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  • 1.  A human tissue-engineered product (hTEP) vs. Cell Therapy Medicinal Product (EMA, ATMP, EU)

    This message was posted by a user wishing to remain anonymous
    Posted 13-Feb-2019 15:00
    This message was posted by a user wishing to remain anonymous

    Does anyone happen to know if stem cells used in oncology or in other areas where they are in suspension (no scaffold, film, or other structured matrix) would be classifed as human tissue-engineered product (hTEP) or as Cell Therapy Medicinal Product (CTMP)?


  • 2.  RE: A human tissue-engineered product (hTEP) vs. Cell Therapy Medicinal Product (EMA, ATMP, EU)

    Posted 15-Feb-2019 15:41
    It depends and is a bit challenging to clearly answer because stem cells used as therapeutic agents for oncology is new. The regulatory guidance is evolving and under development. Regardless what the stem cells are called, what really matters is to treat this as case by case to demonstrate they are safe and effective for the intended indication. You can find some guidance from FDA or EMA websites but if you want further discussion please contact me directly.

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    Gene Zhu
    Independent Consultant
    Basking Ridge NJ
    USA
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    Original Message


  • 3.  RE: A human tissue-engineered product (hTEP) vs. Cell Therapy Medicinal Product (EMA, ATMP, EU)

    Posted 15-Feb-2019 16:28
    ​

     

    According to EC regulation

    CTMP

    Cell therapy medicinal products (CTMP): These products "contain cells or tissues that have been manipulated to change their biological characteristics or cells or tissues not intended to be used for the same essential functions in the body.

    They can be used to cure, diagnose or prevent diseases. And are presented as having properties for, or is used in or administered to human beings with a view to treating, preventing or diagnosing a disease through the pharmacological, immunological or metabolic action of its cells or tissues. (Part IV of Annex I to Directive 2001/83/EC,) (https://ec.europa.eu/health//sites/health/files/files/eudralex/vol-1/dir_2001_83_consol_2012/dir_2001_83_cons_2012_en.pdf)

    TEP

    Tissue engineered product (TEP): These products "contain engineered cells or tissues (that have been modified ) to be used to repair, regenerate or replace human tissue" (The cells or tissues may be viable or non-viable. It may also contain additional substances, such as cellular products, bio-molecules, biomaterials, chemical substances, scaffolds or matrices) ((https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:324:0121:0137:en:PDF)

    My opinion: Suspended stem cells that are manipulated and are not being used for same body function are CTMP. However, if the same cells are seeded on scaffold with intent of repairing, rejuvenate or replace a human tissue will be referred as hTEP.



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    Ashwani Khurana, PhD RAC
    MN, United States
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    Original Message


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