Cord blood beyond transplantation: can we use the experience to advance all cell therapies?

Unrelated cord blood (CB) units, already manufactured, fully tested and stored, are high-quality products for haematopoietic stem cell transplantation and cell therapies, as well as an optimal starting material for cell expansion, cell engineering or cell re-programming technologies. CB banks have been pioneers in the development and implementation of Current Good Manufacturing Practices for cell-therapy products. Sharing their technological and regulatory experience will help advance all cell therapies, CB-derived or not, particularly as they transition from autologous, individually manufactured products to stored, 'off-the shelf' treatments. Such strategies will allow broader patient access and wide product utilisation.

Report from the GHPP-BloodTrain inspection workshop in Harare the 20th to the 24th of May 2019.

During the training workshop on Inspection of Blood Establishments, which was hosted by the PEI GHPP BloodTrain in Harare from the 20th to the 24th of May 2019, participants from the National Regulatory Authorities from seven Sub-Sahara African countries presented their current experiences related to regulation and inspection of blood establishments in their respective countries. While in all seven countries regulation and inspection of conventional medicinal products manufacturer is performed, the regulatory situation of blood and blood components as well as inspection of blood establishments is still heterogeneous.

Attitudes of dog owners in Edinburgh towards canine blood donation.

The establishment of animal blood banks following legislative changes in the UK in 2005 has led to increasing accessibility and use of animal blood products. However, the supply of animal blood is currently not meeting demand. This study aims to identify potential methods of increasing donor recruitment to meet this demand. A questionnaire was constructed, consisting of three sections designed to evaluate owner perceptions, identify incentives for donation and to obtain demographic data. Seventy-nine responses were included, 76 of which were previous non-donors. The top three reasons for not donating in this group were uncertainty over where to donate, veterinarians not expressing the need for donors and lack of awareness. Considering these results, one method of potentially increasing donor recruitment is encouraging more veterinarians to actively advertise local donor programmes. Emphasising the mandatory inclusion of a free annual health check in the donor process may also be helpful as many respondents rated this highly. It is the authors' hope that this preliminary data may lead to increased willingness of owners to nominate their dogs for donation by guiding the provision of appropriate incentives and education to quell owner concerns as highlighted by this study.

[Structural or functional relationship between immunohematology and distribution - Which elements for controlling risks?] / Lien immunohématologie-délivrance structurel ou fonctionnel ­ Quels éléments pour la maîtrise des risques ?

OBJECTIVE: Transfusion safety is based on the availability of safe and compatible blood products at the right time and to the right patient, and requires close monitoring in order to detect possible incidents. The decree of June 20th 2018, which establishes the national blood transfusion's guiding plan, states that the organization that prevails throughout the national territory is built around an inseparable link between the implementation of erythrocyte immunohematology and the labile blood products delivery by authorised structures. METHOD: The article describes the two types of the link's organization, structural or functional, used to develop the comparative risk-benefit analysis. RESULTS: The structural link, which has fewer interfaces, reduces risk situations that lead to delays in release by default of a compatible product. The cases in which a functional link may have a greater benefit than the risks generated are those related to a geographical distance between the delivery site and the patient's place of care. In these cases, a functional link is possible provided that certain organizational points are mastered. CONCLUSION: The comparative analysis shows that the structural link is to be favoured since that the coherence of the patient's care and his care path is ensured. In certain situations, mainly geographical, the functional link can have a benefit that offsets the risks generated by the new interfaces; provided that the system is secured by a real tripartite collaboration between health care institution, biology laboratory and delivery site.

Banking feces: a new frontier for public blood banks?

Fecal microbiota transplantation (FMT) is an effective treatment for recurrent Clostridioides difficile infection and is potentially beneficial in other microbiota-related disorders. The provision of FMT in routine clinical practice requires an extensive infrastructure that is reliant on voluntary donors. Alongside an increasing demand for FMT, the logistic barriers of a large-scale donor-dependent operation and the difficulties among health authorities to regulate FMT limit the dissemination of sustainable FMT services. Blood centers are large organizations that handle a multitude of donor-dependent operations on a daily basis. Blood and feces share many of the same dependencies, and feces may present a new opportunity for the blood services to handle. In this paper, we describe how an FMT service may be established and embedded within the blood service infrastructure, and we explain the benefits of using blood donors as feces donors. We further explore the current indications of FMT, the challenges related to the lack of legislation, and the future perspectives for blood banks to meet a new and increasing demand.

