Frequently asked questions

What information will give you the result received?

The result will give you both qualitative and quantitative information on the parameters of the collected sample. In terms of quality, it will indicate if placental blood sample is sterile bacteriologically / mycologically and if it can be used as a graft for stem cell transplantation.

In terms of quantitative parameters, it will specify the volume of collected blood, the cellularity of this sample and the weight of the receiver (the person with the indication of stem cell transplantation). Quantitative parameters vary broadly, being individual for each sample of blood collected and strictly dependent on the birth dynamics. The volume of blood collected can vary between 20 ml and 100 ml, 150 ml very rarely and sample cellularity, relative even to the same volume of placental blood, can be different from one birth to another.

The significance of quantitative parameters: Knowledge of these parameters is important in terms of performing a stem cell transplant in the field of haematology. Medical studies conducted in this area have established minimum criteria for cellularity calculated per kg body weight of the receiver, that each placental blood graft should meet one in order to obtain a successful outcome of transplantation.

From a statistical viewpoint, the majority of placental blood grafts harvested meet quantitative parameters necessary to perform a transplant in optimal conditions, up to a receiver weight appropriate for a grown-up child / adolescents.(40 - 50 kg). There are however also situations in which quantitative parameters of the graft corresponding to a small weight of the receiver, of up to 5-10 kg. More frequently, they occur in case of premature births, of multiple pregnancies or of complications associated with pregnancy. There is also the possibility to achieve placental blood grafts corresponding to the weight of an adult person (over 70 kg). In order to obtain results as favourable as possible, but impossible to predict before birth, the medical staff is trained to harvest the maximum amount of blood available in the cord and placenta, individual to each birth.

Overweight mentioned on the certificate does not mean that the unit of placental blood is useless, Cell viability (preserving the capacity to repopulate the bone marrow with cells) is kept indefinitely, regardless of the graft cell concentration. But in this situation, to ensure successful transplantation, an increased number of stem cells from the graft are needed. This is possible by choice, depending on the situation, of one of the 3 solutions:

1.    Association to the initial placental blood graft, of another stem cell sources, namely hematogenic bone marrow or peripheral blood.
2.    Association to the initial placental blood graft, of a compatible stem cell graft from the public register.
3.    Application of stem cells multiplying techniques from the harvested unit of blood. So far, these techniques are applied only in the case of patients carefully selected to participate in medical studies currently in progress. These patients are monitored in terms of evolution, in order to assess the effectiveness and safety of their application. Partial results reported until now, support the efficacy of the application of these techniques of cell expansion on placental blood grafts.

What is the difference between whole blood processing and volumetric reduction (or cell separation)?

Currently, there are 2 main possibilities placental blood processing. The first procedure would be the preservation of all cellular elements and of a part of placental blood plasma component and the second, only strict separation and cryopreservation of nucleated cells, after the prior removal of plasma and blood erythrocytes. In our laboratories, the procedure of whole blood processing and cryopreservation is applied. We opted for the application of the procedure of processing and cryopreservation of whole blood because it is the only one that ensures the preservation of maximum cell concentration in each sample of blood processed, cell loss due to processing being insignificant. The technique of cell separation, or reduction in volume, with the elimination of plasma and red blood cell component of the blood sample, implies the risk of cell loss assessed at 10 -15% of manufacturers of automatic processing systems, but according to findings from practical activity, cell loss would be even higher. This should be evaluated in the context of clinical activity, that is the administration of placental blood graft within a stem cell transplant. In such a situation the cellularity of the transplanted graft is extremely important in terms of transplant outcome and further development of the patient. Any team of transplant doctors desire is to have a graft with higher cellularity available for transplantation. Moreover, the good results of the first placental blood transplants have been obtained by administration of some non-manipulated grafts, grafts of whole blood, confirming the safety and efficiency of their administration. Therefore, it is necessary to separate the cellular component of placental blood sample to save the life of a patient.

Maximum cell concentration preservation is important not only in terms of hematologic indications for transplantation. It is also important in terms of the development of regenerative tissue and organic medicine. The cellular population of placental blood is heterogeneous, in addition to hematopoietic stem cells and hematopoietic progenitors, there being other types of cells, too (e.g. mesenchymal stem cells, endothelial progenitor cells).These cells could form the basis of new therapeutic applications in the future.

Another important issue arises from medical studies published in recent years on the cryopreservation agent (DMSO).

Initially "washing" the de-cryopreserved placental blood unit was considered as necessary before administering it as a transplant graft, in order to remove DMSO and eventually the hemoglobin resulting from eritocitary hemolysis.

