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Clinical Efficacy and Compatibility of Allogeneic Avital Tissue Transplants Sterilized with a Peracetic Acid/Ethanol Mixture

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Abstract

In the course of the past 20 years a quantity of approximately 60,000 allogeneic avital tissue grafts sterilized with the peracetic acid–ethanol method (PES) were transplanted successfully. Based on a retrospective report of clinical experience of the years 1997–2001 on the overall scope of tissue grafts manufactured by the Tissue Banks of the University Hospital Charité and the German Institute for Cell and Tissue Replacement, the clinical efficacy and side effects of 18.3% (3.087/16.823) of all transplants were studied. Cancellous (1.601/3.087) and cortical (291/3.087) bone transplants as well as amnion (1.027/3.087) constituted the greatest part. In 91% of the examined patients (2.369/2.592) tissue integration ratios ranging from good up to very well could be observed. The transplant function of defect replacement or of a spacer respectively could be obtained for all types of tissue. The clinical effect caused by the transplant resulted in more than 99% of the transplants in primary integration or in the desired aim of the therapy (defect replacement, stabilization in case of palliative operations, etc.). In less than 1% (9/2.592) of cases a secondary healing occurred for cancellous bone transplantations or, revisional operations became necessary. In all cases severe side effects, in particular transmission of infectious diseases or transplant rejections, were not observed.

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References

  • Allard RHB, Lekas C and Swart JGN (1987) Autologous versus homologus bone grafting in osteotomies, secondary cleft repairs and ridge augmentations: A clinical study. Oral Surg, Oral Med, Oral Pathol 64: 269–274

    Article  CAS  Google Scholar 

  • Aspenberg P and Lindqvist SB (1998) Ethylene oxide and bone induction. Controversy remains. Acta Orthop Scand 69: 173–176

    PubMed  CAS  Google Scholar 

  • Baker TM and Courtiss EH (1994) Temporalis fascia grafts in open secondary rhinoplasty. Plast Reconstr Surg 93: 802–810

    Article  PubMed  CAS  Google Scholar 

  • Ben-Bassat H, Chaouat M, Zumai E, Segal N, Cinamon U, Ron M, Wexler MR and Eldada A (2000) The Israel National Skin Bank: Quality assurance and graft performance of stored tissues. Cell Tissue Banking 1: 303–312

    Article  Google Scholar 

  • Beyer W, Mau H and Lorenz C (1990) Die Anwendung von homologen Spongiosachips bei der Behandlung juveniler Knochenzysten. Beitr Orthop Traumatol 37: 466–467

    PubMed  CAS  Google Scholar 

  • Bundesärztekammer, Wissenschaftlicher Beirat (2001) Richtlinien zum Führen einer Knochenbank. Dtsch Ärzteblatt 98: A1011–1016

    Google Scholar 

  • Bundesgesundheitsamt (1986) Empfehlungen des BGA. BGB 1: 21–22

    Google Scholar 

  • Burchardt H (1987) Biology of bone transplantation. Orthop Clin North Am 18: 187–196

    PubMed  CAS  Google Scholar 

  • Denner K and von Versen R (1991) Demineralisierte Knochenmatrix - tierexperimentelle Untersuchungen und erste klinische Erfahrungen. Habilitationsschrift, Humboldt-Universität zu Berlin

    Google Scholar 

  • Eastlund DT (1995) Bone transplantation and bone banking. In: Lonstein et al. (eds) Textbook of Scoliosis and Other Spinal Deformities, 3rd edn, pp 581–595. W.B. Saunders Company

  • EATB/EAMST (1997) Common standards for musculo skeletal tissue banking. OBIG-Transplant, Vienna

  • Friedlaender GE (1985) Bone banking and clinical application. Transpl Proc 17: 99–104

    CAS  Google Scholar 

  • Friedlaender GE (1987) Bone grafts. J Bone Joint Surg 69-A: 786–790

    PubMed  Google Scholar 

  • Geipel E and Zippel H (1990) Autogene und allogene Knochengewebsübertragung im Fachgebiet Orthopädie. Beitr Orthop Traumatol 37: 475

