Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133+ Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy
Joint Authors
Biondi, A.
Gaipa, Giuseppe
Belotti, Daniela
Bassetti, Beatrice
Cabiati, Benedetta
Spaltro, Gabriella
Biagi, Ettore
Parma, Matteo
Cavallotti, Laura
Gambini, Elisa
Pompilio, Giulio
Source
Issue
Vol. 2015, Issue 2015 (31 Dec. 2015), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2015-10-01
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract EN
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).
American Psychological Association (APA)
Belotti, Daniela& Gaipa, Giuseppe& Bassetti, Beatrice& Cabiati, Benedetta& Spaltro, Gabriella& Biagi, Ettore…[et al.]. 2015. Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133+ Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy. BioMed Research International،Vol. 2015, no. 2015, pp.1-10.
https://search.emarefa.net/detail/BIM-1055611
Modern Language Association (MLA)
Belotti, Daniela…[et al.]. Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133+ Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy. BioMed Research International No. 2015 (2015), pp.1-10.
https://search.emarefa.net/detail/BIM-1055611
American Medical Association (AMA)
Belotti, Daniela& Gaipa, Giuseppe& Bassetti, Beatrice& Cabiati, Benedetta& Spaltro, Gabriella& Biagi, Ettore…[et al.]. Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133+ Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy. BioMed Research International. 2015. Vol. 2015, no. 2015, pp.1-10.
https://search.emarefa.net/detail/BIM-1055611
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1055611