PMID- 35619293
OWN - NLM
STAT- MEDLINE
DCOM- 20230714
LR  - 20230718
IS  - 2212-3946 (Electronic)
IS  - 1574-888X (Linking)
VI  - 18
IP  - 8
DP  - 2023
TI  - Quality Control Analysis of Mesenchymal Stem/Stromal Cells During Investigational 
      New Drug Application for GvHD Administration in China.
PG  - 1032-1040
LID - 10.2174/1574888X17666220520155212 [doi]
AB  - Graft-versus-host disease (GvHD), including the acute and chronic types (aGvHD, 
      cGvHD), arise as the dominating secondary disease in patients with unsatisfying 
      consequences of allogeneic hematopoietic stem cell transplantation (HSCT). 
      Approximately half of GvHD patients were steroid-resistant, with a two-year 
      overall survival rate lower than 20%. Worse still, there are no standardized 
      criteria for an optimal second-line therapy for steroid-resistant aGVHD patients. 
      Notably, pioneering investigators have highlighted the ameliorative or 
      therapeutic effects of human umbilical cord-derived mesenchymal stem/stromal 
      cells (hUC-MSCs) upon GvHD largely attributed to their unique 
      hematopoietic-supporting and immunomodulatory properties. Of note, quality 
      control (QC) is the prerequisite to assure the safety and quality of hUC-MSCs 
      before investigational new drug (IND) applications and large-scale clinical 
      applications. Herein, we summarize the state-of-the-art updates upon 
      IND-associated QC and clinical trials of hUC-MSCs during allogeneic HSCT in 
      China. Meanwhile, the supervisory policy and medical ethics of current licensed 
      MSC products for GvHD administration and the concomitant opportunities and 
      challenges have also been discussed.
CI  - Copyright(c) Bentham Science Publishers; For any queries, please email at 
      epub@benthamscience.net.
FAU - Wang, Aitong
AU  - Wang A
AUID- ORCID: 0000-0003-3547-3329
AD  - National Engineering Research Center of Cell Products, AmCellGene Engineering 
      Co., Ltd., Tianjin, 300457, China.
AD  - Tianjin Key Laboratory of Engineering Technologies for Cell Pharmaceutical, 
      Tianjin, 300457, China.
FAU - Zhang, Leisheng
AU  - Zhang L
AUID- ORCID: 0000-0001-6540-0943
AD  - The Postdoctoral Research Station, School of Medicine, Nankai University, 
      Tianjin, 300071, China.
AD  - Institute of Stem Cells, Health- Biotech (Tianjin) Stem Cell Research Institute 
      Co., Ltd., Tianjin, 301700, China.
AD  - Key Laboratory of Radiation Technology and Biophysics, Institute of Biology & 
      Hefei Institute of Physical Science, Chinese Academy of Sciences, Hefei, 230031, 
      China.
AD  - Key Laboratory of Molecular Diagnostics and Precision Medicine for Surgical 
      Oncology in Gansu Province & NHC Key Laboratory of Diagnosis and Therapy of 
      Gastrointestinal Tumor, Gansu Provincial Hospital, Lanzhou, 730000, China.
FAU - Zhao, Meng
AU  - Zhao M
AUID- ORCID: 0000-0002-8255-7659
AD  - National Engineering Research Center of Cell Products, AmCellGene Engineering 
      Co., Ltd., Tianjin, 300457, China.
AD  - Tianjin Key Laboratory of Engineering Technologies for Cell Pharmaceutical, 
      Tianjin, 300457, China.
FAU - Yu, Hao
AU  - Yu H
AUID- ORCID: 0000-0002-8355-8741
AD  - National Engineering Research Center of Cell Products, AmCellGene Engineering 
      Co., Ltd., Tianjin, 300457, China.
AD  - Tianjin Key Laboratory of Engineering Technologies for Cell Pharmaceutical, 
      Tianjin, 300457, China.
AD  - The Postdoctoral Research Station, School of Medicine, Nankai University, 
      Tianjin, 300071, China.
LA  - eng
PT  - Journal Article
PL  - United Arab Emirates
TA  - Curr Stem Cell Res Ther
JT  - Current stem cell research & therapy
JID - 101272517
SB  - IM
MH  - Humans
MH  - Investigational New Drug Application
MH  - *Graft vs Host Disease/therapy
MH  - *Hematopoietic Stem Cell Transplantation
MH  - *Mesenchymal Stem Cells
MH  - Immunomodulation
MH  - *Mesenchymal Stem Cell Transplantation
OTO - NOTNLM
OT  - GvHD
OT  - HSCT
OT  - QC
OT  - UC-MSCs
OT  - clinical trials
OT  - stem cell transplantation
EDAT- 2022/05/28 06:00
MHDA- 2023/07/14 13:05
CRDT- 2022/05/27 01:13
PHST- 2022/01/04 00:00 [received]
PHST- 2022/04/02 00:00 [revised]
PHST- 2022/04/07 00:00 [accepted]
PHST- 2023/07/14 13:05 [medline]
PHST- 2022/05/28 06:00 [pubmed]
PHST- 2022/05/27 01:13 [entrez]
AID - CSCR-EPUB-123836 [pii]
AID - 10.2174/1574888X17666220520155212 [doi]
PST - ppublish
SO  - Curr Stem Cell Res Ther. 2023;18(8):1032-1040. doi: 
      10.2174/1574888X17666220520155212.