Stem cell banking is seen as a form of medical insurance – by investing in the service, you buy a “ticket” to future medical options.

You should strongly consider stem cell banking if:

• There is a family history of certain diseases treatable by stem cells in your family;
• There is a sibling with a disease treatable using stem cells;
• You are a family of African descent or a mixed race couple, as such people are under-represented in donor banks/registries;

Remember, if you do not collect and store your baby’s stem cells at birth, there are still other options available to you, including getting stem cells from a donor:

• Matched sibling (related);
• International or local Donor Registry (unrelated)

However, this is not guaranteed, can take time, and be extremely costly.

No. The doctor or midwife can collect umbilical cord blood and tissue at either type of delivery.

The stem cells are a perfect match for the child whose cells have been stored, and there is a 1 in 4 possibility that the stem cells will be a match for a sibling (brother or sister).

Please note, the child’s own stem cells cannot be used to treat certain inherited disorders, as the genes that code for the inherited disorder will be present in those stem cells. In this case, a sibling or unrelated donor’s stem cells would be needed.

Cord blood and cord tissue contain different types of cells that have different uses.

Cord blood stem cells can be used to regenerate bone marrow to treat a range of blood disorders and immune system conditions such as leukaemia, anaemia and autoimmune diseases. They are largely used in the treatment of children, but have also started being used for adults following chemotherapy treatment.

Cord blood is also being researched for use in regenerative medicine where stem cells may help induce healing or regenerate cells to repair damaged tissues. This research has led to clinical trials using cord blood in experimental therapies to treat cerebral palsy, brain injury and juvenile (type 1) diabetes.

Clinical Trials.gov

Furthermore, many clinical trials are underway looking at the use of stem cells taken from bone marrow. For many of these potential treatments, cord blood stems cells may be a suitable substitute and offer many advantages over bone marrow.

Cord tissue contains mesenchymal stem cells that are being employed in both research and clinical environments for a variety of aesthetic and medical conditions, including skin regeneration, neurology (motor neuron disease, multiple sclerosis), orthopaedics (cartilage and bone repair), sports injury (cartilage and ligament repair); cardiology (heart muscle regeneration) and many other areas.

Ideally, your child or their sibling’s stem cells will never be needed, and should be regarded as an extra form of medical insurance.

Studies in the USA have been done to calculate a lifetime probability (age 0-70) that a person will undergo a stem cell transplant:

• 1 in 435 people may receive their own stem cells
• 1 in 400 people will receive someone else’s cells
• The total combined number of stem cell transplants is 1 in 217 people.

Legend:

Odds of a child using its own (autologous) cord blood stem cells

Table copyright Frances Verter, PhD 2014 – References Below

Odds of a child using donor (allogeneic, includes siblings) cord blood stem cells

Table copyright Frances Verter, PhD 2014

If stem cells are not collected at birth, there are other options available.

Should your child need a bone marrow transplant, stem cells can be collected from donor bone marrow or blood from a:

• Matched sibling (related)
• Matched unrelated donor from a registry (local or international)

This is, however, not guaranteed, as matches cannot always be easily found, they take time and are extremely costly.

Mesenchymal stem cells can be found in most of or tissues or organs, but can be difficult to harvest. They’re most readily available from adult fat (adipose) tissue, but the “young cells” from umbilical cord tissue have better regenerative potential, and are easily collected with no discomfort to mother or child.

Probability of finding a match for patients in need of an HSC transplant depends on race/ethnicity as our HLA/ tissue types are different.

• For Caucasians the chance of finding a match is 1 in 100 000
• For mixed race children and ethnic minorities (groups under-represented on stem cell registries, Africans in particular) the chance of finding a match is 1 in 400 000.

References

1. Sunflower fund.
   
2. South African Bone Marrow Registry.
3. Gragert et al., NEJM 2014; 371:339-348 HLA Match Likelihoods for Hematopoietic Stem-Cell Grafts in the U.S. Registry

There are 2 types of transplants:

• Autologous (from the patient themselves) transplants .i.e. the donor and the recipient are the same person. In this situation, the child’s own stem cells are used. This would not be possible if the child has an inherited disease as the stem cells will have the same genetic problem.
• Allogeneic transplant (this can be from a related matched family member or a completely unrelated person found on a donor registry). This can be used in the treatment of inherited or non-inherited diseases.

