Lead sponsor for HR-2520 is Congressman Chris Smith (R, New Jersey). This legislation is similar in intent to S-681 which was recently introduced in the Senate by Senators Orrin Hatch (R, Utah), Arlen Specter (R, Pennsylvania), Chris Dodd (D, Connecticut), Sam Brownback (R, Kansas) and Tom Harkin (D, Iowa).

ThermoGenesis has actively supported this legislation since its initiation in 2003 and has assisted the evolution of this new stem cell therapy by introducing, in 1999, the BioArchive(R) System that is now used by the major cord blood stem cell banks in 25 countries. More than 75% of the cord blood stem cell transplants worldwide were provided by cord blood banks who have adopted the BioArchive technology. The BioArchive System is a computer-driven robotic system that allows users to cryopreserve and archive up to 3,626 units
of blood components in minus 196 degrees C liquid nitrogen. The BioArchive System can cryopreserve, archive and retrieve samples within liquid nitrogen without exposing the samples to detrimental transient warming events (TWE), which can reduce cell viability. Since January 2004, the Company has maintained a Master File on the BioArchive System with the FDA.

Landmark Legislation

According to Philip Coelho, CEO, "This landmark bi-partisan legislation is a healthcare milestone that will create an inventory that will be a national treasure. Cord blood stem cell transplants are already curing hundreds of U.S. patients from these otherwise lethal diseases each year. This 150,000-unit inventory will provide life saving stem cell transplants for the more than ten thousand patients each year who need them and cannot currently get them from the "walking donor" bone marrow registries (as disclosed in the GAO Report, October 2002). Mr. Coelho further noted that "recent peer review articles provide increasing evidence that stem cells residing in cord blood can differentiate into other tissues of the body, thereby becoming candidate cells to explore treatments such as diabetes, spinal cord damage and Parkinson's."

Diseases Treated

Neonatal cord blood stem cells are used in the treatment of more than 60 malignant, genetic and acquired blood diseases, such as leukemia, lymphoma, sickle cell anemia, thalassemia, and immunodeficiency (boy in the bubble). Cord blood as a source of stem cells is more rapidly available than bone marrow, and provides survival rates for patients with these usually fatal diseases that can be as good, or better, than those following adult donor bone marrow stem cell transplants.

History of Cord Blood Transplants

Following the first sibling-donor cord blood transplant in 1988, the NIH awarded Dr. Pablo Rubinstein a grant to develop the worlds first cord blood program at the New York Blood Center (NYBC), in order to establish the inventory of stem cell units necessary to provide unrelated, matched grafts for patients (1992). In 1993, Dr. Joanne Kurtzberg, Duke University Medical Center, performed the first two successful cord blood transplants, in the unrelated setting, one of which cured a patient with acute lymphoblastic leukemia (ALL). Currently, more than 6,000 unrelated transplants have been provided to patients worldwide.

FDA Regulation

By 1996, with more than 300 unrelated transplants accomplished, the FDA accepted the NYBC's request for an Investigational New Drug (IND) Exemption which allowed the expansion of the clinical use of cord blood under conditions that documented the critical processing protocols and the clinical outcome data which would allow the FDA to understand how best to regulate this promising cell therapy. Today, the FDA is preparing to license this cell therapy product and, therefore assure that this national inventory will be in compliance with the highest quality standards.

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