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Maternal Gene Therapy Trials, Expectant Mothers Give the “Go Ahead”!!

maternal gene therapy trials
Dr. Monika Bhanushali
Dr. Monika Bhanushali
April15/ 2016

According to a recent study, carried out to examine the ethical and legal questions raised against the maternal gene therapy, comes up with a very positive result. The expectant mothers, who were the subjects in this study, have expressed willingness to participate in trials with maternal gene therapy for the treatment of severe intra-uterine growth restriction of the foetus also known as foetal growth restriction (FGR).

Foetal growth restriction affects almost 8% of all the pregnancies. The main underlying cause in this scenario is the inadequate blood flow to the uterus and the placenta. This is known as placental insufficiency in technical terminology. There has been no definitive treatment for this problem so far.

Foetal growth restriction is mostly identified in the middle of the pregnancy where the couples face two options. One is either to go ahead with the pregnancy and risk delivering prematurely keeping in mind that the baby may die in the intensive care unit or continue till the term and risk the likelihood of intra-uterine death of the foetus (baby dying in the womb). These babies after birth not only are prone to develop cerebral palsy, but they also have increased chances of long term complications like heart diseases and diabetes in their adulthood.

There is a study proposed by few prestigious medical institutions in UK which are keen on giving maternal growth factor gene therapy in order to treat FGR. This study trial aims at helping the expectant mothers who are carrying foetuses with growth restriction. This trail is going to be carried out for testing the efficacy and safety of this newly developed treatment. Although before going forward with the proposed trial, these researchers have conducted a study to make certain of the responses to the ethical and legal questions raised against this trial.

In this clinical trial, a Vascular Endothelial Growth Factor (VEGF) will be administered in the uterine arteries of the expectant mothers in the middle of the pregnancy affected by severe early onset FGR with the help of intervention radiology.  It has been found in the previously performed pre clinical studies that VEGF gene therapy increases the blood flow in the uterine artery which increases the perfusion (blood supply) of the uterus and the placenta. It leads to increase in the growth of the foetus and the birth weight of the new born in the growth restricted pregnancies.

To establish its legal and ethical connotations, the study involved interviewing the patients (expectant mothers and mothers affected by FGR in their previous pregnancies), parental support groups, medical faculty members, midwifery members. The object of this study was to evaluate the social and ethical acceptability of the proposed VEGF trial for Foetal growth restriction. As per one of the researchers in the study, almost all the women who have had FGR in their previous pregnancies, felt that they would have participated in the trial had they been given the option. This study was well received and welcomed by the other interviewed members as well.

Studies like this should be encouraged in order to find treatment options for diseases like FGR having no treatments in today’s era. It will lead to significant benefits in reducing the chances of still births and neonatal deaths and improve the long term healthy survival of the affected babies.

Dr. Monika Bhanushali
Dr. Monika Bhanushali

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