Chapter 2

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REVIEW OF

LITERATURE
REVIEW OF LITERATURE

The literature review involves the systematic identifications, scrutiny and summary of
written materials that contain the information on research problem (Polit and Hungler
1982). It refers to activities involved in searching for information on a topic and
developing a comprehensive picture of the state of knowledge on that topic.
The purpose of reviewing the literature in any field is to help the individual gain
information as to what has been investigated, which methodology was used, what were
the conclusions and as to what more need to be done in the future.
For the better understanding of the present study the review of the studies in this
chapter is organized into 3 sections.
Section I- Deals with literature related to knowledge and attitude of mothers regarding
cord blood banking.

Section II- Deals with literature related to the effectiveness of stem cell transplantation.

Section III- Deals with literature related to method of collection and preservation

Section I-
Deals with literature related to knowledge and attitude of mothers regarding cord
blood banking.
Patricia E. Palten and Joachim W. Dudenhausen (2010) conducted a study
among 300 German speaking pregnant women in Berlin to know whether a relation
between women’s knowledge about umbilical cord blood banking and level of education.
The data collected by using anonymous questionnaire. Among them 3 quarters of the
population heard of umbilical cord blood banking, most had no further knowledge about
the method. Only one third of the interviewed women were informed about whether
certain diseases had been treated with umbilical cord blood banking by the time the
survey was being conducted, whereas 50-60% did not know how to answer these
questions.
Dinc H. and Sahin N.H(2009) conducted an exploratory descriptive study among
334 pregnant women to determine pregnant women’s knowledge and attitudes about stem
cells and cord blood banking in Istanbul, Turkey. The data collected through interviews. The
study revealed that majority of participants had lack of knowledge regarding stem cells and
cord blood banking and wanted more information.
Conrad V. Fernandez, Kevin Gordon et al (2001) conducted a study among 443
pregnant women on knowledge and attitudes with regard to collection, testing and banking
of cord blood stem cells in antenatal assessment clinics at the IWK Health Centre, Halifax,
NS. Data collected by structured questionnaire. The study revealed that about 70% of the
women reported poor or very poor knowledge about cord blood banking.
Scott Fitzgerald.F(2001) conducted a study in North America among 443 antenatal
mothers to assess their Knowledge and attitude with regard to collection, testing and
banking cord blood stem cells in July2001. Study finding shows that 86%of the women
elected to store Cord blood in Public Bank, 14% in Private Banks. 67% mothers accepted
use of Cord blood for research and 39% accepted for Gene Therapy. Most of the women
supported Cord Blood Donation to Public banks for Transplantation.

Edgar Allan Poe (2005) conducted a study by using an anonymous questionnaire


given to German-speaking women in Berlin, Germany. A total of 300 questionnaires were
evaluated. Although three quarters of the population heard of Umbilical Cord Blood Bank,
most had no further knowledge about the method. Only about one-third of the interviewed
women were informed about whether certain diseases had been treated with umbilical cord
blood (UCB) by the time the survey was being conducted, whereas 50–65% did not know
how to answer these questions. Women in Berlin were poorly educated about the usefulness,
the costs and the methods of cryopreservation. To some extent there is a correlation between
women's level of education and their knowledge regarding Umbilical Cord Blood.

Frank Baum.L(2001) conducted a study in Delhi by using questionnaire examining


socio demographic factors and women's attitudes to cord blood banking was developed on
the basis of findings from 2 focus groups and a pilot study. The questionnaire was
distributed to 650 women attending antenatal clinics at a regional women's hospital between
April and July 2001. A total of 443 women (68%) responded. More than half of the women
reported poor or very poor knowledge about cord blood banking. Many of the respondents
thought that physicians should talk to pregnant women about the collection of cord blood,
and they wanted to receive information about this topic from health care professionals
(290/441 or 66% [95% CI 61% to 70%]) or prenatal classes (308/441 or 70% [95% CI 65%
to 74%]). Most of the women (379/442 or 86% [95% CI 82% to 89%]) would elect to store
cord blood in a public bank, many citing altruism as the reason for this choice. Most of the
women in this study supported the donation of cord blood to public cord blood banks for
potential transplantation and research.