    PubMed  CAS  Google Scholar 

  • Gertzman AA and Sunwoo MH (2001) A pilot study evaluating sodium hyaluronate as a carrier for freeze-dried demineralized bone powder. Cell Tissue Banking 2: 87–94

    Article  CAS  Google Scholar 

  • Gher ME, Williams JE, Vernino AR, Strong DM and Pelleu GB (1980) Evaluation of the immunogenecity of freeze-dried skin allografts in humans. J Periodontol 51: 571–577

    PubMed  Google Scholar 

  • Glowacki J, Kaban LB, Sonis ST, Rosenthal RK and Mulliken JB (1984) Physiological aspects of bone repair using demineralized bone. In: Hunt TK, Heppenstall RB, Pines E and Rovee D (eds) Soft and Hard Tissue Repair, pp 265–280

  • Göbel P and Schubert W (1990) Unsere Erfahrungen mit der Deckung kindlicher Verbrennungswunden durch Amnion. Beitr Orthop Traumatol 37: 495–498

    PubMed  Google Scholar 

  • Goble EM and Kane SM (1995) Meniscal allografts. In: Czitrom AA and Winkler H (eds) Orthopaedic Allograft Surgery, pp 243–252

  • Hansbrough JF (1992) Woundcoverage - Allograft (homograft) Skin, pp 21–40. R.G. Landes Company, Austin

    Google Scholar 

  • Haynert W (1990a) Langzeitergebnisse nach Acetabuloplastiken mit kortikospongiösen Bankspänen bei Hüftdysplasien und - luxationen. Beitr Orthop Traumatol 37: 468–475

    PubMed  CAS  Google Scholar 

  • Haynert W (1990b) Application possibilities of human bonecollagen substance as a transplant in skeletal surgery. Beitr Orthop Traumatol 37: 453–461

    PubMed  CAS  Google Scholar 

  • International Atomic Energy Agency (IAEA) (1990) Sterility assurance level. In: Guidelines for Industrial Radiation Sterilization of Disposable Medical Products (Cobalt-60 Gamma Irradiation), IAEA-TECDOC-539, p 39. IAEA, Vienna

    Google Scholar 

  • Johnson DL and Harner CD (1995) The use of fresh frozen soft tissue allografts in knee ligament surgery. In: Czitrom AA and Winkler H (eds) Orthopaedic Allograft Surgery, pp 234–242

  • Kastenbauer ER (1983) Konservierung und Anwendungsm öglichkeiten allogener (homologer) Transplantate im Hals-Nasen-Ohrenbereich. HNO 31: 371–380

    PubMed  CAS  Google Scholar 

  • Klen R (1982) Biological Principles of Tissue Banking, p 122. Pergamon Press, New York

    Google Scholar 

  • Knöfler E (1976) Ergebnisse der homologen Knochentransplantation. Nova Acta Leopoldina 44: 413–418

    Google Scholar 

  • Komender J, Marczynski W, Tylman D, Malczewska H, Komender A and Sladowski D (2001) Preserved tissue allografts in reconstructive surgery. Cell Tissue Banking 2: 103–112

    Article  CAS  Google Scholar 

  • Kucan JO, Robson MC and Parsons RW (1982) Amniotic membranes as dressing following facial dermabrasion. Ann. Plastic Surg 8: 323–327

    Google Scholar 

  • Kuhls R, Werner-Rustner M, Küchler I and Soost F (2001) Human demineralized bone matrix as a bone substitute for reconstruction of cystic defects of the lower jaw. Cell Tissue Banking 2: 143–153

    Article  CAS  Google Scholar 

  • Lechat A and Martens M (1995) Clinical application of tendon allografts. In: Czitrom AA and Winkler H (eds) Orthopaedic Allograft Surgery, pp 227–233

  • Lin SD, Lai CS, Hou MF and Yang C (1985) Amion overlay meshed skin autograft. Burns 11: 374–378

    Article  CAS  Google Scholar 

  • Lo Grippo GA (1957) Procedure for bone sterilization with betapropiolactone. J Bone Joint Surg (Am) 39: 1356–1364

