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1.  Ethical issues relating to the banking of umbilical cord blood in Mexico 
BMC Medical Ethics  2009;10:12.
Umbilical cord banks are a central component, as umbilical cord tissue providers, in both medical treatment and scientific research with stem cells. But, whereas the creation of umbilical cord banks is seen as successful practice, it is perceived as a risky style of play by others. This article examines and discusses the ethical, medical and legal considerations that arise from the operation of umbilical cord banks in Mexico.
A number of experts have stated that the use of umbilical cord goes beyond the mere utilization of human tissues for the purpose of treatment. This tissue is also used in research studies: genetic studies, studies to evaluate the effectiveness of new antibiotics, studies to identify new proteins, etc. Meanwhile, others claim that the law and other norms for the functioning of cord banks are not consistent and are poorly defined. Some of these critics point out that the confidentiality of donor information is handled differently in different places. The fact that private cord banks offer their services as "biological insurance" in order to obtain informed consent by promising the parents that the tissue that will be stored insures the health of their child in the future raises the issue of whether the consent is freely given or given under coercion. Another consideration that must be made in relation to privately owned cord banks has to do with the ownership of the stored umbilical cord.
Conflicts between moral principles and economic interests (non-moral principles) cause dilemmas in the clinical practice of umbilical cord blood storage and use especially in privately owned banks. This article presents a reflection and some of the guidelines that must be followed by umbilical cord banks in order to deal with these conflicts. This reflection is based on the fundamental notions of ethics and public health and seeks to be a contribution towards the improvement of umbilical cord banks' performance.
PMCID: PMC2745420  PMID: 19678958
2.  Informed consent for cord blood donation. A theoretical and empirical study 
Blood Transfusion  2011;9(3):292-300.
Background and objectives
Umbilical cord blood (CB) banking and therapeutic use raise several ethical issues: medical indications, legal framework, public versus private biobanks, autologous versus allogeneic use, ownership, commercialisation, quality assurance and many others. Surrogate informed consent is one of the most notable controversial ethical issues. The aim of this study was to analyse and compare informed consent forms for CB collection, storage and use in the 18 accredited biobanks of the Italian Network.
Material and methods
The first part of the article gives a brief overview of the scientific framework, the comparison of allogeneic and autologous use and Italian regulations. In the second part the contents of the consent forms from the 18 Italian biobanks are compared with the “NetCord-FACT International Standards for Cord Blood Collection, Banking, and Release for Administration”.
Most of the Italian consent forms differ significantly from the NetCord-FACT Standards, with regards both to formal and substantial aspects.
Italian forms for CB collection, storage and use need standardisation to meet international criteria.
PMCID: PMC3136597  PMID: 21251456
cord blood; informed consent; biological specimens banks; transplantation
3.  Knowledge about umbilical cord blood banking among Greek citizens 
Blood Transfusion  2014;12(Suppl 1):s353-s360.
Umbilical cord blood supplies in Greece are not sufficient to meet the high transfusion needs. This study was designed to determine Greeks’ opinion about umbilical cord blood, identify the reasons for the lack of motivation to donate umbilical cord blood and allow experts to establish better recruitment campaigns to enrich the donor pool.
Materials and methods
The attitudes and knowledge about umbilical cord blood of randomly selected Greek citizens (n=1,019) were assessed by means of a standardised anonymous questionnaire. The results were analysed using the χ2test and Spearman’s correlation coefficient.
Forty-eight percent of respondents knew about umbilical cord blood and had full knowledge about what storage/donation offers. Media (35%) and doctors (25%) were the main source of information. The information from the state was considered either inadequate or non-existent by 85% of the responders. Ninety-five percent of the people questioned would like further information regarding umbilical cord blood transplantation and umbilical cord blood storage/donation. Six percent of the respondents who had children and were in favour of umbilical cord blood transplantation, had stored/donated UCB. With regards to future decisions, 84% of the sample would store/donate umbilical cord blood, of whom 57% would keep the umbilical cord blood in a private bank.
It was concluded that Greek citizens receive information about umbilical cord blood from both the state and advertising campaigns by the Ministry of Health and Social Solidarity. A kind of cooperation between all hospitals and public umbilical cord blood banks would be advisable in order to facilitate access to umbilical cord blood donations.
PMCID: PMC3934280  PMID: 24120604
umbilical cord blood; umbilical cord blood banking; attitude; knowledge; information
4.  The role and potential of umbilical cord blood in an era of new therapies: a review 
In light of pioneering findings in the 1980s and an estimation of more than 130 million global annual births, umbilical cord blood (UCB) is considered to be the most plentiful reservoir of cells and to have regenerative potential for many clinical applications. Although UCB is used mainly against blood disorders, the spectrum of diseases for which it provides effective therapy has been expanded to include non-hematopoietic conditions; UCB has also been used as source for regenerative cell therapy and immune modulation. Thus, collection and banking of UCB-derived cells have become a popular option. However, there are questions regarding the cost versus the benefits of UCB banking, and it also raises complex ethical and legal issues. This review discusses many issues surrounding the conservation of UCB-derived cells and the great potential and current clinical applications of UCB in an era of new therapies. In particular, we describe the practical issues inherent in UCB collection, processing, and long-term storage as well as the different types of ‘stem’ or progenitor cells circulating in UCB and their uses in multiple clinical settings. Given these considerations, the trend toward UCB will continue to provide growing assistance to health care worldwide.
