• Yes, we are AABB and FACT accredited.
• We are also Health Canada inspected and compliant.

• In Mississauga, Ontario.
• Our storage facility is located at the same site as our processing lab.
• All samples processed in Mississauga are stored in Mississauga.
  • Cord blood units previously processed in Burnaby, BC, remain in Burnaby.
  • Cord blood units previously banked with Cells for Life, and processed in Toronto, remain in Toronto.

• Both the Mississauga and Burnaby storage facilities are AABB and FACT accredited.
  • Samples previously banked with Cells for Life and processed in Toronto are stored at Core Cryolab.
    • Core Cryolab is a company specialized in providing cryogenic services to the medical and scientific communities including storage and shipment.
    • Core Cryolab has been inspected by Insception and meets the requirements of our rigorous quality management system.

• Once a cord blood unit has been cryopreserved, it is best for the product to be maintained in the storage tank until it is required for use.
• We do not recommend transferring products from one bank to another.

• Only Insception/Cells for Life samples are stored in our tanks.
• Core Cryolab stores samples previously banked for Cells for Life in dedicated tanks.

• • We have secured our facility with a long-term lease structure.
  • We do reserve the right to change our storage facilities, as future storage volumes may drive that need.

• In a move scenario, we would ensure that the facility is built to meet regulatory and standard requirements. This would drive the level of quality of any new facility.

• We would enlist the services of specialized vendors with expertise in this area.
• In 2004, Insception orchestrated the move of the complete cord blood inventory from Mount Sinai Hospital, in downtown Toronto, to our current facility in Mississauga. We have the experience required to arrange a move should it be required.

• Our buildings are alarmed and secured with motion detection sensors.
• In the event of an alarm after hours, appropriate staff are notified and a security guard is dispatched as required.

• Our facility is equipped with natural gas backup generators.
• All critical pieces of equipment in the lab are connected to the backup generator to ensure processing can continue seamlessly in a power interruption scenario.
• All critical equipment is also connected to UPSs.
• The IT servers are also on the backup generator and on UPSs to allow a controlled shut down should this be needed.

• We have a secured, external 5000 L LN2 tank at our facility.
• Holds enough volume to handle 2-3 weeks of activity.
• Our external tank is filled regularly every two weeks.
• Emergency fills can be performed by our vendor (Praxair) within two hours should it be required.
• Our LN2 storage tanks will maintain temperature without a fill (if unopened) for a period of 2-3 weeks.

• LN2 tanks are monitored continuously for temperature and LN2 levels.
• Alarms will be triggered and appropriate staff notified, 24/7, if the temperature gets too warm or if the LN2 level gets too low.
• The alarm system is on our backup generator.
• As a check on the continuous monitoring, every 5 minutes a view of the data is captured and stored. In the event the file does not update in this timeline, then the monitoring system sends an alert to the IT Department flagging that the monitoring system is not active.
• In the event that our continuous monitoring system is interrupted, we would monitor our tanks manually by reading temperatures and measuring LN2 levels 3 times per day as stipulated by regulatory and accrediting bodies.

• Yes. Cord blood can be used by other family members that are an acceptable match. We have released cord blood for use by the donor, a sibling, and, though very rare, a cousin.

• All released cord blood units have been viable and 100% of released cord blood units have been infused into the intended recipient, either for bone marrow transplant or clinical trials in regenerative medicine.

• Cell Care, our parent company is actively supporting clinical trials for cerebral palsy and type-1 diabetes in Australia.
• Many of our clients have participated in clinical trials related to cerebral palsy, autism, and type-1 diabetes.

• As our number of releases increases regularly, we have a document with all of our cord blood releases available on our website.

• Cord blood collection is performed by the healthcare provider using a Health Canada approved cord blood collection bag.
• Cord blood collection is typically performed while the placenta is in utero, allowing the mother’s contractions to assist with the cord blood collection.
• Cord blood can also be collected after the placenta has been expelled by gravity flow.
• To maximize the cord blood collection, we recommend collecting cord blood until it stops flowing into the collection bag.

• There is a correlation between volume of cord blood collected and number of total nucleated cells stored.
• Transplant outcomes, and data for cerebral palsy patients treated with cord blood, indicate that better outcomes are obtained with higher cell doses.
• As such, we recommend collecting as much cord blood as possible, i.e. that the cord blood collection is performed until cord blood stops draining into the collection bag.

• Yes. Delayed cord clamping and cord blood banking can be achieved through planning and communication with your obstetrician or midwife.
• Given that up to 80% of blood volume is transferred from the placenta to the baby in the first minute after birth, we recommend no more than 1 minute of delayed cord clamping before attempting a cord blood collection.
• Extended delays in clamping beyond 60 seconds is likely to have a negative impact on the amount of cord blood that may be collected for storage, and if it can be used for future medical treatments.

