Scientists at the New York Blood Center's
National Cord Blood Program developed the concept of a full-service public bank of frozen, ready-to-use cord blood units donated by delivering mothers for use by any patient who might
need a stem cell transplant.
A brief overview of our Milestones includes:
- Drs. Pablo Rubinstein and Cladd E. Stevens of the New York Blood Center present the original
concept of public cord blood banking to the National Heart, Lung and Blood Institute (NHLBI)
of the National Institutes of Health (NIH). Their proposal is to assess
the practical feasibility of banking donated cord blood as an alternative source
of hematopoietic (blood-forming) stem cells and to investigate its
efficacy for bone marrow restoration in unrelated patient recipients.
- The New York Blood Center (NYBC) receives a three-year grant from NHLBI
(HL 48031), establishing the first Program for public cord blood banking.
The Program's first cord blood collection site opens in February at Mount Sinai Hospital in New York City. (Collections moved to
Brooklyn Hospital Center in 1997, increasing donations from ethnic minority mothers)
- NYBC's new Program provides the first two unrelated
cord blood units from its public inventory ever to be used for transplant The cord blood transplants
are performed on two pediatric patients by Dr. Joanne Kurtzberg at Duke University Hospital in August and September. These two cases are reported at an international transplant meeting in November and are published later in 1994.
Dr. Rubinstein and colleagues report the development of a process
for reducing the volume of cord blood units with minimal loss of
hematopoietic cells, allowing more than a five-fold reduction in storage
space and making the development of large inventories feasible.
- The U.S. Food and Drug Administration (FDA) grants the Program the
first Investigational New Drug (IND) exemption to collect, process,
store and provide cord blood as a stem cell source in clinical transplantation.
- Dr. Joanne Kurtzberg (with Drs. Rubinstein and Stevens) reports
the results of unrelated cord blood transplantation in her first
25 patients, published in the New England Journal of Medicine.
An analysis of results from the Program's first 562 transplant recipients is published
in the November 26th issue of the New England Journal of
Medicine. The study supported the usefulness of cord blood as a source of stem cells for hematopoietic stem cell transplant. In addition, the results suggested that the effectiveness of cord blood transplants depends, in part, on the cell dose and on the degree of matching for HLA antigens between the patient and the cord blood unit.
- The Program's second cord blood collection site opens at North Shore University Hospital in Manhasset, Long Island.
- The Program implements freezing and storage of cord blood units
in robotic freezers (BioArchive™, developed by ThermoGenesis Corporation with the help and advice of NCBP staff).
- The 1,000th patient receives a transplant using a matching cord blood unit from the Program's public inventory.
- The Starr Foundation grants the NY Blood Center's public cord blood banking Program $2 million over two years.
- In response to further encouraging scientific publications indicating that patient survival may improve with better tissue matching and higher cell dose, the NYBC begins to expand its Program by adding new collaborating hospitals for cord blood collection. The expanded Program is renamed the New York Blood Center's National Cord Blood Program (NCBP).
- NCBP's third and fourth cord blood collection sites open at Inova-Fairfax Hospital in Falls Church, Virginia and New York Presbyterian Hospital in New York City.
Mary Horowitz, M.D., Scientific Director of the International Bone
Marrow Transplant Registry (IBMTR), in collaboration with NCBP scientists,
presents the following data from an IBMTR-NCBP collaboration at the December 2001 meeting of the American Society of Hematology
(ASH): "A comparison of unrelated transplantation with cord blood and bone marrow
in children under age 16 with leukemia or
myelodysplasia."The study suggests that cord blood transplants with a 5/6 match or better (HLA-A, -B, DRB1) may have had outcomes similar to those of fully-matched bone marrow recipients.
- NCBP provides raw data to the U.S. Food and Drug Administration
(FDA) on the first 562 patients receiving cord blood from the Program's public inventory to help develop
guidelines for licensure of cord blood banking for clinical transplantation.
The Starr Foundation makes a second grant of $5 million over two years to the NYBC's National Cord Blood Program.
Dr. Rubinstein presents data on the outcome of transplants with
NCBP cord blood units to a U.S. FDA advisory panel considering cord blood licensure.
- On June 6th, the New York Blood Center's National Cord Blood Program receives NetCord-FACT (Foundation for Accreditation of Cell Therapy) accreditation,
becoming the first cord blood bank to be certified for compliance with the Netcord-FACT Standards.
Mary Laughlin, M.D., Case Western University, presents data from
an IBMTR-NCBP collaboration comparing unrelated
cord blood transplants in adults at the December ASH meeting. The outcomes of patients given cord blood units with one, two or more HLA mismatches were similar to those of bone marrow transplants with one mismatch. Patients who received fully matched (6/6) bone marrow from unrelated donors (so-called "MUD" transplants) did better. There were too few adult cord blood recipients of fully-matched cord blood for valid comparisons.
- The National Cord Blood Program celebrates its Tenth Anniversary, along with Mitch Santana,
the longest surviving recipient of an unrelated cord blood transplant in the world.
[See Mitch's story in Patients and Outcomes.]