PMCID: PMC4489204  PMID: 26133757
5.  Untying the Gordian knot: policies, practices, and ethical issues related to banking of umbilical cord blood 
Journal of Clinical Investigation  2005;115(10):2592-2597.
Since the first successful transplantation of umbilical cord blood in 1988, cord blood has become an important source of hematopoietic stem and progenitor cells for the treatment of blood and genetic disorders. Significant progress has been accompanied by challenges for scientists, ethicists, and health policy makers. With the recent recognition of the need for a national system for the collection, banking, distribution, and use of cord blood and the increasing focus on cord blood as an alternative to embryos as a source of tissue for regenerative medicine, cord blood has garnered significant attention. We review the development of cord blood banking and transplantation and then discuss the scientific and ethical issues influencing both established and investigational practices surrounding cord blood collection, banking, and use.
PMCID: PMC1236704  PMID: 16200191
6.  Defining Permissible Time Lapse between Umbilical Cord Tissue Collection and Commencement of Cell Isolation 
Umbilical cord tissue is a very rich source of mesenchymal stem cells. Instead of discarding this source we are banking the tissue along with cord blood for possible future cell based applications. The cord tissue needs to be transported and stored properly in order for it to be good enough for cell isolation at a later date. In this paper we have carried out a validation study to determine the maximum permissible time between cord tissue collection and beginning of cell culture process under defined conditions of temperature and collection media.
Ten cord tissue samples were used for this study. The umbilical cord tissue segments were transported and stored at 2 – 8°C for varying periods of time viz. 04, 11, 22 and 30 days in a defined medium after which MSCs were isolated and characterized by flow cytometry. Karyotypic studies were also performed on the isolated cells at the above time points.
MSCs could be successfully isolated from 09 even samples after a storage period of 22 days and from 07 samples after a period of 30 days from the date of collection. There was no change in the morphology, immunophenotye, karyotypye and growth potential of the cells isolated from cord tissue after the maximum storage period of 30 days.
The umbilical cord tissue is stable for as long as 22 days if stored at the recommended storage conditions of 2 – 8°C in the defined medium.
PMCID: PMC3915426  PMID: 24505538
Adult stem cells; Umbilical cord tissue; Mesenchymal stem cells; Transportation
7.  Stem Cells in the Umbilical Cord 
Stem cell reviews  2006;2(2):155-162.
Stem cells are the next frontier in medicine. Stem cells are thought to have great therapeutic and biotechnological potential. This will not only to replace damaged or dysfunctional cells, but also rescue them and/or deliver therapeutic proteins after they have been engineered to do so. Currently, ethical and scientific issues surround both embryonic and fetal stem cells and hinder their widespread implementation. In contrast, stem cells recovered postnatally from the umbilical cord, including the umbilical cord blood cells, amnion/placenta, umbilical cord vein, or umbilical cord matrix cells, are a readily available and inexpensive source of cells that are capable of forming many different cell types (i.e., they are “multipotent”). This review will focus on the umbilical cord-derived stem cells and compare those cells with adult bone marrow-derived mesenchymal stem cells.
PMCID: PMC3753204  PMID: 17237554
Umbilical cord matrix cells; Wharton’s Jelly; mesenchymal stem cells; umbilical cord blood cells
8.  Prenatal recruitment of participants for a birth cohort study including cord blood collection: results of a feasibility study in Bremen, Germany 
GMS German Medical Science  2015;13:Doc04.
Background: Prospective birth cohort studies comprising follow up of children from pregnancy or birth over a long period of time, and collecting various biological samples at different times through the life-course offer a promising approach to enhance etiologic knowledge of various diseases. Especially for those where early lifetime exposures and conditions are thought to play an important role. The collection and storage of biological samples is a critical component in epidemiological studies, notably for research regarding prenatal exposures to various environmental factors as well as for DNA extraction. Our feasibility study for a birth cohort within the scope of etiology of childhood leukemia with prospective sampling of mothers and their future newborns aimed to investigate the willingness of pregnant women to participate in a birth cohort study involving collection of blood and umbilical cord blood samples. The overall aim was to develop practice-based research recommendations for a possible German birth cohort study.
Methods: The study was conducted in Bremen, Germany, between January 2012 and March 2013. Pregnant women were eligible for recruitment if (i) their expected date of delivery was during the study recruitment phase (September 2012–February 2013), (ii) they planned to give birth at the cooperating hospital’s obstetric unit and (iii) their knowledge of the German language was sufficient to understand study materials, details of participation and to fill out the prenatal self-administered questionnaire. Maternal blood and umbilical cord blood samples to be used for later research activities were collected and stored at a stem cell bank already collaborating with the hospital. 22 primary care gynecologists were invited to enroll pregnant women for the study and cooperation with one hospital was established. Expectant women were recruited during the last trimester of pregnancy, either during one of their prenatal care visits at their primary care gynecologist or later on in hospital by the attending obstetricians or project staff.
