Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133 (+) Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy.
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 cardiovas...
| Publicado en: | BioMed Research International Vol. 2015; pp. 1 - 11 |
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| Autores principales: | , , , , , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Wiley-Blackwell
10/1/2015
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| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=110311228&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 110311228 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 23146133 FT2T jtl: BioMed Research International issn: 23146133 maglogo: N pubinfo: dt: 10/1/2015 vid: 2015 pid: 480 pub: Wiley-Blackwell place: Malden, Massachusetts artinfo: ui: 110311228 110311228 NLM26495296 110311228 10.1155/2015/473159 NLM26495296 PMC4606188 110311228 ppf: 1 ppct: 10 formats: fmt: @attributes: type: P tig: atl: Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133 (+) Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy. aug: au: Belotti, Daniela Gaipa, Giuseppe Bassetti, Beatrice Cabiati, Benedetta Spaltro, Gabriella Biagi, Ettore Parma, Matteo Biondi, Andrea Cavallotti, Laura Gambini, Elisa Pompilio, Giulio affil: Laboratory of Cell Therapy “Stefano Verri”, Azienda Ospedaliera San Gerardo, Via Pergolesi 33, 20900 Monza, Italy sug: subj: Cell Culture Techniques Bone Marrow Myocardial Diseases Therapy Myocardial Ischemia Human Drug Design ab: 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). pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
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