Nicholson Baker(2002) conducted a descriptive study in two antenatal


outpatient clinics in Istanbul to determine pregnant women’s knowledge and attitude
towards placental stem cells and their banking. The sample consisted of 334 pregnant
women during routine prenatal visits. Data were collected in an interview. At the end of the
study, it was revealed that the majority (86.6%) of the participants had a lack of knowledge
about stem cells and placental stem cell banking and wanted information from media. It was
determined that they wanted information before they conceived, more from their
obstetrician but also from nurses and midwives. The majority (78.2%) also wanted to store
their infants placental and cord blood and stated that they would be more likely to chose a
public cord blood bank .The study concluded that those giving antenatal and perinatal care
need to offer a accurate and scientific counseling services on this subjects to parents who
need to be informed.

Kevin(2010) conducted a study in Kasargoad on effectiveness of self


instructional module on the knowledge regarding placental cord blood banking among staff
nurses in selected hospitals, by approaching one group pre test post test design. The sample
consisted 60 staff nurses selected by convenient sampling and data was collected by using
structured knowledge questionnaire .The result showed the significant difference suggesting
that self instructional module was effective in increasing the knowledge of staff nurses
(t=14.34).The mean post test knowledge (x2=43.17) higher than the mean pre test
knowledge(x1=30.40).There was no association between the pre test knowledge scores and
the selected demographic variables.
Samuel R(2009) conducted a study in Bangalore to evaluate the effectiveness of
planned teaching programme on knowledge and attitude of various health professionals’
regarding placental stem cell and its utilization at selected hospitals in Bangalore. Purposive
sampling technique was used. One group pre test post test design with pre experimental
approach was adopted. The data was collected from 50 respondents before and after
administration of planned teaching programme. The pre test median score was (20.1) and
that of the post test was (40.5).Hence, the planned teaching programme was effective in
improving the knowledge of staff nurses.

Fred Gipson(2000) conducted a study in Bangalore to evaluate and better understand the
knowledge regarding issues of umbilical cord blood banking among 400 pregnant
women. The research revealed that 3% of patients were extremely knowledgeable, 74%
were minimally informed. Only 14% of pregnant women stated that they had been
educated about umbilical cord blood banking by an obstetrical care provider, but 90% did
have an expectation that their obstetrician could answer their questions on this topic. The
researcher concluded that the pregnant women have less knowledge regarding issues of
umbilical cord blood banking.

Gurney Norman(2002) conducted a study in Brazil to assess the knowledge and


attitudes of pregnant women with regard to collection, testing and banking of cord blood
stem cells. Data was collected from 650 pregnant women using questionnaire. The study
results showed that more than half (70%) reported poor or very poor knowledge about
cord blood banking. Many of respondents (68%) thought that physicians should talk to
pregnant women about the collection of cord blood, and they wanted to receive
information about this topic from healthcare professionals or prenatal classes. Most of
women would elect to store cord blood in a public bank and a much smaller portion
(14%) would elect private banking. The study has concluded that most women in this
study supported the donation of cord blood to public cord blood bank for potential
transplantation and research.

John Steinbeck(1998) conducted a study on banking, characterizing, and


distributing placental blood, also called umbilical-cord blood. It provided grafts for
transplantation for 562 patients between August 24, 1992, to January 30, 1998. Placental
blood was stored under liquid nitrogen and selected for specific patients on the basis of
Human Leucocyte Antigen type and leukocyte content. Patients were prepared for the
transplantation of allogeneic hematopoietic cells in the placental blood and received
prophylaxis against graft-versus-host disease according to routine procedures at each center.
Outcomes at 100 days after transplantation were known for all 562 patients, and outcomes at
1 year for 94 percent of eligible recipients. The cumulative rates of engraftment among the
recipients, according to actuarial analysis, were 81 percent by day 42 for neutrophils
(median time to engraftment, 28 days) and 85 percent by day 180 for platelets (median, day
90). The speed of myeloid engraftment was associated primarily with the leukocyte content
of the graft, whereas transplantation-related events were associated with the patient's
underlying disease and age, the number of leukocytes in the graft, the degree of Human
Leucocyte Antigen disparity, and the transplantation center. After engraftment, age, Human
Leucocyte Antigen disparity, and center were the primary predictors of outcome. Study
concluded that Placental blood is a useful source of allogeneic hematopoietic stem cells for
bone marrow reconstitution.

