Donate or store umbilical cord blood? Let’s clarify

On the subject of umbilical cord blood stem cells and autologous donation or conservation, there are many conflicting opinions. Here the expert explains everything.

To clarify, we interviewed Valeriana Marchesin, President of ADISCO of the Tuscany region, an association that deals with the promotion of umbilical cord blood (SCO) donation in Italy.

What does it mean to donate cord blood?

From a human and social point of view, it means giving hope of cure to people affected by pathologies that can be treated with hematopoietic stem cells (HSCs) from umbilical cord blood (SCO) or its derivatives, sharing with them the happiness that birth is for the parents, giving the joy of life back to these patients.

From a bureaucratic point of view it means being in good health conditions  in order to minimize the risk of transmitting diseases to the recipient.

It is necessary to give birth in an accredited centre , i.e. a hospital authorized to carry out sco sampling for charitable purposes and to sign the informed consent to the donation by which the donor couple declares their willingness to keep the sample free of charge at the public bank connected to the sampling centre. Still the couple consents to the laboratory investigations and genetic tests required by law to ascertain their suitability for therapeutic purposes or for use for research purposes.

Why is donation important?

Because the use of CSE from SCO allows the treatment of various hematopoietic pathologies while its derivatives treat other pathologies with considerably reduced healing times .

How is cord blood used?

With reference to its components, cord blood can be used for:

• transplantation purposes to patients affected by hematopoietic diseases,
• transfusion purposes for the transfusion of red blood cells to premature babies,
• to create platelet gel for the treatment of diabetic foot ulcers, bed sores
• for the epidermolysis bullosa of the so-called “butterfly children”
• to create eye drops for Des syndrome ;

finally for the purposes of scientific research which today, after more than twenty years from the first use of the SCO, has identified new clinical trials of application (platelet gel, eye drops, etc.).

Questions and answers

Let’s see some of the most common questions that are asked on this topic in order to dispel the main doubts.

What should a mum and dad who wish to donate do?

They must go to an accredited center to carry out a family history which consists in administering a questionnaire to each parent to verify the present, past and genetic state of health of both, which can be transmitted to the unborn child.

The family history will be carried out by a doctor identified directly by the hospital. Furthermore, future parents will have to sign the Informed Consent to the donation.

Is it always possible to donate it?

The donation of umbilical cord blood  is not always possible , there are causes of exclusion that can be identified directly thanks to the family history mentioned above, or if there are reasons for exclusion from the donation (e.g. genetic pathologies, gestation less than 34 weeks, rupture of membranes exceeding 12 hours; mother’s fever exceeding 38° at the time of delivery; fetal stress, etc.).

Finally, but a priority aspect, if the hospital is not accredited, it is not possible to donate umbilical cord blood  since Italian law authorizes allogeneic sampling only in accredited structures where the medical personnel are trained for this purpose. Furthermore, the donation cannot be made if only one parent has a family history.

If a child of a couple who has chosen the donation of cord blood cells falls ill with a pathology that would require stem cells, what happens in these cases?

If the child who falls ill were to be the same child from whom the cord blood stem cells were taken and if they were found to be suitable for banking and not already used for other patients, it must first of all be considered that they might not be used because it would be equivalent to an autologous HSC transplant , which could lead to either a failure to heal or a relapse of the disease because the HSCs come from the same individual.

If, on the other hand, they were necessary for a brother or sister of the unborn child, and they were always cryopreserved and available at the public umbilical cord blood bank, then they would certainly be used.

Even the public bank allows dedicated donations. When it is possible?

Yes. It is possible to make the dedicated donation only for a brother or sister of the unborn child who has pathologies for which the use of SCO HSCs is proven.

Many mothers write on the net asking if the private conservation of CSEs of the SCO in foreign banks makes sense. Can you give us the opinion of science on this?

As stated in the document of the Ministry of Health – ” Appropriate use of stem cells from umbilical cord blood ” it is necessary to distinguish from what the scientific evidence affirms with respect to the two types of transplantation of hematopoietic stem cells from umbilical cord blood that can be performed, i.e. between allogeneic and autologous transplantation (private in foreign banks), or:

The allogeneic transplant

The use of allogeneic transplantation is appropriate in all those cases in which there is a need to replace a “diseased” marrow with a healthy one taken from a donor (family and non-family donor). The combined effect of chemo-radiotherapy treatment and infusion of allogeneic hematopoietic stem cells involves:

1.  disease eradication;
2. creation of the necessary space for the implantation of allogeneic stem cells (engraftment);
3. destruction of the patient’s immune system for the prevention of a rejection;
4. reconstitution of the marrow environment by the infused cells after a period of aplasia (period during which the patient is at risk of infections and bleeding due to the lack of white blood cells and platelets, which together with the red blood cells have been destroyed by the chemo -radiotherapy);
5. elimination of the diseased cells left after chemo and/or radiotherapy treatment, thanks to the ability of particular types of donor white blood cells to recognize as foreign and destroy the residual diseased cells, thus carrying out a real “cell therapy” (Graft versus Leukemia” -GVL-, or “reaction of transplantation against leukemia”).

The autologous transplant

The effects listed above and above all the last effect cannot be obtained if the hematopoietic cells come from the patient himself (autologous transplant), since the possibility of a “cell therapy” is completely missing.

In fact, the cells generated by the patient’s stem cells very often may not be able to recognize the diseased cells as foreign, given that they come from the same organism anyway.

