial and primary follicle
density, serves to specify the fertility reserve and to determine
later the number of pieces for transplantation [1, 3, 23].
5. The establishment of the method for determining the primordial and primary follicle density also serves to ensure that
sampling, transport from the sampling institution to the cooperating cryobank, processing, and also cryopreservation or the
subsequent thawing of the tissue have not led to any relevant
damage to follicles and their host oocytes [1, 3, 23].
6. Ovarian tissue material should not be released for therapeutic
use/storage until the quality has been assessed as satisfactory
and can be demonstrated in writing. Tissue collection must
therefore always be accompanied by a small tissue sample for
histopathological examination, in order to exclude infections
and the presence of malignant/transformed cells (metastases)
[3, 23].
7. A verifiable quality management system should be implemented and demonstrate all these principles and working methods
of good professional practice for all responsible and executing
persons.
488
Jana Liebenthron and Markus Montag