Results: Of the 22 invited primary care gynecologists requested to enroll pregnant women for the study, 8 gynecologists actually collaborated. A total of 200 eligible women were invited to participate in the study, 48 (24%) of whom agreed. 34 women were enrolled by primary care gynecologists, with one gynecologist enrolling 26 women. Twelve of 14 women recruited via hospitals were enrolled by study staff. A total of 41 women consented to the collection of umbilical cord blood and maternal blood samples, and samples could be stored for 54% of them. Reason for non-participation were the uncertainty whether or not the full study would be conducted and the fact that the participants were not willing to decide for their children whether or not genetic information (cord blood) can be stored for research purposes.
Conclusion: Enrolling parents in a birth cohort study that includes biosampling is a challenge, but participation can be improved through close collaboration with primary care gynecologists and maternity hospitals. Cord blood collection may impede participation, especially when maternity hospitals offer an alternative option for cord blood donation.
PMCID: PMC4397994  PMID: 25908931
umbilical cord blood; leukemia; children; feasibility study; birth cohort study
9.  Private Cord Blood Banking: Experiences And Views Of Pediatric Hematopoietic Cell Transplantation Physicians 
Pediatrics  2009;123(3):1011-1017.
Private cord blood banks are for-profit companies that facilitate storage of umbilical cord blood for personal or family use. Pediatric hematopoietic cell transplantation (HCT) physicians are currently best situated to use cord blood therapeutically. We sought to describe the experiences and views of these physicians regarding private cord blood banking.
Participants and Methods
Emailed cross-sectional survey of pediatric HCT physicians in the United States and Canada. 93/152 potentially eligible physicians (93/130 confirmed survey recipients) from 57 centers responded. Questions addressed the number of transplants performed using privately banked cord blood, willingness to use banked autologous cord blood in specific clinical settings, and recommendations to parents regarding private cord blood banking.
Respondents reported having performed 9 autologous and 41 allogeneic transplants using privately banked cord blood. In 36/40 allogeneic cases for which data were available, the cord blood had been collected because of a known indication in the recipient. Few respondents would choose autologous cord blood over alternative stem cell sources for treatment of acute lymphoblastic leukemia in second remission. In contrast, 55% would choose autologous cord blood to treat high-risk neuroblastoma, or to treat severe aplastic anemia in the absence of an available sibling donor. No respondent would recommend private cord blood banking for a newborn with one healthy sibling when both parents were of Northern European descent; 11% would recommend banking when parents were of different minority ethnicities.
Few transplants have been performed using cord blood stored in the absence of a known indication in the recipient. Willingness to use banked autologous cord blood varies depending on disease and availability of alternative stem cell sources. Few pediatric HCT physicians endorse private cord blood banking in the absence of an identified recipient, even for mixed-ethnicity children for whom finding a suitably matched unrelated donor may be difficult.
PMCID: PMC3120215  PMID: 19255033
Hematopoietic Stem Cell Transplantation; Cord Blood Stem Cell Transplantation; Bioethics
10.  Long-term storage of blood RNA collected in RNA stabilizing Tempus tubes in a large biobank – evaluation of RNA quality and stability 
BMC Research Notes  2014;7:633.
Establishing methods for secure long term storage of RNA is critical to realizing the promise of biobanks in biomedical research. Here, we describe the results of yearly analyses of the same set of umbilical cord and adult whole blood RNA collected in Tempus Blood RNA tubes and stored at -80°C, over a period of up to six years. We systematically investigated the effects of long-term storage of samples (75 Tempus tubes form three adult donors and 30 Tempus tubes from three cord blood donors) on the RNA quality and transcript stability of six selected genes (CDKN1A, FOS, IL1B, IL8, MYC and TP53). This is the first systematic study of both cord and adult blood samples stored for many years.
The RNA purity and integrity, expressed as RIN-values, were stable up to six years of storage, and there were no storage-related deleterious effects on RNA purity. There were limited intra- and inter-individual variations in RNA yields; however, no consistent trend of decreasing RNA yield was observed with the duration of storage. Some long-term storage effects were found on the relative transcript levels of the six genes when compared to the year 0 samples. However, these changes were within ± 2–fold for both types of blood samples, except for two genes. Our results show that storage of these samples for up to six years did not have significant effects on the RNA quality and transcript stability of the six genes.
Blood RNA is stable in Tempus tubes stored at -80°C over a period of six years. Intact and good-quality RNA suitable for transcript profiling analyses in epidemiological studies was obtained from blood samples stored in Tempus tubes. This suggests that blood samples collected in large biobanks–such as the Mother and Child (MoBa) Cohort at Norwegian Institute of Public Health (NIPH) and frozen in suitable collection tubes for total RNA stabilization, can be used for quantitative studies after at least six years of storage.
Electronic supplementary material
The online version of this article (doi:10.1186/1756-0500-7-633) contains supplementary material, which is available to authorized users.
PMCID: PMC4168124  PMID: 25214016
Tempus tubes; Cord blood; Long-term storage; Quality control; RNA stabilization; Biobank
11.  Health Professionals’ knowledge and attitude towards the Umbilical Cord Blood donation in Greece 
Hippokratia  2014;18(2):110-115.