- The Cord Blood Stem Cell Act of 2003 is drafted. The U.S. House of Representatives and the U.S. Senate introduce legislation to fund building a public inventory of 150,000 high quality, ethnically diverse cord blood units for transplantation to unrelated recipients. The legislation would create a network of public banks meeting the highest collection and preservation standards. The New York Blood Center's NCBP Directors, along with the ThermoGenesis Corporation worked with legislators for more than a year to help develop this legislation. Dr. Rubinstein (NCBP), Dr. Kurtzberg (Duke University), NCBP cord blood recipients Stephen Sprague and Keone Penn, along with Steve Barsh, whose son, Spencer, was a cord blood recipient, testify on behalf of the legislation at a Senate Subcommittee hearing chaired by Senator Sam Brownback (R-KS). Senator Arlen Specter (R-PA) subsequently initiates a $10 million appropriation to jump-start the legislation.
- Howard P. Milstein, Chair of the New York Blood Center Board of Trustees, pledges $1 million to the National Cord Blood Program.
- The F.M. Kirby Foundation, Inc. makes a $100,000 grant to develop a Website for the NCBP.
- NCBP's fifth cord blood collection site opens at MacDonald Hospital for Women, University Hospitals of Cleveland, Ohio.
- The NY Blood Center's National Cord Blood Program holds its first Physicians' Symposium (May) and Patient Workshop (October) on cord blood as an alternative to bone marrow for stem cell transplant.
- In April, at the request of Congress, the Institute of Medicine (IoM) issues a detailed report and recommendations regarding the possible structure and function of a National Cord Blood Stem Cell Bank Program.
- The November 25, 2004 issue of the New England Journal of Medicine contains four articles about cord blood and its potential benefit for adult transplant patients.
- In October, NCBP's sixth cord blood collection site opens at Long Island Jewish (LIJ) Medical Center in New Hyde Park, NY.
- In November, the NY Blood Center's National Cord Blood program joins our international colleagues in celebrating the recognition of the 10 millionth volunteer stem cell donor worldwide. These include both potential bone marrow donors as well as donated cord blood units already collected, in public inventories around the world. Together, these registries, including NCBP, have provided matching stem cells to over 55,000 patients in desperate need of transplant.
- On December 20th, President Bush signs the "Stem Cell Therapeutic and Research Act of 2005," passed earlier by unanimous votes in both the US House and Senate. This legislation authorizes $79M in new federal funding to establish a public cord blood banking network.
- In August, NCBP implemented automated processing cord blood units using the AutoXpress (AXP) platform. This advanced method allows for functionally closed processing, compliant with cGMP.
- A second meeting with FDA occurred on October 13th, where discussions clarified several important issues including the changes in processing technology and their consequences for the comparability of units prepared at different times.
- In January, the seventh cord blood collection site opens at Montefiore-Weiler Hospital in Bronx, New York.
- In March, Dr. Pablo Rubinstein updates FDA on progress in cord blood banking and transplantation including NCBP’s results in a presentation entitled: “Unrelated Cord Blood Transplantation: End of the Beginning (1992-2007)”.
- In June, Dr. Mary Eapen from the Center for International Blood and Marrow Transplant Research (CIBMTR), in collaboration with NCBP scientists publishes in the journal Lancet, “Outcomes of transplantation of unrelated donor umbilical cord blood and bone marrow in children with acute leukaemia: a comparison study”.
- In March, NCBP presented the Howard P. Milstein Symposium “Basic and Applied Research on the Nature and Use of Cord Blood, Hematopoietic and Related Stem and Progenitor Cells” at the main Auditorium at NYBC Headquarters.
- In May, NCBP opens the eighth cord blood collection site at Mount Sinai Hospital in New York City.
- NCBP joins in the celebration of the 20th Anniversary of the first Cord Blood Transplant by Prof. Eliane Gluckman, in Paris (1988) by participating in the International Conference on Biology and Clinical Applications of Cord Blood Cells, in Mandelieu, France, October, 16-20. NCBP’s presentation was entitled: “Role of HLA and Cell Dose in Cord Blood Transplantation”.
- In February, the NCBP receives NetCord-FACT re-accreditation.
- In May, the NCBP moves its Processing and Quality Control Laboratories and the Medical and Administration offices, to a new, state of the art, cGMP facility in Long Island City, New York.
- In June, NCBP and NMDP implement the Distributed Search, a unique application of Information Technology, enabling the participation of the NCBP in HRSA’s Single Point of Access, as an independent Bank. Distributed Search allows NCBP to respond to patients’ Search Requests through NMDP, within seconds, and the transplant centers to receive one search report with all potential matched units.
- HRSA agrees to extend its contract with NCBP for a third year.
- In November, in collaboration with Prof. Jon van Rood, NCBP publishes a groundbreaking article on NIMA: “Re-exposure of cord blood to noninherited maternal HLA antigens improves transplant outcome in hematological malignancies” in the Proc. Natl. Acad. Sci. USA.
- More than 53,000 public cord blood donations have been incorporated to the NCBP inventory since the inception of the Program.
- The 3,500th patient receives an unrelated cord blood transplant with a matched NCBP unit; more than 3,900 cord blood units shipped for clinical use to US and international transplant centers.
- The new WebSearch application is completed. It is being deployed in stages, after completing beta testing at one transplant center. Training of transplant and registry coordinators is ongoing.