• Processing time, i.e. time between the cord blood collection and the start of processing, is dependent on time and location of birth.
• Within the Greater Toronto Area, time to processing is typically between 18-24 hrs.
• Nationwide, time to processing is typically <36 hrs.
• The processing lab and couriers operate 365 days/year.

• We use dedicated couriers to transport the cord blood from the collection site to our processing lab.
• Shipments are tracked and traced from pick up from client to our lab.
• While FACT standards stipulate cord blood must be processed within 72 hours of delivery, we strive to complete processing within 48 hrs of delivery.
• Once your child is born and everything is ready for pick up you simply give us a call and we send a courier directly to you at the hospital for pick up. (Note that pick up may not be same day.)

• Yes, all kits contain a temperature data logger.

• Our transport parameters are between 4°C-25°C.
• For ‘local’ samples, cord blood and cord tissue samples can be maintained at room temperature for up to 48 hours.
• For cord blood and cord tissue samples coming from greater distances, and being flown to the processing lab, a cooler and ice pack are provided in the kit to help maintain the desired temperature for up to 72 hours, to buffer against any delays that may occur during transit.
• As part of our normal processing, all samples are assessed for post processing viability and cell counts.
• Test results are compared to our internal acceptance criteria.
• If a cord blood sample does not meet acceptance criteria and the client opts not to bank the cord blood, then the client is refunded.

• • No, but we do capture and keep this information as part of your storage file with us.

• We rely on trusted partners for shipments.
  • First International for long haul national business.
  • Vital Line, a dedicated courier partner that only services Insception/Cells for Life, for all samples delivered within a ~250km radius of our facility in Mississauga.
• We have been working in partnership with our 2 couriers since 2004.

• We process 7 days a week, 365 days a year.

• Insception uses a modified version of the Rubinstein method.
  • Rubinstein method is based on volume reduction of the cord blood by removing most of the plasma and red cells.

• Our Total Nucleated Cell recovery is ~90%.

• We use a closed-system method.
• Our method is semi-automated, using a MacoPressSmart.

The following tests are performed on all processed cord blood units:

• Total nucleated cell count and viability.
• CD34+ cell count and viability.
  • CD34+ is a marker for hematopoietic (blood) stem cells.
  • This test is performed using a flow cytometer.
• Sterility testing for both aerobic and anaerobic microorganisms.

• We do not routinely provide such a report, but the data can be provided if requested.

• The main cord blood units are stored in a Cryostore Freezing Bag with 4 integrally attached segments for testing purposes.
• In addition, 2 cryovials (0.5 mL each) of processed cord blood are stored in the cassette with the cord blood unit.

• We do not use an overwrap for our cryopreserved cord blood units.
• Overwrap is required for cord blood units stored in liquid nitrogen. Our cord blood units are stored in the vapour phase of LN2 which eliminates the risk of cross contamination.

• We store cryopreserved cord blood units in vacuum jacketed, high efficiency LN2 storage tanks. Specifically, Chart MVE HEco 1500 Series freezers.
• Cord Blood units are maintained at <-150°C, as per FACT and AABB requirements.
• LN2 tanks are monitored continuously for temperature and LN2 levels. Alarms will be triggered and appropriate staff notified, 24/7, if the temperature gets too warm or if the LN2 level gets too low.
• LN2 tanks are designated for either cord blood storage or cord tissue storage, i.e. only one product type per tank.

• Once processed, cryoprotectant is added to the cord blood cells and the sample is frozen using a controlled rate freezer with a defined freezing protocol.
• Once frozen, the cord blood is transferred to LN2 storage tanks for long-term storage. Our samples are maintained at approximately -185°C, in the vapour phase of nitrogen.

• A CryoCart is used to minimize transient warming events between the controlled-rate freezer and the storage tank.
  • A CryoCart is a portable work station, allowing samples to be moved and manipulated at <-150°C.

• Cord tissue is collected after the cord blood has been collected.
• A section of cord approximately 15–20 cm long is collected and placed into the provided specimen container.

• The cord tissue is cleaned, disinfected, and then cut into smaller uniformly sized pieces which are then placed into a cryoprotectant solution prior to cryopreservation.
• Cord tissue is cryopreserved in 5 cryovials.
• Individual cell types are not isolated prior to freezing. This provides flexibility and ensures that, at the time of use, the physician will be able to use the preferred mode of processing to prepare the cord tissue sample prior to infusion.