In the last years a major emphasis is laid on the Allogeneic Transplantation of Blood Stem Cells from the Umbilical Cord Blood with a simultaneous development of Umbilical Cord Blood bank. The attitude and knowledge of Health Professionals is vital to the success of this attempt as it affects significantly the promotion of Umbilical Cord Blood donation. The aim of present study is the examination of Health Professionals’ knowledge and attitudes towards Umbilical Cord Blood in Greece.
Material and Methods:
The study was conducted from April 25th 2012 to May 7th 2012. The sample consisted of 109 Health Professionals from 3 provincial hospitals and 2 hospitals in Thessaloniki. In order to collect the data, a questionnaire was used. The questionnaire was designed by the researcher and a group of experts to serve the mission of the present study. From the 130 questionnaires sent, 109 were completely answered (response rate 84%).
Of those who participated to the research, 23.9% were physicians, 34.9% were midwives, and 34.8% were nurses. As far as the Health Professionals’ knowledge on the Umbilical Cord Blood is concerned, only 15.6% of the participants declared to be quite or well informed on the collection methods and the usage of Umbilical Cord Blood. The vast majority of the participants (89%), declared that a well-organized program on a continual training is very essential. 93.5% of the participants declared that in the last 5 years received no or very little training regarding the collection, storing and transplantation of Umbilical Cord Blood.
Although according to a relevant research health professionals are considered by the public as the most credible source of information about Umbilical Cord Blood, their level of knowledge on the usage and storing of Umbilical Cord Blood is inadequate. The present study indicates the necessity of creation or reinforcing of effective programs of continual training with the use of technology (i.e. Internet).
PMCID: PMC4201394  PMID: 25336871
Blood Stem Cells; Umbilical Cord Blood; transplantation
12.  Normal Ranges for Acute Phase Reactants (Interleukin-6, Tumour Necrosis Factor-alpha and C-reactive Protein) in Umbilical Cord Blood of Healthy Term Neonates at the Mount Hope Women's Hospital, Trinidad 
The West Indian Medical Journal  2015;63(5):465-469.
To determine normal ranges for interleukin-6 (IL-6), tumour necrosis factor-alpha (TNF-α) and C-reactive protein (CRP) in umbilical cord blood from healthy term neonates at the Mount Hope Women's Hospital (MHWH), Trinidad.
A prospective cohort study was conducted on healthy pregnant women admitted to the MHWH during the period October 1 to December 31, 2010. Women who were term with no signs of or risk factors for sepsis were recruited into the study after informed consent was obtained. Data were collected including maternal age, antenatal and perinatal history. Umbilical cord blood samples were collected and analysed for IL-6, TNF-α and CRP. Ethical approval was obtained from the Ethics Committee, Faculty of Medical Sciences, The University of the West Indies, Trinidad and Tobago.
One hundred and sixty-two samples from healthy term neonates were analysed for IL-6 and TNF-α. One hundred and thirty-one samples were analysed for CRP due to one faulty kit. There were almost equal numbers of males (55%) and females (45%). Ninety per cent were > 2500 g at birth and 10% had low birthweight. Reference ranges of 0–16.4 pg/mL, 0–29.4 pg/mL and 0–12.4 mg/L were found for IL-6, TNF-α and CRP, respectively, with 95% confidence intervals (11.6, 21.5 pg/mL; 24.0, 33.1 and 8.4, 15.1, respectively).
The normal ranges for IL-6, TNF-α and CRP in umbilical cord blood for healthy term Trinidadian neonates were 0–16.4 pg/mL, 0–29.4 pg/mL and 0–12.4 mg/L, respectively.
PMCID: PMC4655679  PMID: 25781284
Acute phase reactants; cord blood
13.  Isolation of mesenchymal stem cells from equine umbilical cord blood 
BMC Biotechnology  2007;7:26.
There are no published studies on stem cells from equine cord blood although commercial storage of equine cord blood for future autologous stem cell transplantations is available. Mesenchymal stem cells (MSC) have been isolated from fresh umbilical cord blood of humans collected non-invasively at the time of birth and from sheep cord blood collected invasively by a surgical intrauterine approach. Mesenchymal stem cells isolation percentage from frozen-thawed human cord blood is low and the future isolation percentage of MSCs from cryopreserved equine cord blood is therefore expectedly low. The hypothesis of this study was that equine MSCs could be isolated from fresh whole equine cord blood.
Cord blood was collected from 7 foals immediately after foaling. The mononuclear cell fraction was isolated by Ficoll density centrifugation and cultured in a DMEM low glucose based media at 38.5°C in humidified atmosphere containing 5% CO2. In 4 out of 7 samples colonies with MSC morphology were observed. Cellular morphology varied between monolayers of elongated spindle-shaped cells to layered cell clusters of cuboidal cells with shorter cytoplasmic extensions. Positive Alizarin Red and von Kossa staining as well as significant calcium deposition and alkaline phosphatase activity confirmed osteogenesis. Histology and positive Safranin O staining of matrix glycosaminoglycans illustrated chondrogenesis. Oil Red O staining of lipid droplets confirmed adipogenesis.
We here report, for the first time, the isolation of mesenchymal-like stem cells from fresh equine cord blood and their differentiation into osteocytes, chondrocytes and adipocytes. This novel isolation of equine cord blood MSCs and their preliminary in vitro differentiation positions the horse as the ideal pre-clinical animal model for proof-of-principle studies of cord blood derived MSCs.
