PMID- 21958114
OWN - NLM
STAT- MEDLINE
DCOM- 20121002
LR  - 20181201
IS  - 1557-8534 (Electronic)
IS  - 1547-3287 (Linking)
VI  - 21
IP  - 9
DP  - 2012 Jun 10
TI  - A toxicity study of multiple-administration human umbilical cord mesenchymal stem 
      cells in cynomolgus monkeys.
PG  - 1401-8
LID - 10.1089/scd.2011.0441 [doi]
AB  - Therapies based on stem cells have shown very attractive potential in many 
      clinical studies. However, the data about the safety of stem cells application 
      remains insufficient. The present study was designed to evaluate the overall 
      toxicology of human umbilical cord mesenchymal stem cells (hUC-MSCs) in 
      cynomolgus monkeys with repeated administrations. hUC-MSCs were administered by 
      intravenous injection once every 2 weeks for 6 weeks. The dose levels employed in 
      this study were 2x10(6), 1x10(7) cells/kg body weight. Toxicity was evaluated by 
      clinical observations (body weight, body temperature, and ophthalmology exams), 
      pathology (blood cell counts, clinical biochemistry, urinalysis, and bone marrow 
      smears), immunologic consequences (lymphoproliferation assay, the secretion of 
      interferon-gamma and interleukin-4, the percentage of CD3, CD4, CD8 T cells, and the 
      ratio of CD4 and CD8 T cells) and anatomic pathology. Pharmacodynamics in blood 
      and distribution of hUC-MSCs in the tissues of cynomolgus monkeys were measured 
      by real-time polymerase chain reaction. All animals survived until scheduled 
      euthanasia. No stem cells transplantation-related toxicity was found in this 
      study. hUC-MSCs could be found in the blood of cynomolgus monkeys beyond 8 h. The 
      findings of this 6-week toxicity study showed that the transplantation of 
      hUC-MSCs did not affect the general health of cynomolgus monkeys.
FAU - Wang, Youwei
AU  - Wang Y
AD  - Chinese Academy of Medical Sciences and Peking Union Medical College, Institute 
      of Hematology and Blood Diseases Hospital, Tianjin, China.
FAU - Han, Zhi-Bo
AU  - Han ZB
FAU - Ma, Jinling
AU  - Ma J
FAU - Zuo, Conglin
AU  - Zuo C
FAU - Geng, Jie
AU  - Geng J
FAU - Gong, Wei
AU  - Gong W
FAU - Sun, Yunxia
AU  - Sun Y
FAU - Li, Hongzhen
AU  - Li H
FAU - Wang, Bin
AU  - Wang B
FAU - Zhang, Lei
AU  - Zhang L
FAU - He, Yanan
AU  - He Y
FAU - Han, Zhong Chao
AU  - Han ZC
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20111122
PL  - United States
TA  - Stem Cells Dev
JT  - Stem cells and development
JID - 101197107
RN  - 0 (Antigens, CD)
RN  - 0 (IL4 protein, human)
RN  - 207137-56-2 (Interleukin-4)
RN  - 82115-62-6 (Interferon-gamma)
SB  - IM
MH  - Animals
MH  - Antigens, CD/blood
MH  - CD4-CD8 Ratio
MH  - Female
MH  - Humans
MH  - Interferon-gamma/blood
MH  - Interleukin-4/blood
MH  - Macaca fascicularis
MH  - Male
MH  - Mesenchymal Stem Cell Transplantation/*adverse effects
MH  - Mesenchymal Stem Cells/*cytology/metabolism
MH  - T-Lymphocytes/cytology/metabolism
MH  - Transplantation, Heterologous
MH  - Umbilical Cord/*cytology/metabolism
EDAT- 2011/10/01 06:00
MHDA- 2012/10/04 06:00
CRDT- 2011/10/01 06:00
PHST- 2011/10/01 06:00 [entrez]
PHST- 2011/10/01 06:00 [pubmed]
PHST- 2012/10/04 06:00 [medline]
AID - 10.1089/scd.2011.0441 [doi]
PST - ppublish
SO  - Stem Cells Dev. 2012 Jun 10;21(9):1401-8. doi: 10.1089/scd.2011.0441. Epub 2011 
      Nov 22.