    Google Scholar 

  • Lomas R, Drummond O and Kearney JN (2000) Processing of whole femoral head allografts: A method for improving clinical efficacy and safety. Cell Tissue Banking 1: 193–200

    Article  CAS  Google Scholar 

  • Malinin TI, Claflin AJ, Brown MD and Arango A (1978) Experience with bone and dura mater allografts at the University of Miami Tissue Bank. Acta Med Pol 19: 215–228

    PubMed  CAS  Google Scholar 

  • Matthes G and von Versen R (1990) Tissue preservation in the GDR. Beitr Orthop Traumatol 37(8): 435–440

    PubMed  CAS  Google Scholar 

  • May SR (1991) The effect of biological wound dressing on the healing process. Clin Mater 8: 243–249

    Article  PubMed  CAS  Google Scholar 

  • Meeuwsen F and de Vries PA (1995) Preservation of human costal cartilage for transplants in nasal surgery. In: Byk Ch, Lechat A and von Versen R (eds) 4th International Conference on Tissue Banking. Monduzzi Editore

  • Nather A (2000) Biological healing of large diaphyseal deep-frozen allografts transplants. Cell Tissue Banking 2: 3–7

    Article  Google Scholar 

  • Oakeshott RD, Morgan DAF, Zukor DJ, Rudan JF, Brooks PJ and Gross AE (1987) Revision total hip arthrosplasty with osseous allograft reconstruction. Clin Orthop 255: 37–61

    Google Scholar 

  • Paul B and von Frankenberg E (1990) Die allogene lyophilisierte Fascia lata ‘weich’ als extraartikulärer Stabilisator bei einfacher und komplexer Kniegelenkinstabilität. Beitr Orthop Traumatol 37: 483–489

    PubMed  CAS  Google Scholar 

  • Prabhasawat P and Tesavibul N (2001) Preserved amniotic membrane transplantation for conjunctival surface reconstruction. Cell Tissue Banking 2: 31–39

    Article  Google Scholar 

  • Pruss A, Kao M, Kiesewetter H, von Versen R and Pauli G (1999) Virus safety of avital bone tissue transplants: Evaluation of sterilization steps of spongiosa cuboids using a peracetic acid- methanol mixture. Biologicals 27: 195–201

    Article  PubMed  CAS  Google Scholar 

  • Pruss A, Baumann B, Seibold M, Kao M, Tintelnot K, von Versen R, Radtke H, Dörner T, Pauli G and Göbel UB (2001a) Validation of the sterilization procedure of allogeinic avital bone transplants using peracetic acid- ethanol. Biologicals 29: 59–66

    Article  PubMed  CAS  Google Scholar 

  • Pruss A, Hansen A, Kao M, Gürtler L, Pauli G, Benedix F and von Versen R (2001b) Comparison of the efficacy of virus inactivation methods in allogeneic avital bone tissue transplants. Cell Tissue Banking 2: 201–215

    Article  CAS  Google Scholar 

  • Rama P, Giannini R, Bruni A, Gatto C, Tiso R and Ponzin D (2001) Further evaluation of amniotic membrane banking for transplantation in ocular surface diseases. Cell Tissue Banking 2: 155–163

    Article  CAS  Google Scholar 

  • Reddi AH (1984) Role of extracellular matrix components in local control of bone regeneration, remodelling and repair. In: Hunt TK, Heppenstall RB, Pines E and Rovee D (eds) Soft and Hard Tissue Repair, pp 255–264

  • Salai M, Dudkiewicz I, Blankstein A, Israeli A, Chechik A and Amit Y (2000) Bone allograft in revision total knee replacement. Cell Tissue Banking 1: 291–294

    Article  CAS  Google Scholar 

  • Siegert R, Maerker R and Pfeifer G (1988) Lyophilisierter homologer Knorpel als Knochenersatzmaterial im Kiefer. Dtsch Zahnärztl Z 43: 105–107

    PubMed  CAS  Google Scholar 

  • Sprössig M and Mücke H (1969) Die Virusdesinfektion durch Peressigsäure in Gegenwart von Alkoholen. Wiss Z Humboldt-Univ Math-Nat R 18: 1171–1173