• We cryopreserve intact segments of cord tissue.
  • These segments of cord tissue contain MSCs and other cell types, including endothelial and epithelial cells, which may have therapeutic potential on their own.
  • Cryopreservation of intact cord tissue provides greater flexibility for downstream applications.
• Peristem uses a single cell suspension of MSCs extracted from the tissue surrounding the blood vessels of the baby’s umbilical cord. Therefore, the Peristem product does not include other cell types that may be valuable in the future.

• We have validated our cord tissue processing method and have confirmed viable MSCs can be cultured from the thawed cord tissue.
  • Cells were confirmed to be MSCs by immunostaining for MSC-specific markers.

• We communicate to our previous clients via email on a bi-monthly basis. We keep our clients informed about the latest scientific developments in cord blood in addition to offers and research.

• Excellent. We pride ourselves on having the largest Client Services team of all cord blood banks in Canada. We have a dedicated team on-call from 9-5 Monday to Friday.

• An SMS is sent to clients as soon as the cord blood unit arrives at our facility.
• A confirmation letter is emailed to clients confirming the arrival, processing and storage of their samples.

• Yes, if the sample does not meet our acceptance criteria, and a client does not want to store the sample, then a full refund of all monies paid is provided.

• The cord blood and/or cord tissue agreement does state that the annual storage fee is subject to an annual increase in July of each year.
• This increase is set based on the CPI set by Stats Canada each year.

• If there is a medical need for the stem cells for an approved therapy or clinical trial then there is no cost to the client for release or transport of the sample.
• Under the rare circumstance that a client wishes to transfer their cord blood unit to another bank, there may be costs associated with the release or transport of the sample.

• No, courier fees are additional. Fees will vary depending on your location.

• If you cancel your account for no apparent reason, you do not have to continue paying annual storage fees, however the prepaid portion of your samples would not be refunded.
• If you decided to transfer your cells to another institution, you would need to arrange this at your own cost.

• Yes. We offer a full refund of all monies paid if your cord blood or tissue is not collected or stored for any reason.

• We have multiple scientific and commercial partners that we work closely with. In the highly unlikely event this occurred, we would work to ensure that the samples are kept safe.

• Yes, we are accredited by both FACT and AABB. We are also compliant with Health Canada regulations.

• The quality and regulatory accreditations ensure we work to the highest standards of record keeping.
• The business is externally audited on average every other year by FACT, AABB or Health Canada who scrutinize our processes intensely.
• We also perform internal audits annually to ensure we meet standards and regulations and our staff are performing at a high level and adhere to standard operating procedures.

• Insception has always been compliant with Health Canada.
• As an organization we take our Health Canada regulatory responsibilities very seriously and work tirelessly to ensure we maintain our compliant status.

In December 2017, Cells for Life joined the international group of cord blood companies that comprises Cell Care in Australia and Insception Lifebank in Canada. We are processing ALL Cells for Life clients’ samples centrally at the Mississauga facility since March 2018. There is no impact on stored cord blood and tissue samples prior to the partnership. They continue to be stored at Core Cryolab to the same high quality standards.

• The combined International Group now creates one of the world’s top companies in the sector with over 11,000 new samples to be processed each year, and 150,000 samples stored.
• Through the additional scale and synergies achieved, the transaction will assist in funding clinical trials which will serve to grow the industry and contribute to increased uses for cord blood.
• Cells for Life and Insception Lifebank will both continue to operate in the market to provide health care professional and consumer education to expand the awareness of cord blood banking.

There is no evidence that COVID-19 can be transmitted through cord blood, nor is there evidence of intrauterine vertical transmission from the mother. Since cord blood collections require thorough screening of the mother (including medical history), the chance of any transmission via cord blood is considered extremely low to non-existent.

(Source:Qiao J et al (The Lancet 395); Chen H et al (The Lancet 395); MedPage ed. Feb 12
(Walker M))

Blood cells lack the binding sites required by the coronavirus to bind and replicate. The virus is focused on attacking the respiratory and digestive systems. Like the SARS virus, COVID-19 must enter a cell before it can start replicating. Access points for COVID-19 are indeed expressed almost all over the human body, but at high levels in the lungs and intestines, and in the oral and nasal mucosa and tongue.

Insception is not currently testing blood samples for COVID-19. Our Medical Questionnaire, completed by mothers prior to cord blood collection is being updated to request information related to the infection, including recent travel patterns and potential close contact with someone diagnosed with COVID-19. The responses will determine the requirement for follow
up testing.

NB: Blood cells (maternal, umbilical) lack the binding sites required by the coronavirus to bind and replicate.

While the COVID-19 situation continues to evolve, we are doing everything possible to maintain business as usual. If you have further questions, do not hesitate to contact our Client Services team 1-866-606-2790.