Patients are given chemotherapy to destroy the existing damaged or diseased bone marrow, and then the new stem cells are infused.

The cord blood stem cells are ready to use and require thawing before they are infused into the patient. If your child requires a stem cell transplant your doctor should contact us for all the necessary documentation to decide if the treatment should go ahead. Next Biosciences will only release the stem cells upon written approval from the parents and the treating doctor indicating the date, time and place of the transplant (to allow us to plan the transport of the unit).

If an allogeneic transplant is needed (for a sibling) then HLA (human leukocyte antigen) matching needs to take place. This process takes approximately 3 weeks and requires a blood sample from the child who needs the transplant, and we send off a sample of the cord blood (we store 2 extra frozen vials for this purpose). If there is an acceptable match, the doctor will request the stem cells to be transported to their facility.

Next Biosciences will cover the cost of transport within South Africa, but the cost of transport internationally will be for the client’s own account, as per the storage agreement.

Delayed cord clamping can be beneficial to the baby, but delaying too long for the cord to stop pulsating carries the risk of there being not enough blood available in the placenta to be collected, as it begins to clot and the placenta separates from the womb.

A reasonable recommended delay of 60-90 secs should enable the doctor or midwife to collect enough blood for a sufficient sample for banking. HOWEVER each birthing situation is unique and there is always a risk that there may not be enough blood for a collection due to unforeseen complications such as bleeding, small or premature babies, small calcified placenta, thin umbilical cords, or if the placenta comes away from the womb earlier than expected. Ultimately, the more blood in the collection bag, the more stem cells are available to be stored, which is more useful for treatment in the long term.

This depends on the number of stem cells stored in each individual unit and the size of the person who requires the transplant. The optimal dose is 10 -20 million nucleated (CD45) cells per kilogram of body weight. The cell counts are different for every collection, and depend on the volume of blood collected as well as other factors in pregnancy. Your baby’s cell counts will be reported to you on your storage certificate.

The average number of stem cells collected from an average volume of 100 ml can usually treat up to a 50kg person, but this varies. In larger adults, often two matched units can be combined (either from a sibling or an unrelated donor).

Companies are developing techniques to expand (grow more) stem cells in a laboratory environment, and we hope this will become a reality soon.

It must be noted that lower stem cell counts are currently being used in clinical trials for cerebral palsy and brain injury, as these recipients are often small, low birth weight babies and children.

Our storage tanks do NOT operate off electricity. The stem cells are stored in the vapour phase of liquid nitrogen, which is readily available in South Africa. Electricity is critical to our laboratory equipment, and we have UPS backup on all equipment, as well as a large generator, so we can continue to process during load shedding.

Theoretically, the stem cells can be stored forever, as they are cryopreserved and stored at -196 degrees Celsius, where all ageing is halted. However, there is only scientific proof that stem cells are viable for as long as 23 years, as this is this is currently the longest period in which stem cells have been stored, thawed and tested for viability.

You are able to pay for storage annually in advance, or buy upfront storage for periods of 5 or 10 years. Storage fees currently average around R300 per annum, and these will be adjusted annually for inflation. Storage fees will be market related and, if at any time you wish to move your stem cells to alternative storage location, you’re welcome to do so.

More than 90% of the work involving stem cells is not controversial. This includes research, accredited processing and storage facilities such as ours and legitimate therapies being administered around the world.

However, there are a few areas that are controversial:

• Embryonic stem cells are derived from embryos and result in the destruction of the embryo and the loss of potential life. Next Biosciences is not involved in any form of embryonic stem cell science.
• Cloning is banned worldwide in humans, as it involves making a copy of a something from a single cell.
• Non-regulated stem cell clinics operating worldwide offering unproven therapies at exorbitant prices to many vulnerable and desperate patients. These unproven treatments generally don’t comply with the ethical, legal and scientific standards required of registered clinical trials.