Effect of a liberal versus a restrictive pre-donation blood pressure policy on whole-blood donor adverse reactions.

BACKGROUND AND OBJECTIVES: The role of pre-donation blood pressure (BP) as independent contributor to post-donation vasovagal reactions (VVRs) is still debated. Differences between a liberal (i.e., inclusion of hypotensive donors) and a restrictive policy (i.e., not accepting hypotensive donors) should be investigated. This study aims to investigate the consequences of a liberal policy in development of VVRs after whole-blood donations. MATERIALS AND METHODS: We compared the incidence of VVRs between 2015 (restrictive policy) and 2016 (liberal policy) and the associated risk factors. We evaluated respectively 22 789 vs. 21 676 blood donations obtained from 18 001 blood donors (12 501 donated in both years). RESULTS: Comparing the results we obtained between 2015 and 2016, donations showed an overlap of the cohorts. Two hundred fifteen VVRs (incidence rate 0·48%) were observed, 104 (0·46%) of which in 2015, and 111 (0·51%) in 2016. A preliminary univariate analysis showed that donors with systolic BP <110 mm Hg had a two-fold risk of VVRs compared to normotensive donors (VVR/donation rate of 0·99% vs. 0·46%; P = 0·001). The subsequent multivariable logistic regression model showed that VVRs were highly associated with weight, site of collection, age and number of donations, excluding a role for systolic and diastolic BP. CONCLUSION: A liberal pre-donation BP policy seems to be safe for blood donors. Our analysis confirms that older donors with higher body-weight who already had donated blood are unlikely to experience VVRs.

Attitudes and perceptions among men having sex with men towards a new non-deferral blood donation policy in Israel.

BACKGROUND: In June 2017, Israel lifted the ban on blood donations from men who have sex with men (MSM) and accepts donations if 12 months have passed since the last sexual contact. Recently, the National Blood Services suggested a novel approach that involves acceptance of MSM blood donations without deferral, keeping solely the frozen plasma in quarantine and releasing it for transfusion if a subsequent donation, at least 4 months later, is found negative for transfusion-transmitted agents. In this study, we examined the attitudes and perceptions of MSM to the new Frozen Plasma Quarantine Policy (FPQP). METHOD: A survey was published on gay-oriented websites, collecting anonymous demographic data, history of blood donations and attitudes towards the new policy. RESULTS: We analysed responses from 1233 MSM. Of these, 13·4% had donated blood at least once during the previous year, almost all of them (89·7%) not complying with the current 12-month deferral. Most respondents (64·5%) supported the suggested new approach and would consider donating blood if it were introduced. Of MSM who had donated blood in the previous year, 85% stated they would agree to reveal their sexual practice in the donor health questionnaire (DHQ) in order to be included in the programme, compared with 8·5% under the current 12-month deferral policy. CONCLUSION: The suggested Plasma Quarantine Policy may be more acceptable to MSM than a 12-month deferral and increase their compliance with the blood services policy. This and retesting of donors may increase blood safety.

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.

[The "specific" liability regime for blood products]. / Chapitre 8. Le régime « spécifique ¼ de responsabilité du fait des produits sanguins.

Based on the system of liability for defective products as organized by the European Directive of 25 July 1985, responsibility for blood products does not therefore constitute a genuine specific regime. However, European law leaves States a margin of discretion in the implementation of the Directive with regard to health products. This is the case in particular with the exemption for development risk.

[Control of potential risk in blood establishments in Brazil: a strategy for regulating authorities]. / Controle de riscos potenciais em serviços de hemoterapia no Brasil: uma abordagem para autoridades reguladoras.

