Lifeline - Romania

About

Lifeline, established since 2002, is one of the few banks in Europe that bears the AABB accreditation. Lifeline is strategically located in Cyprus, with operations in Europe, North Africa, Middle East and the Gulf Region. Lifeline performs cord blood and cord tissue processing, clinical testing and cryopreservation, using state-of-the-art approved automated methods. Lifeline is committed to offering quality cellular therapy services of the highest professional standards, with respect to the parents that have trusted the bank with their children's stem cells.

Business Experience

• 1994 - Incorporation of Lifeline Biotec in UK
• 2002 - Incorporation of C.B.B. Lifeline Biotech, a regional cord blood bank in CY
• 2006 - Relocation of operations in state-of-art facilities                                                      
• 2008 - ISO15189 accreditation, standard for medical laboratories                                   
• 2009 - State registrations and licensure based on EU Directives (License No. 5.4.03.2.4)                                                    
• 2010 - Introduction of “LifeCord” Cord Tissue service with innovative scientific methodology        
• 2011 - Winner of Cyprus Innovation Award, services field, for the "LifeCord" pioneering methodology                                           
• 2012 - AABB Accreditation based on International Quality and Safety Standards
• 2014 - Winner of the "National Champion" title in the European Business Awards
• 2014 - "LifeCord" Patent Granted from the United States Patent Office
• 2015 - New LifeKit, technologically advanced collection and transportation Kit
• 2015 - LifeKit, evaluated as one of the Best Submissions, at the Excellence Cold Chain Awards, Boston
• 2016 - Reassessment by AABB
• 2017- Reevaluation of Clinical Laboratory Accreditation
• 2018 – Reassessment by AABB
• 2019 – LifeKit, technologically advanced collection and transportation kit, is granted Patent from the European Patent Office
• 2019– Relocation to brand new, state-of-the-art, laboratories

Collection Kit

Cord Blood and Tissue procurement is performed using the consumables included in the LifeKit which is provided to the parents upon registration to the services. The LifeKit is a stainless steel cylinder, containing sterile consumables, for the procurement of Cord Blood and Tissue. The medical service providers (Obstetricians/Gynecologists) and the paramedical staff are trained to follow the written instructions given by Lifeline for the procedure of collecting umbilical cord blood and /or cord tissue. The cord blood collection bag contains the correct volume of anti-coagulant for cord blood and is packed in individual aluminium sterile packaging. Each bag carries two needles of optimal diameter, for increased collection of blood and additional safety. All consumables used for the procurement of Cord Blood and Tissue are sterile, suitable for use in an operating room during C-Section.

Transportation Container

LifeKit: Lifeline uses a novel device, the LifeKit, for the collection and transportation of the biological materials to Lifeline’s banking facilities. The LifeKit protects umbilical cord samples during shipment,  it maintains the cells potency and ensures safe delivery of stem xells to the bank.  The LifeKit relates to a portable device for maintaining and for transporting biological materials  within a predefined temperature range, in an insulated environment for a prolonged period of time or course of shipment. It completely eliminates the influence and protects its contents from external temperature variations during shipment. The Lifekit also provides safety and protection from accidental damage to its contents during the course of shipment. This invention is proprietary to Lifeline and protected by intellectual rights.

LifeKit is ideal for maintaining the integrity and the quality of the precious stem cells it carries:

• Enables the cryopreservation of more viable cells
• Maintains its content to constantly low temperature
• Continuous electronic recording of the contents temperature
• Constructed of stainless steel offering enhanced physical protection
• Bears a unique identification number linking parents and newborn to all procedures that will follow

Shipping Info

Lifeline receives samples 365 days a year. The shipping price is included to the service fees. Soon after birth, the LifeKit is picked up, on behalf of Lifeline, by an authorized courier and delivered within a 48hours time window to Lifeline's laboratories for processing and testing.

Processing Method

The cord blood units are processed by the Biosafe Sepax 2 automated cell separation technology. Sepax, offers highly efficient cell recoveries, safety of processing and full traceability of the cellular therapy products. Additionally, Sepax conforms to EU and International Quality Standards, while its processing kit is functionally closed, sterile and single-use. Over 11,000 cord blood units (CBUs) processed with Sepax have already been transplanted to patients worldwide.   

Components Stored

After processing with the Sepax 2, the final product is the "Buffy Coat" of the blood containing white cells and viable stem cells and this is stored as a cellular therapy product. Parents are provided with a certificate for the banking of their cellular therapy products, which includes, detailed information such as blood volume, the blood group of the infant, viable stem cells content and the results of the clinical tests.  Doctors are provided with a document including the collected Cord Blood volume, the collected Cord Tissue weight and the Stem Cell content of each product.

Storage Method

Cell separation is followed by air tight sealing of the blood in a double compartment cryobag which is placed in a predefined location in cryogenic nitrogen bank for long term storage. Lifeline preserves units in dedicated state-of-the-art cryobanks in cryogenic nitrogen vapour, reaching -196°C, offering temperature stability, while temperature readings are recorded electronically every 15 minutes.

Licensing & Accreditation

• AABB Accreditation for the cord blood services                                                      
• ISO 15189 standards for medical laboratories applies to all tests performed
• Licensed by the local authorities (License 5.4.03.2.4), based on European Union Directives

Guarantees

Lifeline carries professional indemnity insurance by a leading specialist in professional risk. This constitutes recognition and assurance of Lifeline's professionalism and the quality of the service.

Community Service

Lifeline offers the banking of cord blood free of charge to families who have a member who suffers from a life-threatening disease treatable by stem cells transplantation.

Prices

Cord Blood banking: Total cost  €1615.
This includes the LifeKit (collection kit), clinical fees, and cryopreservation for 20 years.
Minor deviations between countries due to different costs involved.

Additional Services

Cord Tissue banking:

"LifeCord"  is a patented (USPTO 8900863B2) and award-winning scientific methodology developed by Lifeline's Research and Development Team for the processing and banking of umbilical Cord Tissue.

The implementation of LifeCord results in the cryopreservation of a cellular therapy product containing TWO types of cells from the Cord Tissue:

• the Mesenchymal Stem Cells, deriving from the Wharton's Jelly that fills the cord and
• the Endothelial Stem Cells, deriving from the cord's Vascular System.

Cord Tissue is processed to obtain individual cells by tissue dissociation. Individual cells are efficiently prepared for cryopreservation in the same way cord blood stem cells are cryopreserved resulting in:

• More efficient cryopreservation
• More viable cells at thawing

The dissociation of the tissue with the use of mechanical equipment instead of additives results in:

• Protection from the detrimental effects of the enzymatic dissociation on the cells properties
• Cell remains in their original form until they are needed

Lifeline cryopreserves pure cellular therapy products from the Cord Tissue, avoids completely the manipulation or the treatment of the cells under current technology, allows the use of future technology when these cells are needed.