PMCID: PMC1904213  PMID: 17537254
14.  Maternal nutritional status during pregnancy and surma use determine cord lead levels in Karachi Pakistan 
Environmental research  2008;108(1):69-79.
To estimate the umbilical cord blood lead levels (BLLs) of Pakistani neonates and to identify determinants for umbilical BLLs.
We conducted a cross-sectional study of mothers and infants at one of the two obstetric units of two tertiary care hospitals in Karachi during January to August 2005. Information from 540 mothers selected randomly from those registered for delivery was obtained about their pregnancy, diet, and current and past lead exposures. We collected umbilical cord blood for lead levels analyzed using graphite furnace atomic absorption spectrophotometry. We computed geometric and arithmetic means. We performed multiple linear regression analysis to identify factors associated with log transformed umbilical cord BLLs. We also performed logistic regression analysis to identify determinants of high lead cord BLLs (≥10μg/dl).
The geometric mean cord BLLs of the neonates was 9.6μg/dl; arithmetic mean (SD) was 10.8 μg/dl (5.7) with a median of 9.7μg/dl and a range of 1.8 μg/dl–48.9μg/dl. Women who reported intake of less than 58.5 mg of elemental iron supplement per day during pregnancy had cord BLL of 10.0μg/dl; in comparison those women who had higher iron intake had lower cord BLL (8.4μg/dl). Those who used surma (an eye cosmetic) daily had higher cord BLL (11.5 μg/dl) as compared to those who used it less frequently (9.4μg/dl). In multivariable linear regression model, higher iron intake, owning a car, and being in 2nd quartile of mid arm circumference were associated with low lead levels while father’s occupation in lead based industry were associated with significantly higher umbilical cord blood lead levels. There was interaction of daily surma use and ethnicity. Geometric mean BLLs were varied among surma users by ethnicity.
Umbilical cord BLLs are high in Karachi, Pakistan in comparison to those in developed countries such as United States. Measures are needed to reduce fetal lead exposure to prevent adverse affect on neurocognitive development. Association of low iron (below RDA of 60 mg per day) with high umbilical cord has implications for strengthening iron supplement intake during pregnancy. Umbilical cord BLLs of differed among surma users by ethnicity.
PMCID: PMC2581773  PMID: 18656859
Umbilical cord blood lead levels; iron; surma; socioeconomic status; Pakistan
15.  Prenatal Arsenic Exposure and Shifts in the Newborn Proteome: Interindividual Differences in Tumor Necrosis Factor (TNF)-Responsive Signaling 
Toxicological Sciences  2014;139(2):328-337.
Editor's Highlight: Babies, infants and young children are not just small adults; their physiology and biochemistry differs in countless ways creating a need for research on this vulnerable population. But such research poses numerous ethical and moral challenges. The acquisition of umbilical cord blood provides an opportunity to assess the newborn's environment without risk to the child. In this issue of the Journal, Bailey and coworkers used antibody arrays to examine protein profiles in umbilical cord blood and compared it to levels of arsenic in the mothers' urine and drinking water. The study population was based in G'omez Palacio, Mexico, where arsenic levels are well above regulatory guidelines. Protein network analysis revealed several proteins involved in tumor necrosis factor signaling were elevated in the offspring of highly exposed mothers, suggesting that elevated arsenic induces widespread inflammatory signaling. Such markers could ultimately be used to assess the impact of arsenic exposure in this and other vulnerable populations and may lead to mechanisms whereby arsenic exposure in utero contributes to adverse outcomes later in life. —Gary W. Miller and Ronald N. Hines
Exposure to inorganic arsenic (iAs) early in life is associated with adverse health effects in infants, children, and adults, and yet the biological mechanisms that underlie these effects are understudied. The objective of this research was to examine the proteomic shifts associated with prenatal iAs exposure using cord blood samples isolated from 50 newborns from Gómez Palacio, Mexico. Levels of iAs in maternal drinking water (DW-iAs) and the sum of iAs and iAs metabolites in maternal urine (U-tAs) were determined. Cord blood samples representing varying iAs exposure levels during the prenatal period (DW-iAs ranging from <1 to 236 μg As/l) were analyzed for altered expression of proteins associated with U-tAs using a high throughput, antibody-based method. A total of 111 proteins were identified that had a significant association between protein level in newborn cord blood and maternal U-tAs. Many of these proteins are regulated by tumor necrosis factor and are enriched in functionality related to immune/inflammatory response and cellular development/proliferation. Interindividual differences in proteomic response were observed in which 30 newborns were “activators,” displaying a positive relationship between protein expression and maternal U-tAs. For 20 “repressor” newborns, a negative relationship between protein expression level and maternal U-tAs was observed. The activator/repressor status was significantly associated with maternal U-tAs and head circumference in newborn males. These results may provide a critical groundwork for understanding the diverse health effects associated with prenatal arsenic exposure and highlight interindividual responses to arsenic that likely influence differential susceptibility to adverse health outcomes.
