Thumbnail
Access Restriction
Open

Author Spaltro, Gabriella ♦ Gambini, Elisa ♦ Biagi, Ettore ♦ Pompilio, Giulio ♦ Cabiati, Benedetta ♦ Belotti, Daniela ♦ Biondi, Andrea ♦ Bassetti, Beatrice ♦ Parma, Matteo ♦ Gaipa, Giuseppe ♦ Cavallotti, Laura
Source Directory of Open Access Journals (DOAJ)
Content type Text
Publisher Hindawi Limited
File Format HTM / HTML
Date Created 2015-10-12
Copyright Year ©2015
Language English
Subject Domain (in LCC) R
Subject Keyword Medicine
Abstract 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 × 106 of CD133+ cells (range 2.85 × 106–30.84 × 106), 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 × 106 cells, sterile, and endotoxin-free. The abovementioned criteria are currently applied in our Phase I clinical trial (RECARDIO Trial).
ISSN 23146133
Age Range 18 to 22 years ♦ above 22 year
Educational Use Research
Education Level UG and PG ♦ Career/Technical Study
Learning Resource Type Article
Publisher Date 2015-01-01
e-ISSN 23146133
Journal BioMed Research International
Volume Number 2015


Source: Directory of Open Access Journals (DOAJ)