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BioMed Research International
Volume 2015 (2015), Article ID 473159, 10 pages
http://dx.doi.org/10.1155/2015/473159
Research Article

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

1Laboratory of Cell Therapy “Stefano Verri”, Azienda Ospedaliera San Gerardo, Via Pergolesi 33, 20900 Monza, Italy
2Department of Health Science, Università degli Studi di Milano-Bicocca, piazza dell’Ateneo Nuovo 1, 20126 Milan, Italy
3Tettamanti Research Center, Azienda Ospedaliera San Gerardo, Via Pergolesi 33, 20900 Monza, Italy
4Laboratory of Vascular Biology and Regenerative Medicine, Centro Cardiologico Monzino, IRCCS, Via Parea 4, 20138 Milan, Italy
5Department of Pediatrics, MBBM Foundation, Ospedale San Gerardo, Via Pergolesi 33, 20900 Monza, Italy
6Department of Ematology, Azienda Ospedaliera San Gerardo, Via Pergolesi 33, 20900 Monza, Italy
7Department of Cardiovascular Surgery, Centro Cardiologico Monzino, IRCCS, Via Parea 4, 20138 Milan, Italy
8Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Via Festa del Perdono 7, 20122 Milan, Italy

Received 19 March 2015; Accepted 11 May 2015

Academic Editor: Sebastiano Sciarretta

Copyright © 2015 Daniela Belotti et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Supplementary Material

Table S1. Parameters relative to demographic and clinical characteristic variables of treated patients. Demographic variables include age and sex; clinical characteristics consist of cardiac surgical and percutaneous intervention and concomitant medications.

Table S2. Details of quality control tests performed throughout the manufacturing steps both for drug substance (in-process controls, IPC) and medicinal product (final-product controls, FPC).

Table S3. Upper table summarize characteristics (reactivity, clone number, conjugated fluorochrome, and brand) of monoclonal antibodies used for immunphenotyping; Lower table include combination of antibodies used for immunphenotyping:

- Tube 1 contain only propidium iodide and represent the negative control for CD34, CD133 and CD45 staining.

- Tube 2 contains CD34, CD45, IgG2b antibodies and propidium iodide and represent the minus 1 control strategy with the whole marked staining excepted for the more important antigen, in our case CD133.

- Tube 3 contains CD34, CD45 and CD133 antibodies and propidium iodide for the identification of positive population.

Table S4. Details of release test, methods used and acceptance criteria applied to ATMP-CD133 final product.

  1. Supplementary Material