Abstract:
BACKGROUND:Hematopoietic progenitor stem cells (HPSC) are a specialized transfusion product used for transplantation. Microbial contamination may occur during harvest or subsequent manipulation of these cells. The same difficulties in ensuring a safe, sterile, final product are faced in the preparation of other cell-therapy products directly obtained from donors. Detection of contamination is problematic, and the clinical significance of infusing contaminated HPSC is controversial. METHODS:Chimeric Therapies' manufacturing and clinical experience with BM HPSC products and validation of a culture method for detection are described. In addition, this paper reviews the literature concerning contaminated blood products, including rates and circumstances of contamination, organisms, methods of detection, and the clinical significance of infusion of contaminated products. RESULTS:Seven of 33 BM harvest products received at Chimeric Therapies were culture positive for skin commensal organisms. Three of seven were culture positive in the infused product. This compares with literature reports of 0-42%. No patients had significant infusion reactions or evidence of infection related to the contamination. DISCUSSION:The risks associated with microbial contamination with skin commensals are insignificant compared with other components of transplantation. Contamination with pathogens can be eliminated with careful good manufacturing practices (GMP). A series of practical recommendations are presented for the reduction of contamination in HPSC and cell-therapy products.
journal_name
Cytotherapyjournal_title
Cytotherapyauthors
Lowder JN,Whelton Pdoi
10.1080/14653240310003044keywords:
subject
Has Abstractpub_date
2003-01-01 00:00:00pages
377-90issue
5eissn
1465-3249issn
1477-2566pii
36C247KRW0NYGWDPjournal_volume
5pub_type
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