In recent years, however, studies have been published to show that for  low concentrations of DMSO it is no longer necessary to "wash" the placental blood unit prior to administration, because the risk of adverse effects associated with the DMSO or with the risk of hemolysis associated to cryopreservation and DMSO  become insignificant.

Instead, by non "washing" before the graft administration the risk of cell loss associated with this procedure is eliminated.

The decision on whether or not to apply this procedure and also on how the graft is to be released will be taken by transplant centre where the transplant is to be made.

Therefore, we opt for whole blood processing, a procedure by which we ensure for you the preservation of the maximum cell concentration in the blood sample harvested, both during processing and in the preparation stage of the graft in view of the transplant.

Who can benefit from the harvested placental blood unit?
The placental blood graft processed and stored can be used for autologous transplant (by the child at the birth of whose the placental blood sample was harvested) or for allogeneic related transplant (by an immunologically compatible person with the child at the birth of whose harvesting was made). In case of an allogeneic related transplant, brothers with the same biological parents have the best chance of immunological compatibility, valued at 25%. For other relatives in the first degree the chance for the immunological compatibility to exist in case of performing a transplant is much smaller.

How long can harvested cells be preserved?

The preservation of the viability of stem cells is that which conditions the graft use period (that is the period they remain "alive" = able to give birth to the hematopoietic cells needed for restocking the bone marrow).

In 2006 a group of Japanese researchers published the results of a medical study that aimed at checking the preservation of cell viability on placental blood samples cryopreserved for 15 years. The conclusion of this study was that during their cryopreservation and storage in liquid nitrogen, the cells haven’t lost viability. So far, these were the oldest placental blood grafts tested in terms of preserving cell viability, in the form of cryogenic storage. The results of this study do not mean that this is the maximum period for the preservation of cell viability. In this regard, the guidelines developed by the Department of Health of the State of New York, on the collection, processing and storing of placental stem cells specify that so far, in terms of cryopreservation and storage of the placental blood to -196 Celsius degrees, under constant thermal and pressure parameters, there is no evidence of loss of cell viability and biological activity, on their testing in vitro. Consequently, placental blood grafts stored continuously in liquid nitrogen, would have no term of validity. This is also why the deposit of the graft in the bank is made for an indefinite period.

What tests should the future mommy undergo before deciding for the placental blood collection?

In the first pregnancy trimester it is indicated to undergo the infectious TORCH screening, which involves testing for the infection with Toxoplasma gondii, rubella virus, cytomegalovirus and herpes virus, only the cases with acute infection contacted during pregnancy or at most 3 months before pregnancy, the screening for HIV, syphilis (VDRL) and indentifying a possible chronic infection with hepatitis B (HBsAg) or C (Ac-HCV) (see details of contraindications for harvesting), being significant.

Can I harvest placental blood if I am a "healthy carrier" of hepatitis B or C virus?

In case of a chronic infection with hepatitis B, with non-detectable levels of viraemia, the absence of markers of viral replication, the high infection and the lack of evidence of active disease (inactive state of chronic carrier of HBV), the likelihood of contamination of placental blood is small / very small. So far, there were published 3 medical studies that aimed to evaluate the presence of hepatitis B virus in placental blood samples collected at birth and which were positive in terms of Ac HBc. (the published studies: Retrovirus Epidemiology Donor Study (REDS) Group, the American Red Cross (ARC) and Roche Ampliscreen HBV clinical trial). Their conclusion was that out of the total number of over 7000 samples tested only 0.24% to 0.63%, had detectable levels of viraemia for HBV. Using a placental blood graft positive for HBc Action, is not contrary to the provisions made by the FDA (Food and Drug Administration) of the USA, in the guidelines "Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT / Ps ) "(May 2004). Therefore, in case of the establishment of indications for the use of the stored placental blood unit, the transplant doctor will need to be informed of the existence of maternal infection with hepatitis B / C, during pregnancy, in order to take optimal therapeutic conduct.

Can the harvested blood be used multiple times in case there is need for a transplant?

In general, having in view the current standard indications in terms of making a stem cell transplant, harvest parameters allow a unique use of the placental blood cryogenic unit. Even in the case of a cellularity that is higher than the strictly necessary the whole placental blood quantity is preferred, in order to ensure the premises of a best result of the transplantation.

Are there cases in Romania in which a placental blood graft was used for a stem cell transplantation?