Another problem arises from the fact that the patient’s infused stem cells could contain residual diseased cells , capable of determining a recurrence of the disease.

These concepts, which are the basis of transplant science, are also applicable to cord blood hematopoietic stem cell transplants. The lack of a scientific rationale for conservation for autologous use arises precisely from these scientifically proven evidences.

Therefore, if the conservation of cord blood can have a rationale in the event that there is a family member (generally a brother or sister) suffering from a pathology that can be treated with an allogeneic transplant, there is no scientific evidence that justifies a purely autologous conservation, dedicated to the same newborn.

The activity of autologous cord blood storage is not authorized in Italy, but is carried out by private banks set up in other European and non-European countries, where it is possible to export and store cord blood for “personal” use.

For the purposes of export for autologous use, the collection of cord blood is allowed in public and private birth centers.

Italian legislation provides that the National Health Service ensures, through public financial resources, the protection of health as a fundamental right of the individual, with respect for the dignity and freedom of the human person, without distinction of individual or social conditions and according to methods that ensure the equality of citizens and equal opportunities to access welfare services.

All these activities are paid for by the National Health Service and do not involve any expense on the part of the citizen, since they are configured as essential levels of assistance (LEA), i.e. benefits and services that are provided at the expense of the public service as they are supported by the scientific evidence of a significant benefit in terms of health at an individual and/or collective level and are appropriate from a clinical point of view with respect to specific needs.

In a context in which the level of attention to the provision, within the NHS, of appropriate performance and services is increasingly high, for some years the activity of autologous conservation of cord blood has taken hold and is advertised, regardless of the existence of actual or potential pathological conditions, but as ” biological insurance ” for the newborn. This activity and the assumptions that drive it not only do not meet the principles of effectiveness and appropriateness as defined above, but also open up important ethical problems.

More and more mothers tend to ask for the delayed cutting of the umbilical cord up to the most extreme cases such as Lotus Birth. All situations that prevent the SCO donation. What is your position on this.

On the Lotus Birth we share the official position of the SIN (Italian Society of Neonatology) and the note of the institutes of the CNS/CNT respectively National Blood and Transplant Center. See attached documents.

Since 1995, the year of its establishment, ADISCO has been involved in promoting the donation of umbilical cord blood (SCO) in Italy.

The birth of the Association is due to the initiative of eminent Italian hematologists at a time when research on stem cells was developing.

In 1988, the first umbilical cord blood transplant was performed (E. Gluckman). In the 1990s, umbilical cord donation was only experimental and targeted.

In other words, the collection and conservation proposal was made to women who already had a sick child and were about to give birth to another child. But research was in the meantime progressing, highlighting the need for a more capillary and systematic collection, a prerequisite for creating structures on the national territory that could in turn guarantee the process of collection and conservation of cord blood for its therapeutic use in the hematological field .

Following the need for a greater and more systematic collection of cord blood, carried out according to uniform quality and safety requirements throughout the territory, the need arose for this specific clinical activity to be supported by a national network of specialized and qualified structures for this activities (cord blood banks) and that this network was related to similar structures already existing in the world.

This is how the first Umbilical Cord Blood Banks were born (Milan Cord Blood Bank in 1993).

The Association was therefore formed, under the encouragement of Prof. Mandelli and Prof. Sirchia, to assist and support the hematological centers in starting their transplantation activity of cord blood stem cells.

From the outset, ADISCO has collaborated, and still cooperates, with institutions in order to support donation, collection and conservation activities.

In these twenty years of life, the Association has tried to spread itself in all the Regions to promote the culture of the donation of cord blood in terms of a collective gesture, reaching today 62 percent of presence, through the Regional and Territorial Sections, on the national territory.

ADISCO promotes and supports the activation of specific promotion and information campaigns on umbilical cord blood donation aimed at strengthening and increasing cryopreserved cord blood units for allogeneic/dedicated use, for which until now the economic resources allocated have been scarce.

In fact, it is important to know that even if the donated unit is not suitable for transplantation, the cord blood can be used for clinical studies aimed at developing other therapeutic purposes. The research protocols are subject to a further request for consent and are illustrated at the time of joining the donation.

At national level Adisco carries out multiple activities for the dissemination of the culture of SCO donation including:

• Advocacy at government institutions and bodies on the issue of solidarity collection and conservation of cord blood;
• Conducting refresher courses for midwives;
• Donations of equipment to umbilical cord banks;
• Incurring costs for the transport of cord blood;
• Organization of scientific conferences;
• Counseling activity aimed at parents who contact our facilities;
• Territorial and national events;
• Disclosure of the donation through Radio, TV, newspapers and multilingual DVDs;
• Scientific meetings at Scholastic Institutes;
• Crowdfunding in partnership with national and local companies

In addition to the above activities, Adisco promotes initiatives aimed at enhancing the development of umbilical cord blood donation by collaborating with legislative and government bodies, state and regional, and other local bodies for the formulation of plans and study programs and for the promotion of measures, including regulatory measures, aimed at protecting donors and newborns.

Furthermore, it supports the activities of the umbilical cord blood banks and of the research centers connected to them with the purchase of material, equipment and with the provision of scholarships and/or fees to dedicated personnel to stimulate and encourage research in the hematopoietic stem cell sector.

The Association makes use of every tool useful for the achievement of the social aims and in particular of the collaboration with the local authorities, also through the stipulation of specific agreements, of the participation in other associations, companies or bodies having similar or connected aims to its own. The Association is open to anyone who shares principles of solidarity.