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Good manufacturing practice-compliant validation and preparation of BM cells for the therapy of acute myocardial infarction.

Abstract：

BACKGROUND:Intracoronary application of BM-derived cells for the treatment of acute myocardial infarction (AMI) is currently being studied intensively. Simultaneously, strict legal requirements surround the production of cells for clinical studies. Thus good manufacturing practice (GMP)-compliant collection and preparation of BM for patients with AMI was established by the Cytonet group. METHODS:As well as fulfillment of standard GMP requirements, including a manufacturing license, validation of the preparation process and the final product was performed. Whole blood (n=6) and BM (n=3) validation samples were processed under GMP conditions by gelafundin or hydroxyethylstarch sedimentation in order to reduce erythrocytes/platelets and volume and to achieve specifications defined in advance. Special attention was paid to the free potassium (<6 mmol/L), some rheologically relevant cellular characteristics (hematocrit <0.45, platelets <450 x 10(6)/mL) and the sterility of the final product. RESULTS:The data were reviewed and GMP compliance was confirmed by the German authorities (Paul-Ehrlich Institute). Forty-five BM cell preparations for clinical use were carried out following the validated methodology and standards. Additionally three selections of CD34+ BM cells for infusion were performed. All specification limits were met. Discussion In conclusion, preparation of BM cells for intracoronary application is feasible under GMP conditions. As the results of sterility testing may not be available at the time of intracoronary application, the highest possible standards to avoid bacterial and other contaminations have to be applied. The increased expense of the GMP-compliant process can be justified by higher safety for patients and better control of the final product.

journal_name

Cytotherapy

journal_title

Cytotherapy

authors

Griesel C,Heuft HG,Herrmann D,Franke A,Ladas D,Stiehler N,Stucki A,Braun M,Wollert KC,Meyer GP,Drexler H,Hertenstein B,Ganser A,Rüdinger W,Arseniev L

doi

10.1080/14653240601052734

subject

Has Abstract

pub_date

2007-01-01 00:00:00

pages

35-43

issue

1

eissn

1465-3249

issn

1477-2566

pii

769973511

journal_volume

9

pub_type

杂志文章

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