Our company has been performing collections for almost 4 years. So far, we have received 3 requests for testing the immunological compatibility between donor and recipient, the potential recipients of the grafts being siblings of children at birth of whose harvesting had been done (there were indications of performing an allogeneic fraternal transplant). But tests did not reveal a degree of immunological compatibility necessary for a stem cell transplant.

Where can placental blood transplants be performed?

According to the current standard indications (see more details - treatable diseases) for making a stem cell transplant, this therapeutic procedure can only be in one of the transplant centres affiliated haematology or oncology hospitals.

In Romania there are 3 transplant centres, in Timisoara, Tg. Mures and Bucharest (Fundeni). They have all the necessary equipment and specialized medical personnel in the field of hematopoietic stem cell transplantation. The experience of these centres focuses bone marrow transplantation, mainly.

However, there are no major differences between the stem cell transplantation from the placental blood or from the bone marrow. Therefore, all the necessary conditions for the performance of placental blood transplantation are accomplished in these centres, in case of establishment of such an indication.
In Europe and the U.S.A. there are many transplant centres which perform transplantation with placental blood grafts.

(Medical centers in Europe where placental blood transplantation procedures are performed)

What happens to the contaminated unit of placental blood?

This will not be destroyed, but kept in cryogenic state, under the same standard conditions of storage, but in the storage tanks for quarantine. From a financial perspective, the customer will not pay for cleaning services, transportation, processing and storage.

Currently there are laboratories that investigate possible decontamination techniques that should ensure blood sterilization without affecting the viability of stem cells.

When these techniques become current practice, the contaminated samples will be used for transplantation.

What should I do to take possession of the stored transplant graft?

If the indication for making a transplant has been established and the release of placental blood cryogenic unit is needed, you will have to submit a written agreement from the institution where the transplant is to be conducted and a request from the contract holder, which should request the graft release from the storage place. These documents should be sent to Cord Blood Center Ro
Within 24 hours of receipt of these documents, the necessary arrangements shall start, in order to meet the legal framework for the graft release from the storage place and to prepare the graft in view of the transplant. Graft preparation and release from storage place is free of charge. The graft shall be delivered to the authorized person, authorized in writing by the Customer, at the headquarters of CBC LAB, or at any of its place of business, no later than 14 calendar days after the receipt by the CBC LAB of request to that effect, and of the accept of the receiving unit to receive the Transplant.

This period may be extended only with the number of days required to perform mandatory testing (as required by the legislation in force, on tissue banks) or testing required by the receiving unit. The placental blood graft will be delivered at the CBC Laboratories.

Transplantation can be taken only by an authorized person, authorized in writing by the Customer, that is the express courier company representative authorized to conduct ADR transport of biological material.

Our work for the graft release will be coordinated with its reception, so that the graft should to get in the best conditions to the transplantation centre. Also, we will assist you, providing you with support information for identifying the best transport options.

Where is the collected placental blood stored?

Currently, there is the possibility of processing and storing the collected placental blood samples in 3 banks operating in Cluj, Bucharest and in Slovakia. The activity in each of these banks develops according to the standards in the field of placental blood banking and follow the same SOP's (standard operational procedure).

When the harvested blood sample reaches the laboratory based on a decision algorithm (the time elapsed from the time of harvesting, the territorial distribution of maternity hospitals, whether or not there is a risk evidence....) the bank in which it is to be analyzed, processed and stored in optimal conditions is to be determined. The result that you would receive is issued by the bank where the placental blood sample was processed and stored.

Is also possible for you to express your option on the bank where you want your harvested placental blood sample to be processed and stored. In this case you will have to let us know about your option when we schedule your send the  contract. The sample of the customer will be treated with priority in this respect, but not before samples that require immediate processing, in order not to exceed the time limit to the start of viability lose.

Will the placental blood units collected so far be brought to the bank in Cluj?

Placental blood grafts will continue to be deposited in the bank in Slovakia since the lack of adequate infrastructure (a highway Oradea - Cluj) makes impossible the safe transport of liquid nitrogen storage tanks.

Why the annual deposit cannot be paid for in advance?

Cord Blood Centre Ro considered as correct only the billing of the services that have already been provided.

When can I address to the place of business existing in Bucharest?

The place of business in Bucharest is designed especially for "emergency situations", that is for the future mothers in Bucharest with a range less than one month before the probable date of delivery or at risk of premature delivery. Future mothers with a range longer than one month until the expected date of delivery are requested to address our headquarters in Cluj, and Timisoara, to start proceedings.