Susan Minot(2001) conducted a study in Brazil to evaluate bio antioxidants in


cryopreservation of umbilical cord blood using cryo-protectants and low concentrations
of dimethylsulphoxide. Umbilical cord blood was processed and subjected to
cryopreservation in solutions containing different concentrations of dimethylsulphoxide,
bioantioxidants and disaccharides. The study results showed that antioxidants, principally
catalase, performed greater preservation of CD34+ cells, CD123+ cells, colony forming
units, and cell viability all post- thawed, compared with the standard solution of
cryopreservation. The study was concluded that the addition of catalase improved the
cryopreservation outcome.

Poornaranjitham(2001) conducted a study in Mangalore by using


questionnaires that was collected from 325 pregnant patients seen in an Antepartum Testing
Unit. Compared to those donating to a public bank, women planning on storing with a
private/commercial company were less likely to believe that a suitable donor could be found
from a public cord blood bank. Women had a strikingly poor understanding regarding the
current uses for cord blood therapy. When asked whether cord blood has been used
successfully to treat Alzheimer's disease, Parkinson's disease, and spinal cord injury only
28%, 24%, and 24%, respectively, correctly knew that it had not. Obstetricians should
assume that pregnant women are poorly informed about cord blood banking. The decision
making process should be conducted with the goal of ensuring every pregnant woman the
opportunity to make a well informed decision about cord blood banking.
Sarojamma(2000) conducted a prospective open study in Chennai using a
structured, anonymous questionnaire at the University of Basel Women's Hospital
pregnancy outpatient clinic. After concise information on the use of cord blood for
transplantation, questions were asked concerning previous knowledge of the use of placenta
and cord blood in general, concerning the attitude to donation of cord blood for
transplantation, and the respondents willingness to donate cord blood of her own child.
Women of different ethnic background were compared. From 300 questionnaires handed out
to pregnant women of different ethnic background attending our outpatient clinic, 250
(83%) were returned, and 245 could be evaluated for final analysis. Only 40% indicated that
they did know what usually happens to the placenta after birth. In contrast, the vast majority
(95%) supported the idea of umbilical cord blood for banking and later use for stem cell
transplantation. Similarly, 93% stated that they would agree to donate the cord blood from
their own child for this purpose, while no statistically significant differences could be
identified either between women with or without previous knowledge or of different ethnic
background.This study shows the high acceptance of umbilical cord blood donation for
banking and stem cell transplantation purposes in pregnant women, irrespective of previous
knowledge. As there are no major differences between women of different ethnic
background, a high degree of diversity of Human Leucocyte Antigen -types of donated cord
blood samples can be expected and may offset the underrepresentation of ethnic minorities
in bone marrow donor registries.
Yanichin(2002) conducted an exploratory descriptive study in two antenatal
outpatient clinics in Istanbul. The sample consisted of 334 pregnant women during routine
prenatal visits. Data were collected in interviews by using an interview form developed by
the researchers according to the literature. The form included demographic characteristics of
participants and 20 questions about stem cells, storing cord blood and banking and 10
independent attitude statements. The majority of the participants had a lack of knowledge
about stem cells and cord blood banking and wanted more information. Before pregnancy,
they received some information through the media (newspaper, Internet, television, etc.), but
unintentionally. It was determined that they wanted information before becoming pregnant,
more from their obstetrician but also from nurses and midwives. The majority also wanted
to store their infants' cord blood and stated that they would be more likely to choose a public
cord blood bank. Those giving ante- and perinatal care need to offer accurate and scientific
counselling services on this subject to parents who need to be informed.

Lydia(2005) conducted a study in Kenya on “The acceptability of a woman to the


donation and transfusion of umbilical cord blood for severe anemia” among 180 women,
showed that donation and transfusion of cord blood were acceptable to 81% and 78%,
respectively.

Robert.L(2006) conducted a prospective study in German on “Acceptance of


umbilical cord blood donations by pregnant patients” shows that out of 250 mothers
participated in the study 95% of mothers supported the idea of cord blood banking and stem
cell transplantation and 93% agreed to donate the cord blood.

Section II-

Deals with literature related to the effectiveness of stem cell transplantation.

