English (United Kingdom)

https://curated-unify.zendy.io/wp-json/zendy-region/v1/featured_content/oa?rat=en

https://curated-unify.zendy.io/wp-json/zendy-region/v1/highlighted_journal/

Global: Zendy Plus annual

Presents the access of premium content as premium feature

Premium Content

Presents the keyphrase highlighting as premium feature

Keyphrase Highlighting

Presents the summarisation as premium feature

Summarisation

Insights

Presents the pdf analysis as premium feature

PDF Analysis

Presents the zaia usage as premium feature

ZAIA

Global: Zendy Plus monthly

Global: Zendy Tools annual

Global: Zendy Tools monthly

Global: Zendy Free Plan

According to the European Medicine Agency (EMA) regulatory frameworks, Advanced Therapy Medicinal Products (ATMP) represent a new category of drugs in which the active ingredient consists of cells, genes, or tissues. ATMP-CD133 has been widely investigated in controlled clinical trials for cardiovascular diseases, making CD133 +  cells one of the most well characterized cell-derived drugs in this field. To ensure high quality and safety standards for clinical use, the manufacturing process must be accomplished in certified facilities following standard operative procedures (SOPs). In the present work, we report the fully compliant GMP-grade production of ATMP-CD133 which aims to address the treatment of chronic refractory ischemic heart failure. Starting from bone marrow (BM), ATMP-CD133 manufacturing output yielded a median of 6.66 × 10 6  of CD133 +  cells (range 2.85 × 10 6 –30.84 × 10 6 ), with a viability ranged between 96,03% and 99,97% (median 99,87%) and a median purity of CD133 +  cells of 90,60% (range 81,40%–96,20%). Based on these results we defined our final release criteria for ATMP-CD133: purity ≥ 70%, viability ≥ 80%, cellularity between 1 and 12 × 10 6  cells, sterile, and endotoxin-free. The abovementioned criteria are currently applied in our Phase I clinical trial (RECARDIO Trial).

biomed research international

Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133<sup><b>+</b></sup>Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy

Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133+Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy

Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133⁺Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy