Research changes tissue medicine

The successes of tissue engineering and new approaches from research open up unforeseen possibilities for tissue medicine. A lot of what seemed experimental years ago has now arrived in medical applications. Tissue donation, tissue processing and transplantation will continue to evolve over the next few years. It is still a long way before doctors can transplant organs and tissue cultivated in the laboratory. This is why classical tissue transplants will continue to play an important role in the care of patients. At the same time, research for the development of new processing and surgical methods continues in the tissue network. Whether corneas, heart valves, blood vessels or bone implants – the trend towards improving tissue transplants is irreversible.

An overview:
Research projects in which the DGFG is involved

LaMEK – Pre-Cut Grafts for DMEK

Lamellar corneal transplants are operations on the eye in which surgeons only transplant ultra-thin layers of the cornea. Ophthalmologists have so far prepared these thin lamellas directly before transplantation in the operating theatre. The risk of failure, especially of inexperienced transplanters, is high. The DGFG has developed a unique process in Germany to produce lamellas for DMEK directly in the corneal bank. The approval of the Paul Ehrlich Institute for distribution has been available since December 2015. The work and time required by ophthalmologists in the operating room is reduced. At the same time, it is ensured that the corneal transplantation actually takes place. A study is currently investigating the use of a newly developed transport cartridge for optimal insertion of the lamella into the patient’s eye.

Learn more about LaMEK

International Journal of Eyebanking 2018 Vol. 6, No 3

Pre-prepared Corneal Grafts for Facilitated Descemet Membrane Endothelial Keratoplasty (DMEK) — Controlled and Standardized Manufacturing in the Eye Bank May Lead to Reduced re-DMEK Rates

LaMEK – Pre-Cut Grafts for DMEK

An overview of the advantages of LaMEK

Report: Use of pre-prepared corneal transplants for DMEK (DE)

State of knowledge on transplant survivability and clinical success

Der Augenspiegel 09/2016 (DE)

Pre-cut lamellar grafts for DMEK – Fabrication under controlled and standardized conditions

Report: LaMEK makes the DMEK-OP safer (DE)

Allocation of the 100th pre-prepared corneal lamella for a patient from Rostock

AmnioClip-plus

Ophthalmologists often treat corneal diseases or injuries with amniotic transplants. This membrane, obtained from the maternal placenta, has excellent anti-inflammatory and wound healing properties. Until now, ophthalmologists have secured the transplant to the patient’s eye with a suture. This means an additional injury to the already damaged cornea. In the project AmnioClip-plus (AC+) an interdisciplinary team of the DGFG developed together with an external partner a clip ring similar to a contact lens. The amniotic membrane is clamped into this ring system and placed on the eye to be treated without any sutures. At the beginning of 2019, the Paul-Ehrlich-Institute (PEI) has approved the AmnioClip-plus as medicinal product for the use in the eye. Therapy without trauma with the AmnioClip-plus – a breakthrough in the treatment of corneal diseases of the eye.

Extended application for amniotic membrane

In ophthalmology, the amniotic membrane has been used for many years for the emergency care of the eye. However, the thin membrane has also proven to be extremely effective in other medical therapies. In mid-2017, the DGFG was approved by the PEI to use human amniotic membranes also for implantation in orbital, oral and maxillofacial surgery, gynecological surgery (uterus and vagina) and as temporary skin replacements for thermal injuries and wound healing disorders. This opens up new therapeutic options. Therefore, the DGFG would like to significantly expand the use of the amniotic membrane and is involved in several innovative projects: In a research project in cooperation with the Leibniz Institute for Polymer Research Dresden, a combination of amniotic membrane and hydrogels is now being developed to create new application possibilities. Another project is investigating the application of the amniotic membrane in ear, nose and throat medicine in collaboration with the Hannover Medical School (MHH). In addition, a joint project of the DGFG and the Institute for Transfusion Medicine of the MHH is dealing with changes in the biochemical and biomechanical properties of the amniotic membrane after multiple cryopreservation.

