A good indication of whether a company will be around in the future is how long they have been in business. Look for a cord blood bank that possesses a strong track record. Founded in 1989, Cryo-Cell is the world's first family cord blood bank. Today, it remains one of the world's largest family cord blood banks, serving clients from 87 countries.
Certainly one measure to validate a company’s laboratory operation is whether or not the stem cells are usable in transplant upon thawing. Every sample released by Cryo-Cell has been viable upon thawing. This perfect record allows Cryo-Cell to offer the industry’s best Cryo-Cell Cares $100,000 Payment Guarantee. Furthermore, samples processed and banked by Cryo-Cell have been successfully used in many life-saving stem cell transplants. View Transplant Matrix.
In May 2005, the U.S.. Food and Drug Administration (FDA) began regulating family cord blood banks through promulgation of 21 CFR 1271, current Good Tissue Practices. Beyond the federal government, several states (California, Illinois, New York, New Jersey, and Maryland) have applicable regulations. In addition, several organizations offer accreditation to their standards—AABB is one. Cryo-Cell is FDA registered, cGMP-/cGTP-compliant and is licensed in all states requiring licensure. Besides being AABB accredited, Cryo-Cell is also the first U.S. (for private use only) cord blood bank to receive FACT accreditation for adhering to the most stringent cord blood quality standards set by any internationally recognized, independent accrediting organization. In addition, Cryo-Cell is ISO 13485:2003 certified by TÜV, an internationally recognized quality assessment organization. This comprehensive list of licenses and accreditations makes Cryo-Cell the recognized quality leader.
Unless a company is publicly traded, it is difficult to determine their financial status. As a publicly traded company, Cryo-Cell has the obligation to continually disclose its accreditation status to the public.
Best Transport Protection in the Industry
Some companies use bags that contain heparin to transport cord blood while others transport cord tissues in dry cups. Heparin has long been linked to toxicity and allergy reaction among transplant patients. Cryo-Cell follows the FDA recommendation and uses heparin-free bags to transport cord blood. It also transports cord tissues in a saline solution, combined with antibiotics, to best preserve and protect specimens during transport.
Cryo-Cell also uses a collection kit that can safeguard stem cells approximately 30 times longer than competitions’ kits. The performance statistics was confirmed through multiple cross-continent tests under extreme temperature variations.
Control of Processing and Storage
Make sure the cord blood bank you choose is not simply a marketing outlet. Some companies do not perform their own processing or storage. Cryo-Cell operates its own state-of-the-art processing, testing and cryopreservation operation. It is in complete control of every step, ensuring the highest quality available today.
In the Cryo-Cell laboratory, only qualified technologists handle specimens, and the specimens are individually processed using PrepaCyte® CB, the most advanced processing technology in the field, to maximize the recovery of stem cells. This method depletes up to 99% of the red blood cells and recovers the highest number of Colony-forming Units, which are the stem cells that are the best predictor of patient outcomes.
Foresight and Going the Extra Mile
Cryo-Cell routinely implements measures above and beyond the general industry practice to offer its clients added measures of assurance.
One example is that Cryo-Cell retains some of the specimens that other competitors regularly discard and uses them as additional Quality Control samples. This includes mom’s peripheral blood and baby’s cord blood that does not contain stem cells. The additional samples are stored in a separate freezer and can be accessed for testing without disturbing the principal cord blood unit. This measure goes above and beyond the industry standard because Cryo-Cell is committed to offer its clients as many options as possible if there were ever a need for their specimens.
Cryo-Cell’s laboratory operates in accordance with the guidelines set forth by Dr. Linda Kelley. Prior to joining Cryo-Cell, Dr. Kelley was the director of the Connell O’Reilly Cell Manipulation Core Facility of Dana-Farber Cancer Institute at Harvard. Dr. Kelley is an expert on stem cell transplantation and regenerative medicine. Widely recognized as the world’s preeminent auditor of cord blood laboratories, Dr. Kelley has served on boards and committees that establish standards and regulations for the cellular therapy field and recently was the Chairwoman for the Standards Committee of FACT (The Foundation for the Accreditation of Cellular Therapy). Dr. Kelley is always forward thinking and attentive to the processes and technologies deployed in the lab, and she is also well connected and respected in the stem cell and cancer research communities to preview and influence current and future research directions.
Cryo-Cell has a history of industry firsts. In addition to being a pioneer in cord blood banking, it is also on the forefront of cord blood research and development through closely working with a number of research partners such as Stanford University and Saneron-CCEL Therapeutics. Click here to learn more about Saneron
Your choice of a cord blood bank is not something to experiment with, as it is literally a once-in-a-lifetime opportunity to collect your child’s precious cord blood and tissue. Follow the recommendation of thousands of OB/GYNs and parents around the globe. Choose Cryo-Cell to safeguard this life-saving resource for your family. View our Competitive Code of Conduct
For more information, please contact us at 800-786-7235 or request more information.