Stem cell transplantation offers promise in the field of regenerative medicine. However,its application must follow strict rules. Some differences exist among Western and Eastern European countries. This brief review summarizes the state‐of‐the‐art stem cell regulation in European countries,such as Italy and Ukraine.

In Italy,the research concerning stem cells is regulated by the Italian Law 40 (February 19,2004), which outlines the standards of medically assisted reproduction^[1]. Accordingly,it prohibits “the creation of human embryos for research,experimentation,or purposes other than those intended by this law” (Article 13). Indeed,Italian legislation recognizes the embryo as a subject of rights from the moment of the fertilization^[2]. Of course,human cloning is prohibited.

Nevertheless,adult stem cell research is possible. After the mother has signed a written consent,it is possible to donate fetal stem cells for research purposes. It is also conceivable to use human umbilical cord‐derived stem cells. In this case,both parents must provide consent. However,the cryopreservation of stem cells is prohibited in Italy. Therefore,parents must use foreign specialized clinical centers outside Italy,i.e.,in Switzerland or San Marino. In addition, the decree of the President of the Council of Ministers (November 21,2001) has included in the basic healthcare levels the collection,processing,control, and distribution of blood components and transfusion services,as well as stem cell analysis and retrieval from registers,in addition to domestic and foreign cell banks^[3]. Transplantation of hematopoietic stem cells in humans is only allowed for blood‐derived diseases. However,stem cell transplantation in humans is prohibited in Italy. Until recently,the only way to undergo a stem cell treatment was being offered one by the Italian law Turco‐Fazio (Italian Ministerial Decree 05/12/2006),which authorized cell‐based therapies only as compassionate use (the term compassionate use indicates the access to experimental drug therapies, outside of clinical trials,in patients with serious or rare diseases or who are in danger of life,when,in the opinion of the physician,there are no further valid therapeutic alternatives)^{[4, 5]}. A great debate was triggered by the Stamina case^[6]. To avoid false hope and expectations in the general population on the use of mesenchymal stem cells,the Italian Parliament updated the legislation regarding the regulation of mesenchymalstem cell research with the Italian Ministerial Decree #24 (March 25,2013) and later with the Italian Law 57 (May 23,2013)^{[7, 8]}. However, the scientific committee rejected the Stamina method and the research has been stopped^[9].

Currently,and according to the European Union (EU) legislation,the only way to undergo stem cell transplantation is by being enrolled in a clinical trial, in agreement with the Clinical Trials Directive^[10]. The EU provides legislation (Tissues and Cells Directive 2004/23/EC and Commission Directive EU 2015/566) about quality and safety of cells and tissues for human applications^{[11, 12]}. However,the final decision on their use relies on the single member state. Each member state’s legislation often shows different or divergent positions reflecting the cultural,ethical,and religious views on the issue^[13]. For example,Germany and Italy adopt a more restrictive approach,as they prohibit or severely restrict the use of embryonic stem cells (in Italy it is possible to use only imported already existing embryonic stem cell lines),whereas Belgium, the Czech Republic,Finland,Israel,Portugal,Spain, Sweden,and the United Kingdom authorize the use of this type of stem cells. Research on embryonic stem cells is permitted in Denmark,France,Hungary,the Netherlands,Norway,and Switzerland,but therapeutic cloning is not. Otherwise,the UK,Belgium,Spain, and Sweden have legalized therapeutic cloning of embryos^[13].

On the other hand,in Ukraine,an Eastern Europe republic that is not a member state of the EU,stem cell treatment is legal and is regulated by the Ukrainian legislation^[14]. The treatment with umbilical cord blood, bone marrow,and fetal stem cells is permitted on Ukrainian territory. However,patients must sign an informed consent prior to each treatment. In the case of underage patients,informed consent must be given by both parents. Bio‐banks for human cord blood exist in Ukraine,as well as for other cells and tissues. All of these facilities undergo a specific regulation, i.e.,molecular biology laboratories must be equipped with specialized PCR equipment capable of detecting pathogenic biological agents of the hazard groups 1-4 in every biological material. The staff at these biobanks must have competent medical and/or biological education,and the director must have a higher medical or biological education,as required by the Ukrainian Ministry of Health.

For the medical staff acting as such,the corresponding qualification requirements have been established by the following guidelines: article #78 Health Care, approved and implemented by the decree #117 at the Ukrainian Ministry of Health (March 29,2002). Requirements to qualifications among the medical staff are defined by the decree #359 at the Ministry of Health of Ukraine (December 19,1997) about advanced medical training of doctors registered at the Ministry of Justice of Ukraine (January 14,1998) with the reference #14/2454,and decree #742 at the Ministry of Health of Ukraine (November 23,2007) about certification of junior medical specialists,registered by the Ministry of Justice of Ukraine (December 12,2007) with the reference #1368/14635.

In conclusion stem cell therapy has recently acquired impulse to its emerging development which is connected with establishing the new characteristic features of stem cells. Many differences still perxist among different Western and Eastern European countries. In the countries of the European Union licensing and other permissions for clinical use of the high technology therapeutic methods including gene engineering,stem cell therapy and treatment using somatic cells have been regulated by the standards of European Medical Association and the statement of Directive 2001/83/EU I Regulation (EU) #1394/2007 on advanced‐therapy medicinal product(ATMP).

Consequently,Committee for Medicinal Products for Human Use (СНМР) establishes the requirements for application for the suggested treatment method registration and issuing the corresponding licenses and restrictions,in particular: the Directive 2001/20/EU of 04/04/2001 concerning clinical trials and the Directive 2005/28/EU of 08/04/2005 on application of such a method in clinical practice.

Legislative and regulatory frameworks which remain in force in Ukraine stipulate the requirements on license provisions and are not complying with complex standards on АТМР in the European Union.

However,the above licensing regulations permit experimental studies and clinical application of preparations including stem cells such as: bone marrow stem cells,autologous stem cells,adipose‐derived and fetal stem cells.