ESPOIR – European Clinical Study for the Application of Regenerative Heart Valves

Aim of the Europe-wide study ESPOIR (2012-2015) is to modify and transplant a donor heart valve in such a way that it is not rejected, lasts a lifetime and even grows with children. The heart valves are freed from their cells by an elaborate procedure. Only a collagen matrix remains. This decellularized scaffold is repopulated in the recipient organism by the body’s own cells. There are many indications that these heart valves last much longer than conventional heart valves.

Prof. Dr. Dr. h.c. Axel Haverich, Head of the Clinic for Cardiac, Thoracic, Transplantation and Vascular Surgery (HTTG) at Hanover Medical School (MHH), an interview:

Tissue donation is indispensable, as it cannot be more. It is the basic prerequisite for offering this form of therapy to our patients, especially children.

ARISE – Aortic Valve Replacement using Individualised Regenerative Allografts: Bridging the Therapeutic Gap

Medical researchers under the leadership of the MHH are using the principle of the decellularized heart valve, as already used in the ESPOIR study for the pulmonary artery valve (pulmonary valve), for a new aortic valve replacement. Five other leading European heart centres are participating in the ARISE study in cooperation with the MHH. Since 2015, around 120 patients have been treated in the ARISE study. The studies were funded by the European Union. The human donor valves originate from tissue donations received from two non-profit organisations, the DGFG and the European Homograft Bank Brussels. The decellularisation of the heart valves was carried out by the Corlife oHG.

BioGelenk healing trials

Since 2015, the DGFG has been supporting a project for the precise transplantation of cartilage cells as part of patient healing trials. The procedure developed under the guidance of Univ.-Prof. Dr. med. Christian Krettek by the Clinic for Trauma Surgery at Hanover Medical School is often the only therapy option, especially for young patients. It protects them from premature artificial joint replacement. Prof. Krettek requires thin cartilage transplants for knee and ankle joints of deceased tissue donors, which are precisely cut to size.

EuroGTP II – Good Practices for demonstrating safety and quality through recipient follow up

Since 2017 the DGFG is project partner of the European joint project EuroGTP II. It is about more safety and quality in tissue transplantation. Funding is provided over a period of three years under the Horizon 2020 Health Programme. In cooperation with tissue banks from Spain, Italy, Croatia, the UK, Poland, the Netherlands, Belgium, Bulgaria, Hungary and Finland, the DGFG is developing “good practices” guidelines for cell, tissue processing and patient follow-up that apply throughout Europe within the framework of EuroGTP II. The partners of EuroGTP II want to achieve greater safety and efficiency in the use of established therapies for all tissue processing and transplant facilities.

EuroGTP-II-Info-Flyer

EuroGTP II Joint Newsletter January 2018

EuroGTP II Newsletter July 2017

EuroGTP II Newsletter January 2017

International cooperation with…

Looking for network partners for research

Many of the upcoming tasks and studies can only be solved within a network. We would like to invite experts from research and practice to collect ideas, jointly search for solutions and transfer them into clinical application. Our goal is the transfer of research into actual application. We support scientists on this tedious path: with our comprehensive infrastructure, with the execution of studies and with our scientific expertise. Our tissue network connects research ideas across national borders. The focus is on the:

Establishment of new scientific/technological methods
Support and realization of studies and research work
Organization of meetings for scientific exchange
Cooperation with international partners

Dr. rer. nat. Nicola Hofmann

Scientific head of research & development

Dr. rer. nat. Anna-Katharina Salz

Research & Development

Scientific publications

Current presentations & poster in 2021

Koechel, D., Hofmann, N., Unterlauft, J.D. et al. Descemet membrane endothelial keratoplasty (DMEK): clinical results of precut versus surgeon-cut grafts. Graefes Arch Clin Exp Ophthalmol 259, 113–119 (2021). https://doi.org/10.1007/s00417-020-04901-7

Scientific publications in 2021

Odet, S., Louvrier, A., Meyer, C., Nicolas, F. J., Hofman, N., Chatelain, B., Mauprivez, C., Laurence, S., Kerdjoudj, H., Zwetyenga, N., Fricain, J.-C., Lafarge, X., Pouthier, F., Marchetti, P., Gauthier, A.-S., Fenelon, M., Gindraux, F. (2021). Surgical Application of Human Amniotic Membrane and Amnion-Chorion Membrane in the Oral Cavity and Efficacy Evaluation: Corollary With Ophthalmological and Wound Healing Experiences. Front. Bioeng. Biotechnol. 9:685128. doi: 10.3389/fbioe.2021.685128

