Stemlife tomorrow s lifeline

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1 StemlifeTM Frequently Asked Questions TM Stemlife

2 1. COLLECTION OF CORD STEM CELLS Does Stemlife collect Cord Tissue? Absolutely. In fact, Stemlife provides the most advanced Cord Tissue collection and storage. This is offered in conjunction with collection and storage of your baby s cord blood. Cord tissue is a source of many cell types. Researchers have discovered that these stem cells play a major role in future clinical therapies using Regenerative Medicine. This research holds the promise of regenerating damaged tissue and organs by stimulating the body to heal itself. Trials are underway using these stem cells to treat debilitating conditions, such as heart disease, stroke, liver disease, Parkinson s disease and spinal cord injury. Processing and storage of the cord tissue is outsourced to Californian based FamilyCord in an exclusive Australian partnership with Stemlife. This is because there is no licence currently available in Australia for cord tissue banking. FamilyCord has been providing stem cell services for over 15 years and is a recognised leader in cord stem cell processing and storage. FamilyCord takes extra steps to give you more confidence with your cord tissue banking. The quantity and quality of your baby s tissue stem cells are verified before placing them into storage. The stem cells are extracted from the cord tissue into a solution because storing cells as a solution (rather than tissue segments) allows for superior cryopreservation that maximises cells for future use. A small sample of the solution is taken to perform expansion of your baby s cells to demonstrate that they can grow. Cell expansion provides important information about the quality of stem cells for future therapies. Family Cord will provide you with a photo certificate showing: 1. total cell count and viability (pre-freeze), 2. verified growth of the treatment-ready cells, and 3. photograph of the expanded MSC sample All arrangements for the cord tissue banking are organised and managed by Stemlife. How are my doctors and hospital informed? A letter is sent to your attending doctor and hospital to notify them of your decision to store your baby s cord blood and tissue with Stemlife. If a Stemlife collector is not involved it is the responsibility of the parents to ensure the collection kit is taken into the delivery suite/operating theatre and to remind the attending doctor/ midwife to collect the blood and tissue. If a Stemlife collector is involved with the collection, the parents will need to contact the collector when labour pains/contractions commence, to ensure the collector has adequate time to travel to the hospital. You will be provided with the collectors contact details well before your baby s due date. Is the cord blood collected before or after delivery of the placenta? At most hospitals and in most circumstances it will be prior to the delivery of the placenta. However, as the delivery of the placenta can occasionally be shorter than the required collection time, collection after delivery of the placenta may occur. Either method can be used and the volumes collected are generally comparable.

3 What storage container does Stemlife use? Vials or a bag? Stemlife collect and store in Closed System bags. Bags are more resistant to impact and handling. What equipment is provided in the kit for the Doctor/Collector? Are there any spares? All necessary equipment is provided in the collection kit. If the kit is accidently damaged or lost prior to the birth, please contact Stemlife immediately. Every effort will be made to replace the kit in sufficient time for the cord blood and tissue to be collected. What instruction tools are provided for the attending doctor? Cord blood and tissue collection are becoming more recognised as a regular part of the birthing process so most obstetricians and midwives are familiar with the process already. All attending doctors are offered education and familiarization sessions by Stemlife. Stemlife is committed to further inservice training for midwives and obstetricians where necessary. 2. SHIPPING & HANDLING Is shipping included in the contract? Yes. All shipping and handling costs for metropolitan and major regional centre hospitals are included in the Stemlife service price. A transport fee may be charged to cover additional courier costs from rural hospitals. A quote will be provided upon request. Does Stemlife provide secure chain-of-custody handling? Yes. Stemlife ensures that there is somebody responsible for the safety of the cord blood from the point of pick-up at the hospital through to placement in long-term storage facility. Does the laboratory operate on weekends? Stemlife s laboratory is operational 7 days a week. 3. LABORATORY TESTING & ACCREDITATION What tests are performed on the mother s blood? Stemlife tests for contamination, Hepatitis B and C, HIV, CMV, Syphilis and HTLV. If the mother s blood tests come back positive for any of the above, Stemlife will notify the mother s doctor for further clinical management. Will Stemlife notify us of any abnormal results? (Infectious disease markers) Yes. If there are any positive results from either the mother s blood sample or the cord material, the parents are notified immediately and confidentially, either by Stemlife or the doctor. If the cord product needs to be discarded, a refund of the remaining processing and storage component will apply. Is Stemlife accredited? Yes. Stemlife is fully licensed with the Therapeutic Goods Administration (TGA).