Objective To describe the sanitary status of Brazilian blood establishments (BE) assessed by the national health surveillance system in 2013. Method In the present descriptive study, the sanitary profile of BE was assessed using the Blood Establishment Potential Risk Assessment Method (Método de Avaliação de Risco Potencial de Serviços de Hemoterapia, MARPSH), developed by the National Sanitary Surveillance Agency (Anvisa). The MARPSH involves the evaluation of 471 structure and process items to produce an assessment of potential risk associated with critical control points in the blood cycle (vein-to-vein). Based on this assessment, BE are classified into five risk categories: low, medium-low, medium, medium-high, and high. The results were analyzed regarding the type of service (considering all levels, from coordinating centers to collection units), type of financing (public/private) and geographic region. Results Of the existing BE, 1 212 (60%) were assessed in 2013. Of these, 81% met ≥ 70% of the sanitary requirements (satisfactory status, corresponding to medium, medium-low, and low risk categories). Transfusion agencies (hospital units with the role of storing, running compatibility tests between donors and recipients, and transfusing blood components) and public establishments had the highest number of non-conformity structure and process items. Conclusion The use of the MARPSH facilitated the assessment of BE in Brazil and revealed objective opportunities for improvement. These gaps should be addressed by regulating authorities, especially in public services.

Developing Induced Pluripotent Stem Cell-Based Therapy for the Masses.

The discovery of induced pluripotent stem cells and the ability to manufacture them using clinically compliant protocols has the potential to revolutionize the field of regenerative medicine. However, realizing this potential requires the development of processes that are reliable, reproducible, and cost-effective and that at the same time do not compromise the safety of the individuals receiving this therapy. In the present report, we discuss how cost reductions can be obtained using our experience with obtaining approval of biologic agents, autologous therapy, and the recent approval of cord blood banks. Significance: For therapy to be widely available, the cost of manufacturing stem cells must be reduced. The steps proposed in the present report, when implemented, have the potential to reduce these costs significantly.

[Position of French transfusion operator in the regulation of territorial care in a changing context]. / L'inscription de l'EFS dans la régulation territoriale de l'offre de soins à l'aune d'enjeux nouveaux.

Since the first law regarding the French transfusion, the public service of blood transfusion has always evolved. Today, different factors are changing: consequences of combination of French laws and European rules, new regulations and required levels of blood products. Moreover, those changes lead us to look at the position of the EFS in his health's territory which is actually changing too. The study of the context and actual laws could draw a first picture of the opportunities available for the EFS to face those new challenges.

Ethics, Human Use, and the Department of Defense Serum Repository.

The Department of Defense Serum Repository (DoDSR) contains a growing archive of sera from service members collected to perform medical surveillance, clinical diagnosis, and epidemiologic studies to identify, prevent, and control diseases associated with military service. The specimens are a mandatory collection under DoD and U.S. regulations and do not include informed consent for uses beyond force health protection. Any use of the specimens for research requires deidentification of the samples and must be approved by Institutional Review Boards. However, as expansion of the DoDSR is contemplated, ethical considerations of sample collection, storage, and use must be carefully reconsidered. Other similar programs for research use of specimens collected for public health purpose are also undergoing similar reviews. It is recommended that at a minimum, service members are informed of the potential storage and use of their specimens and are allowed to opt out of additional use, or a broad informed consent is provided. The DoDSR provides a tremendous resource to the DoD and global health community, and to ensure its continued existence and improvement, the DoD must stay consistent with all principles of research ethics.

A Need for Renewed and Cohesive US Policy on Cord Blood Banking.

Stem cells obtained from umbilical cord blood (CB) are used to treat more than 80 different diseases and are a standard treatment for many types of leukemias, lymphomas, myelodysplasias, and inherited immune system disorders. CB transplants have been carried out in humans for over 25 years, and hundreds of clinical trials are currently underway investigating CB's therapeutic potential for a wide range of disorders, including autism, diabetes, cerebral palsy, and spinal cord injury. Extensive storage facilities have been established in the United States and around the world to collect, test, and freeze CB for later use in medical procedures. However, a divide between two different banking models-public versus private-has emerged, presenting several policy challenges. While the Food and Drug Administration currently regulates CB storage and use in the United States, other state and federal guidelines on CB education, awareness, and ethical considerations remain variable, and no mandatory international guidelines exist. In addition, federal funding for an important CB collection initiative that specifically targets minority populations is set to expire by the end of FY2015. To help organize and coordinate efforts across the United States and other nations, policymakers should implement regulations for: high quality standards for both private and public CB banks, a commitment to ethical practices, and an investment in educational campaigns and training programs for all steps of the CB banking process.