Protect your family's future health by storing your newborn baby's cord blood and cord tissue stem cells

Accreditations

When you choose a private stem cell bank, you need to make sure it holds the right accreditations and licences, specific to human tissue storage. Otherwise you run the risk of storing a stem cell sample that will not be accepted for therapeutic use in the future.

UK Licensed Laboratory

The HTA is the Competent Authority in the UK under the EU Tissues and Cells Directives with responsibility for licensing the storage of human tissue. See The Human Tissue (Quality and Safety for Human Application) Regulations 2007. Anyone storing human tissue and cells for therapeutic use must be in possession of a license from the HTA.

Back in 2006 Future Health was the FIRST private Human Tissue Bank to receive a full Human Tissue Authority (HTA) licence, reference number 11058. The HTA licence was renewed in November 2008 (reference number 22503). Then in February 2011 we had our Human Tissue Authority (HTA) license renewed again (license number 22503 / 14-02-11).

In January 2011 Future Health was also awarded with a Blood Establishment Authorisation BEA21314 from the Medicines and Healthcare products Regulatory Agency (MHRA) the FIRST cord blood and tissue bank to receive this licence for the storage of adult human blood in the UK.

Further accreditations:

In 2004 Future Health was the first Human Tissue Bank to receive the initial Accreditation as a Human Tissue Bank from the UK MHRA (Medicines and Health care Products Regulatory Agency).

In 2010, Future Health received the ISO9001:2008 accreditation for quality management for our processes and systems in the UK, so parents can be assured that our service and facilities meet the highest standards.

Swiss license Authorization

In order for a laboratory to operate in Switzerland the laboratory must obtain a license from the governmental organizations which provide such licenses. In Switzerland, the licenses are awarded by Swissmedic and the Federal Office of Public Health.

Swissmedic conducts the inspections necessary in order for a license to be granted. The Swiss legislation has decided to use the NetCord/FACT guidelines as part of the regulations that are followed in order to inspect and grant the necessary authorizations to Human Tissue and Cell Establishments operating in Switzerland. With regard to the manufacturing of products for cellular therapy for autologous and allogeneic transplantation, the International Guidelines on Good Manufacturing Practice (GMP) have to be followed.

Future Health Biobank S.A. was inspected by Swissmedic and has received a license based on the said regulations (Netcord/FACT and GMP) in order to manufacture products for cell-therapy for autologous and allogeneic applications. This license includes processing and storing samples of cord tissue as well as umbilical cord blood stem cell for autologous and allogeneic applications.

Based on Swissmedic’s license, Future Health Biobank S.A. is licensed to store samples and manufacture products for cell-therapy for autologous and allogeneic applications. Such products may be used:

a. by the person who donated the sample (the newborn baby) – autologous application

b. by any member of their family – related allogeneic application

c. by any other person (if the donor decides to donate the sample) – unrelated allogeneic application

Future Health Biobank S.A. is the first private laboratory in Switzerland to have received such a license. 

HTA (Human Tissue Authority) HTA-Licence

We were also the first to receive a full Human Tissue Authority (HTA) licence, reference number 11058. It was renewed for a further 3 years in November 2008 and again in February 2011 (licence renewal number 22503).

The HTA has now become the Competent Authority in the UK under the EU Tissues and Cells Directives with responsibility for licensing the storage of human tissue. See The Human Tissue (Quality and Safety for Human Application) Regulations 2007 . Anyone storing human tissue and cells for therapeutic use must now be in possession of a license from the HTA.

MHRA (Medicines and Healthcare Products Regulatory Agency)

In January 2011 Future Health was awarded with a Blood Establishment Authorisation BEA21314 from the Medicines and Healthcare products Regulatory Agency (MHRA) the first cord blood and tissue bank to receive this licence in the UK.

ISO Quality Management System ISO-9001-Certificate-210110

Also in 2010, Future Health received the ISO9001:2008 accreditation for quality management for our processes and systems in the UK, so parents can rest assured that our service and facilities meet the highest standards.