PMCID: PMC4031624  PMID: 24675094
arsenic; arsenic metabolism; in utero; metals; pregnancy; birth outcomes
16.  Ethical issues in stem cell research and therapy 
Rapid progress in biotechnology has introduced a host of pressing ethical and policy issues pertaining to stem cell research. In this review, we provide an overview of the most significant issues with which the stem cell research community should be familiar. We draw on a sample of the bioethics and scientific literatures to address issues that are specific to stem cell research and therapy, as well as issues that are important for stem cell research and therapy but also for translational research in related fields, and issues that apply to all clinical research and therapy. Although debate about the moral status of the embryo in human embryonic stem cell research continues to have relevance, the discovery of other highly multipotent stem cell types and alternative methods of isolating and creating highly multipotent stem cells has raised new questions and concerns. Induced pluripotent stem cells hold great promise, but care is needed to ensure their safety in translational clinical trials, despite the temptation to move quickly from bench to bedside. A variety of highly multipotent stem cells - such as mesenchymal stem/stromal cells and stem cells derived from amniotic fluid, umbilical cord blood, adipose tissue, or urine - present the opportunity for widespread biobanking and increased access. With these increased opportunities, however, come pressing policy issues of consent, control, and justice. The imperatives to minimize risks of harm, obtain informed consent, reduce the likelihood of the therapeutic misconception, and facilitate sound translation from bench to bedside are not unique to stem cell research; their application to stem cell research and therapy nonetheless merits particular attention. Because stem cell research is both scientifically promising and ethically challenging, both the application of existing ethical frameworks and careful consideration of new ethical implications are necessary as this broad and diverse field moves forward.
PMCID: PMC4097842  PMID: 25157428
17.  Manufacturing blood ex vivo: a futuristic approach to deal with the supply and safety concerns 
Blood transfusions are routinely done in every medical regimen and a worldwide established collection, processing/storage centers provide their services for the same. There have been extreme global demands for both raising the current collections and supply of safe/adequate blood due to increasingly demanding population. With, various risks remain associated with the donor derived blood, and a number of post collection blood screening and processing methods put extreme constraints on supply system especially in the underdeveloped countries. A logistic approach to manufacture erythrocytes ex-vivo by using modern tissue culture techniques have surfaced in the past few years. There are several reports showing the possibilities of RBCs (and even platelets/neutrophils) expansion under tightly regulated conditions. In fact, ex vivo synthesis of the few units of clinical grade RBCs from a single dose of starting material such as umbilical cord blood (CB) has been well established. Similarly, many different sources are also being explored for the same purpose, such as embryonic stem cells, induced pluripotent stem cells. However, the major concerns remain elusive before the manufacture and clinical use of different blood components may be used to successfully replace the present system of donor derived blood transfusion. The most important factor shall include the large scale of RBCs production from each donated unit within a limited time period and cost of their production, both of these issues need to be handled carefully since many of the recipients among developing countries are unable to pay even for the freely available donor derived blood. Anyways, keeping these issues in mind, present article shall be focused on the possibilities of blood production and their use in the near future.
PMCID: PMC4206981  PMID: 25364733
RBCs; ex-vivo erythrocytes; manufacturing blood; hematopoietic stem cells; induced pluripotent stem cells
18.  Non-Hematopoietic Stem Cells in Umbilical Cord Blood 
Allogeneic umbilical cord blood (UCB) transplantation has been used to treat a variety of malignant and non-malignant diseases. Recent studies show convincing evidence that UCB contains not only hematopoietic progenitors, but also several types of stem and progenitor cells providing a high proliferative capacity and a variety of differentiation potentials. UCB-derived cells offer multiple advantages over adult stem cells from other sources like bone marrow (BM), because UCB can be collected without painful procedure, easily available in virtually unlimited supply, and has not been exposed to immunologic challenge. In addition, cord blood transplantation is now an established field with great potential and no serious ethical issue by establishment of public UCB banks throughout the world. Therefore UCB-derived non-hematopoietic stem cells may provide an attractive cell source for tissue repair and regeneration. It is generally accepted that UCB contains endothelial progenitor cells (EPC), mesenchymal stromal cells (MSC), unrestricted somatic stem cells (USSC), very small embryonic-like stem cells (VSEL), multilineage progenitor cells (MLPC), and neuronal progenitor cells. This review focuses on biological properties of these non-hematopoietic stem/progenitor cells derived from human UCB and their potential use in cell based therapies.
PMCID: PMC4021761  PMID: 24855525
Endothelial progenitor cell; Mesenchymal stem cell; Unrestricted somatic stem cell; Embryonic stem-like cell; Neuronal progenitor cell; Umbilical cord transplantation
19.  Qualitative and quantitative cell recovery in umbilical cord blood processed by two automated devices in routine cord blood banking: a comparative study 
Blood Transfusion  2013;11(3):405-411.
Volume reduction is a widely used procedure in umbilical cord blood banking. It concentrates progenitor cells by reducing plasma and red blood cells, thereby optimising the use of storage space. Sepax and AXP are automated systems specifically developed for umbilical cord blood processing. These systems basically consist of a bag processing set into which cord blood is transferred and a device that automatically separates the different components during centrifugation.
The aim of this study was to analyse and compare cell recovery of umbilical cord blood units processed with Sepax and AXP at Valencia Cord Blood Bank. Cell counts were performed before and after volume reduction with AXP and Sepax.
