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Full GMP-Compliant Validation of Bone Marrow-Derived Human CD133+ Cells as Advanced Therapy Medicinal Product for Refractory Ischemic Cardiomyopathy
المؤلفون المشاركون
Biondi, A.
Gaipa, Giuseppe
Belotti, Daniela
Bassetti, Beatrice
Cabiati, Benedetta
Spaltro, Gabriella
Biagi, Ettore
Parma, Matteo
Cavallotti, Laura
Gambini, Elisa
Pompilio, Giulio
المصدر
العدد
المجلد 2015، العدد 2015 (31 ديسمبر/كانون الأول 2015)، ص ص. 1-10، 10ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2015-10-01
دولة النشر
مصر
عدد الصفحات
10
التخصصات الرئيسية
الملخص 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).
نمط استشهاد جمعية علماء النفس الأمريكية (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
نمط استشهاد الجمعية الأمريكية للغات الحديثة (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
نمط استشهاد الجمعية الطبية الأمريكية (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
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1055611
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
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