Procedures for Banking

Enrollment Forms

There are four forms in the enrollment package: the Client Contact Information, Maternal Medical History Form, Informed Consent, and Enrollment Agreement. All four forms must be completed to fulfill the enrollment process. Select your preferred financing option and submit initial payment.  Once the enrollment process is complete, you will receive your cord blood collection kit to take to the hospital at the time of delivery.

In some cases, they fear that this collection process involves draining or removing some amount of blood from their baby's umbilical cord blood. Obviously this causes a lot of concern and fear about the possible harm to the baby or the mother during the collection of umbilical cord blood, and whether it might result in infections etc. The first thing to understand is that this collection of umbilical cord blood does not happen directly from the baby and does not include draining of any blood directly from the baby.

Two types of cord blood collection procedure are typically used: the bag method or the syringe method. Your care provider will decide which of these procedures is preferable in your situation.

The Bag Method

With the Bag Method, the caregiver should first wait for the umbilical cord to stop pulsating (usually less than 5 minutes for a natural delivery and up to 15 minutes for a medicated birth, including cesarean section), then clamp the cord and cut it. Once this is completed, the placenta and cord are elevated, using the forces of gravity to drain the blood from the placenta into the bag.

The Syringe Method

With the Syringe method, the caregiver should also wait for the umbilical cord to stop pulsating before then clamping and cutting it. Then, similar to the procedure used for a simple blood draw, an empty syringe is used to extra blood from the placenta and remaining cord.

In either method, the bag/syringe is pre-marked with a number specially coded to your baby. The collection must occur within the first fifteen minutes after birth. The laboratory should process the cord blood sample within two days.

Both methods should take less than five minutes to complete and should not cause you or the baby any discomfort. The collection procedure should not interfere with your birth or later bonding and can be performed after both cesarean sections and vaginal births. However, if delayed cord clamping is not performed as the first step, then the baby is at greater risk of anemia and other assorted complications due to unnecessary lack of blood volume. While delayed cord clamping is a research-based practice, many care providers will fail to follow this critical first step due to fear of obtaining less than 75ml of blood, the minimum required. However, the research supports that the newborn should receive as much blood volume as needed at birth, in which case it's preferable for the baby to receive the blood rather than a collection which in most cases will never be used.

OR

Maternal Blood Samples

Your physician will fill three vials of maternal blood for viral disease screenings required by the federal government.

Cord Blood Collection Procedure

Your physician will follow standard protocol in delivering your newborn baby. After a baby's birth, once the umbilical cord is clamped, a small amount of residual blood remains in the umbilical cord. This is collected into a special blood bag and then taken for storing and processing. As the collection of the umbilical cord blood happens after the baby's birth, it does not affect the baby's birth and also no harm is caused to the baby or the mother. Since collection of cord blood happens from the umbilical cord, the term 'umbilical cord blood' is being used. Collection of blood cells can happen from the umbilical cord even in the case of a C-section, which might sound surprising.

The blood thus collected is then mailed to the umbilical cord blood banks, where it will be tested for various eligibility criteria and then stored in deep freeze containers for future use. Once a person expresses his or her interest in donating the cord blood of their child, the expectant mother and the corresponding obstetrician or midwife are sent pamphlet and other materials to understand the process of collection of umbilical cord blood.

This way, the parents of the unborn child clearly understand what happens during the process. They should also consult their doctors to discuss their questions and any other details regarding the cord blood donation. Umbilical cord blood is found to be rich in stem cells that can generate a lot of blood cells. Collection of umbilical cord blood is a very easy, non-invasive and less time consuming process.

Cord Blood Collection Kit

On your delivery day, bring your complete cord blood collection kit to the hospital and give it to your physician.

Kit Contains

	Mother's Blood Draw Kit
	Donor Care Needle Guard
	Alcohol Wipes
	Betadine Swab stick
	Baxter Blood Collection Bag (250 mL) with CPD anticoagulant and 16 gauge needle
	C-Section Adapter Kit (sterile)
	Personalized Preprinted Barcode Labels
	Plastic zip bag with adhesive backing and absorbent towels

Transport by Experienced Medical Courier

After cord blood and maternal blood collection, call the toll-free 24-hour customer service number provided in your cord blood collection kit. An experienced medical courier will arrive at the hospital and transport your child's cord blood and maternal blood samples.

Laboratory Testing

Upon receipt of your cord and maternal blood, our laboratories will test for the viability of the stem cells and conduct viral disease screenings.

On Maternal Blood for Infectious Diseases
	HIV1/2
	VDRL
	HBsAg
	HCV
	CMV (Cytomegalovirus)
	HTLV I/I (Human T-Lymphotropic Virus)
On Cord Blood
	Pre & Post Nucleated Cell Count
	Cell Viability
	ABO & Rh
	CD34
	Bacteria Culture
	Fungal Culture

Cord Blood Processing

Volume Reduction can be accomplished either by sedimentation or spinning in a centrifuge. (Note: sedimentation uses a chemical called "Hespan Starch" or "Hetastarch".) Afterwards, the blood components are separated so that: red cells are on the bottom, plasma (a clear white liquid) is on top, and in the middle is a pinkish layer called the "buffy coat" which contains the white blood cells (WBC), including stem cells. At this point, a gentle spin in a centrifuge is sufficient to isolate the white blood cells (WBC). Most public banks stop processing at this point and store the WBC in bags.

