What are stem cells?

Stem cells are cells that are not specialized, i.e. have not differentiated into a specific cellular function. These are cells that are capable of dividing and renewing them selves for long period of times, and can give rise to specialized cell types.

What differences are there among different types of stem cells?

There are two main types of stem cells: embryonic stem cells and adult stem cells(also known as somatic stem cells). The embryonic stem cells are those derived from the embryo. Although researchers are very interested in these types of stem cells, their use raises some ethical concerns. Stemway Biotech, in respect of current laws, does not perform the conservation or differentiation of embryonic stem cells, nor does it support the use of these cells in the countries where it operates. The adult stem cells are present in some of our organs and tissues, their primary roles are to maintain and repair the tissue in which they are found.

Why is umbilical cord blood important?

Umbilical cord blood is the blood remaining in the cord that is usually discarded after delivery. This blood, is however very important being rich in stem cells that could be collected and stored and used for future therapies. This is why umbilical cord blood can also be donated to public blood banks.

What type of cells are found in the umbilical cord?

The stem cells present in the umbilical cord blood are adult stem cells. There for their collection, storage and use raise no ethical concerns. In 2006 the Catholic Church recognized the scientific value of using umbilical cord stem (UCB) cells.

Do other sources of stem cells exist?

Yes, several other organs, such as liver or bone marrow have adult stem cells, although these are less versatile and more difficult to collect than UCB cells.

It is possible to sell our stem cells to third parties?

Absolutely not. European laws as well as bioethical rules forbid selling stem cells, as they forbid lucrative activities on organs or other parts of the human body.

Some scientist claim that the current therapeutic applications of umbilical cord blood stem cells do not justify performing autologous conservation. It is true?

Absolutely not. The scientific research on this topic carried out internationally strongly supports autologous conservation due to current therapeutic possibilities and due to those possibilities that are envisioned in the near future. We believe that it is unlikely that hundreds of scientists all over the world spend time and funds working on aspects that are scientifically unsound!

What diseases can be treated to date with stem cells?

Today most beneficiaries of stem cells transplants are patients suffering from some types of tumors such as leukemia and lymphoma. In addition, stem cells have been used for the therapy of myocardial infarction and in the treatment of patients that need a bone marrow transplant. Several other therapeutic applications are in an experimental phase, in some cases further advanced, but to date it would not be correct to state a date or time lapse in which these experiments will lead to new therapeutic approaches, although research in this field advances extremely rapidly. The scientific community believes that in the near future stem cell therapies will be used extensively for diseases such as:

  • Spinal cord injuries due to trauma
  • Neurodegenerative disorders such as Alzheimer or Parkinson
  • Muscular-skeletal diseases
  • Retinal degenerations, corneal degeneration and deafness
  • Metabolic diseases such as diabetes
  • Bone reconstruction

What is the difference between donation and autologous conservation?

The donation is the action with which, on occasion of the birth of their own child, parents decide to donate the UCB stem cells of the baby to a public bank that will use them in transplants for patients that had not conserved their own cells. The autologous conservation, instead, allows ones own genetic patrimony to be conserved and used in the future if necessary.

Why should we store the cells collected from the umbilical cord for autologous use?

Because it’s ’once-in-a-lifetime chance’ for a human being to be able to store stem cells for possible use later before the insurgence of disease. The advantage of having access to ones own stem cells in the case of having to use stem cells for therapy of a disease is evident. It avoids the lengthy process of searching for a compatible donor, which in cases is negative in addition to the complications of allogenic transplants in terms of possible rejections and infections.

Why don’t public banks succeed in obtaining the necessary number of donations?

The management of public structures claim a number of different reasons. There are problems due to the collection and transport of the cells upon delivery that often render the donation unusable. There are also problems related to the financing, with public funds, of the operating costs of the public Banks.

How long can stem cells be conserved and why?

Todate, it is appropriate to conserve cells for 25 years. Several studies have been performed to determine the vitality of cells after longer periods of conservation and the results guarantee the first 25 years. In the future we might have more information on the possibility of conserving for longer periods but, to date we believe that offering our clients to pay for 25 years of conservation is the most serious and acceptable practice. For more information please read answer number 23.

Why should we trust StemWay Biotech Ltd.?

