SPECIAL REPORT

Sources of Stem Cells

The two broad types of stem cells found in people are adult stems cells and embryonic stem cells.

Adult stem cells

• Cord blood, umbilical cord blood
• Bone marrow
• Blood, peripheral blood stem cells
• Menstrual blood
• Skin
• Teeth
• Placental tissue

All of these sources of adult stem cells share some characteristics. Others are unique and options are being researched daily.

Embryonic stem cells

• Human embryos
• Fetal tissue

What is the importance of where stem cells come from?

Today, the most common medical treatment using stem cells are transplants to patients with serious diseases of the blood, such as Leukemia or Lymphoma. These diseases can progress rapidly. If the patient's physician believes a transplant offers the best chance of recovery for the patient, it can literally be a race against time to find a donor match.

A transplant patient needs stem cells that match their own tissue type as closely as possible. This is called an HLA match. Stem cells from a relative are always the best source for a match. The better the match, the less likely the patient will experience some of the most serious side effects associated with transplants.

Another source for collecting stems cells comes from umbilical cord blood. This is the blood remaining in the umbilical cord and placenta of a newborn baby. These healthy blood-forming cells can be collected immediately after childbirth and stored at a cord blood bank. If the parents elect private cord blood banking, the umbilical cord blood is sent to the cord blood bank via a medical courier for processing and storage. A sample of the cord blood specimen is then readily available to a transplant surgeon.

When stem cells for a patient are not available from their family's specimen stored at a private cord blood bank, a search is done to find a match using a public source.

There are areas to consider with each option.

What are the pros and cons of each?

Private Cord Blood Banking
Pros

• Umbilical cord blood is preserved at birth for future use by your family.
• Umbilical cord blood stem cells can be a life-saving treatment option. Thousands of transplants have been performed with this type of stem cell.
• The stem cells are always readily available for transplant, should they be needed by your family.
• Studies show cells should be medically viable for decades.
• Diseases requiring treatment with these stem cells are progressive, meaning the short time needed to retrieve your family's stem cells could be a life saver.
• When used for transplant, the most common complications are less likely to occur than in transplants done using bone marrow stem cells.
• No one outside of your family can decide to dispose of these cells, give them away or use them for research.
• A transplant of these cells can be made to that child, or often to a brother or sister.
• Sometimes parents have been able to receive the stem cells for a transplant. In rare cases, another relative may be able to receive them as well.
• The peace of mind provided by having the cells available is priceless.
• Ethnic minorities or ethnically mixed couples are underrepresented in public banks, meaning they would have a lesser chance of finding a suitable match should the cells be needed for transplants.
• Births involving adoptions, a sperm donor, or a surrogate mother offer only one opportunity to obtain umbilical cord blood stem cells that perfectly match the child.
• Couples who have experienced difficulty conceiving a child may not be planning to have other children, offering only one opportunity to obtain umbilical cord blood stem cells that perfectly match the child.
• Insurance may pay for associated expenses if the cells are used for transplant.

Cons

• There is a financial cost to have the cells collected, processed and stored.

Donation to a Public Cord Blood Bank, or for Research
Pros

• The stem cells could be a match to someone searching the public registries because they need a transplant.
• The cells are not discarded as medical waste, but rather used to help people.
• There is often no cost to the parents for public donation.
• Parents are sometimes able to specify that their child's donated stem cells be used only for transplant, research, or either.

Cons

• Parents have no right to use the donated stem cells.
• If the family were to need the stem cells in the future they would not necessarily be available.
• Obtaining a donated specimen from a public bank is often $35,000 or higher.
• The Board on Health Sciences Policy made a recommendation that parents considering public donation should not be given the impression that the unit will be available after donation¹.
• In one survey, almost one-half of respondents said the reason they donated their cord blood to a public bank was to protect their child's future health. Unfortunately, the specimens are rarely available to family that donated them.
• Misconceptions about the collection process, the associated risks, and the availability and access of the stem cells are common among cord blood bank donors.
• Donations are often suggested after the mother has gone into labor.
• Public banks rely largely on grant funding. When grant funds lapse to pay for the collection of new stem cell specimens, the donation program is unable to accept new donations.
• Processing the specimen is more expensive for public banks, because full tissue typing must be done at the time of processing in order to be useful as an anonymous specimen to the thousands of people searching the database for a match.

Bone Marrow as a Source of Stem Cells

For a patient needing a transplant, but with no access to umbilical cord blood stem cells, a bone marrow transplant may save their life.

Bone marrow is the tissue that makes blood cells. When stem cells are needed from a bone marrow donor, the aspiration procedure uses a special needle inserted into the bone to collect the cells. Although the procedure is uncomfortable it can be tolerated by both children and adults. The collection site is often the back of the hip bone. For stem cell transplants, aspiration will likely be done in several locations to ensure plenty of stem cells are available for the transplant.

See illustration of the procedure:
http://www.nlm.nih.gov/medlineplus/ency/imagepages/1129.htm

Pros

• A donor may be found to help the patient, which increases their chance of survival from roughly 0 to 15% without a transplant to 30 to 60% with a transplant from an unrelated donor.
• The public banking community is committed to serving the needs of patients needing donors. Thousands of transplants have been completed in the past twenty years.