4 4. PROCESSING Is the blood stored whole or processed? Stemlife processes the cord blood product to extract the stem cells for long term storage. This ensures that the cord blood product (mainly stem cells) is in the best possible form for long term storage and subsequent usage. What is the minimum volume Stemlife will accept for storage? 20mls. Whilst the optimal volume is between 50ml and 150ml, Stemlife will store as little as 20ml, as improvement in expansion technology indicates that this volume is usable. Is the blood stored as a single unit or several samples? Stemlife stores the cord blood product in a dual storage system for greater safety and future flexibility. The main advantage is that dual sample storage allows for possible multiple utilisation for the child. 5. STORAGE FACILITY Does Stemlife operate its own storage facility? Stemlife operates its own long term storage facilities. There are two storage locations and both locations have back-up alarm, electricity generation and liquid nitrogen systems and 24 hour security. Dual storage facilities are available if desired, where your baby s stem cells can be stored at two separate sites as added security. Are the cord blood samples in a dedicated freezer? Yes. The vapour nitrogen freeze tanks are used solely for the purpose of storing Stemlife cord blood. No other material is stored in the tanks. Does Stemlife freeze in liquid or vapour phase nitrogen? Stemlife uses vapour phase nitrogen. This ensures no transmission of contaminates from the surface of one container to another. What type of notification will we receive upon Storage? Stemlife will provide you with confirmation when your baby s cord stem cells are safely stored in the long term storage facility. Processing results will also be advised. 6. COMPANY STABILITY Is the company involved in bio-technology research and development? No. Stemlife has no links with any research and development facility, nor will it undertake any stem cell research or development, whether embryonic, cord blood or adult in origin. Stemlife s sole purpose is to provide the most secure, safe, ethical collection and storage of your baby s cord blood stem cells. Stemlife holds this material in trust for you. We cannot and will not utilise or allow any other person, company or research facility to access your baby s blood product without your written authorisation.

5 What other medical services does the company perform? Stemlife provides no services other than cord blood and tissue collection, processing and storage. Who directs the day-to-day business of the company? Stemlife is managed day to day by a CEO with over 30 years experience in the finance industry. The CEO reports to a board of directors comprising scientists, specialist medical practitioners and leading businessmen, including a qualified accountant and hospital administrator with over 15 years experience in the hospital and medical environment. 7. CONSUMER RIGHTS In the event that Stemlife ever suffered financial difficulties, what would happen to my baby s stem cells? Stemlife has been operational since Over the last two years the company has built its own laboratory and expanded services to include cord tissue storage in partnership with a leading US cord and tissue banking company. In the unlikely event that Stemlife ever encountered financial difficulties, escrow arrangements with another cord blood bank will ensure cord blood product security. Part of each service fee received is allocated to a sinking fund for this purpose. If the storage fee is not paid, what happens to the cord stem cells? Stemlife will use its best endeavours to contact the parents (including guardians) by telephone and provide notification in writing that if fees are not paid by a designated date then the cord stem cells may be discarded 90 days thereafter. Does the company take ANY portion of the cord blood for proprietary purposes, or does 100% go into storage? 100% of the product is stored on behalf of your child. Are there any late enrolment fees charged? An additional fee may apply for late/ urgent enrolments. Please call Stemlife to discuss. What is the fee for a multiple pregnancy for cord blood samples from multiple births? There is a $750 discount for a multiple birth collection. If we have a second or subsequent baby, is there a discount? Yes, a discount of $250 applies to repeat clients. If the cord stem cell collection is unsuccessful for any reason, are parents offered any refunds? Yes. Respective refund amounts are detailed on the application form TM Stemlife