Each year thousands of patients are diagnosed with a disease that might have to be treated with hematopoietic or blood stem cell transplant. Traditionally, these stem cells come from bone marrow donation, from either a relative or from an unrelated volunteer donor.
Most patients, however, have no relative that matches their HLA tissue type. Other patients don't have enough time to find an unrelated bone marrow donor due to the rapid progression of their disease.
Cord blood is now another option.
Cord blood donations have been used to treat over 70 different diseases. There have been about 16,000 cord blood transplants throughout the world.
The Tel Hashomer (Sheba) Cord Blood Bank was founded in 2001.
Cord Blood Bank performs allogeneic unrelated cord blood collection and banking from voluntary donors.
The Cord Blood Bank consists of an integral team and operates in compliance with local and national licensing requirements, all applicable governmental regulation and international standards for cord blood collection, processing, testing, banking, selection and release.
Cord blood units are currently collected at the largest obstetric department in Israel, which is located at the Tel Hashomer (Sheba) Medical Center.
Separate areas are maintained for processing and stored of cord blood units and have limit access to authorized individuals. A special monitoring and alarm system secures both the Processing Laboratory and the function of the Storage Rooms.
Laboratory analysis concerning the CB units and the mother are performed at the laboratories of the Tel Hashomer (Sheba) Medical Center.
Each unit is tested for the number of nucleated cells, CD34+ cell number colony forming cells (CFU), ABO blood group and Rh type, hemoglobinopathy, HLA type and bacterial culture.
The cord blood unit and the mother are also tested for certain transmissible infectious diseases.
All laboratories utilized for testing on mother and child are accredited and certified by the Israel Laboratory Accreditation Authority. The Tissue Typing Laboratory is accredited by the European Foundation of Immunogenetics (EFI).
We are committed to providing high quality cord blood units and promoting high standards in cord blood banking.
In 2002 was performed the first cord blood transplantation from a cord blood unit harvested and frozen down at the Tel Hashomer (Sheba) Cord Blood Bank. The cord blood unit was transplanted in a child with Fanconi's Anemia.
Now our Cord Blood Bank has approximately 3,000 cord blood units banked and has released 48 cord blood units for cord blood transplantation.
There is no cost for donating. The unrelated donor cord blood bank will take care of the procedure and will cover the cost of processing and storing your baby's cord blood unit.
Prof. Arnon Nagler has headed Tel Hashomer (Sheba) Cord Blood Bank since 2001.
Dr. Nagler is a Professor Medicine at Tel-Aviv University, Director of Hematology at Chaim Sheba Medical Center, Tel-Hashomer and is also Director of Bone Marrow Transplantation
Professor Nagler is founding member of NetCord and EuroCord (the European network of cord blood banks and transplants) and is a formal cord blood inspection of the FACHT/NetCord organization.
Cord Blood Collection
Although some patients have family members who can donate stem cells, nearly 75% of patients will not find a matching donor in their family. Cord blood donation can give more patients hope by finding a suitable donor.
Cord Blood Unit is the nucleated cells including stem and hematopoietic progenitor cells
harvested from placental and umbilical cord blood vessels from placenta after the infant has been delivered and separated from the umbilical cord.
The cord blood is collected only with the mother's signed consent.
Collecting of the cord blood poses no health risk either to the mother or to the infant donor.
No collection is made if there are any complications during delivery.
To collect the cord blood remaining in the umbilical vein and placenta, the cord blood collector uses a sterile blood collection bag set with attached needle and punctures the cleaned surface of the cord with the needle to enter the umbilical vein. The cord drains through the tubing into the bag by gravity.
Cord blood can be donated only if the mother and infant are eligible.
Cord blood cannot be collected:
1. When the mother had an infectious disease during pregnancy that could have been transmitted to the infant before or during birth.
2. There is a family history of genetic disease that might be present in the baby.
3. The pregnancy was the result of an egg or sperm donation.
4. The infant has one of several genetic or inherited diseases.
Cord Blood Processing
Processing involves a series of steps to remove excess red blood cells (RBC's) and plasma and bring each collection down to a uniform single unit volume of 20 ml.
The processing is performed by an automated Sepax system. This system allows the fast, automated and reproducible processing of blood component in a functionally-closed and sterile environment.
The uniform single unit volume contains nearly all of the mononuclear blood cells present in the original collection, including the hematopoietic (blood-forming) stem cells. We combine this cell suspension with a preservative (DMSO) that protects the cells from damage during freezing. The "cryoprotected" cells are then transferred to a specially designed freezer bag.
Each cord blood unit is frozen using a controlled rate freezing. A record of the freezing curve is maintained on each unit.
Processing must be completed and cord blood units frozen within 36 hours of collection.
Frozen cord blood units are maintained in quarantine storage until infectious disease test results and bacterial culture test results are obtained.
After that cord blood units are released from quarantine and placed in permanent storage in liquid nitrogen.
Storage devices for cord blood units and associated samples have alarm systems that are continuously active. The storage freezers are connected to the Security Department of the Sheba Medical Center and under supervision during 24 hours.
Shipping the cord blood unit for transplantation
After one or more cord blood units have been selected for transplantation, the Transplant Center may request shipment, on a specific date, scheduled to arrive before the patient begins conditioning to prepare for the transplant. For shipment, the unit is placed in a CryoShipper, a cylindrical container that stores liquid nitrogen within the shipper's honey-combed walls and maintains the inside temperature under minus 150°C for up to 7 days. A temperature monitor measures continuously and documents the temperature inside the shipper.
1.National Marrow Donor Program (NMDP), member
The NMDP is one of the largest and most prestigious bone marrow and stem cell registry in the United States.
Membership as a NMDP Cord Blood Bank requires a rigorous accreditation process.
The NMDP registry lists more than 185,000 cord blood units collected, every cord blood bank that joins to NMDP meets and maintains strict standards.
Since its accreditation in May 2005 on the Tel Hashomer Cord Blood Bank in one of the two European cord blood banks in the NMDP.
2. AABB (American Association of Blood Banks)
Sheba Cord Blood Bank having been assessed by AABB has been found to meet the requirement of applicable Standards of this organization and therefore is granted this Certificate of Accreditation.
Sheba Cord Blood Bank having been assessed by FACT/NETCORD has been found to meet the requirement of applicable Standards of this organization and therefore is granted this Certificate of Accreditation. The FACT Standards promote improvement and progress in cellular therapy. Meeting these requirements demonstrates a commitment to controlling every aspect that impacts the quality of products and therapeutic care.
4. FDA: Sheba Cord Blood bank is register with the U.S. Food and Drug Administration (FDA).
Under HCT/P regulations, "Manufacture means, but is not limited to, any or all steps in the recovery, processing, storage, labeling, packaging, or distribution" of an HCT/P, as well as the screening or testing of the donor 21 C.F.R. § 1271.3(e)