The role of policies and networks in development of cord blood usage in China.

Research regarding the use of cord blood (CB) has focused on antigen match and the number of stem cells, with policies and networks related to its use being under researched. This article is based on fieldwork in China from 2013 to 2015 and examines ways that the studied CB bank enhances CB usage in China. This article identifies that in addition to finding a match, CB use is linked to the policies and networks, release fee and public awareness that enable CB usage development.

Clinical Use and Patentability of Cord Blood.

BACKGROUND: The blood in the umbilical cord that provides the connection between mother and fetus during pregnancy is called cord blood. The blood of umbilical cord which is usually got rid of following birth, is a very rich stem cell source. OBJECTIVE: Cord blood collection gives no harm to the mother and baby. Besides, its allogeneic and autologous usage, the most important disadvantage is that the number of cells is insufficient in adults. CONCLUSION: Today, it is predominantly used for therapeutic purposes for many diseases. The aim of this review is giving a detailed information about groups of stem cells in cord blood and determining the point of clinical use.

The Interfamilial Principle and the Harvest Festival.

It is widely accepted that younger children can act as saviour siblings by donating cord blood or bone marrow to their gravely-ill brothers or sisters. However, it is under dispute whether these procedures are in the best interests of the child. This article suggests that parents may be relying on a thinly-veiled interfamilial approach, where the wider benefit to the whole family is used to justify the procedure to the Human Tissue Authority in the United Kingdom. This article suggests that the merging of familial interests to validate a non-therapeutic bone marrow harvest on a child forces altruism in a patient too young to understand, rendering the harvests unlawful under current law.

Umbilical cord blood banks. Ethical aspects. Public versus private banks.

The creation of umbilical cord blood (UCB) banks raises interesting medical, social, economic and ethical issues. This paper reviews the ethical problems specifically. In this respect, it evaluates: a) whether there are advantages to the use of UCB compared to bone marrow, b) whether or not it is ethical to create UCB banks, c) whether their creation is ethically acceptable in terms of their clinical usefulness or d) the use made of them for therapeutic purposes, and finally e) whether their creation is ethically justified from a cost/profitability point of view. We focus primarily on evaluating the ethical controversy between public and private banks, particularly on whether it is ethical to bank autologous blood in private UCB banks, on the basis of its limited possibilities for use by the cord blood donor. We can conclude that, from an ethical point of view, autologous blood banks have limited acceptance among specialised researchers, scientific societies and other public institutions. Therefore, we believe that it is ethically more acceptable to support the creation of public UCB banks for medical and social reasons and, above all, based on the principle of justice and human solidarity. Nevertheless, there is no definitive ethical argument why a couple, according to their autonomy and freedom, cannot bank their child's UCB in a private bank. An equally acceptable solution could be the creation of mixed banks, such as that proposed by the Virgin Health Bank or like the Spanish system where autologous samples can be stored in public banks but with the proviso that if at any time the stored sample is required by any person other than the donor, it would have to be given to them.

Italian ethical committee intervention in a case of embryo-fetal medicine.

Embryo-fetal experimentation is intuitively associated with a therapeutic intent, according to a consolidated line of thought on the international and national levels. We report on a researcher's request for Ethics Committee approval to perform intrauterine transplantation of stem cells via cordocentesis on a fetus diagnosed with dystrophic epidermolysis bullosa, using stem cells obtained from a sibling's umbilical cord blood. The Ethics Committee rejected the request because of deontological issues and clinical judgments about the potential good to be derived from the procedure. In particular, in this case there was no preclinical or animal research on the procedure, the risk factors for mother and fetus were unknown, there was no way to guarantee compliance with Italian laws regarding safety and quality of the donor cells, and there was lack of clear informed consent.

Umbilical cord blood: a guide for primary care physicians.

Umbilical cord blood stem cell transplants are used to treat a variety of oncologic, genetic, hematologic, and immunodeficiency disorders. Physicians have an important role in educating, counseling, and offering umbilical cord blood donation and storage options to patients. Parents may donate their infant's cord blood to a public bank, pay to store it in a private bank, or have it discarded. The federal government and many state governments have passed laws and issued regulations regarding umbilical cord blood, and some states require physicians to discuss cord blood options with pregnant women. Five prominent medical organizations have published recommendations about cord blood donation and storage. Current guidelines recommend donation of umbilical cord blood to public banks when possible, or storage through the Related Donor Cord Blood Program when a sibling has a disease that may require a stem cell transplant. Experts do not currently recommend private banking for unidentified possible future use. Step-by-step guidance and electronic resources are available to physicians whose patients are considering saving or donating their infant's umbilical cord blood.

