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Bone Banks: Technical Aspects of the Preparation and Preservation of Articular Allografts

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Abstract

For the technical aspects of this subject the Marseilles team collaborated with the Etablissement de Transfusion Sanguine Alpes-Provence (Alpes-Provence Blood Transfusion Service) to set up a bone bank on their premises because it has a competent cryobiology department equipped with storage tanks containing liquid nitrogen and a temperature-lowering programmer. This laboratory, which for a long time has been storing bone marrow, platelets, and various cryopreserved tissues, has the virology, bacteriology, quality control, and quality assurance laboratories of the Blood Transfusion Service and is accustomed to applying the transfusion safety standards. It was also one of the first in France to obtain the approval of the Microbiological Safety Committee of the Directorate General of Health in April 1996. Banks which were developed nationally have followed the same principles and currently more a hundred have been registered and some are awaiting authorization.

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Appendix

Appendix

Recommendations for Setting Up a Tissue Bank for the Locomotor Apparatus

These recommendations are those used by the Blood Transfusion Center of Marseilles to, among other things, preserve bone, cartilage, and ligament grafts.

The Organization of a Tissue Bank

General

The need for:

  • a tissue removal team approved by the Ministry, a geographical location for treating, storing, and making the tissue available.

Equipment

A preservation department equipped with storage tanks or apparatus, a temperature-lowering programmer indispensable for preserving bone, cartilage, and ligament tissue.Laboratories experienced in the following quality controls:

  • donor control,

  • tissue control,

  • validation of the preservation techniques.

Personnel

At the hospital:

  • the person in charge of tissue removal checks that removal from a subject in a state of brain death is in line with the regulations,

  • the surgical teams remove and treat the tissue.

At the tissue bank:

  • the bank receives the tissue,

  • the technical staff at the bank treats the tissue,

  • the laboratories perform viral serological tests on the donor and a bacteriological examination of the tissue removed,

  • the bank’s medical supervisor oversees everything.

Techniques

For each tissue, all the technical aspects of the removal, treatment, storage, quality control, distribution, and results of examinations are recorded in a manual updated regularly.

Information

Information on the donor:

  • Identity, sex, age;

  • Radiography of the tissue if necessary;

  • Cause of death;

  • Medical history;

  • ABO blood group and HLA if known;

  • Operating protocol of removal, therapies used;

  • Results of any laboratory examinations;

  • Results of the control examinations;

  • Tissue removal center and department.

Information on the host:

  • Identity, sex, age;

  • Origin of the graft;

  • Attribution criteria;

  • Identification of the use of the graft, site and date;

  • Possible response to implantation of the graft;

  • ABO blood group and HLA if known;

  • Results of the culture at the time of the graft;

  • Note any departure from the guidelines for handling and reconstitution;

  • An estimate of the clinical results.

Quality Control

Each tissue preservation department has to take part in the development of the methods which make it possible to evaluate the indications of the tissue grafts preserved. Periodical monitoring of the bacteriological status has to be practiced, checking, before they are dispatched, at least 5 % of the grafts every 6 months and more if problems with bacterial contamination are suspected.

Tissue Removal
General Ethical and Legal Considerations

In general, acceptable sources of tissues are cadavers less than 6 h after circulation has stopped, patients in a state of brain death, and patients who have had part of their tissue removed for therapeutic purposes (femoral head).The Caillavet law considers a donor to be any person who, during his lifetime, did not express any opposition to removal of his or her tissue. It is difficult, in practice, not to consider the pain suffered by those close to the person they have lost.

Selection Criteria

These vary depending on the tissue removed. Age may be a limiting factor following the use which will be made of the tissue taken. For cartilage in particular, it seems to be necessary to graft only normal joint surfaces which have been taken from healthy subjects.

Tissue may be removed from the cadaver for 5 h after his or her death if it is kept at ambient temperature and for approximately 12 h if the cadaver is stored at 4 °C immediately after death. The tissue removed from a live patient can be placed in a container, closed immediately and refrigerated at 4 °C. A valid preservation technique can be considered to be up to 12 h after the tissue has been removed and stored at the preservation temperature.

A medical history of the donor has to be sent. Potential donors will be excluded if their current medical history mentions:

  • developing septicemia,

  • a localized infection in the tissue to be removed,

  • a slowly developing viral episode

  • malignant neoplasia except for most of the cerebral tumors,

  • the existence of active hepatitis or unexplained jaundice,

  • systemic disease,

  • a patient belonging to the risk groups,

  • heavy irradiation on risk groups,

  • treatment with drugs which are toxic to the tissue to be removed.

Laboratory tests have to be performed on the blood of the cadaver or on the live donor:

  • a test for the hepatitis B virus,

  • a test for syphilis,

  • a test for HIV antibodies,

  • the transaminase levels,

  • a test for anti-HBc antibodies,

  • a test for anti-HCV antibodies,

  • a test for anti-HTL V1 and anti-HTL V2 antibodies

  • a test for anti-CMV antibodies.

The erythrocyte blood groups and tissue groups should be used and a serum bank should be set up.

Wherever possible, the tissue should be removed under sterile conditions in an operating theatre. If the allografts are removed in a non-sterile manner, it should be ensured that effective sterilization techniques can be used without damaging the tissue structure.

If a collecting medium is used, it has to be sterile and physiological.

If antibiotics are used, the bacterial cultures have to be grown before they are added and the type of antibiotics has to be clearly recorded. A final bacteriological check is recommended before the tissues are dispatched.

Fragments of tissues to be grafted have to undergo bacteriological and fungal studies using current methods and media. Cultures of the donor blood have to be carried out when the tissue is removed as well as a urine culture and possibly also a culture of a pleural effusion.

Secondary sterilization. If it is carried out, the biological and biochemical integrity of the graft has to be maintained. The methods used for decontaminating surfaces are acceptable if only the surface can be contaminated.

Preservation and Storage

The methods used to preserve and store tissue allografts vary according to the type of tissue and the clinical application in which they are included. Although the optimum methods have not been defined, the best for long-term preservation would appear to be preservation at very low temperatures (−80 °C). Continuous monitoring of the temperature may be necessary. Storage for 12 h at the most at 4 °C may be practiced from the time the tissue was removed. Only materials which are resistant to low temperatures are suitable for this type of preservation. They have to be sterile. The culture media may vary and have to be defined for each type of cell. Precautions have to be taken to check the persistence of the activity of the cells being cultured and for the absence of contamination.

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Poitout, D.G., de Gorce, Y.N. (2016). Bone Banks: Technical Aspects of the Preparation and Preservation of Articular Allografts. In: Poitout, D. (eds) Biomechanics and Biomaterials in Orthopedics. Springer, London. https://doi.org/10.1007/978-1-84882-664-9_7

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