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News related to Regenerative Medicine, Tissue Engineering, Medical devices, Pharmaceutical industry with focus on achievements and the legal, ethical, and regulatory aspects of the field

ATMP related targeted stakeholder consultation

Several weeks ago, the summary of the responses to the consultation on the development of Guidelines for Good Manufacturing Practice for Advanced Therapy Medicinal Products was announced. It has been developed on the basis of the comments received during the consultation as well as input from consultation with the European Medicines Agency and competent authorities in the Member States. The Commission services developed draft Guidelines on Good Manufacturing Practice (“GMP”) specific to ATMPs.
You can read more at European Commission website.

Stem cells from bone marrow delay diabetes type I progression

In diabetes type I, there is a progressive decline of insulin-producing pancreatic beta cells, which is caused by the development of immune response directed to autoantigens of pancreatic islets. In advanced diabetes, the patient is completely dependent on exogenous insulin. Therefore, a medical team from Uppsala University Hospital has conducted a clinical trial on the application of autologous bone marrow mesenchymal stem cells (MSC) with the aim of inhibiting progression of diabetes.

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ISSCR publishes guidelines for stem cell science

The International Society for Stem Cell Research (ISSCR), an international organization that gathers scientists from the area of stem cells, is currently preparing a document, that will provide information on good practices in stem cell research and stem cells based experimental therapies. Draft of the document has been already posted on-line but now the organization it accepting comments from the scientific community before publishing the final version.

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Allogeneic Mesenchymal Stem Cells – safety and efficacy

Mesenchymal stem cells (MSC) isolated from bone marrow or adipose tissue are usually being used in clinical trials in an autologous settings, i.e. the patient receives his own cells. Intra-articular injections of autologous MSC were proved to be effective in the treatment of knee osteoarthritis. MSC isolated from the patient’s bone marrow or adipose tissue reduced pain 3 to 6 months after treatment when injected intra-articulary.

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Stem cells from adipose tissue are effective in anti-aging therapy

Scientists from the University of Verona and University of Rio de Janeiro applied an anti-aging skin treatment basing on autologous stem cells isolated from adipose tissue. The study involved application of two methods for preparation of cell suspension. In the first method, purified and expanded stem cells were used. The second method utilized fat enriched in so called stromal-vascular fraction, which contains several cell types.

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New regulations in in vitro fertilization procedure in Poland

The new act sets strict regulations in the in vitro fertilization procedure. Destruction of embryos capable of normal development will be prohibited. Preimplantation genetic testing for selection of phenotypic traits will be also forbidden. Genetic screening will be only possible if the child would be likely to suffer from a severe genetic disease.

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Statement of the Minister of Health

Minister of Health recalls that all activities within the scope of the “Polish Act on the collection, storage and transplantation of cells, tissues and organs” (Journal of Laws No. 169, item 1411, as amended) on the basis of only the consent of the Bioethics Committee, without the permission of the Minister of Health is violation of regulations of the Act. The law penalizes all activities conducted without the required permit.

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Public Stem Cell Bank

Public Stem Cell Bank at Regional Science-Technology Centre in Podzamcze was launched on November 4th. The Bank was established as a result of the project within the framework of the Regional Operational Programme 2007-2013 for Świętokrzyskie region. Public Stem Cell Bank in Podzamcze joined the elite group of five other public banks of umbilical cord blood in Poland. BMCT held patronage over the press conference promoting the project.

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Nowe wytyczne GMP dla badanych produktów leczniczych

W związku z nowym rozporządzeniem UE w sprawie Dobrej Praktyki Klinicznej 536/2014 Komisja UE opublikowała w dniu 16 września …

Nowelizacja Prawa Farmaceutycznego

Będąca w pracach komisji prawniczej nowela Prawa Farmaceutycznego przyniesie zmiany dla wytwórców produktów leczniczych …

Rewizja wytycznych dotyczących produktów leczniczych zawierających genetycznie zmodyfikowane komórki

Wytyczne z 2012 r. koncentrowały się na tradycyjnych metodach modyfikacji genetycznej komórek opartych na wykorzystaniu …