As a matter of law, stem cells harvested from the umbilical cord blood or bone marrow and prepared for therapeutic applications are considered drugs. As a result, all processes related to the removal, preparation, storage and application of these stem cells are subject to respective statutes. The fundamental statutes are the provisions of the strict European Union Guideline, which also defines the principles and guidelines for Good Manufacturing Practices (GMP) for drugs.

Cells4health cooperates closely with the laboratories at the XCell-Center in Cologne and in Jena (Germany), both of which work in compliance with the highest worldwide standards and are consequently certified to operate under the provisions of Good Manufacturing Practices. This means that every step of the way, i.e. from the removal, to the preparation to the storage of the stem cells, all pertinent GMP Guidelines are being applied. All actions taken are documented, so that for instance the confusion of your stored stem cells with those of other individuals can be ruled out. Laboratory access is highly restricted and only trained and authorized laboratory staff may enter these areas. The laboratories are also inspected by government institutions at regular intervals.

Guarantee

	By complying with the GMP Guidelines, Cells4health warrants that The stem cell specimens are transported in a specially designated box at consistent temperatures. The courier has received specific training for the transportation of blood and plasma components. The specimens are processed under sterile conditions in so-called clean rooms. The specimens are examined to ensure the absence of certain bacteria or viruses The specimens are tested for quantity and their potential of survival. While being stored for many years, the specimens in nitrate tanks are monitored twenty-four-seven.