Separation of mononuclear cells is accomplished by further centrifuge spinning of the white cells. One protocol for doing this which is routinely used by stem cell researchers is called "Ficoll-Hypaque" density gradient centrifuge. The separation step reduces the volume of the collection to only a few milliliters, which makes storage in vials feasible.

Mononuclear Cells

Hematopoietic stem cells are identified with a characteristic surface molecule called "CD34+", but only 1-2% of the MNC are actually stem cells. When parents bank cord blood, and they receive a follow-up lab report saying that so many billions of cells were stored, the lab is actually counting MNC, not stem cells. This is the standard medical procedure. Your cord blood cells will be processed by medical technologists specialized in handling and preparing stem cells for storage (cryopreservation) in liquid nitrogen.

Detailed Report

After your cord blood has been successfully stored, you will be mailed a certificate confirming that your child's cord blood has been successfully stored in our cryopreservation bank.

Cryopreservation

Cells should be cryopreserved by methods detailed in written procedures using reagents approved for human use. Methods should be well described in the medical literature or approved by an institutional review board. Non-human animal colloids should not be used.

Storage Temperature

After processing, cells should be stored within a temperature range of minus 196 degrees Celsius to minus 80 degrees Celsius. If the storage period exceeds one year, cells should be stored at a temperature of less than minus 130 degrees Celsius. Cells should be stored continuously in either a mechanical freezer or liquid nitrogen tank equipped with an audible alarm. Refrigeration devices used should be reserved for hematopoietic progenitor cells, other tissues intended for transplantation, and/or blood intended for transfusion. A backup system should be in place in the event of unexpected mechanical failure or liquid nitrogen loss.

Length of Storage

1. There is no evidence at present that cells stored at minus 196 degrees Celsius in an undisturbed manner lose either in vitro-determined viability or biological activity. Therefore, at the current time, no expiration date need be assigned to cord blood stored continuously under liquid nitrogen.

2. For specimens whose storage may have been compromised, assessment of the accepted in vitro correlates for transplant ability should be performed on similarly stored samples of the product prior to ablative therapy of the prospective patient. Such analyses may include colony growth assays, CD34 enumeration, viability testing, or other appropriate indices of viability acceptable to the transplant physician. Appropriate microbiologic assays should be performed. Results should be communicated to the physician responsible for the patient's care and documented.

Ongoing Storage

Your child's cord blood will remain safely cryopreserved in our laboratories.

Annual Storage Payment

Unless you elected to pay for the storage of your cord blood stem cells upfront, your storage payment will be due, each year, on the anniversary of your child's birth.

Labeling

The final product container should be labeled and/or tagged in accordance with Department of Health regulations for labeling hematopoietic progenitor cells found in 10 NYCRR Section 58-5.6(d)(4). The label should be legible and indelible and, at a minimum, should contain the donor's identification code and, if positive for any required tests for infectious disease markers (other than tests for CMV), a biohazard label.

Safeguards to Prevent Mix-Ups

The director should be responsible for implementing safeguards to prevent mix-up of specimens during collection and processing.

Sample retention

1. Two or more samples of cord blood should be retained from each donor in order to provide adequate material for confirmatory testing, additional HLA typing, and for other additional testing (other than genetic testing) that is currently not standard practice, but may become important as the field matures and more information is known about in vitro characteristics affecting component transplant ability. It may also be desirable to save similar samples from the mother's blood.

2. It is recommended that cellular samples be either physically stored with the actual component from which derived or under similar conditions. A system should be in place to ensure that the contents of the sample tube are actually derived from the cord blood product they intend to represent. Such assurance should be reflected in the standard operating procedures for preparation of cellular samples, labeling of sample tubes and storage containers, and for process control.

3. for all products still in storage or already transplanted, samples should be retained for an appropriate period of time. For discarded cord blood and for specimens used for research, samples need not be retained indefinitely and may be discarded at the time the cord blood is removed from inventory.

Release

At the time of release for infusion, a tag should be attached to the container bearing information sufficient for identification of the proper recipient and the component, and clearly listing any relevant product testing. In addition, information received after, during or as a result of the processing procedure, including, but not limited to, type and volume of any additive, method(s) of manipulation, and most recent test results, should be included on the container tag or packing slip.

Follow-up Information

As a participant in the Cord Blood program, new information about the use of stem cells will be sent to you to keep you thoroughly up to date on the latest advances and applications.

Congratulations! You now have the lifelong assurance that your child's preserved stem cells is available should your child or family members need it in the future!

There are no boundaries for the health of a baby!

The following is a list of countries with parents currently storing their baby's cord blood with SCGF.
SCGF is committed to helping parents from around the world successfully store their baby's cord blood. While we can receive cord blood from almost any country in the world, we now have joined with local partners in México, Panamá, Peru, and Venezuela.

Our carefully selected local partners will handle all the paperwork and logistics so that you can focus on your baby. If you are going to deliver in any other country, we provide you information about the procedures and fees.

NORTH AMERICA United States Canada Mexico ASIA China Japan Philippines Taiwan Singapore SOUTH AMERICA Brazil Columbia Peru Venezuela Ecuador

EUROPE Albania Austria Belgium Cyprus France Germany Gibraltar Italy Spain Switzerland United Kingdom Turkey OCEANIA Australia New Zealand

CENTRAL AMERICA Costa Rica Panama CARIBBEAN Dominican Republic Puerto Rico MIDDLE EAST Israel United Arab Emirates Turkey