Banking somatic stem cells for screening applications.

With somatic stem cells cultures one can try to mimic the tissues in the human
body, either healthy or diseased, but at a miniature size and outside the body.
As an advantage, experiments can be performed without risk to a living human
being. In these experiments, test can be performed to identify benefits from a
specific drug for the client, or for example are at high risk of specific drug
toxicity, it also opens the road towards more personalized and safer use of
drugs. For these kind of tests we need somatic stem cells cultures and the
easiest way to procure and bank somatic stem cells, is from discarded tumors
and umbilical cords.

Banking somatic stem cells for clients, from discarded umbilical cords or
tumors and giving clients the opportunity to use their somatic stem cells for
analytical applications.

Many years after banking somatic stem cells, screening applications can be
performed in which the stem cells undergo some kind of intervention in order to
evaluate the impact. The controlled intervention studies will primarily focus
on testing pharmaceutical products containing only well-established drugs that
are licensed by the Nederlandse College ter Beoordeling van Geneesmiddelen
(CBG) or the the european commission. Before somatic stem cells can be used in
screening applications they need to be procured, transported, processed and
banked.

Procurement
The obstetrician or the oncologist will receive the collection kit. The
protocols inside the collection kit give the obstetrician or oncologist clear
instructions how to procure the stem cells.

Transport
After somatic stem cells procurement, Stem Cells Technologies will arrange a
pick-up from the hospital and delivery to the Laboratory, all within 48 hours.

Processing
In the laboratory the somatic stem cells will be processed for cryogenic
storage.

Banking
The stem cells will then be banked for 25 years.

Drug toxicity tests
When clients file for a screening test, the researcher will design a screening
application. The researcher has control over the intervention, its timing, and
dose or intensity. In its simplest form, an experimental study to test the
effect of a treatment will follow these steps:

- The researcher formally states the hypothesis to be tested
- The researcher selects the banked specimen eligible for the treatment
- The sample is divided into two groups
- One group (the experimental, or intervention group) is given the intervention
while the other (the control group) is not
- Outcomes of interest are recorded over time and the results compared between
the two groups

The conclusion will be send to the doctor with recommendations for a specific
drug for the client

All clients need to enrol and answer a questionnaire.
After delivery or before the operation, one blood samples of 10ml will be taken
for serology testing.
After delivery or operation the stem cells will be procured outside the body
and client should not feel any discomfort.