Family-directed umbilical cord blood banking.

Umbilical cord blood transplantation from HLA-identical siblings provides good results in children. These results support targeted efforts to bank family cord blood units that can be used for a sibling diagnosed with a disease which can be cured by allogeneic hematopoietic stem cell transplantation or for research that investigates the use of allogeneic or autologous cord blood cells. Over 500 patients transplanted with related cord blood units have been reported to the Eurocord registry with a 4-year overall survival of 91% for patients with non-malignant diseases and 56% for patients with malignant diseases. Main hematologic indications in children are leukemia, hemoglobinopathies or inherited hematologic, immunological or metabolic disorders. However, family-directed cord blood banking is not widely promoted; many cord blood units used in sibling transplantation have been obtained from private banks that do not meet the necessary criteria required to store these units. Marketing by private banks who predominantly store autologous cord blood units has created public confusion. There are very few current validated indications for autologous storage but some new indications might appear in the future. Little effort is devoted to provide unbiased information and to educate the public as to the distinction between the different types of banking, economic models and standards involved in such programs. In order to provide a better service for families in need, directed-family cord blood banking activities should be encouraged and closely monitored with common standards, and better information on current and future indications should be made available.

Regulatory issues in cord blood banking and transplantation.

When selecting a cord blood unit for transplantation a transplant program must, in addition to considering HLA match and cell dose, know that the unit is potent, pure and will not transfer an infectious, hematologic or immunologic disease. While these same issues also apply to adult unrelated donors the fact that cord blood has been processed and stored, often years earlier, at a cell processing facility other than the one affiliated with the transplant program has resulted in a transfer of responsibilities from the transplant program to the cord bank. The transplant programs rely on the cord blood banks for all aspects of collection, screening, testing, processing and storage. Additionally the intermediary registries that are responsible for coordinating communications between the banks and transplant programs are important partners in a comprehensive approach to cord blood quality management. Since cord blood units frequently cross international borders it is critical that international regulatory standards be established and implemented to cover all steps in the production and sharing of cord blood for transplantation. Activities of NetCord/FACT, AABB, CIBMTR, World Marrow Donor Association and others are coming together under the Alliance for Harmonization of Cellular Therapy Accreditation to harmonize practice worldwide.

Stem cell biobanks.

Stem cells contribute to innate healing and harbor a promising role for regenerative medicine. Stem cell banking through long-term storage of different stem cell platforms represents a fundamental source to preserve original features of stem cells for patient-specific clinical applications. Stem cell research and clinical translation constitute fundamental and indivisible modules catalyzed through biobanking activity, generating a return of investment.

[Ethical aspects of human embryonic stem cell use and commercial umbilical cord blood stem cell banking. Ethical reflections on the occasion of the regulation of the European Council and Parliament on advanced therapy medicinal products]. / Bioethische und sozialethische Probleme bei der Verwendung von Geweben aus humanen embryonalen Stammzellen sowie der Aufbewahrung von Stammzellen aus dem Nabelschnurblut durch private Firmen zum autologen Gebrauch. Ethische Uberlegungen anlässlich der Verordnung (EG) Nr. 1394/2007 des europäischen Parlaments und des Rates über Arzneimittel für Neuartige Therapien.

The regulation of the European Council and Parliament on advanced therapy medicinal products also includes therapies with human embryonic stem cells. The use of these stem cells is controversially and heavily discussed. Contrary to the use of adult stem cells, medical and ethical problems concerning the use of human embryonic stem cells persists, because this use is based on the destruction of human life at the very beginning. The regulation foresees, therefore, subsidiarity within the European Member States. Although there are no ethical problems in principle with the use of stem cells from the umbilical cord blood, there are social ethical doubts with the banking of these stem cells for autologous use without any currently foreseeable medical advantage by commercial blood banks. Also in this case subsidiarity is valid.

