Bibliographic Source(s)

• American Academy of Pediatrics Section on Hematology/Oncology American Academy of Pediatrics Section on Allergy/Immunology Lubin BH Shearer WT. Cord blood banking for potential future transplantation. Pediatrics 2007 Jan;119(1):165-70. [62 references] PubMed

Guideline Status

This is the current release of the guideline.

All clinical reports and policy statements from the American Academy of Pediatrics automatically expire 5 years after publication unless reaffirmed revised or retired at or before that time.

Guideline Category

Counseling
Management

Intended Users

Physicians

Guideline Objective(s)

• To provide information to guide physicians in responding to parents' questions about cord blood donation and banking and the types and quality of cord blood banks
• To provide recommendations about appropriate ethical and operational standards including informed consent policies financial disclosures and conflict-of-interest policies for physicians institutions and organizations that operate or have a relationship with cord blood-banking programs

Target Population

Prospective parents seeking information on cord blood banking

Interventions and Practices Considered

1. Counseling of prospective parents about benefits and risks of cord blood banking and transplantation
2. Obtaining informed and written consent for cord blood donation
3. Cord blood banking (when there is knowledge of a full sibling in the family with a medical condition that could potentially benefit from cord blood transplantation)
4. Cord blood donation
5. Genetic and infectious disease testing of donated cord blood
6. Appropriate policies and procedures for cord blood collection processing and storage
7. Appropriate ethical and legal standards for cord blood banking including financial disclosures and conflict-of-interest polices for physicians and institutions

Major Outcomes Considered

Not stated

Methods Used to Collect/Select Evidence

Searches of Electronic Databases

Description of Methods used to Collect/Select the Evidence

Not stated

Number of Source Documents

Not stated

Methods Used to Assess the Quality and Strength of the Evidence

Not stated

Rating Scheme for the Strength of the Evidence

Not applicable

Methods Used to Analyze the Evidence

Review

Description of the Methods Used to Analyze the Evidence

Not stated

Methods Used to Formulate the Recommendations

Not stated

Rating Scheme for the Strength of the Recommendations

Not applicable

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation

Not stated

Description of Method of Guideline Validation

Not applicable

Major Recommendations

Cord blood transplantation has been shown to be curative in patients with a variety of serious diseases. Physicians should be familiar with the rationale for cord blood banking and with the types of cord blood-banking programs available. Physicians consulted by prospective parents about cord blood banking can provide the following information:

1. Cord blood donation should be discouraged when cord blood stored in a bank is to be directed for later personal or family use because most conditions that might be helped by cord blood stem cells already exist in the infant's cord blood (i.e. premalignant changes in stem cells). Physicians should be aware of the unsubstantiated claims of private cord blood banks made to future parents that promise to insure infants or family members against serious illnesses in the future by use of the stem cells contained in cord blood. Although not standard of care directed cord blood banking should be encouraged when there is knowledge of a full sibling in the family with a medical condition (malignant or genetic) that could potentially benefit from cord blood transplantation.
2. Cord blood donation should be encouraged when the cord blood is stored in a bank for public use. Parents should recognize that genetic (e.g. chromosomal abnormalities) and infectious disease testing is performed on the cord blood and that if abnormalities are identified they will be notified. Parents should also be informed that the cord blood banked in a public program may not be accessible for future private use.
3. Because there are no scientific data at the present time to support autologous cord blood banking and given the difficulty of making an accurate estimate of the need for autologous transplantation and the ready availability of allogeneic transplantation private storage of cord blood as "biological insurance" should be discouraged. Cord blood banks should comply with national accreditation standards developed by the Foundation for the Accreditation of Cellular Therapy (FACT) the US Food and Drug Administration (FDA) the Federal Trade Commission and similar state agencies. At a minimum physicians involved in procurement of cord blood should be aware of cord blood collection processing and storage procedures as shown in the table below.

Table. Recommended Procedures for Related and Unrelated Cord Blood Banking

Institutions or organizations (private or public) involved in cord blood banking should consider the following recommendations:

1. Cord blood-banking recruitment practices should be developed with an awareness of the possible emotional vulnerability of pregnant women and their families and friends. Efforts should be made to minimize the effect of this vulnerability on cord blood banking decisions.
2. Accurate information about the potential benefits and limitations of allogeneic and autologous cord blood banking and transplantation should be provided. Parents should be informed that autologous cord blood would not be used as a stem cell source if the donor developed leukemia later in life. Parents should recognize that there are no scientific data to support the claim that autologous cord blood is a tissue source proven to be of value for regenerative medical purposes. The current standard uses of cord blood transplantation are listed in the table below:

   Table: Disease Treatable with Umbilical Cord Blood Transplantation

   Malignancies Bone marrow failure Hemoglobinopathies Immunodeficiencies Inborn errors of metabolism