Cons

• Once a possible match is found, the average time for a donor workup is four to six weeks.
• Not everyone is successful at finding a match. On any given day, 6,000 people are searching the registry for a donor.
• Ethnic minorities or ethnically mixed couples are underrepresented in public registries, meaning they would have a lesser chance of finding a suitable donor.
• The donation process is not without pain for the donor. While complications are not common, they include:
• • Excessive bleeding, particularly in people with a low platelet count or people taking aspirin or anticoagulants, such as Warfarin
  • Infection, especially in people with compromised immune systems
  • Breaking of needles within the bone, which may cause infection or bleeding
  • Penetration of the breastbone (sternum) during sternal aspirations, which can cause heart or lung problems
  • Long-lasting pain
  • Complications related to IV sedation, such as an allergic reaction, nausea or irregular heartbeats

Sources:

http://www.mayoclinic.com/health/bone-marrow-biopsy/CA00068
http://www.webmd.com/a-to-z-guides/bone-marrow-aspiration-and-biopsy
http://www.marrow.org/ABOUT/Need_for_Donors/index.html
http://www.marrow.org/DONOR/When_You_re_Asked_to_Donate_fo/PDF/now_youre_a_match.pdf

Peripheral Blood Stem Cell as a Source of Stem Cells

The patient's physician may find a donor for peripheral blood stem cells (PBSCs) or he or she may determine this source of stem cell is preferable to bone marrow for a particular case. Similar to the process of finding a donor for bone marrow, registries are searched for a suitable match.

Blood circulating through the body does not typically contain enough blood-forming cells for a transplant, so the donor receives the drug Filgrastim to move more stem cells from the bone marrow into the bloodstream. Filgrastim is administered daily by injection for five days prior to collection.

The process of collection is called aphaeresis. A needle is placed into each of the donor's arms. Blood will be removed from a vein in one arm and passed through tubing into a blood cell separator machine. The blood is spun at high speed and the cells separate into layers.

The machine collects blood-forming cells, platelets and some white blood cells. Plasma and red blood cells are returned to the donor through the other arm while the blood-forming cells are put into a collection bag. One aphaeresis donation may take up to eight hours. Sometimes two donations are done on separate days, with each collection taking four to six hours.

Pros

• A donor may be found, increasing a patient's chance of survival from roughly 0 to 15% without a transplant to 30 to 60% with a transplant from an unrelated donor.
• The public banking community is committed to serving the needs of patients needing donors. Thousands of transplants have been completed in the past twenty years.

Cons

• Once a possible match is found, the average time for a donor workup is four to six weeks.
• Not everyone is successful at finding a match. On any given day, 6,000 people are searching the registry for a donor.
• Ethnic minorities or ethnically mixed couples are underrepresented in public registries, meaning they would have a lesser chance of finding a suitable donor.
• The donation process has some side effects for the donor, but they are typically not serious and most PBSC donors report full recovery within one week of donation. Serious complications occur in less than 1% of PBSC donors.

Source:

http://www.marrow.org/DONOR/When_You_re_Asked_to_Donate_fo/PDF/now_youre_a_match.pdf

What criteria should private cord blood banks maintain for the highest quality?

When considering cord blood banking it is important make an informed decision based upon the following criterion, including:

• Accreditation - Food and Drug Administration (FDA) registration, Advancing Transfusion and Cellular Therapy Worldwide (AABB) accreditation & International Organization for Standardization (ISO) certification
• Cost - fixed cord blood processing costs, annual fees, payment programs & cord blood preservation guarantees
• Business model - sustained, secure and profitable business operations (eg. ISO Class 7 Room Cord Blood Storage Facility)
• Successful Procedures - the cord blood bank should have a proven track record of successful use in a real world situation (eg. successful blood transfusions)
• Clinical support - 24/7 support staff and a personal medical courier service

The FDA is a government run agency responsible for enforcing safety guidelines associated with regulation of foods, drugs, supplements, biological products and blood products (eg. cord blood). Visit www.fda.org for more information.

The AABB is an international institution that represents institutions and institutions involved in activities related to cellular therapies and blood transfusion. Since the associations founding in 1947, member facilities have been responsible for processing over 80% of blood and blood components in the United States. Visit www.aabb.org for more information.

The ISO is the world’s largest developer and publisher of international standards. The non-governmental organization has instituted specific requirements in over 150 countries, inclusive of mandating cord blood banking criterion. Visit www.iso.org for more information.

Comparison of Leading Cord Blood Banks 2

		Cord Blood Registry, Inc.	Viacord
Year Established	1989	1995	1993
Superior Quality with all of the following:   . FDA Registered   . cGMP/cGTP- compliant3   . AABB accredited   . ISO 9001:2000 certified	Yes	No	No
24/7 Clinical Support	Yes	No	Yes
Approximate number of clients	Over 150,000 Worldwide	Over 180,000	Over 110,000
First Year Fees for Cord Blood Service:     Processing & Testing Fee +     Shipping (U.S. & Puerto Rico only) +     Annual Storage Fee Total	$1,595 + 0 + $125 ------- $1,720	$1,875 + $150 + $125 -------- $2,150	$1,845 + $150 + $125 -------- $2,120
Successful Transplants	Yes	Yes	Yes
Money back for college	Yes	No	No
$50,000 Guarantee4	Yes	Yes	No
$10,000 Cryo-Cell CaresT Payment Program4	Yes	No	No
Client for LifeT Program4 (Locked in pricing for returning clients)	Yes	No	No

¹ Cord Blood: Establishing a National Hematopoietic Stem Cell Bank Program; Recommendation 5.3, page 111.

²This information was accurate as of August, 2007.

³Why is cGMP/cGTP compliance important? cGMP and cGTP are standards established by the FDA. In May 2005, FDA established current Good Tissue Practices (cGTPs) for cord blood banks. Cryo-Cell exceeds FDA requirements by operating a cGMP/cGTP compliant facility.

⁴See Cryo-Cell's Features & Benefits page for more details. Certain terms and conditions apply, as outlined in their U-Cord® service Contract.