Robin Douglass(2009) conducted a study on “transplantation of unrelated donor


umbilical cord blood for non malignant diseases” in Taiwan among 45 patients with median
age of 4.5 years between October 2003 and February 2009 and evaluated on May 2009.
Incidences of neutrophil engraftment were 88% and platelet engraftment was 82%.
Incidence of Graft Versus Host Disease [GVHD] 42%, 5 years overall survival 88% and
disease free survival 77.1%. Incidence of treatment related mortality at 2 years 12% and
identified that unrelated cord blood transplantation is a promising approach for curative
therapy of nonmalignant diseases.
Melvin Dixon(2005) conducted a study in USA to investigate placental blood as a
source of hematopoietic stem cells for transplantation into unrelated recipients by duke
university medical centre. Twenty five consecutive patients, primarily children were
evaluated for hematogenic and immunologic reconstitution. Human leukocyte antigen
(HLA) matching was done before transplantation by serologic typing and best match was
selected. In 23 of the 25 transplant recipients, the infused hematopoietic stem cells
engrafted. Acute graft versus host disease occurred in 2 of the 21 patients who could be
evaluated and 2 patients had chronic graft versus host disease. Invitro proliferative responses
of T cells and B cells to plant mitogens were detected 60 days after the transplantation. With
a median follow up 13 months and a minimal follow up of 100 days, the overall 100 day
survival rate among these patients was 64% and overall event free survival rate was
48%.Study concluded that HLA mismatched placental blood from unrelated donors is an
alternate source of stem cells for hematopoietic reconstitution in children

Richard Ford(1998) conducted an exploration study in Tamil Naidu on umbilical


cord mesenchymal stem cell transplantation in severe and refractory systemic lupus
erythematosus among 16 patients, mostly women aged 17-55 years. All 16 patients
received the stem cells as an infusion in an amount that was based on their body weight.
The study reveals that all 16 patients successfully completed the protocol and were also
seen for follow-up visits at 1, 3, 6, 12, and 18 months for an evaluation of their lupus
disease activity and for repeated blood tests in turkey. The study concluded that this
method is reasonably safe and effective.

Russell Hoban(2004) conducted a study in Calcutta on placental umbilical cord


whole blood transfusions. The sample consisted of 62 patients from nine years of age, of
whom 32 were suffering from varying stages and grades of malignancy. The remaining
30 patients included patients suffering from thalassemia major, aplastic anaemia,
systemic lupus erythematous, chronic renal failure, rheumatoid arthritis, ankylosing
spondylitis, and a geriatric group of patients with benign prostatic hypertrophy. One
hundred and seventy-four units of umbilical cord whole blood was collected aseptically
from the umbilical vein after caesarean section in standard paediatric blood transfusion
bags, after the removal of the baby from the operative field and after confirming the
stable condition of the mother. It was concluded that it also has the advantage of a higher
oxygen carrying capacity of foetal haemoglobin in addition to many growth factors and
other cytokine filled cord blood plasma along with its hypoantigenicity.

William Melvin Kelley(2002) conducted a study in USA to overcome the


barriers to umbilical cord blood transplantation. The study results showed that there has
been marked increase in the utilisation of umbilical cord blood transplantation (UCBT) in
recent years, especially in the paediatric population. However graft failure, delayed
engraftment, and profound delay in immune reconstitution led to significant morbidity
and mortality in adults. It was concluded that the ability to transplant across Human
Leucocytic Antigen (HLA) disparities, rapid procurement time and decreased graft versus
host disease (GVHD) seen with unit cord blood transplant made it a promising stem cell
source and while barriers existed, consistent progress was being made to overcome them.

