Risk of tumorigenicity in mesenchymal stromal cell-based therapies-Bridging scientific observations and regulatory viewpoints

被引：299

作者：

Barkholt, Lisbeth ^{[1
,8
]}

Flory, Egbert ^{[1
,2
,9
]}

Jekerle, Veronika ^{[1
]}

Lucas-Samuel, Sophie ^{[1
,10
]}

Ahnert, Peter ^{[3
,4
]}

Bisset, Louise ^{[1
,13
]}

Buescher, Dirk ^{[11
]}

Fibbe, Willem ^{[12
]}

Foussat, Arnaud ^{[5
]}

Kwa, Marcel ^{[1
,14
]}

Lantz, Olivier ^{[6
]}

Maciulaitis, Romaldas ^{[15
,16
]}

Palomaki, Tiina ^{[1
,17
]}

Schneider, Christian K. ^{[2
,18
,19
]}

Sensebe, Lug ^{[20
]}

Tachdjian, Gerard ^{[7
]}

Tarte, Karin ^{[21
]}

Tosca, Lucie ^{[7
]}

Salmikangas, Paula ^{[1
,2
,17
]}

机构：

[1] European Med Agcy, CPWP, London, England

[2] European Med Agcy, CAT, London, England

[3] Univ Leipzig, Inst Med Informat Stat & Epidemiol, D-04109 Leipzig, Germany

[4] Univ Leipzig, Translat Ctr Regenerat Med, D-04109 Leipzig, Germany

[5] TxCell, Valbonne, France

[6] Inst Curie, Inserm U932, Paris, France

[7] Univ Paris 11, Inserm U935, Paris, France

[8] MPA, Uppsala, Sweden

[9] Paul Ehrlich Inst, Langen, Germany

[10] Agence Natl Securite Medicament & Prod Sante ANSM, Paris, France

[11] GRI CEL, Barcelona, Spain

[12] Leiden Univ, Med Ctr, Leiden, Netherlands

[13] Med & Healthcare Prod Regulatory Agcy MHRA, London, England

[14] MEB, Utrecht, Netherlands

[15] Lithuanian Univ Hlth Sci, Med Acad, State Med Control Agcy, Vilnius, Lithuania

[16] Lithuanian Univ Hlth Sci, Med Acad, Inst Physiol & Pharmacol, Nephrol Clin, Vilnius, Lithuania

[17] Finnish Med Agcy FIMEA, Helsinki, Finland

[18] Danish Hlth & Med Author, Copenhagen, Denmark

[19] Twincore Ctr Expt & Clin Infect Res, Hannover, Germany

[20] UMR5273 INSERM U1031, EFS, Toulouse, France

[21] INSERM U917, Rennes, France

来源：

CYTOTHERAPY | 2013年 / 15卷 / 07期

关键词：

cell; mesenchymal; stromal; tumorigenicity; SPONTANEOUS MALIGNANT-TRANSFORMATION; LONG-TERM CULTURES; STEM-CELLS; BONE-MARROW; CHROMOSOMAL-ABERRATIONS; TRANSPLANT RECIPIENTS; CROSS-CONTAMINATION; CANCER; ACQUISITION; DIFFERENTIATION;

D O I：

10.1016/j.jcyt.2013.03.005

中图分类号：

Q813 [细胞工程];

学科分类号：

摘要：

In the past decade, the therapeutic value of mesenchymal stromal cells (MSCs) has been studied in various indications, thereby taking advantage of their immunosuppressive properties. Easy procurement from bone marrow, adipose tissue or other sources and conventional in vitro expansion culture have made their clinical use attractive. Bridging the gap between current scientific knowledge and regulatory prospects on the transformation potential and possible tumorigenicity of MSCs, the Cell Products Working Party and the Committee for Advanced. Therapies organized a meeting with leading European experts in the field of MSCs. This meeting elucidated the risk of potential tumorigenicity related to MSC-based therapies from two angles: the scientific perspective and the regulatory point of view. The conclusions of this meeting, including the current regulatory thinking on quality, nonclinical and clinical aspects for MSCs, are presented in this review, leading to a clearer way forward for the development of such products.

引用

页码：753 / 759

页数：7

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