Salz, A.K., Acharya, M., Hofmann, N., Wittmershaus, I., Sangwan, V., Börgel, M. et al. (2021). Risk of SARS‑CoV‑2 virus transmission from donor corneal tissue: A review. Indian Journal of Ophthalmology 2021;69:1592-7, DOI: 10.4103/ijo.IJO_3249_20

Céline Trigaux, Sabine Salla, Jan Schroeter, Theofilos Tourtas, Henning Thomasen, Philip Maier, Olaf J.C. Hellwinkel, Ilka Wittmershaus, Patrick R. Merz, Berthold Seitz, Bernhard Nölle, Norbert Schrage, Sigrid Roters, Melissa Apel, Andrea Gareiss-Lok, Constantin E. Uhlig, Sebastian Thaler, Florian Raber, Daniel Kampik, Gerd Geerling & Johannes Menzel-Severing (2021) SARS-CoV-2: Impact on, Risk Assessment and Countermeasures in German Eye Banks, Current Eye Research, 46:5, 666-671, DOI: 10.1080/02713683.2020.1828487

Sandiumenge, A., Domínguez‐Gil, B., Pont, T., Sánchez Ibáñez, J., Chandrasekar, A., Bokhorst, A., Filipe Severino, P., Oliveira, J., Boergel, M., Ponzin, D., Trias, E. and (2021), Critical pathway for deceased tissue donation: a novel adaptative European systematic approach. Transpl Int. https://doi.org/10.1111/tri.13841

Presentations & poster in 2020

N. Hofmann, S. Wahl, M. Börgel, P. Szurmann: Pre-Cut LaMEK enables cell recovery through rest period before surgery. Vortrag auf dem XXXII Annual Meeting of the European Eye Bank Association, EEBA, 16-18 January 2020, Hannover

S. Schmidt, A. Ghouzi, G. Petrov, N. Hofmann, M. Börgel, S. U. Sixt: Cornea donation in Germany: Obtaining consent. Vortrag auf dem XXXII Annual Meeting of the European Eye Bank Association, EEBA, 16-18 January 2020, Hannover

N. Hofmann, N. Möhle, K. Becke, K. Engelmann, M. Börgel: Expert and user feedback on the application of AmnioClip plus. Vortrag auf dem XXXII Annual Meeting of the European Eye Bank Association, EEBA, 16-18 January 2020, Hannover

N. Hofmann, I. Wittmershaus, A.-K. Salz, M. Börgel: Influence of time limits in donation on tissue quality and processing rate. E-Poster auf der 53. Jahrestagung der Deutschen Gesellschaft für Transfusionsmedizin und Immunhämatologie e. V. (online), 16. bis 18.09.2020

N. Hofmann, I. Wittmershaus, A.-K. Salz, J.-M. Blesin, N. Schwertner, M. Börgel: Globale Bedarfsanalyse – Angebot und Nachfrage nach Hornhauttransplantaten in Abhängigkeit der OP-Methode. Vortrag auf der 118. DOG (online), 08.-10.10.2020

Scientific publications in 2020

N. Hofmann, I. Wittmershaus, A.-K. Salz, M. Börgel: Cornea procurement and processing up to 72 hours – no risk for cornea transplant quality. Transfus Med Hemother., 2020 October, doi: 10.1159/000510588.

C. Trigaux, S. Salla, J. Schroeter, T. Tourtas, H. Thomasen, P. Maier, O. J. C. Hellwinkel, I. Wittmershaus, P. Merz, B. Seitz, B. Nölle, N. F. Schrage, S. Roters, M. Apel, A. Gareiss-Lok, C. Uhlig, S. Thaler, F. Raber, D. Kampik, G. Geerling, J. Menzel-Severing: SARS-CoV-2: Impact on, Risk Assessment and Countermeasures in German Eye Banks. Current Eye Research DOI: 10.1080/02713683.2020.1828487

A. Walckling, N. Noerenberg, N. Hofmann, M. Börgel, T. A. Fuchsluger: Entquellungsrate zur Evaluation endothelialer Pumpfunktion per OCT ermitteln – ein neuer Qualitätsparameter? OPHTHALMO-CHIRURGIE 32, Heft 5: 279 (2020).

D. Wille, J. Heinzelmann, N. Hofmann, M. Börgel, A. Kehlen, A. Müller, A. Viestenz: Fallbericht – eine Hornhaut-Spenderin mit einem positiven SARS-CoV-2 Nachweis (Case report – a cornea donor with a positive SARS-CoV-2 finding). Der Ophthalmologe, 2020, 118:710-713. doi: 10.1007/s00347-020-01264-6

D. Wille, J. Heinzelmann, N. Hofmann, M. Börgel, A. Kehlen, A. Müller, A. Viestenz: Case report – a cornea donor with a positive SARS-CoV-2 finding. Research Square DOI:10.21203/rs.3.rs-88018/v1

O. Pogozhykh, N. Hofmann, O. Gryshkov et al.: Repeated Freezing Procedures Preserve Structural and Functional Properties of Amniotic Membrane for Application in Ophthalmology. International Journal of Molecular Sciences. 2020;21(11):E4029. Published 2020 Jun 4. doi:10.3390/ijms21114029

A. Rickmann, S. Wahl, N. Hofmann, J. Knakowski, A. Haus, M. Börgel, P. Szurman: Comparison of preloaded grafts for Descemet membrane endothelial keratoplasty (DMEK) in a novel preloaded transport cartridge compared to conventional precut grafts. Cell Tissue Bank. 2020 Jun;21(2):205-213.

Schmidt, A. Ghouzi, G. Petrov, N. Hofmann, M. Boergel, S. U. Sixt: Cornea donation in Germany: Obtaining consent. Clinical Transplant. 2020 May 2;e13895. doi: 10.1111/ctr.13895.

N. Hofmann, A.-K. Salz, K. Becke, N. Möhle, M. Börgel, N. Diedenhofen, K. Engelmann. AmnioClip-plus – die nahtlose Amnionmembranbehandlung. OPHTHALMO-CHIRURGIE 2020;32(4): 179-183.

L.-M. Sara, T. Kern, N. Hofmann, O. Pogozhykh, C. Framme, M. Börgel, C. Figueiredo, B. Glasmacher, O. Gryshkov: Human Amniotic Membrane: A review on tissue engineering, application, and storage. Journal of Biomedical Materials Research Part B: Applied Biomaterials Published Dec 2 2020. DOI: 10.1002/jbm.b.34782

Research changes tissue medicine

LaMEK – Pre-Cut Grafts for DMEK

Learn more about LaMEK

International Journal of Eyebanking 2018 Vol. 6, No 3

LaMEK – Pre-Cut Grafts for DMEK

Report: Use of pre-prepared corneal transplants for DMEK (DE)

Der Augenspiegel 09/2016 (DE)

Report: LaMEK makes the DMEK-OP safer (DE)

AmnioClip-plus

Extended application for amniotic membrane

ESPOIR – European Clinical Study for the Application of Regenerative Heart Valves

Read more

ARISE – Aortic Valve Replacement using Individualised Regenerative Allografts: Bridging the Therapeutic Gap

BioGelenk healing trials

EuroGTP II – Good Practices for demonstrating safety and quality through recipient follow up

Read more

International cooperation with…

EATCB

European Association of Cell and Tissue Banks

EEBA

European Eye Bank Association

WUTBA

World Union of Tissue Banking Associations

EDQM

European Directorate for the Quality of Medicines & Healthcare

Eurocode

International Blood Labeling Systems e.V.

SPRINT supported by COST

Int. Network for Translating Research on Perinatal Derivates into Therapeutic Appr.

Looking for network partners for research

Dr. rer. nat. Nicola Hofmann

Dr. rer. nat. Anna-Katharina Salz

Scientific publications

Current presentations & poster in 2021

Scientific publications in 2021

Presentations & poster in 2020

Scientific publications in 2020