StemWay is not a business that only offers to its clients cryo-conservation of stem cells. StemWay Biotech Ltd. offers serious clinical and scientific knowledge in the field of stem cells, ensuring our customers complete access to all scientific and clinical aspects of this emerging field. Furthermore, the laboratories in which cells are conserved are the most advanced of Europe, adhering to the most server standards in terms of certification and quality that commits to store your baby’s cells for 25 years. Another important procedure implemented by our laboratories is that of dividing the collected samples into different collection bags that are then stored in two different laboratories thus limiting the risk of loosing a sample. Further more, the protocols of separation and cryo-conservation, an important point in the storing procedure, has been validated and tested on over 100,000 samples. Although StemWay is an English company, all our documents will be provided to our clients in their own language and the contract will meet requirements and laws in place at in the country of residence of our clients, and when appropriate that of the EU.

Is it necessary to deliver near the conservation center chosen?

Absolutely not. You can deliver in any structure you chose on Italian soil and perform blood collection in the delivery room that will then be shipped to the storage laboratories. Current Italian laws do not for bid the collection and subsequent export of blood to foreign laboratories where cells will be conserved, as long as these laboratories adhere to strict regulation and quality control norms.

The services offered by StemWay Biotech Ltd.?

Once future parents have decided to enroll with StemWay Biotech Ltd. they must request the KIT for blood collection and transport to the chosen laboratory after paying the 290 euro fee. After payment, future parents will receive the KIT, which also include all the necessary information to request to the Ministry of Health the authorization for umbilical cord blood export and the necessary documentation and instructions for your caregiver to perform UCB collection.
The authorization might take some time so we recommend to request the KIT in the sixth or seventh month of pregnancy and to inform your caregiver and sanitary structure where delivery will take place that you plan to collect and store UCB.
When you go to deliver your baby you must bring the KIT with you and to give it to the caregiver responsible for collection. Cord blood is collected from the umbilical cord immediately after the birth of the baby and after the cord has been cut. Once the collection has been performed you need to contact the number stated on the KIT in order to follow the previously established instructions for shipping to the laboratory. At this time, as at all times, parents can contact StemWay personnel for further support and assistance. Once in the laboratory the stem cells will be counted and isolated, then cryogenically frozen and stored ready for use should they be required.

How much does it cost to store my baby’s UCB with StemWay?

The price to save your baby’s stem cells and Cord tissue with StemWay BIOTECH Ltd. is 2590 euro and it foresees stem cell conservation for 25 years as well as a personalized service of assistance and clinical consultancy for the same length of time. After the purchase of the kit, the total amount due will be paid to StemWay BIOTECH Ltd. before UBC collection and transport to the laboratory for storage (if by any chance the collection is not successful, this amount will be reimbursed discounting any expenses that were incurred to that point, such as shipping or mailing).

The 2590 euro fee includes:

  • Customer support in a call centre by specialized personnel
  • Collection kit shipping and transport of UCB blood
  • Outbound KIT shipping from delivery site to laboratory for storage
  • The appropriate testing on blood sample
  • The processing, testing and separation of the stem cells
  • Quality service guarantee and certificate of deposit
  • The storage of stem cells for 25 years
  • Retrieval of preserved specimen and transportation in a special
    container to the transplant location indicated by parents
  • Personalized scientific consultations for 25 years

If you choose only stem cells conservation and medical-scientific advisory custom throughout the period of cryopreservation on total price of the service is euro 2390.

Will I be reimbursed if conservation of stem cells does not take place?

If by any motive, independent of StemWay, the conservation of stem cells does not take place, you will be reimbursed the full amount paid to Stem Way minus any costs incurred as stipulated in the contract.

Do you have special rates for multiple births?

Certainly. Multiple births can have access to a special service contract, after having ordered the KIT, in which the final fee is only 4550 euro. If you choose only the service of stem cells cryopreservation for 25 years without cord tissue the price is 3950 euro including both kits.

How can I retrieve the stem cells stored by StemWay Biotech Ltd.?

The cells stored by StemWay BIOTECH Ltd. are owned by the person who deposited them, or whilst a minor, by the legal guardian. Should the need arise, StemWay BIOTECH Ltd. will make arrangements for confirmatory testing, release, and transportation of your baby’s stem cells to a designated hospital at no additional cost.

Can I use the cells stored by StemWay Biotech Ltd. more than once?

Currently, the amount of cells collected from one umbilical cord does not allow this possibility. The personalized consultancy service offered by StemWay Biotech Ltd., once you subscribe to our services, will continuously update our clients on the technological and scientific progress obtained in the field of cell amplification that could make the multiple use of stored stem cells possible.

What happens if another family member needs to use the stem cells stored?

The cells stored by StemWay BIOTECH Ltd. are owned by the person who deposited them, or whilst a minor, by the legal guardian. Only the owner can decide how to use the cells, therefore, there is no legal or contractual limitation for these cells to be used by another family member. The limitations could arise due to incompability between donor and recipient, although outcome data show that, there is a greater chance for success in a stem cell transplant between siblings than with unrelated donors. Moreover, there is less chance for severe graft-versus-host disease (GVHD) following transplantation.

