PMID- 22309358
OWN - NLM
STAT- MEDLINE
DCOM- 20120518
LR  - 20211021
IS  - 1479-5876 (Electronic)
IS  - 1479-5876 (Linking)
VI  - 10
DP  - 2012 Feb 6
TI  - The establishment of a bank of stored clinical bone marrow stromal cell products.
PG  - 23
LID - 10.1186/1479-5876-10-23 [doi]
AB  - BACKGROUND: Bone marrow stromal cells (BMSCs) are being used to treat a variety 
      of conditions. For many applications a supply of cryopreserved products that can 
      be used for acute therapy is needed. The establishment of a bank of BMSC products 
      from healthy third party donors is described. METHODS: The recruitment of healthy 
      subjects willing to donate marrow for BMSC production and the Good Manufacturing 
      Practices (GMP) used for assessing potential donors, collecting marrow, culturing 
      BMSCs and BMSC cryopreservation are described. RESULTS: Seventeen subjects were 
      enrolled in our marrow collection protocol for BMSC production. Six of the 17 
      subjects were found to be ineligible during the donor screening process and one 
      became ill and their donation was cancelled. Approximately 12 ml of marrow was 
      aspirated from one posterior iliac crest of 10 donors; one donor donated twice. 
      The BMSCs were initially cultured in T-75 flasks and then expanded for three 
      passages in multilayer cell factories. The final BMSC product was packaged into 
      units of 100 x 106 viable cells, cryopreserved and stored in a vapor phase liquid 
      nitrogen tank under continuous monitoring. BMSC products meeting all lot release 
      criteria were obtained from 8 of the 11 marrow collections. The rate of growth of 
      the primary cultures was similar for all products except those generated from the 
      two oldest donors. One lot did not meet the criteria for final release; its CD34 
      antigen expression was greater than the cut off set at 5%. The mean number of 
      BMSC units obtained from each donor was 17 and ranged from 3 to 40. CONCLUSIONS: 
      The production of large numbers of BMSCs from bone marrow aspirates of healthy 
      donors is feasible, but is limited by the high number of donors that did not meet 
      eligibility criteria and products that did not meet lot release criteria.
FAU - Sabatino, Marianna
AU  - Sabatino M
AD  - Department of Transfusion Medicine, Clinical Center, National Institutes of 
      Health, Building 10, Room 1C711, Bethesda, MD 20892-1184, USA.
FAU - Ren, Jiaqiang
AU  - Ren J
FAU - David-Ocampo, Virginia
AU  - David-Ocampo V
FAU - England, Lee
AU  - England L
FAU - McGann, Michael
AU  - McGann M
FAU - Tran, Minh
AU  - Tran M
FAU - Kuznetsov, Sergei A
AU  - Kuznetsov SA
FAU - Khuu, Hanh
AU  - Khuu H
FAU - Balakumaran, Arun
AU  - Balakumaran A
FAU - Klein, Harvey G
AU  - Klein HG
FAU - Robey, Pamela G
AU  - Robey PG
FAU - Stroncek, David F
AU  - Stroncek DF
LA  - eng
PT  - Journal Article
PT  - Research Support, N.I.H., Extramural
DEP - 20120206
PL  - England
TA  - J Transl Med
JT  - Journal of translational medicine
JID - 101190741
RN  - 0 (Antigens, CD34)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aging/physiology
MH  - Antigens, CD34/metabolism
MH  - Bone Marrow Cells/*cytology
MH  - Cell Count
MH  - Cell Nucleus/metabolism
MH  - Cell Proliferation
MH  - Cells, Cultured
MH  - Colony-Forming Units Assay
MH  - Female
MH  - Health
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Stromal Cells/cytology
MH  - Time Factors
MH  - *Tissue Banks
MH  - Tissue Donors
MH  - Tissue Preservation/*methods
MH  - Young Adult
PMC - PMC3309931
EDAT- 2012/02/09 06:00
MHDA- 2012/05/19 06:00
PMCR- 2012/02/06
CRDT- 2012/02/08 06:00
PHST- 2012/01/05 00:00 [received]
PHST- 2012/02/06 00:00 [accepted]
PHST- 2012/02/08 06:00 [entrez]
PHST- 2012/02/09 06:00 [pubmed]
PHST- 2012/05/19 06:00 [medline]
PHST- 2012/02/06 00:00 [pmc-release]
AID - 1479-5876-10-23 [pii]
AID - 10.1186/1479-5876-10-23 [doi]
PST - epublish
SO  - J Transl Med. 2012 Feb 6;10:23. doi: 10.1186/1479-5876-10-23.