3. A policy should be developed by cord blood banks regarding disclosing to the parents any abnormal findings in the harvested blood.
4. Specific permission for maintaining demographic medical information should be obtained and the potential risks of breaches of confidentiality should be disclosed.
5. Written permission for obtaining cord blood should be obtained before onset of active labor.
6. If the cord blood bank is conducting research an institutional review board must review and approve recruitment strategies and consent forms.
7. Cord blood collection should not be performed in complicated deliveries. The cord blood stem cell–collection program should not alter routine practice for the timing of umbilical cord clamping.
8. Regulatory agencies (e.g. FDA Federal Trade Commission and state equivalents of these federal agencies) are encouraged to have an active role in providing oversight of the cord blood program. All cord blood–banking programs should comply with FACT or equivalent accreditation standards.
9. Physicians or other professionals who recruit pregnant women and their families for for-profit placental cord blood stem cell banking should disclose any financial interest or other potential conflict of interest they have in the procedure to their patients.
10. Professionals affiliated with institutions or organizations that promote for-profit placental blood stem cell banking should make annual financial-disclosure and potential-conflicts-of-interest statements to an appropriate institutional review committee that possesses oversight authority.
11. Targeted efforts should be made to recruit underserved minorities (black Hispanic American Indian/Alaska Native individuals) in public cord blood– banking programs to extend to them potential treatments afforded other segments of society.

Clinical Algorithm(s)

None provided

Type of Evidence supporting the Recommendations

The type of evidence supporting the recommendations is not specifically stated.

Potential Benefits

• Appropriate counseling for parents seeking information about cord blood donation and banking
• Appropriate ethical and operational standards for cord blood-banking programs

Potential Harms

Not stated

Description of Implementation Strategy

An implementation strategy was not provided.

IOM Care Need

Staying Healthy

IOM Domain

Effectiveness
Patient-centeredness

Bibliographic Source(s)

• American Academy of Pediatrics Section on Hematology/Oncology American Academy of Pediatrics Section on Allergy/Immunology Lubin BH Shearer WT. Cord blood banking for potential future transplantation. Pediatrics 2007 Jan;119(1):165-70. [62 references] PubMed

Adaptation

Not applicable: The guideline was not adapted from another source.

Source(s) of Funding

American Academy of Pediatrics

Guideline Committee

Section on Hematology/Oncology

Section on Allergy/Immunology

Composition of Group that Authored the Guideline

Writing Panel: Mitchell S. Cairo MD; Joanne Kurtzberg MD; *Bertram H. Lubin MD; *William T. Shearer MD PhD

Section on Hematology/Oncology 2005-2006: Stephen A. Feig MD Chairperson; James J. Corrigan MD; Alan S. Gamis MD; Eric D. Kodish MD; Peter A. Lane MD; John J. Hutter MD; Roger L. Berkow MD Immediate Past Chairperson; Mitchell S. Cairo MD Past Executive Committee Member

Liaisons: Naomi L. Lubin MD American Association of Blood Banks; Edwin N. Forman MD Childhood Cancer Alliance

Staff: Laura Laskosz MPH

Section on Allergy/Immunology 2005-2006: Paul V. Williams MD Chairperson; Bradley E. Chipps MD; Mary B. Fasano MD; Mitchell R. Lester MD; Scott H. Sicherer MD; Frank S. Virant MD; Sami L. Bahna MD; Michael J. Welch MD Immediate Past Chairperson

Liaisons: Gary S. Rachelefsky MD American Academy of Allergy Asthma and Immunology; Todd A. Mahr MD American College of Allergy Asthma and Immunology

Staff: Pamela T. Kanda MPH

*Lead authors

Financial Disclosures/Conflicts of Interest

Not stated

Guideline Status

This is the current release of the guideline.

All clinical reports and policy statements from the American Academy of Pediatrics automatically expire 5 years after publication unless reaffirmed revised or retired at or before that time.

Guideline Availability

Electronic copies: Available from the American Academy of Pediatrics (AAP) Policy Web site.

Print copies: Available from American Academy of Pediatrics 141 Northwest Point Blvd. P.O. Box 927 Elk Grove Village IL 60009-0927.

Availability of Companion Documents

None available

Patient Resources

None available

NGC STATUS

This NGC summary was completed by ECRI on April 20 2007. The information was verified by the guideline developer on April 23 2007.

COPYRIGHT STATEMENT

This NGC summary is based on the original guideline which is subject to the guideline developer's copyright restrictions. Please contact the Permissions Editor American Academy of Pediatrics (AAP) 141 Northwest Point Blvd Elk Grove Village IL 60007.

NGC Disclaimer

The National Guideline Clearinghouse™ (NGC) does not develop produce approve or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced under the auspices of medical specialty societies relevant professional associations public or private organizations other government agencies health care organizations or plans and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline developers and are screened solely to determine that they meet the NGC Inclusion Criteria which may be found at http://www.guideline.gov/about/inclusion.aspx .

NGC AHRQ and its contractor ECRI Institute make no warranties concerning the content or clinical efficacy or effectiveness of the clinical practice guidelines and related materials represented on this site. Moreover the views and opinions of developers or authors of guidelines represented on this site do not necessarily state or reflect those of NGC AHRQ or its contractor ECRI Institute and inclusion or hosting of guidelines in NGC may not be used for advertising or commercial endorsement purposes.

Readers with questions regarding guideline content are directed to contact the guideline developer.