Family Bank: Crioestaminal

About

Crioestaminal - Ciência Para a Vida - was founded in 2003 as the first cord blood bank in Portugal. In 2011 the company also began to store the mesenchymal stem cells (MSC) found in umbilical cord tissue. Crioestaminal cord blood bank is accredited by the international standards AABB and ISO 9001:2000 for both the processing and storage of umbilical cord blood and cord tissue.

Labs and Locations

Crioestaminal has a state of the art laboratory based in Portugal that is licensed to process and store umbilical cord blood and tissue for use by either the donor, the donor's family, or an unrelated person if authorized by the donor.

Laboratory Location: Crioestaminal, Biocant Park, Núcleo 4, Lote 2, 3060-197 Cantanhede, Portugal

All the 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 conditions are monitored by an alarm center 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 is carried out by highly qualified personnel. Crioestaminal laboratory works 365 days a year and has the capacity to store 300.000 cord blood and tissue samples.

Business Experience

Crioestaminal was created in June 2003 and became the first private cord blood bank operating in the Iberian Peninsula: Portugal & Spain. Crioestaminal has the national authorization of the Portuguese Ministry of Health, according to European directives for cell and tissue banks, operates its own laboratory in a clean room in Biocant Park, and is accredited by the international standards AABB and ISO 9001:2000.

FamiCord Group acquired Crioestaminal and Stemlab during summer 2018, creating a merger of Europe's two leading laboratories for the development of MSC therapies.

Crioestaminal has established several partnerships with universities and research centers in order to develop research project to increase stem cell applications. Some of the projects resulted in the development of patents:

• 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

Crioestaminal collection kit contains everything the healthcare provider needs to easily and safely collect the maximum amount of a newborn's cord blood following birth.

The collection kit has: an instant cooling system; a cord blood collection bag pre-filled with citrate-phosphate-dextrose with adenine (CPDA-1), an anti-coagulant that also functions as a cell preservative, in appropriate volume; a container for cord tissue; maternal blood collection kit; and a disinfecting kit. All the components of the kit are sterile.

Transportation container

The transport container includes a thermally insulated shipping box designed by Crioestaminal that controls temperature during transportation 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

Cord blood samples are transported by specialized courier in temperature controlled vans. Shipping is done 365 days a year and is included in base price.

Processing Method

After arrival at the Crioestaminal / Stemlab 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 via 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.

Crioestaminal offers a second option to parents, which includes an additional processing to recover an extra fraction of stem cells, increasing up to 15% the amount of stem cells cryopreserved.

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. Number of Total Nucleated Cells (TNC), mononuclear cells and CD34+ cells, and cell viability are determined in a sample of the processed unit. The blood type of the baby is determined.

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.

At the time of storage, the parents are provided with a certificate of storage which includes the number of viable leukocytes (CD45+) and Stem Cell (CD34+) count, and results of maternal blood test and bacterial and fungal contamination.

Additionally, Crioestaminal also stores samples of plasma, red blood cells, cord tissue and maternal plasma in a materno-fetal bank.

Storage Method

At the end of the processing, a cryopreservative is added and the cord blood units are cooled down in a computer 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 eliminate 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 emits alerts when 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 maintains standards for cellular therapy services through AABB accreditation.The Crioestaminal / Stemlab laboratory is one of only five stem cell banks in Europe that is accredited for cord blood banking and is the only European bank to be accredited by AABB for cord tissue banking.

Crioestaminal has the national authorization of the Portugese Ministry of Health, according to European directives for cell and tissue banks, and is certified for the quality management of its processes and systems by the international standards ISO 9001:2000.

Clinical Experience

Crioestaminal has released 8 samples for 13 transplants:

• 1 sample had been used in an allogeneic transplant in a sibling to treat a Severe Combined Immuno-Deficiency (SCID)
• 7 samples had been used in autologous therapy, in the context of experimental treatments to help treat Cerebral Palsy

Crioestaminal established partnerships with universities and research center to develop several research projects in order to improve processing methods, and to develop potential therapies with cord blood and tissue.

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 is needed to be used in an hematopoietic stem cell transplant following standard, recognized medical practices Crioestaminal will cover all the fees to a maximum of €20.000, through the Crioestaminal “Plano de Protecção de Tratamento”.    

Community Service

• Crioestaminal has a program for families that have been identified with a medical condition for which stem cells cord blood can be potentially used. The program offers free cord blood processing and storage for qualifying families.
• Crioestaminal also created a cord blood bank for research, which allows parents who do not want to store the cord blood of their babies, to donate their sample so that it can be used in research projects in order to help in the scientific development of the therapeutic potential of these cells.

Prices

Fees (for Single Birth, Cord Blood)

• Standard processing (includes collection kit, transport, processing and storage for 25 years): €1090
• Standard processing year by year (includes collection kit, transport, processing and storage for 1 year): €600 + annual storage fees: €50
• Payment Plans available upon request:  12 month, 18 month, 24 month, 36 month, 48 month, 60 month
• Discount Pricing: Clients that bank more than one child receive a discount on the cost of Crioestaminal service.

Additional Services

Crioestaminal also offers the collection, processing and storage of the umbilical cord tissue. Crioestaminal offers two different methods for the processing of cord tissue:

1. The standard method, that stores fragments of the cord tissue;
2. The extraction method, that stores the stem cells extracted from the surrounding umbilical cord tissue (mesenchymal stem cells or MNC).

Prices with Additional Services

Crioestaminal offers the cord tissue processing and storage with cord blood service. The collection kit and storage fees are only charged once for the combined services.

Fees in Portugal (for Single Births, Cord Blood + Cord Tissue)

• Standard blood + tissue processing (includes collection kit, courier, processing and storage for 25 years of the blood and tissue): €1750
• Standard blood + tissues processing year by year (includes collection kit, courier, processing and storage of the blood and tissue for 1 year): €800 + annual storage fees: €70
• Maximum - 2 blood + 2 tissue processing (includes collection kit, courier, processing and storage for 25 years of the blood and tissue in 4 units): €2450
• Maximum - 2 blood + 2 tissues processing year by year (includes collection kit, courier, processing and storage of the blood and tissue in 4 units for 1 year): €1200 + annual storage fees: €100
• Payment Plans available upon request:  12 month, 18 month,  24 month, 36 month, 48 month, 60 month