National Cord Blood Program

The United States has a national program of coordinating cord blood donations for the public benefit.  A medical patient who needs a matching cord blood transplant can rest assured that the federal government has created a Cord Blood Coordinating Center which will search all the international cord blood registries on behalf of a patient.

Behind the scenes, public cord blood banks are in competition with each other to have their cord blood units preferentially chosen by transplant doctors.  Just because most of them are non-profit organizations does not mean they are not competitive.  Also, some public banks have adopted a for-profit business model, which spares them from being constantly at the mercy of government funding. 

This page endeavors to give a very brief overview of the main elements in the history and current structure of public banking in the United States. 

• NYBC: NY Blood Center
• NMDP: National Marrow Donor Program
  
• Congress2003: Cord Blood Stem Cell Act of 2003
• IoM: Institute of Medicine Report 2005
• Congress2005: Stem Cell Therapeutic and Research Act of 2005
• HRSA: C.W. Bill Young Program
• ...the future...

The NY Blood Center, led by Dr. Pablo Rubinstein, was the world's first public cord blood bank, started in the early 1990's with a grant from NIH.  Dr. Rubinstein is a living legend in the field of cord blood transplantation.  To this day (2009), many cord blood banks around the world say that they process cord blood "with the Rubinstein method" (which means manual processing, using sedimentation followed by light centrifuge).

For many years, the NY Blood Center could claim to have provided the majority of cord blood transplants world-wide.  They are a founding member of the NetCord international network of cord blood banks.  As of June 2009, they are still the world's largest individual public bank, with an inventory of about 50,000 cord blood collections.

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Many people have the impression that the NMDP is a government agency, but in fact they are a non-profit organization which receives funding from the federal Health Resources and Services Administration.  As of spring 2009, the NMDP has re-branded itself as Be The Match.

The NMDP began in the 1986 as an organization created to register volunteer bone marrow donors.  The NMDP has always receiving significant funding from the DoD, due to concerns that military personnel exposed to massive amounts of radiation would need stem cell transplants.  In 1999, the NMDP began to also operate a registry (or data base) of cord blood donations.  The cord blood donations listed on the NMDP registry are actually located around the country at a network of "participating" public cord blood banks.  Most of the big public cord blood banks participate in the NMDP network, with the exception of the NY Blood Center, which has always been fiercely independent.  As of June 2009, the NMDP inventory of cord blood donations was about 102,000.

The legislation which authorizes the national network of cord blood banks has to be re-issued and re-competed every few years.  So far it has always passed and the award for the program has always gone to the NMDP.  The actual size of the budget may fluctuate due to political pressures.

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In 2003, bills were introduced in both the House of Representatives (H.R. 2852) and the Senate (S. 1717) to establish a national program of public cord blood banks.  Use the Library of Congress website "Thomas" to look up the full text of any Congressional legislation.

Unfortunately, this legislation became bogged down in rivalry between the NY Blood Center (NYBC) and the National Marrow Donor Program (NMDP), both of whom wished to control the national cord blood program. 

To clarify these issues, on 23 Jan 2004 Congress commissioned an Institute of Medicine (IoM) study to make recommendations on the ideal structure of a national cord blood program.   The National Academy of Sciences assembled an IoM Committee and held a series of meetings on 2 June,  18-19 August,  29 Sept 2004, and 15 Dec 2004.

The Institute of Medicine released their report, "Establishing a National Hematopoietic Stem Cell Bank Program", at 4PM EST, 14 April 2005.  The IoM did not side with either the NYBC or the NMDP, but set a course down the middle.  

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The IoM report of April 2005 establishes the framework of the national cord blood program which was signed into law in Dec of that year.  Here is an abbreviated summary of the report:

• The primary goal of the national program is to maximize patient access in the most efficient, cost-effective, and ethical manner possible.
• The U.S. Department of Health and Human Services (DHHS) should establish a new National Cord Blood Policy Board to set rules for the donation, collection, and use of this resource.
• The new National Cord Blood Policy Board should be established at the level of the DHHS Secretary to ensure that it is distanced from other HHS programs (such as NMDP).
• The HHS dept HRSA should solicit proposals for a new Cord Blood Coordinating Center to manage daily operations of cord blood banking and allocation nationwide.
• No current organization has all the necessary capabilities to serve as the Cord Blood Coordinating Center (this implicitly means neither NMDP nor NYBC).
• In particular, techniques of HLA typing and measures of quality control both need to be standardized.
• Cord blood donors must give fully informed consent prior to delivery.
• The FDA should move "promptly" to license cord blood.
• The majority of funding available for the national cord blood bank program should be targeted to expanding the inventories of participating banks.
• According to an economic analysis conducted for the study, the point at which the costs of banking exceed the benefits for the patient population is 200,000 units.

Links to the report chapters (each link opens PDF-file in a new window):

Title Page
Cast and Contents
Executive Summary
Chapter 1. Introduction
Chapter 2. HPC Transplantation
Chapter 3. Research on HPC Uses
Chapter 4. Banks and Banking 
Chapter 5. Ethical and Legal Issues
Chapter 6. National Inventory
Chapter 7. Proposed National Structure


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Following the release of the IoM report, new stem cell bills were introduced into the 2005 session of Congress (H.R. 2520 & S. 1317).  These bills re-authorized the bone marrow budget of NMDP and established a parallel cord blood program.  In the waning days of 2005, the NYBC and NMDP finally reached a compromise which allowed the bills to pass unanimously under a suspension of rules.  President George W. Bush signed it into law on 20 Dec 2005.  The official title of the program is the "C.W. Bill Young Cell Transplantation Program."

As a result of this legislation, HRSA released a series of Requests for Proposal (RFPs) to award the following contracts:

1. Participating Cord Blood Banks
2. Bone Marrow Coordinating Center
   
3. Cord Blood Coordinating Center
4. Single-Point of Patient Access (in case 2. and 3. are won by different organizations)
5. Outcomes Database
6. Office of Patient Advocacy

Surprisingly enough, these contracts were all won by the NMDP or its affiliates.  For example, the Outcomes Database is managed by CIBMTR.  Starting in 2007, up to 5% of annual funds in the program may be given to a federal Related Donor Cord Blood Program.  HRSA also established an Advisory Council on Blood Stem Cell Transplantation to oversee the program.