Amniotic fluid, placental and fetal stem cells at birth
We would like to find out whether we can grow stem cells from amniotic fluid, placental tissue and fetal fluid, and if proteins found in the fluid can be used to indicate a long-term outcome for problems such as kidney disease.
Research to date
Stem cells have the remarkable potential to develop into many different cell types in the body. Serving as a repair system for the body, they can theoretically divide without limit to replenish other cells as long as the person or animal is still alive. When a stem cell divides, each new cell has the potential to either remain a stem cell or become another type of cell with a more specialised function, such as a muscle cell, a red blood cell, or a brain cell for example. Adults have stem cells that are commonly collected from the bone marrow. Recent studies have found stem cells in the amniotic fluid and the placenta. Stem cells are more abundant in the fetus than the adult. They may be better able to divide, grow and develop into different cell types.
Process & aims
We would like to study amniotic fluid, placental and fetal stem cells to find out about their characteristics, how they grow and what tissues they can turn into. We will grow them in the laboratory to see if they can repair damaged tissues such as muscle and bone, and analyse the proteins in the amniotic fluid to look for crucial growth factors and chemicals which tell us about the baby’s condition. We are keen to check whether genes that are missing in genetic diseases can be introduced into stem cells. We also want to monitor how cells behave in the body and some cells may be introduced into animals to do this. These animal studies have received ethical approval and are in accordance with relevant legislation.
In the future, it might be possible to use corrected stem cells to treat people with genetic diseases. For example, a stem cell from a patient with thalassaemia, a genetic disease that causes severe anaemia, could have a gene inserted to correct the anaemia. Introduction of the corrected stem cell into the affected patient might then cure the disease.
Why have I been invited to participate?
We are asking pregnant woman who attend UCLH to deliver their baby whether they would take part in this study.
Do I have to take part?
There is no obligation to take part and your decision will not have any affect on your future medical care. It is up to you to decide whether you would like to be involved. We will give you an information sheet to look at and keep, then ask if you are happy to sign a consent form. You are still free to withdraw at any time without giving a reason even if you decide to take part.
What will happen to me if I take part?
The placenta, umbilical cord and amniotic membranes that deliver after your baby is born are checked by your midwife and then usually discarded. We would like to collect samples of the amniotic membrane, placental cells or whole placenta, the umbilical cord blood and umbilical cord from your placenta after it has been checked.
If your baby is born by Caesarean section, the amniotic fluid is usually collected during surgery and discarded at the end of the operation. We will collect a sample of amniotic fluid if you deliver your baby by Caesarean section for research and biobanking. We will only take samples from your placenta, umbilical cord or the amniotic fluid for research and for biobanking purposes if otherwise discarded. We are asking for your permission to store and use these tissues or cells for ethically approved research studies and clinical trials. If you agree to biobank your samples we will collect a sample of your blood (20mls or equivalent to 4 teaspoons) from your arm to test for infections. By gifting the samples to the Principal Investigator, you will give up all rights over the samples.
If you agree to the cells being stored in the biobank for future therapeutic use, you retain the right to withdraw them from the biobank after which they will be destroyed. After seven years, the cells may become unsuitable for future therapeutic use but they can still continue to be used for research purposes. We will assign to the samples and the information we collect about you a unique identifying number so that the information becomes anonymous to the researchers. You do not have to do anything different during your tests or during the rest of your pregnancy if you take part in this study.
What tests will be done on the amniotic fluid, placental and fetal cells?
We will study the chemicals and proteins in the amniotic fluid, how the cells grow and develop, what cell types they become and whether corrective genes can be introduced into them. For some studies the sample may leave the UK for analysis in other countries, but your personal details will not be revealed. If you agree to biobank the cells we will store them for future ethically approved research and clinical studies, and you will retain the right at any time over the next 30 years, to request these cells or tissues are removed from the biobank and then destroyed. For the imaging studies, the whole placenta will be taken to the lab where we will visualise the placenta using different imaging modalities.
Will you require access to my medical records?
What are known risks of the study?
What are the possible benefits of taking part?
What if something goes wrong?
Will my taking part in this study be kept confidential?
All information collected about you during the research will be kept strictly confidential and samples will be anonymised to the individual researchers. Any information about you, which leaves the hospital will have your name, hospital or NHS number and address removed so that you cannot be recognised from it. All data will be kept safe and secure in accordance with the Data Protection Act 1998 and will be collected, stored and handled by the researchers listed at UCL.
Who is organising and funding the research?
What will happen to the results of the research study?
The results will be analysed, presented in scientific meetings and published in peer reviewed journals. Your identity will not be revealed in any report or publication. You may obtain a copy of the results from Dr Anna David at the Institute for Women’s Health at UCL (firstname.lastname@example.org)