How do you ascertain compatibility between donor and recipient?

The stem cells collected from the cord blood are only compatible at 100% with a monozygotic twin of the donor. The compatibility can be verified using HLA testing. Thanks to the methodology used for storage by StemWay BIOTECH Ltd., this can be determined without unfreezing the cells.

What happens once the 25 years established in the contract have expired?

The expiration of the contract after 25 years has been determined based on the scientific knowledge acquired to date (i.e stem cells can be effectively stored for 25 years). The personalized consultancy service offered by StemWay BIOTECH Ltd., once you subscribe to our services, will continuously update clients on the technological and scientific progress obtained in the field of cell conservation and provide the client with the necessary information to decide which are the best options after 25 years of storage. Once the contract expires the “owner” of the sample deposited and stored by StemWay Biotech, who will already by a legal adult, will decide whether to continue or not storing the cells. We believe that our customer, satisfied with the service offered by StemWay Biotech Ltd., will choose to continue storing the cells and have access to our scientific consultancy services at the economic and contractual conditions established at that time by the StemWay BIOTECH Ltd.

Is the procedure complicated or painful?

Absolutely not. The collection process is easy and painless, and does not interfere with the delivery or subsequent care for your newborn. Cord blood is collected from the umbilical cord immediately after the birth of the baby and after the cord has been cut. This blood is routinely discarded and collecting it does not alter normal birthing procedures. The collection can be performed by your caregiver and occurs after delivery has taken place and after any complication during delivery has been taken care of.

Can the cord blood be collected after a c-section?

Certainly. The collection of blood in the cord can be performed from a normal delivery and from a c-section and comprises no risk for the mother or for the baby. Studies comparing vaginal vs. cesarean delivery show that the collection volumes are comparable.

How is the cord blood collected? Who performs it?

After your baby is born, but before the placenta is delivered, your obstetrician or midwife cleans a four- to eight- inch area of umbilical cord with antiseptic solution and inserts the blood bag needle into the umbilical vein. The blood flows into the bag by gravity until it stops, after which the collection is complete. The blood bag is clamped, sealed, and labeled. The collection typically takes two to four minutes. Your caregiver, who has been previously informed, can perform the collection.

Are there any risks or difficulties associated to cord blood collection?

There is no risk to mother or child during the cord blood collection process. It is usually performed by your caregiver/obstetrician who is present in the delivery room, who has been properly informed about the procedure.

Are there cases in which blood collection cannot be performed?

If major complications arise during delivery your caregiver must suspend any procedures that are not performed to ensure safety and well being of mother and baby. However, these cases are very rare.

Is the amount of blood collected important?

The amount of stem cells recovered is directly proportional to the amount of blood collected. Therefore, it is of critical importance to collect as much blood as possible from the cord. In any case, the concentration of stem cells present in the blood also represents an important factor for the conservation of a high number of stem cells. Therefore, even if the amount of blood is low, the laboratory test could identify high number of stem cells. If the procedure established by StemWay Biotech determines that the amount of stem cells is low, or the quality is not satisfactory, the Parents will be properly informed and cryo-conservation will only take place prior signed written consent by the parents.

How much blood needs to be collected?

The sterile bag included in the KIT needs to be filled as much as possible. StemWay BIOTECH Ltd., due to moral and ethical reasons does not process samples that have less than 20 ml of blood because scientific and technological data have determined that the amount of cells recovered might not have therapeutic efficacy. In any case, if the Parents choose to conserve the cells also in cases in which blood collection is less then 20 ml, StemWay BIOTECH Ltd. will perform it prior signed written consent by the parents.

How should we proceed in case of multiple births?

In case of multiple births you will need to use two KITS (or as many as babies expected) to be requested to StemWay Biotech Ltd. as soon as possible and to take advantage of the special fee available.

How is the blood sent to your laboratories?

The blood sample needs to be shipped, appropriately packaged, in the KIT that is given to clients by StemWay Biotech Ltd. This KIT abides to the IATA PI650 procedure, which is the international standard for international delivery of diagnostic samples.

Who performs the shipping?

The shipping of samples to the laboratory chosen is performed by an authorized courier service that specializes in the transport of biological material, and that assures deliver in the least possible time, and surely in time to perform the appropriate treatments for cell recovery.

How long will the blood stem cells remain viable in the kit after collection?

Treatment can be performed up to 72 hours after delivery, however best results are obtained if cells are recovered in the first 48 hours. StemWay Biotech Ltd. performs 80% of treatments in the first 36 hours after delivery.