Family Bank: Futura Stem Cells

About

Futura SC S.r.l. is an Italian company that offers the services of the first cord blood bank in Portugal: Crioestaminal (StemLab).

Labs and Locations

Futura leads the future parents toward cord stem cells cryopreservation entrusting the samples to Crioestaminal’s laboratory, located in Biocant Park, the Portuguese science park entirely devoted to biotechnology. Biocant Park arises as the first park specialized in biotechnology, setting out a cluster of companies and research centers of excellence in the middle region of Portugal.

Crioestaminal’s laboratory is licensed to process and store umbilical cord blood and tissue. The whole processing of the samples is performed in "clean rooms" to ensure maximum sterility of the samples and prevent contamination. The access to the laboratory is electronically controlled. All laboratory’s conditions are monitored by an alarm center in order to detect any anomaly. The laboratory also possesses an early-warning fire detection system. To prevent any electricity failure the laboratory is equipped with a backup power system. All the process are carried out by highly qualified staff. Crioestaminal laboratory works 365 days a year and has the capacity to store 300.000 cord blood and tissue samples.

Business Experience

Futura’s specialized staff inform future parents about the possibilities of cryopreserving umbilical cord stem cells and follow them, step by step, in a such delicate moment, working 365 days a year.

Our parent bank, Crioestaminal/Stemlab, was created in June 2003 and became the first private cord blood bank operating in the Iberian Peninsula: Portugal & Spain. Crioestaminal has established several partnerships with universities and research centers in order to develop research project to increase stem cell applications. Some of the patents resulting after these collaborations:

• In 2012, in partnership with Biocant, Crioestaminal co-developed the first Portuguese patent to target chronic wounds in diabetic people.
• In 2013, in partnership with Biocant, Crioestaminal co-developed a patent in the field of ischemic disease.
• In 2015, in a partnership with Chronic Diseases Research Center (CEDOC) from NOVA Medical School, Crioestaminal co-developed a patent in the field of dendritic cells vaccination for tumor treatment.
• Also in 2015, in partnership with Centre for Neuroscience and Cell Biology (CNC) and Biocant, Crioestaminal co-developed a patent in the field of wound healing.

Collection Kit

Futura’s collection kit contains everything the healthcare provider needs to easily and safely collect, after birth, the maximum amount of a newborn's cord blood, maternal blood, and cord tissue. The collection kit includes: an instant cooling system; a cord blood collection bag pre-filled with citrate-phosphate-dextrose with adenine (CPDA-1), an anti-coagulant that also works as a cell preservative; a container for cord tissue; maternal blood collection kit; a disinfecting kit. All the components of the kit are sterile.

Transportation container

The transport container includes a thermally insulated shipping box that controls temperature during transport to Crioestaminal processing laboratory. The container includes an instant cooling system, to stabilize temperature, and a temperature data logger, to monitor shipping conditions. Samples remain at room temperature and are shipped directly to Crioestaminal laboratory for processing.

Shipping Info

Shipping is done 365 days a year, 24 hours a day, by specialized courier, TRASER Srl (i.e., the first courier in Italy for biological samples), in controlled temperature vans. Futura’s collection kit is pick up by TRASER from selected hospital and transported to Crioestaminal lab in right time to be processed. 

Processing Method

• After arrival at the Crioestaminal/Stemlab’s laboratory, the kit is inspected and the cord blood unit is tested for sterility, viability, and cell count.
• Crioestaminal processes cord blood using the AutoXpress Platform (AXP®) - a fully automated, closed processing technology, designed for the separation of the stem cell enriched fraction of the blood through a volume reduction method that reduces red cells and plasma content.
• Samples from all components of the cord blood are kept as part of the stored samples.
• In addition, maternal blood tests for viral contamination are carried out using serology and nucleic acid testing, by real time PCR.
• Testing of the plasma for bacterial and fungal contamination is performed, including antibiotic sensitivity tests for contaminated samples.
• A report on the sample includes the number of Total Nucleated Cells (TNC), mononuclear cells, cord blood stem cells (CD34+ cells), and cell viability.

Components Stored

Crioestaminal stores a stem cell enriched fraction of the cord blood in a criobag consisting of two compartments (one with 80% of the sample and the other with 20%) and three attached segments used for testing. After the storage, the parents received a certificate of storage which includes the number of viable TNC and CD34+, the results of bacterial and fungal contamination ans maternal blood test.

Storage Method

After processing in Crioestaminal laboratory to isolate stem cells, a cryopreservative is added and the cord blood units are cooled down in a controlled-rate freezing device. At the end of the procedure the cord blood units are stored suspended above a pool of liquid nitrogen that creates a vapor phase of cryogenic nitrogen keeping the environment close to minus 196ºC. This keeps the units cold and eliminates the risk of contamination between samples. The storage condition parameters of the freezer tanks are continuously recorded (24 hours a day, 365 days a year) and  alerts should a change occur. All sample are identified by a bar coded label, that is registered in a data base to allow for the rapid recovery of the unit when needed.

Licensing & Accreditation

• Crioestaminal/Stemlab’s laboratory is one of the 5^Th stem cell banks in Europe accredited by American Association of Blood Bank (AABB) for cord blood banking and is the only European bank accredited by AABB for cord tissue banking.
• Crioestaminal/Stemlab’s laboratory has the national authorization of the Portugese Ministry of Health, according to European directives for cell and tissue banks.
• Crioestaminal/Stemlab’s laboratory is certified by the international standards ISO 9001:2000 for the quality management of its processes and systems.
• Crioestaminal/Stemlab’s laboratory operates in accordance with international Good Manufacturing Practice procedures protocol drawn up by the W.H.O (World Health Organisation)

Clinical Experience

Crioestaminal has released cord blood samples for 15 therapies in 10 children:

• One sample was used in an allogeneic transplant of a sibling to treat Severe Combined Immuno-Deficiency (SCID)
• The other samples were used in autologous therapies, in the context of experimental treatments to help treat Cerebral Palsy.

Insurance

• If the cord blood fails quality control, there is no charge for processing, and the sample is discarded.
• The laboratory is protected 24h/day, 365 days/year by security systems.
• Crioestaminal has a disaster recovery plan which allows that all cryopreservation tanks are relocated to another licensed facility if any disastrous event occur.
• If the cord blood stem cells processed and stored by Crioestaminal laboratory is needed to be used in a cell transplant following standard, recognized medical practices Futura will cover all the fees to a maximum amount of €15.000.

Prices

Our fees include:

• personal Assistant
• collection kit
• transportation
• processing
• sample(s) analysis
• maternal blood analysis
• cryopreservation for 25 years
• HLA analysis (if necessary)
• Transportation everywhere the transplant occurs (if necessary)
• €15.000 for the duration of contract to support family cost of a transplant

Additional Services

If hematopoietic cord blood stem cells are need to be used, Crioestaminal perform HLA typing of the cord blood.

Cord Tissue storage is available: in particular Crioestaminal’s laboratory processes cord tissue with extraction method and stores the stem cells extracted from the surrounding umbilical cord tissue (mesenchymal stem cells or MSC). With this method the family has the possibility to have viable mesenchymal stem cells cryopreserved to be used inclinical trials.