    Google Scholar 

  • Strauss P and Schreiter K (1979) Konservierte menschliche Knorpelimplantate und körpereigene vitale Transplantate in Nase und Mittelohr. Laryng Rhinol 53: 201–209

    Google Scholar 

  • Teixeira W, Vuillemin T and Altermatt HJ (1990) Lyophilisierter Rippenknorpel als Rekonstruktionsersatzmaterial in der Mittelohrchirurgie. Laryngo Rhino Otol 69: 621–624

    Article  CAS  Google Scholar 

  • Thielicke U, Thielicke B, von Versen R and Denner K (1990) Klinische Studie zum Einsatz von demineralisierter Knochenmatrix (DBM) in der Chirurgischen Stomatologie. [Clinical study on the application of demineralized bone matrix (DBM) in surgical orthodontics.] Beitr Orthop Traumatol 37: 461–465

    PubMed  CAS  Google Scholar 

  • Thomson PD and Parks DH (1981) Monitoring, banking, and clinical use of amnion as a burn wound dressing. Ann. Plastic Surg 7: 354–356

    CAS  Google Scholar 

  • Thoren K and Aspenberg P (1995) Ethylene oxide impairs allograft incorporation in a conduction chamber. Clin Orthop 318: 259–264

    PubMed  Google Scholar 

  • Thoren K, Aspenberg P and Thorngren KG (1995) Lipid extracted bank bone: Bone conductive and mechanical properties. Clin Orthop 311: 232–246

    PubMed  Google Scholar 

  • Tomford WW (2000) Bone allografts: Past, present and future. Cell Tissue Banking 1: 105–109

    Article  CAS  Google Scholar 

  • von Versen R, Denner K, Freistedt B, Sehrt B and Matthes G (1989) Verfahren zur Präparation demineralisierter Knochenmatrix. Z Med Lab Diagn 30: 154–158

    PubMed  CAS  Google Scholar 

  • von Versen R, Heider H, Kleemann I and Starke R (1992) Chemische Sterilisation biologischer Implantate mit einer Kombinationsmethode. Osteologie Aktuell VII(Suppl.): 380–386

    Google Scholar 

  • Ward DJ and Bennett JP (1984) The long-term results of the use of human amnion in the treatment of leg ulcers. Br J Plastic Surg 37: 191–193

    Article  CAS  Google Scholar 

  • Wippermann BW, Schratt HE, Steeg S and Tscherne H (1997) Komplikationen der Spongiosaentnahme am Beckenkamm. Eine retrospektive Analyse von 1191 Fällen. Chirurg 68: 1268–1291

    Article  Google Scholar 

  • Wutzler P and Sauerbrei A (2001) Peressigsäure-Ethanol - Ein potentielles viruzidesHändedesinfektionsmittel. In: Rabenau HF, Thraenhart O and Doerr HW (eds) Nosokomiale Virusinfektionen - Erkennung und Bekämpfung, pp 92–100. Pabst Science Publishers, Lengerich

    Google Scholar 

  • Zazacki W (1991) The efficacy of application of lyophilized, radiation-sterilized bone graft in orthopaedic surgery. Clin Orthop 272: 82–87

    Google Scholar 

  • Zhang Q, Cornu O and Delloye C (1997) Ethylene oxid does not extinguish the osteoinductive capacity of demineralized bone. A reappraisal in rats. Acta Orthop Scand 68: 104–108

    Article  PubMed  CAS  Google Scholar 

  • Zohar Y, Talmi YP, Finkelstein Y, Shivili Y, Sadov R, Laurian N and Tikvah P (1987) Use of human amniotic membrane in otolaryngologic practice. Laryngoscope 97: 978–980

    PubMed  CAS  Google Scholar 

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Pruss, A., Perka, C., Degenhardt, P. et al. Clinical Efficacy and Compatibility of Allogeneic Avital Tissue Transplants Sterilized with a Peracetic Acid/Ethanol Mixture. Cell Tissue Banking 3, 235–243 (2002). https://doi.org/10.1023/A:1024697515420

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