Various companies in Switzerland offer a storage service for umbilical cord blood and cord tissue. The Federal Office of Public Health has published information on blood stem cells obtained from umbilical cord blood:
Background
This publication refers exclusively to umbilical cord tissue.
Companies that store umbilical cord tissue hold out the prospect of the potential future use of the frozen tissue, or the mesenchymal stem cells contained in this tissue, in stem cell therapies.
To date, no clinical trials with products derived from umbilical cord tissue have been approved in Switzerland, and no corresponding manufacturing process or product has been authorised.
Legal classification
According to Art. 2 let. c and d of the Transplantation Ordinance (TpO, SR 810.211) transplant products are products comprising, or containing, human organs, tissues or cells, where
a. the organs, tissues or cells have either been substantially processed or
b. do not perform the same function at the recipient site as at the harvesting site (functional change or non-homologous use).
As well as the Transplantation Act (TpA, SR 810.21), transplant products are also subject to the Therapeutic Products Act (TPA, SR 812.21) and its implementing provisions. Accordingly, all companies and institutions that manufacture or deal with transplant products must obtain corresponding establishment licences from Swissmedic (Art. 5 and 18 TPA). For their use in patients, authorisation is also required from Swissmedic for the transplant products themselves (Art. 9 TPA) or their standardisable manufacturing process (Art. 32 of the Therapeutic Products Ordinance, TPO), or else they may be used only in connection with a clinical trial approved and controlled by Swissmedic (Art. 54, TPA).
In Switzerland, umbilical cord tissue is considered to be a non-ready-to-use transplant product since, on the one hand, it is assumed that it cannot be used without further substantial processing and, on the other, it is not intended to perform the same function in the recipient as in the donor. A functional change then exists if harvested cells or tissues are not used to perform their original basic function in another part of the human body in the same histological environment.
Since mesenchymal stem cells obtained from the umbilical cord are not re-injected into the same histological environment (umbilical cord tissue) but into a different target tissue or for a different purpose, this constitutes a functional change. In this case, it can no longer be assumed that the tissues or cells will perform their original basic function.
Conditions for granting an establishment licence for handling umbilical cord tissue
The Medicinal Products Licensing Ordinance (MPLO, SR 812.212.1) defines the conditions for granting an establishment licence for the manufacture of, wholesale trading in, and the import and export of medicinal products, and trading in medicinal products in foreign countries from Switzerland, as well as for brokerage or agency activities in connection with medicinal products. The MPLO also applies by analogy to the handling of transplant products and therefore to umbilical cord tissue (Art. 1 para. 2, TpO). This means that the handling of umbilical cord tissue is entirely subject to the rules of both Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).
A condition for the granting of an establishment licence is that, as for medicinal products, transplant products must also be manufactured in accordance with the GMP rules (Art. 4 para. 2).
It may be assumed that mesenchymal stem cells obtained from umbilical cord tissue or products manufactured from these cells are administered parenterally (by injection, infusion or transplantation). This means that the umbilical cord tissue must be processed according to the GMP rules for aseptic manufacture and that the corresponding GMP guidelines for the processing of umbilical cord tissue must be applied (PIC/S Guide to Good Manufacturing Practice for Medicinal Products (PE 009), Annexes 1 and 2A; EudraLex, Volume 4, Good Manufacturing Practice guidelines, Part IV).
Accordingly, the aseptic processing of umbilical cord tissue or products manufactured from this tissue takes place in a clean room grade A isolator in a D environment (closed isolator), a C environment (open isolator) or, if an isolator is not used, within a grade A clean room in a class B environment.
Anyone who applies for a licence to import transplant products must prove that the manufacturer of the transplant products to be imported has a manufacturing licence issued by a country whose GMP control system is considered by Swissmedic to be equivalent, or that the transplant products are manufactured in compliance with the GMP rules valid in Switzerland. (Art. 11 para. 1, let. i, MPLO).
A Swiss company applying for, or possessing, an establishment licence for the import of umbilical cord tissue into Switzerland must therefore prove that the manufacturer abroad processes the umbilical cord tissue in accordance with the GMP rules for aseptic manufacture that are valid in Switzerland.
The Good Distribution Practice (GDP) rules for distribution and storage must also be observed.