Bancos de sangue de cordão umbilical e placentário para uso familiar, de caráter privado, no Brasil: subsídios técnicos, legais e éticos para uma análise de implementação / Private umbilical cord blood banks for family use, in Brazil: technical, legal and ethical issues for an implementation analysis

Os bancos de sangue de cordão umbilical e placentário foram criados a partir da comprovação de que o sangue de cordão umbilical e placentário (SCUP) é uma fonte rica em células progenitoras hematopoéticas (CPH) e alternativa às células provenientes da medula óssea para transplante, fato que gerou o interesse pelo armazenamento das células nele contidas. A legislação brasileira distingue bancos para uso alogênico não aparentado (públicos) e para uso exclusivamente autólogo (privados). Por sua vez, o armazenamento de SCUP para uso familiar (doação dirigida) pode ser realizado em bancos de sangue de cordão umbilical e placentário públicos, serviços de hemoterapia ou centros de transplante, quando há um membro da família do nascituro com doença diagnosticada e que necessite de transplante de CPH como tratamento. Apesar de a legislação ser clara, a Anvisa tem identificado o interesse sobre a possibilidade da liberação de unidades de SCUP, armazenadas em bancos autólogos, para a utilização de outrem, familiar, além do recém-nascido beneficiário. O objetivo do trabalho visa promover a reflexão sobre uma possível modificação dos parâmetros legais nacionais que regem os bancos de SCUP autólogo, tornando-os bancos com vistas ao uso familiar, por meio da exposição dos principais elementos relacionados ao tema. O estudo analisou os critérios técnico-sanitários legais para regulamentação dos bancos; descreveu as características das CPH de diversas fontes e tipos de doação para transplante; contextualizou a relação com os princípios da Bioética; avanços sobre terapia e pesquisas relativas às CPH; e discutiu possíveis riscos envolvidos no processo.

Umbilical cord blood banks have been created worldwide after the discovery that umbilical cord blood (UCB) is a rich source of Hematopoietic Stem Cells (HSC) and an alternative to HSC from bone marrow for allogeneic transplantation. According to Brazilian legislation, banks for allogeneic use (government services) and exclusively autologous use (private services) can be created in the country. The storage of UCB units for direct donation (family use) can occur in public cord blood banks, hemotherapy services and transplant centers when there is a specific need to treat a known patient that is a member of the newborn's family. Even with the legislation being quite clear about the creation of cord blood banks and distribution of UCB units, ANVISA has identified an interest, demonstrated by the population and regulated sector, in the possibility of releasing UCB units, stored in autologous cord blood banks, with the purpose of clinical applicability to another family member other than the newborn owner of the cells. The objective of this study is to promote a discussion on a possible alteration in the legal parameters that support the implementation of autologous cord blood banks, towards the constitution of private banks for family use, pointing out the main issues. The study analyzed the technical and legal criteria related to cord blood banks, described the characteristics of HSC from different sources and types of transplant donations and procedures; discussed concerns related to Bioethical principles, current and potential clinical HSC applications, and possibly risks and benefits.

[The bioethics law revision: comparative analysis of contributions from different public and professional offices. Assisted Reproductive Technology, embryo and stem cells research, umbilical cord blood bank]. / La révision de la loi de bioéthique : analyse comparative des contributions de différents organismes publics ou professionnels. Assistance médicale à la procréation, recherche sur l'embryon et les cellules souches, banque de sang du cordon ombilical.

The revision of the bioethics law of 2004 must occur in a five year's time. For this revision, the authorities decided to organize general states of bioethics and requested the production of contributions by the companies, institutions or associations. These texts tackle various subjects, like the Assisted Reproductive Technologies, research on the embryo and the stem cells and the banks of umbilical cord blood. Certain opinions converge, others differ, but all take part in the great debate which will take place at the time of the general conference.

[The banks of umbilical cord blood: biomedical and bioethical issues]. / Los Bancos de sangre de cordón umbilical: aspectos biomédicos y bioéticos.

This paper deals with the actuality of the Umbilical Cord Blood Banks (UCBB). Its aim is to offer the necessary notions for the understanding of their nature and of the ethical problems which they carry associated. In order to do this it will lean, on one hand, on the actual bibliography about blood of the umbilical cord and its present and future applications, and on the other hand, on the document of the European Group of Ethics where this issue is discussed. It is of special interest here the existence of the banks called "autologous" that, for some authors, seem to contradict the principle of solidarity. This work will examine, amidst others, this question, and it will suggest a solution articulating both "liberty" and "solidarity". Other topics such as respect to confidentiality, informed consent and integrity of the body will be approached.