Nora Roberts(2002) conducted a study in USA to evaluate the state of the art of
unrelated donor umbilical cord blood transplantation for the treatment of haematologic
malignancies and discussed the current issues associated with the use of this haematopoetic
stem cell source. The study findings showed that in contrast to the very high transplant-
related mortality associated with early experience of umbilical cord blood transplantation
(UCBT), recent series have been associated with comparable survival to that of human
leucocyte antigen-matched unrelated donor transplantation in children with similarly
promising results in adults with the use of double-unit grafts. In addition, utilisation of
reduced intensity conditioning regimens has been successful extending access to patients
unsuitable for myeloablation. It was concluded that improved transplant outcomes are now
making umbilical cord blood transfusion a rival to unrelated donor transplantation for the
treatment of haematologic malignancies.
Albert(2009) conducted a study in Taiwan on “transplantation of unrelated donor
umbilical cord blood for non malignant diseases” among 45 patients with median age of 4.5
years between October 2003 and February 2009 and evaluated on May 2009. Incidences of
neutrophil engraftment were 88% and platelet engraftment was 82%. Incidence of Graft
Versus Host Disease [GVHD] 42%, 5 years overall survival 88% and disease free survival
77.1%. Incidence of treatment related mortality at 2 years 12% and identified that unrelated
cord blood transplantation is a promising approach for curative therapy of nonmalignant
diseases.
John Steinbeck(1998) conducted a study on banking, characterizing, and
distributing placental blood, also called umbilical-cord blood. It provided grafts for
transplantation for 562 patients between August 24, 1992, to January 30, 1998. Placental
blood was stored under liquid nitrogen and selected for specific patients on the basis of
Human Leucocyte Antigen type and leukocyte content. Patients were prepared for the
transplantation of allogeneic hematopoietic cells in the placental blood and received
prophylaxis against graft-versus-host disease according to routine procedures at each center.
Outcomes at 100 days after transplantation were known for all 562 patients, and outcomes at
1 year for 94 percent of eligible recipients. The cumulative rates of engraftment among the
recipients, according to actuarial analysis, were 81 percent by day 42 for neutrophils
(median time to engraftment, 28 days) and 85 percent by day 180 for platelets (median, day
90). The speed of myeloid engraftment was associated primarily with the leukocyte content
of the graft, whereas transplantation-related events were associated with the patient's
underlying disease and age, the number of leukocytes in the graft, the degree of Human
Leucocyte Antigen disparity, and the transplantation center. After engraftment, age, Human
Leucocyte Antigen disparity, and center were the primary predictors of outcome. Study
concluded that Placental blood is a useful source of allogeneic hematopoietic stem cells for
bone marrow reconstitution.

Christopher M(2007) conducted a study in Coimbatore to evaluate the


effectiveness of structured teaching programme on umbilical cord stem cell collection,
preservation and utilisation. Thirty health professionals were involved in the study. The
study results showed that post-test score (mean: 39.62.57) was higher than that of pre-
test score (mean: 13.233.88). It was concluded that structured teaching programme was
effective in enhancing the knowledge of health professionals regarding umbilical cord
stem cell collection, preservation and utilisation.

Section III-
Deals with literature related to method of collection and preservation of cord blood.
Ridley Pearson(2003) conducted a study in Thailand to evaluate the
collection system and processing of umbilical cord blood donation. A comparison of three
cord blood collection methods, namely, hanging method after delivery of the placenta,
aspiration from in-utero placenta, and the third method is aspiration from in-utero
placenta with the help of syringe assisted aspiration were adopted. The study results
showed that the third method was the best collection method, but it require more trained
personnel and involved a complicated procedure.

Lloyd Alexander(2004) conducted a study to compare the hematopoietic


stem cells with placental blood and umbilical cord blood in children hospital and research
centre, Oakland. Placental haematopoietic progenitors were isolated using the basic method
of isolation of enzymatic digestion treatment of placental cell and staining them. Isolation of
hematopoietic progenitors from umbilical cord blood was done by the same method. At least
three preparations of same type were analysed. Placental samples from 5.4 weeks to 39.5
weeks were analysed for cells expressing both cd34 and cd45 hematopoietic progenitors
cell surface markers , and it was observed that frequency of placental cells was cd34+
cd45(2.86-20.91%) and cd34++cd45low(0.03-1.2%)that was significantly more than
hematopoietic progenitors cell that were found in umbilical cord blood. in addition to
multipotent progenitors ,the placenta contained myeloid and erythroid committed
progenitors indicative of active insitu hematogenesis. These data suggest that the human
placenta is important hematopoietic stem cells along with cord blood for transplantation.

EPILOGUE:

This chapter dealt with review of literature. It was useful to select and justify the statement
of the problem, develop conceptual framework, select the tool and to compare the findings
of the present study with those of the earlier research.

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