Next Biosciences is a processing and storage laboratory, and as such, does not offer treatments to clients. We facilitate the handover of stem cells to the transplanting unit or trial centre.

We released our first cord blood unit in March 2015 to treat an eight-month old baby boy at Duke University in the USA. The patient is being treated for an emerging therapy and the stem cells have already been successfully infused.

We have had a few siblings who required stem cell transplants but these were unfortunately not a match. Our sister company Smart Cells in the UK has already released 13 cord blood units for the treatment for cerebral palsy, thalassaemia, leukaemia, brain injury, severe combined immunodeficiency disorder, sickle cell anaemia and encephalitis.

You should be comfortable with the company you choose, as you are storing your child’s stem cells for life. Do your homework and investigate all your options. Make sure that the company you choose:

• Is officially accredited (link to ‘What does Accredation really mean?’ page on the site) by an international recognizable body to give you assurance that the lab adheres to the strictest international standards for processing and storage. Official accreditation means regular independent audits of the actual facility with a certificate registered to the physical location of that laboratory.
• Has credible partners;
• Has a strong scientific team which is proof of investment in scientific progress;
• Operates on a transparent basis, and that all costs are disclosed upfront;

We collected our first cord blood unit in 2005, and to-date have stored stem cells for over 10,000 babies. In addition to cord blood, we cryogenically store cord tissue, mesenchymal stem cells from adipose (fat) tissue, as well as semen (sperm).

Our sister company, Smart Cells international (the UK’s longest established stem cell bank) will take over the storage of the stem cells in the unlikely event of anything ever happening to Next Biosciences. Next Biosciences and Smart Cells employ the similar technology so it is easy to transfer cells between the two laboratories. Next Biosciences and Smart Cells are each other’s offshore back-up laboratories and Next Biosciences has processed and store stem cells for Smart Cells clients from all over the world, when there have been flight disruptions in the UK and Europe due to weather (volcano, snow) and strikes.

Next Biosciences will always refund the portion of fee relating to the service that wasn’t utilized. Additionally, Next Biosciences takes the risk on processing, so if for whatever reason there are not enough stem cells for storage and you don’t store, then Next Biosciences will refund the processing and storage fee.

The stem cells are stored in cryogenic tanks at our laboratory in Midrand. You are welcome to visit our laboratory at any time to come and see how we process and store stem cells.

It is best to store the whole unit and not to split units into separate bags. This increases the risk of contamination, bears the risk of unnecessary transportation and decreases the cell count available for transplant thus ½ + ½ ≠ 2. Further comment by Dr Pablo Rubenstein who pioneered the cryopreservation of cord blood stem cells: “Given that the cell dose is an important predictor of successful transplant outcomes, such ‘split CB units’ might place their potential recipients at a disadvantage and their application, therefore, unlikely, unless successful stem cell expansion becomes practical in this setting.”1 Reference 1. Rubinstein, P. (2009) Cord blood banking for clinical transplantation. Bone Marrow Transplantation. 44. pp. 635-642

As this is a private bank and we store for your family only, we do not carry out HLA-typing on the stem cells and therefore we will never know if they are a match for anyone else. Additionally, we comply with the Human Tissue Act and therefore we cannot ever use your stem cells for research without your prior written consent.

Once the cord blood and tissue are collected, the cells start deteriorating, so it is imperative to get this to the laboratory as soon as possible. Local storage ensures less transport risk (courier delays, customs clearance, weather disruption, extreme changes in temperature) so that the cells can arrive as soon as possible at the laboratory with least risk of being compromised for processing.

Yes. The stem cells can be shipped in their frozen state anywhere in the world to another stem cell bank that accepts them for storage. The cost of this will, however, be for your own account.

 You will need to liaise with your medical practitioner, who will contact us and inform us that the stem cells are required for transplant, indicating the date, time and place. Next Biosciences will only release the stem cells upon written approval by the mother and treating doctor.