When analysing all the data (n =1,000 for AXP and n= 670 for Sepax), the percentages of total nucleated cell recovery and red blood cell depletion were 76.76±7.51% and 88.28±5.62%, respectively, for AXP and 78.81±7.25% and 88.32±7.94%, respectively, for Sepax (P <0.005 for both variables). CD34+ cell recovery and viability in umbilical cord blood units were similar with both devices. Mononuclear cell recovery was significantly higher when the Sepax system was used.
Both the Sepax and AXP automated systems achieve acceptable total nucleated cell recovery and good CD34+ cell recovery after volume reduction of umbilical cord blood units and maintain cell viability. It should be noted that total nucleated cell recovery is significantly better with the Sepax system. Both systems deplete red blood cells efficiently, especially AXP which works without hydroxyethyl starch.
PMCID: PMC3729132  PMID: 23058859
cord blood; volume reduction; haematopoietic progenitors
20.  Ethical issues in the export, storage and reuse of human biological samples in biomedical research: perspectives of key stakeholders in Ghana and Kenya 
BMC Medical Ethics  2014;15:76.
For many decades, access to human biological samples, such as cells, tissues, organs, blood, and sub-cellular materials such as DNA, for use in biomedical research, has been central in understanding the nature and transmission of diseases across the globe. However, the limitations of current ethical and regulatory frameworks in sub-Saharan Africa to govern the collection, export, storage and reuse of these samples have resulted in inconsistencies in practice and a number of ethical concerns for sample donors, researchers and research ethics committees. This paper examines stakeholders’ perspectives of and responses to the ethical issues arising from these research practices.
We employed a qualitative strategy of inquiry for this research including in-depth interviews and focus group discussions with key research stakeholders in Kenya (Nairobi and Kilifi), and Ghana (Accra and Navrongo).
The stakeholders interviewed emphasised the compelling scientific importance of sample export, storage and reuse, and acknowledged the existence of some structures governing these research practices, but they also highlighted the pressing need for a number of practical ethical concerns to be addressed in order to ensure high standards of practice and to maintain public confidence in international research collaborations. These concerns relate to obtaining culturally appropriate consent for sample export and reuse, understanding cultural sensitivities around the use of blood samples, facilitating a degree of local control of samples and sustainable scientific capacity building.
Drawing on these findings and existing literature, we argue that the ethical issues arising in practice need to be understood in the context of the interactions between host research institutions and local communities and between collaborating institutions. We propose a set of ‘key points-to-consider’ for research institutions, ethics committees and funding agencies to address these issues.
PMCID: PMC4210627  PMID: 25326753
Human biological samples; Broad consent; Research collaboration; Sample export; Africa
21.  The Taiwan Birth Panel Study: a prospective cohort study for environmentally- related child health 
BMC Research Notes  2011;4:291.
The Taiwan Birth Panel Study (TBPS) is a prospective follow-up study to investigate the development of child health and disease in relation to in-utero and/or early childhood environmental exposures. The rationale behind the establishment of such a cohort includes the magnitude of potential environmental exposures, the timing of exposure window, fatal and children's susceptibility to toxicants, early exposure delayed effects, and low-level or unknown neurodevelopmental toxicants.
A total of 486 mother-infant paired was enrolled from April 2004 to January 2005 in this study. Maternal blood before delivery, placenta and umbilical cord blood at birth, and mothers' urine after delivery were collected. The follow-up was scheduled at birth, 4, 6 months, and 1, 2, 3 and 5 years. The children's blood, urine, hair, and saliva were collected at 2 years of age and children's urine was collected at 5 years of age as well. The study has been approved by the ethical committee of National Taiwan University Hospital. All the subjects signed the inform consent on entering the study and each of the follow up.
Through this prospective birth cohort, the main health outcomes were focused on child growth, neurodevelopment, behaviour problem and atopic diseases. We investigated the main prenatal and postnatal factors including smoking, heavy metals, perfluorinated chemicals, and non-persistent pesticides under the consideration of interaction of the environment and genes.
This cohort study bridges knowledge gaps and answers unsolved issues in the low-level, prenatal or postnatal, and multiple exposures, genetic effect modification, and the initiation and progression of "environmentally-related childhood diseases."
PMCID: PMC3170609  PMID: 21838884
Cohort study; prenatal environmental exposure; child growth; neurodevelopment; behaviour problem; single-nucleotide polymorphisms
22.  The quality of stored umbilical cord and adult-donated whole blood in Mombasa, Kenya 
Transfusion  2009;50(3):611-616.
In sub-Saharan Africa umbilical cord blood may be a useful source of blood for transfusion. Before clinical trials, evidence is needed that cord blood donations, which vary greatly in volume, can be collected and stored into a fixed volume of anticoagulant-preservative solution obviating the need for prestorage processing.
Twenty-four umbilical cord whole blood (UC-WB) donations were collected into 21 mL of CPDA-1 and refrigerated for 35 days. The Kenya Blood Transfusion Service provided 12 adult-donated whole blood (AD-WB) controls. Supernatant hemoglobin (Hb) and potassium were assayed at 7-day intervals.
