Press Release Source: CRYO-CELL International, Inc.

U.S. House Passes HR 2520 — Bill Would Allocate $79 Million for Cord Blood Banking & Stem Cell Research

Tuesday May 31, 5:19 pm ET

If Enacted, CRYO-CELL Could Potentially Benefit on Multiple Dimensions

OLDSMAR, Fla., May 31 /PRNewswire-FirstCall/ — On Tuesday, May 24, the U.S. House of Representatives, with a vote of 430 to 1, passed bill HR 2520: Stem Cell Therapeutic and Research Act of 2005. HR 2520 allocates $79 million to compile a national inventory of 150,000 high-quality cord blood units for transplantation. The bill also contemplates the collection of cord blood units for stem cell research.

If the legislation is passed by the Senate and becomes law, CRYO-CELL believes that the Company could potentially benefit on multiple dimensions. First, as public awareness on the value of cord blood is heightened, expectant families may likely become increasingly interested in family stem cell banking. In turn, as research utilizing cord blood cells emerges that may prove successful in potentially treating diseases that afflict vast portions of the population; this should further enhance the perceived future value of cord blood stem cell preservation, which could also serve to significantly broaden participation in stem cell banking.

Under terms of the proposed legislation, the government will utilize a portion of the funding to establish one-time contracts with qualified cord blood stem cell banks to assist in the collection and maintenance of 150,000 units of high-quality human cord blood to be made available for transplantation through the C.W. Bill Young Cell Transplantation Program. Qualified cord blood stem cell banks that apply for these contracts must participate in the C.W. Bill Young Cell Transplantation Program for a period of at least 10 years and must have obtained, among other requirements, all applicable Federal and State licenses, certifications, registrations (including pursuant to the regulations of the Food and Drug Administration), and other authorizations required to operate and maintain a cord blood stem cell bank.

In November 2004, as part of the Company’s long-term strategic plan, CRYO-CELL relocated its corporate headquarters to a newly constructed state- of-the-art facility that is Good Manufacturing Practice and Good Tissue Practice (cGMP/cGTP)-compliant, in anticipation of Food and Drug Administration (FDA) 21 CFR Part 1271. FDA regulation 1271 became effective on May 25, 2005 and requires all cellular and tissue-based products to be manufactured in compliance with current good tissue practice. In recent months, CRYO-CELL hosted a tour for government officials seeking to learn more about the operations of a private state-of-the-art facility.

“The strong, bi-partisan support of HR 2520 underscores the sentiment of federal legislators who are obviously convinced of the public value of non- controversial cord blood stem cells for both research and therapeutic use,” commented Mercedes Walton, CRYO-CELL Chairman and interim CEO.

“In view of the Company’s new state-of-the-art laboratory processing facility, combined with our thirteen-years of operating experience, CRYO-CELL believes it may be well positioned to serve as a model of excellence for the industry and to assist the C.W. Bill Young Cell Transplantation Program in establishing the targeted unit inventory of high-quality, transplantable units.” Ms. Walton continued, “If the proposed legislation is passed by the Senate and becomes law, CRYO-CELL expects to selectively pursue prospective opportunities that may be available in conjunction with the C.W. Bill Young Cell Transplantation Program and which may potentially align with the Company’s aggressive plans for growth and expansion.”

CRYO-CELL has been involved with private family cord blood banking since 1992 and leads the industry with nearly 80,000 units preserved on behalf of its clients. The Company is accredited by the American Association of Blood Banks (AABB) and believes that is the first private bank to process cord blood in its own technologically and operationally advanced cGMP/cGTP-compliant facility.

Author Profile

Jennifer Lahl, CBC President
Jennifer Lahl, CBC President
Jennifer Lahl, MA, BSN, RN, is founder and president of The Center for Bioethics and Culture Network. Lahl couples her 25 years of experience as a pediatric critical care nurse, a hospital administrator, and a senior-level nursing manager with a deep passion to speak for those who have no voice. Lahl’s writings have appeared in various publications including Cambridge University Press, the San Francisco Chronicle, the Dallas Morning News, and the American Journal of Bioethics. As a field expert, she is routinely interviewed on radio and television including ABC, CBS, PBS, and NPR. She is also called upon to speak alongside lawmakers and members of the scientific community, even being invited to speak to members of the European Parliament in Brussels to address issues of egg trafficking; she has three times addressed the United Nations during the Commission on the Status of Women on egg and womb trafficking.