دورية أكاديمية
Quality Control Analysis of Mesenchymal Stem/Stromal Cells During Investigational New Drug Application for GvHD Administration in China.
| العنوان: | Quality Control Analysis of Mesenchymal Stem/Stromal Cells During Investigational New Drug Application for GvHD Administration in China. |
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| المؤلفون: | Wang A; National Engineering Research Center of Cell Products, AmCellGene Engineering Co., Ltd., Tianjin, 300457, China.; Tianjin Key Laboratory of Engineering Technologies for Cell Pharmaceutical, Tianjin, 300457, China., Zhang L; The Postdoctoral Research Station, School of Medicine, Nankai University, Tianjin, 300071, China.; Institute of Stem Cells, Health- Biotech (Tianjin) Stem Cell Research Institute Co., Ltd., Tianjin, 301700, China.; Key Laboratory of Radiation Technology and Biophysics, Institute of Biology & Hefei Institute of Physical Science, Chinese Academy of Sciences, Hefei, 230031, China.; 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., Zhao M; National Engineering Research Center of Cell Products, AmCellGene Engineering Co., Ltd., Tianjin, 300457, China.; Tianjin Key Laboratory of Engineering Technologies for Cell Pharmaceutical, Tianjin, 300457, China., Yu H; National Engineering Research Center of Cell Products, AmCellGene Engineering Co., Ltd., Tianjin, 300457, China.; Tianjin Key Laboratory of Engineering Technologies for Cell Pharmaceutical, Tianjin, 300457, China.; The Postdoctoral Research Station, School of Medicine, Nankai University, Tianjin, 300071, China. |
| المصدر: | Current stem cell research & therapy [Curr Stem Cell Res Ther] 2023; Vol. 18 (8), pp. 1032-1040. |
| نوع المنشور: | Journal Article |
| اللغة: | English |
| بيانات الدورية: | Publisher: Bentham Science Publishers Country of Publication: United Arab Emirates NLM ID: 101272517 Publication Model: Print Cited Medium: Internet ISSN: 2212-3946 (Electronic) Linking ISSN: 1574888X NLM ISO Abbreviation: Curr Stem Cell Res Ther Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Saif Zone, Sharjah, U.A.E. ; San Francisco, CA : Bentham Science Publishers, c2006- |
| مواضيع طبية MeSH: | Graft vs Host Disease*/therapy , Hematopoietic Stem Cell Transplantation* , Mesenchymal Stem Cells* , Mesenchymal Stem Cell Transplantation*, Humans ; