DOCSLIB.ORG

Hand Transplantation

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Hand Transplantation | Hand Transplantation Scott M. Tintle, MD » Upper extremity limb loss is catastrophic. It affects nearly every Benjamin K. Potter, MD activity of daily living, leaving patients with substantial disability. River M. Elliott, MD » Despite high rates of rejection of upper extremity prostheses, hand transplantation remains controversial. L. Scott Levin, MD » The indications for hand transplantation remain relatively ill defined. » The American Society for Reconstructive Transplantation (ASRT) and Investigation performed at the University of Pennsylvania, the International Registry on Hand and Composite Tissue Transplan- Philadelphia, Pennsylvania tation (IRHCTT) have been founded to advance the science, to educate, to report outcomes, and to define the indications for vascularized composite allotransplantation. pper extremity loss repre- Pioneers of hand transplantation rec- sents a life-changing, often ognized that prosthetic devices probably devastating event, affecting would never completely satisfy the upper nearly every activity of daily extremity amputee for these very reasons. livingU and subsequently leaving a patient Even if the prehensile function and dex- with substantial disability1,2. The potential terity of the human hand could be restored, immediate dependency and despair result- these would do little to restore patient ing from the loss of one or both hands body image or hand sensibility, both traits cannot be overstated. Promising techno- coveted by amputees. Rather, they postu- logical advances in upper extremity pros- lated that these could only be replaced with theses include improved neural-control “like” human tissue14. The field of vascu- interfaces, multiple-degrees-of-freedom larized composite allotransplantation has terminal devices, and prototype haptic grown from this basic desire to fully feedback mechanisms3,4. However, the restore both the functional and emotional available literature still demonstrates high aspects of the human hand, building on the prosthesis rejection rates for upper ex- foundations developed by solid organ tremity amputees5-12, suggesting that transplantation, hand surgery, and recon- prostheses continue to inadequately repli- structive microsurgery. cate the complex, prehensile functions of The concept of using composite tissue the native hand and arm. The most com- allograft was first suggested in 1960 by monly cited reasons for upper extremity Peacock, when he utilized cadaveric flexor prosthesis rejection remain limited useful- tendons along with their synovial sheaths ness, weight, and residual limb in order to reconstruct end-stage tendon discomfort5,13. incarcerations that otherwise would have Disclosure: None of the authors received payments or services, either directly or indirectly (i.e., via his or her institution), from a third party in support of any aspect of this work. One or more of the authors, or his or her institution, has had a financial relationship, in the thirty-six months prior to submission of this work, with an entity in the biomedical arena that could be perceived to influence or have the potential to influence what is written in this work. No author has had any other relationships, or has engaged in any other activities, that could be perceived to influence or have the potential to influence what is written in this work. The complete Disclosures of Potential Conflicts of Interest submitted by authors are always provided with the online version of the article. COPYRIGHT © 2014 BY THE Disclaimer: The opinions and assertions contained herein are the private views of the authors and are JOURNAL OF BONE AND JOINT not to be construed as official or as reflecting the views of the United States Army, United States SURGERY, INCORPORATED Navy, Department of Defense, or the US Government. JBJS REVIEWS 2014;2(1):e1 · http://dx.doi.org/10.2106/JBJS.RVW.M.00063 1 | Hand Transplantation required amputation15-18. Shortly after Indications for Transplantation and reconstructive and transplant surgery. this early success with composite tissue Ethical Considerations Last year, the ASRT published guide- allografts, and likely inspired by the “Primum non nocere”—“first do no lines for medical necessity determina- rapid growth of the solid organ trans- harm”—remains a paramount principle tion for transplantation of the hand and/ plantation community, the world’s first as the field of vascularized composite or upper extremity (Fig. 1). hand transplantation was performed in allotransplantation progresses. In the South America in 19641,19,20. Unfor- 2002 position statement of the Ameri- Psychological Screening tunately, probably because of the rela- can Society for Surgery of the Hand, The majority of amputee patients are tively primitive immunosuppression Cooney and Hentz echoed this senti- afflicted by a psychological disorder33. as well as a lack of basic-science prepa- ment when they recommended “great This consideration complicates hand ration, acute rejection predictably caution and a measured approach to the transplantation in that the outcome of occurred and the transplanted limb patient requesting a limb transplant.”28 a hand transplantation is very much was amputated about three weeks This caution, along with appropriate dependent on the participation, coop- later15,21. Perhaps reflecting the scien- ethical considerations, have tempered eration, and compliance of a patient tific hazards of reaching too far, too the growth of vascularized composite with hand therapy, medications, and fast, the next attempt at hand trans- allotransplantation as compared with follow-up screening appointments. plantation did not occur until thirty- solid organ transplantation. Hand A kidney, liver, or heart transplant four years later in Lyon, France, in transplantation is very different from depends only on compliance with 199815,22,23. Technically, this second most solid organ transplantations in medications, and even still there are procedure succeeded; however, this that the candidate for hand transplan- relatively high rates of medication non- success was not functionally realized tation is not faced with a life-or-death compliance in this population34,35.In and sustained because the patient did decision29. For this reason, developing a combined heart and heart/lung trans- not adapt psychologically to the new widely accepted indications for subject- plant population, it was found that hand and discontinued the use of ing a physiologically healthy person to the only risk factor for graft loss between immunosuppressive medications. The the risks of life-long immunosuppres- six and twelve months was being transplanted limb was eventually sion remains a challenge for the allo- unmarried or not living in a stable amputated1. The first hand transplan- transplantation community30. relationship34,35. It is therefore impera- tation in the United States was per- In 2009, Hollenbeck et al. indi- tive that all patients who are to be formed the following year in Louisville, cated that there were no current, well- considered for hand transplantation Kentucky. At the time of writing, this defined indications for vascularized undergo extensive psychological and third patient still had the transplanted composite allotransplantation of the psychiatric screening prior to selection hand, nearly fourteen years later15,24. hand or face14. Unfortunately, this for hand transplantation. In addition, The early success of hand trans- remains the case today31,32—the indi- the social support for an individual plantation in the late 1990s was made cations remain open to interpretation candidate must be identified, and a possible by advances in solid organ by individual vascularized composite transplantation should not occur if transplantation. Specifically, the devel- allotransplantation centers. While this the surgeon is not comfortable with opment of new medications such autonomy to develop indications to the patient’s support system. as cyclosporine, tacrolimus, and accompany slightly different approaches mycophenolate mofetil made the is ostensibly important in a developing Immunosuppression avoidance of rejection possible. In ad- field, the vascularized composite allo- Conventional Immunosuppression dition, animal models of vascularized transplantation community is attempt- Aside from the ethical issues surround- composite allotransplantation provided ing to develop universally accepted ing hand transplantation, perhaps the the basic and translational science evi- indications for hand transplantation most critical reason that vascularized dence that successful composite tissue based on the evidence available. Having composite allotransplantation has lag- allotransplantation without rejection recognized the need for defined and ged behind solid organ transplantation was possible with use of these accepted indications for hand trans- is the skin. Skin is the most antigenic medications15,25-27. Since that time, the plantation, the allotransplantation tissue of the composite tissues that field of vascularized composite allo- community founded the American constitute a hand transplant, and pre- transplantation has grown dramatically. Society for Reconstructive Transplan- venting the immune system from Eighty-nine hand transplantations tation (ASRT) in 2008. The goal rejecting the skin was necessary prior to have been performed worldwide to date, of the ASRT is to provide a platform successful hand transplantation1,36-38. and there are at least seven centers in for the advancement of education, sci- In
Load more

Recommended publications
  • Vascularized Composite Allografts (Lc Cendales, Section Editor)
    View metadata, citation and similar papers at core.ac.uk brought to you by CORE provided by Springer - Publisher Connector Curr Transpl Rep (2014) 1:173–182 DOI 10.1007/s40472-014-0025-6 VASCULARIZED COMPOSITE ALLOGRAFTS (LC CENDALES, SECTION EDITOR) Vascularized Composite Allografts: Procurement, Allocation, and Implementation Axel Rahmel Published online: 3 July 2014 # The Author(s) 2014. This article is published with open access at Springerlink.com Abstract Vascularized composite allotransplantation is a allotransplantation. In 2005, the first face transplantation was continuously evolving area of modern transplant medicine. performed in Lyon [5]; since then the number of face trans- Recently, vascularized composite allografts (VCAs) have plants has increased [6]. This special category of transplants is been formally classified as ‘organs’.Inthisreview,keyas- localized at the border between tissue and organ transplanta- pects of VCA procurement are discussed, with a special focus tion. The term composite tissue allotransplantation (CTA) on interaction with the procurement of classical solid organs. used in the past reflects that it was often considered as a In addition, options for a matching and allocation system that special type of tissue transplantation [7]. Several reports ensures VCA donor organs are allocated to the best-suited looking in-depth at limb and face transplantation made it clear recipients are looked at. Finally, the different steps needed to that vascularized composite allotransplantation is in central promote VCA transplantation in society in general and in the aspects more similar to organ than to tissue transplantation medical community in particular are highlighted. [7–12]. After careful evaluation involving the transplant com- munity and the general public, the United States Department of Health and Human Services recently published its decision Keywords Transplantation .
    [Show full text]
  • Hand Transplantation Open Access to Scientific and Medical Research DOI
    Journal name: Transplant Research and Risk Management Article Designation: Review Year: 2017 Volume: 9 Transplant Research and Risk Management Dovepress Running head verso: Alolabi et al Running head recto: Hand transplantation open access to scientific and medical research DOI: http://dx.doi.org/10.2147/TRRM.S94298 Open Access Full Text Article REVIEW Hand transplantation: current challenges and future prospects Noor Alolabi1 Abstract: Over the last two decades, 113 vascularized composite allotransplantation (VCA) Haley Augustine1 of the hand have been performed in 76 patients globally. The procedure that was once regarded Achilles Thoma1–3 as experimental has certainly emerged as a clinical reality with multiple centers worldwide now performing it. The psychological and physical impact of losing an upper extremity is 1Division of Plastic Surgery, Department of Surgery, 2Surgical profound. Amputees face significant challenges contributing to disability and dependence even Outcomes Research Centre, with activities of daily living. Hand transplantation offers functions with restoring sensation, 3 Department of Clinical Epidemiology voluntary motor control, and proprioception, as well as a sense of feeling “whole” again. Along and Biostatistics, McMaster University, Hamilton, ON, Canada with these benefits, however, transplantation carries a significant risk profile attributed to the complications of life-long immunosuppression and possible rejection. Moreover, the procedure For personal use only. carries a significant financial burden to the health care system. As hand VCA is becoming more widely accepted and performed worldwide, there are still many challenges that will face its rapid growth. This review highlights some of the challenges facing hand VCA including patient selection, effect on quality of life, financial burden, functional outcomes, and complications of immunosuppression.
    [Show full text]
  • James L. Benedict a Revised Consent Model for the Transplantation of Face and Upper Limbs: Covenant Consent International Library of Ethics, Law, and the New Medicine
    International Library of Ethics, Law, and the New Medicine 73 James L. Benedict A Revised Consent Model for the Transplantation of Face and Upper Limbs: Covenant Consent International Library of Ethics, Law, and the New Medicine Volume 73 Series editors David N. Weisstub, University of Montreal Fac. Medicine, Montreal, QC, Canada Dennis R. Cooley, North Dakota State University, History, Philosophy, and Religious Studies, Fargo, ND, USA Founded by Thomasine Kimbrough Kushner, Berkely, USA David C. Thomasma, Dordrecht, The Netherlands David N. Weisstub, Montreal, Canada The book series International Library of Ethics, Law and the New Medicine comprises volumes with an international and interdisciplinary focus. The aim of the Series is to publish books on foundational issues in (bio) ethics, law, international health care and medicine. The 28 volumes that have already appeared in this series address aspects of aging, mental health, AIDS, preventive medicine, bioethics and many other current topics. This Series was conceived against the background of increasing globalization and interdependency of the world’s cultures and govern- ments, with mutual influencing occurring throughout the world in all fields, most surely in health care and its delivery. By means of this Series we aim to contribute and cooperate to meet the challenge of our time: how to aim human technology to good human ends, how to deal with changed values in the areas of religion, society, culture and the self-definition of human persons, and how to formulate a new way of thinking, a new ethic. We welcome book proposals representing the broad interest of the interdisciplinary and international focus of the series.
    [Show full text]
  • The Question of Identity Between the Restorative and Regenerative Organ Transplantations
    Revelation and Science Vol. 08, No. 02 (1440H/2018) 13-20 The Question of Identity between the Restorative and Regenerative Organ Transplantations 1Ibrahim Shogar*, 2Nazri Mohd Yusof, 1Mohamad Ariff Bin Mohamad Yussoff, 1Mohd. Azid Bin Mat Din, 1Iswatun Hasanah Bt. Abdullah Ripain, 1Iffah Inani Bt. Hashim, 1Fatihah Bt. Mohd. Yusof 1Kulliyyah of Science, 2Kulliyyah of Medicine, International Islamic University Malaysia, IIUM. Jalan Sultan Ahmad Shah, Bandar Indera Mahkota, 25200 Kuantan, Pahang Darul Makmur, Malaysia Abstract This paper explores implications of organ transplantation on identity and body integrity. It investigates how advancements in transplant technologies can affect and reshape our conception of identity at individual and social levels. The question of identity as a distinctive code for every organism is increasingly becoming important due to the advanced biomedical technologies and its legal, ethical, and social implications. Modes of organ transplantation, in this paper are divided into two major types (i) restorative and (ii) regenerative. Both types have important implications on conception of identity, at various levels, from both biological and social perspectives. While highlighting all these dimensions, this article focuses on implications of restorative organ transplantation on identity based on four specific cases, which are: (i) hand transplantation, (ii) facial transplantation, (iii) reproductive organ transplantation, and (iv) head / body transplantation. Investigating all these cases, the paper has concluded that while the advanced biomedical technology is essential for survival of many lives, application of such technologies must be consistent with moral values and the universal principles for human dignity and body integrity. Keyword: Organ transplantation, loss of personal identity, cyborg, body transplant, ethical questions.
    [Show full text]
  • Clinical Guidelines for Organ Transplantation from Deceased Donors Version 1.5 – April 2021
    The Transplantation Society of Australia and New Zealand Clinical Guidelines for Organ Transplantation from Deceased Donors Version 1.5 – April 2021 Produced in partnership with Version 1.0 of the Clinical Guidelines for Organ Transplantation from Deceased Donors (the Clinical Guidelines) was released in April 2016. Updates were made in May 2017 (Version 1.1), December 2018 (Version 1.2), May 2019 (Version 1.3), and July 2020 (Version 1.4). The current document, Version 1.5 (April 2021), replaces these previous versions of the Clinical Guidelines. Version control Version # Changes made Approved by Date 1.5 Updated advice related COVID-19 (section 2.3.2.1). Australasian Transplant 28 April 2021 Addition of advice in the event of reactive screening antibody Coordinators Association results (section 2.3.2.9). (ATCA), Transplant Society of Australia and New Zealand Addition of section 2.5 on Risks related to other donor (TSANZ) and Organ and conditions. Tissue Authority (OTA). Updates relating to the Australian and New Zealand paired Kidney Exchange Program (ANZKX) (sections 5.2.5 and 5.4.4). 1.4 Chapter 11 (Paediatric Donors) was added to the Guidelines, Paediatric Donor Working 24 July 2020 providing organ-specific advice on acceptability and allocation Group. Australasian of organs from paediatric donors. Each of the organ- Transplant Coordinators specific chapters in Part B were updated to reflect the new Association (ATCA), recommendations for paediatric donors. Transplant Society of Australia and New Zealand Addition of advice on COVID-19 screening in deceased (TSANZ) and Organ and donors. Tissue Authority (OTA) 1.3 Broad revisions to section 2.3 (Donor assessment) and Australasian Transplant 31 May 2019 section 2.4 (Donor transmitted infectious disease).
    [Show full text]
  • The Promise of Organ and Tissue Preservation to Transform Medicine
    HHS Public Access Author manuscript Author ManuscriptAuthor Manuscript Author Nat Biotechnol Manuscript Author . Author Manuscript Author manuscript; available in PMC 2017 December 11. Published in final edited form as: Nat Biotechnol. 2017 June 07; 35(6): 530–542. doi:10.1038/nbt.3889. The promise of organ and tissue preservation to transform medicine Sebastian Giwa1,2,3,46, Jedediah K Lewis1,46, Luis Alvarez4,5,6, Robert Langer7, Alvin E Roth8, George M Church9, James F Markmann10, David H Sachs11, Anil Chandraker12,13, Jason A Wertheim14,15, Martine Rothblatt16, Edward S Boyden17, Elling Eidbo18, W P Andrew Lee19, Bohdan Pomahac20, Gerald Brandacher19, David M Weinstock21, Gloria Elliott22, David Nelson23, Jason P Acker24,25, Korkut Uygun26, Boris Schmalz1,27, Brad P Weegman1,2, Alessandro Tocchio1,28, Greg M Fahy29, Kenneth B Storey30, Boris Rubinsky31, John Bischof32, Janet A W Elliott24,33, Teresa K Woodruff34, G John Morris35, Utkan Demirci28,36, Kelvin G M Brockbank37, Erik J Woods3,25,38, Robert N Ben39, John G Baust40, Dayong Gao25,41, Barry Fuller42, Yoed Rabin43, David C Kravitz44, Michael J Taylor2,43,45, and Mehmet Toner26 1Organ Preservation Alliance, NASA Research Park, Moffett Field, California, USA 2Sylvatica Biotech, Inc., Charleston, South Carolina, USA 3Ossium Health, San Francisco, California, USA 4Regenerative Biology Research Group, Cancer and Developmental Biology Laboratory, National Cancer Institute, Bethesda, Maryland, USA 5Walter Reed National Military Medical Center, Bethesda, Maryland, USA 6Department of Chemistry and Life Science, United States Military Academy, West Point, New York, USA 7Department of Chemical Engineering, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA 8Department of Economics, Stanford University, Stanford, California, USA 9Department of Genetics, Harvard Medical School, Boston, Massachusetts, USA Reprints and permissions information is available online at http://www.nature.com/reprints/index.html.
    [Show full text]
  • Richmond Group to Oversee Face, Hand Transplants
    Associated Press State & Local December 14, 2013 Saturday 3:14 PM GMT Richmond group to oversee face, hand transplants BYLINE: TAMMIE SMITH, Richmond Times-Dispatch SECTION: STATE AND REGIONAL; Member Exchange LENGTH: 1344 words DATELINE: RICHMOND, Va. RICHMOND, Va. (AP) - When you check the organ donor box on your driver's license application, you're probably thinking your heart, kidney or liver might go to save someone's life in the event of your untimely death. You're probably not thinking that your face, hands or arms could also be removed and used to help someone who is seriously disfigured by burns, bomb blasts or disease. Under new federal transplant policy, faces and hands and other body parts classified as vascularized composite allografts - VCAs for short - will fall under the National Organ Transplant Act. That means face and hand transplant programs will have to meet the same strict regulations and standards as heart and liver programs, for instance - which could have been the case before but there wasn't the formal oversight from the United Network for Organ Sharing, the Richmond-based organization that has a federal contract to oversee and manage the nation's transplant system. It means the supply of faces and hands for transplant might increase exponentially, and will require sorting through delicate issues such as whether signing an organ donor card covers consent for donating one's face or hands. "For most people when they sign on to their state registry or they check off the box on their license, they really are not thinking they are signing on to donate a hand or a face," said Dr.
    [Show full text]
  • Download Index
    Index A mechanisms, 240–243 Accommodation mouse models induction, 248 acute rejection, 112–113 mouse models, 114–115 chronic rejection, 113–114 Acute rejection hyperacute rejection, 112 B-cell role, 56–58 prevention biomarkers, 46–49 accommodation induction, 248 chemokines, 43–45, 52 antibody or antibody-producing cell innate immunity, 52–54, 245–247 removal, 248 antigen removal, 247 kidney transplantation, 344–346 B-cell tolerance induction, 248 mouse models complement cascade prevention, 247–248 antibody-mediated rejection, 112–113 Antilymphocyte serum (ALS), history of use, 13 heart transplantation, 109–110 Antithymocyte globulin (ATG) kidney transplantation, 110–111 immunosuppression induction, 95–96 skin transplantation, 108–109 primate model use, 132–133, 145 overview, 41–42 ATG . See Antithymocyte globulin T-cell role ATRA. See All-trans retinoic acid activation, 54–56 Azathioprine memory T cells, 56 immunosuppression maintenance, 97 regulatory T cells, 55 primate model use, 128 AEB-071. See Sotrastaurin Alefacept, immunosuppression therapy, 102 Alemtuzumab B immunosuppression induction, 96–97 B cell. See also Antibody-mediated rejection; lymphocyte depletion, 146 Lymphocyte depletion Allogeneic response. See also Rejection acute rejection role, 56–58 allogeneic nonself, 30 allogeneic response, 35, 37 B cell, 35, 37 allograft rejection role, 43 graft endothelium role, 36–37, 54 mesenchymal stromal cell interactions with innate immune cells, 32–33, 35–36 allogeneic cells, 231–232 overview, 29–30 tolerance induction, 248 prospects for study, 37 Basiliximab, immunosuppression induction, 96 T cell b-Cell transplantation. See Islet transplantation; alloreactivity, 30–32 Pancreas transplantation T-cell receptor gene rearrangement, 31 Betacept, immunosuppression maintenance, types in transplanted organ recognition, 34–35 99–100 All-trans retinoic acid (ATRA),regulatory T-cell stability Billingham, Rupert, 6–8, 259 effects, 194 Bioethics.
    [Show full text]
  • Future Prospects of Organ Transplantation Mehmet Nur Altinörs
    Chapter Future Prospects of Organ Transplantation Mehmet Nur Altinörs Abstract The gap between organ demand and supply is an universal problem in organ and tissue transplantation therapy. The gap is growing in spite of efforts spent in medi- cal, educational, social areas and mass media support. This reality has created the need for completely new therapeutic alternatives for the management of end-stage organ disease. The present research should continue in future aiming to discover systems and devices capable of totally replacing the traditional transplantation. On the other hand, a different progress in underway in transplantation. The indication for solid organ transplantation is to save life and promote quality of life. The new developing transplantations of composite tissue, uterus and face are performed with completely different indications. Facial defects caused by various insults cause serious functional and esthetic disorders, psychological and social problems. Facial transplant surgery is accomplished to overcome such problems. Uterus transplanta- tion is emerging as an alternative to female infertility. Transplantation of composite tissue includes different organs. The main purpose of composite tissue transplanta- tion is to restore reduced or completely lost functions and to increase the quality of life. Nerve regeneration must occur as a consequence of transplant to regain sensory and motor functions. It appears that the future of transplantation involves devel- opments in two main streams; invention of completely new tools for solid organ transplantation and advances in the transplantation of different organs including uterus, face and composite tissue. Keywords: composite tissue, facial, solid organ, transplantation, uterus 1. Introduction The idea of replacing a malfunctioning diseased organ by the same organ dates back to antiquity, but major inventions and successful practice of transplanting solid organs have occurred in the second half of the 20th century.
    [Show full text]
  • Transplants These Services May Or May Not Be Covered by Your Healthpartners Plan
    Transplants These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. Administrative Process HealthPartners Centers of Excellence Many plans require that transplant procedures be performed at HealthPartners Transplant Centers of Excellence (COE). Some plans allow for use of non-Center of Excellence transplant facilities. Check your plan documents or contact Member Services to determine what facilities are available to you and how your choice will affect your coverage. Please note: Cornea transplants are outside the scope of this policy. They are covered without prior notification or authorization. Cornea transplants may be received from providers outside the HealthPartners Transplant COEs. Prior Notification/Authorization Process 1. Prior to selecting a transplant provider submission of a transplant pre-consultation prior authorization form from the referring physician is required. This prior authorization will support the initiation of care and benefit coordination. 2. Prior notification or prior authorization is required before the actual visit date for pre-transplant evaluation as outlined below. 3. Prior notification or prior authorization is required at the time of pre-transplant listing or start of treatment for deemed transplant candidate as outlined below. For more information, please see the related content at right for the HealthPartners Transplant Resources and COE Networks and for the transplant prior notification and authorization process and form. Prior notification is required for the following situations Prior notification is required at the time of pre-transplant evaluation and at the time of pre-transplant listing when performed at a HealthPartners Transplant Center of Excellence (COE) for the following transplants: 1.
    [Show full text]
  • Meeting of Competent Authorities for Tissues and Cells, 7-8 June 2012
    Ref. Ares(2013)2201122 - 17/06/2013 COMMISSION OF THE EUROPEAN COMMUNITIES HEALTH AND CONSUMERS DIRECTORATE-GENERAL Directorate D - Health Systems and Products D4 – Substances of Human Origin and Tobacco Control Brussels, SANCO D4/IS/gcs ARES(2012) Meeting of the Competent Authorities for Tissues and Cells 7 – 8 June 2012 Summary Report The meeting of the Competent Authorities on Tissues and Cells was convened on 7 and 8 June 2012. The previous meeting of National Competent Authorities (CAs) took place on 8 and 9 December 2011. PARTICIPATION: All Member States, except Lithuania, Luxembourg and Romania, were present at the meeting of the CAs. Norway and Croatia, as well as the European Directorate for the Quality of Medicines and Health Care (EDQM) of the Council of Europe (CoE) and the European Centre for Disease Prevention and Control (ECDC) attended the meeting. European Commission: Chairman: Mr D. SCNNICHELS (SANCO) Ms I. SISKA, Ms H. LE BORGNE, Ms. S. VILLANUEVA, and Mr. S. VAN DER SPIEGEL (SANCO) Administrative assistant: H. PREROVSKA 1. ADOPTION OF THE AGENDA Minutes of the previous meeting were approved. The agenda was adopted with minor changes: - point 2 "Debrief from the Regulatory Committee meeting 7 June a.m" was cancelled, because the CAs meeting started immediately after the Regulatory Committee meeting with the same attendance; - at the request of several CAs point 12.3 " Bone marrow registries in Spain" was re- scheduled for the first day, under point 5; The German representative requested to the Commission to clarify the legal basis for the meetings of the CAs according to Directive 2004/23/EC and also to present the set of Rules of Procedure for these meetings.
    [Show full text]
  • Upper Limb Reconstructive Transplantation in Military Recipients: Summary of World Experience
    6 Journal of the Royal Naval Medical Service 2018; 104(1) Upper limb reconstructive transplantation in military recipients: summary of world experience C A Fries, H L Stark, D Tuder, S Iyer, V S Gorantla, M R Davis, R F Rickard Abstract Lessons from conflict have contributed to military medical advances which have significantly improved the survivability of critically injured servicemen and women. However, survival following such severe combat polytrauma is often associated with devastating tissue loss and functional deficits that challenge conventional reconstruction. Despite recent advances, upper extremity prosthetic alternatives lack the fidelity to restore the complex intrinsic and sensory function of the human hand. Up- per Limb Reconstructive Transplantation, or Vascularised Composite Allotransplantation (VCA), is currently an experimental procedure offering superior anatomical and functional outcomes compared to prostheses. Military candidates for VCA usually enjoy high pre-morbid fitness, mental health resilience and support, and relatively rich provision of rehabilitation. However, co-morbidities of polytrauma, such as traumatic brain injury and post-traumatic stress dis- order, may have an impact on outcomes. Since 1998, over 120 upper limb transplants have been performed worldwide. Of these, six have been performed on service- men and women across three continents. The morbidity and mortality associated with the requirement for lifelong immunosup- pression, however, continues to skew the risk-benefit considerations of these promising procedures when compared to pros- theses. Thus, although the technical surgical feasibility of upper limb and other VCA such as face, abdominal wall, uterus and penis transplants has been established over the past decade, these procedures remain restricted to recipients fulfilling stringent inclusion criteria.
    [Show full text]