UC-WB red blood cell hemolysis and potassium loss increased throughout storage but did not differ significantly with cord blood volume. Hemolysis rates did not differ significantly between UC-WB and AD-WB but UC-WB potassium loss was slightly but significantly greater than AD-WB on Days 2, 7, and 14 (p < 0.05). In the AD-WB controls, eight were low volume (<405 mL), two had total Hb of less than 45 g, and two showed hemolysis greater than 0.8% by Day 28.
Variable volumes of UC-WB can be stored for 35 days without prestorage processing and further work into its suitability for transfusion to children is justified. The quality of conventional AD-WB is a concern and needs further evaluation.
PMCID: PMC2948540  PMID: 19912583
23.  The quality of stored umbilical cord and adult-donated whole blood in Mombasa, Kenya 
Transfusion  2010;50(3):611-616.
In sub-Saharan Africa umbilical cord blood may be a useful source of blood for transfusion. Before clinical trials, evidence is needed that cord blood donations, which vary greatly in volume, can be collected and stored into a fixed volume of anticoagulant-preservative solution obviating the need for prestorage processing.
Twenty-four umbilical cord whole blood (UC-WB) donations were collected into 21 mL of CPDA-1 and refrigerated for 35 days. The Kenya Blood Transfusion Service provided 12 adult-donated whole blood (AD-WB) controls. Supernatant hemoglobin (Hb) and potassium were assayed at 7-day intervals.
UC-WB red blood cell hemolysis and potassium loss increased throughout storage but did not differ significantly with cord blood volume. Hemolysis rates did not differ significantly between UC-WB and AD-WB but UC-WB potassium loss was slightly but significantly greater than AD-WB on Days 2, 7, and 14 (p < 0.05). In the AD-WB controls, eight were low volume (<405 mL), two had total Hb of less than 45 g, and two showed hemolysis greater than 0.8% by Day 28.
Variable volumes of UC-WB can be stored for 35 days without prestorage processing and further work into its suitability for transfusion to children is justified. The quality of conventional AD-WB is a concern and needs further evaluation.
PMCID: PMC2948540  PMID: 19912583
24.  Effects of tobacco smoking during pregnancy on oxidative stress in the umbilical cord and mononuclear blood cells of neonates 
Although cigarette smoke is known to be a complex mixture of over 4000 substances that can lead to damage through active or passive smoking, its mechanisms and biochemical consequences in pregnancy and neonates are not yet fully understood. Therefore, in the present study, we propose to study the impact of smoking during gestation on the viability of blood mononuclear cells (MNC) from umbilical cords of newborns to assess the degree of oxidative stress and cell viability. After childbirth, the cord blood and the umbilical cord were immediately collected in public hospitals in Greater Vitoria, ES, Brazil. Flow cytometry was used to analyze the cord blood followed by biochemical and histological tests to analyze possible changes in the umbilical cord.
Pregnant smokers had a reduction of MNC viability from the umbilical cord (10%), an increase in the production of reactive oxygen species (ROS) and an increase in cell apoptosis (~2-fold) compared to pregnant non-smokers. In the umbilical cord, it was observed an increase of advanced oxidation protein products - AOPP (~2.5-fold) and a loss of the typical architecture and disposition of endothelial cells from the umbilical artery.
These data suggest that maternal cigarette smoking during pregnancy (even in small amounts) may compromise the viability of MNC cells and damage the umbilical cord structure, possibly by excessive ROS bioavailability.
PMCID: PMC4302517  PMID: 25547987
Cigarette smoke; Cord blood; Oxidative stress; Pregnant women; Apoptosis
25.  Migration of Human Umbilical Cord Blood Cells into Rat Liver 
Background and Objectives:
Cell therapy provides an effective strategy for the treatment of an impaired liver. Human umbilical cord blood progenitor cells have the potential to differentiate into hepatocytes. Progenitor cells transplanted into the spleen could migrate directly into the liver through portal circulation. To track migration of human umbilical cord blood progenitor cells in cirrhotic rat liver after intrasplenic transplantation and to prove the possibility similar behavior of human umbilical cord blood nucleated cells in humans.
Methods and Results:
Umbilical cord blood samples from full-term deliveries will be collected after obtaining an informed consent from the mother. The collection procedure will be conducted after completion of delivery and will not interfere with the normal obstetric procedures. Adult male Sprague Dawley rats were subjected to liver cirrhosis by intraperitoneal injection of thioacetamide. Cirrhotic rats were treated with human umbilical cord blood nucleated cells by intra-splenic transplantation. Migration of intrasplenic transplanted human umbilical cord blood cells to the liver was successfully documented with Immunohistochemistry. The liver and spleen from recipient animals were removed. Histopathological and immunohistochemical analysis were performed 20 weeks after intrasplenic injection of the cells. Intrasplenically injected cells migrate to the liver of recipient animals.
Human cord blood nucleated cells have the potential to differentiate into hepatocytes and substantially improve the histology and function of the cirrhotic liver in rats. Relocation into liver after intrasplenic transplantation could be detected by immunohistochemistry. Transdifferentiated cells could be efficiently stained with antihuman hepatocytes.
PMCID: PMC4021809  PMID: 24855553
Cord blood; Progenitor cells; Intrasplenic transpl; Liver regeneration

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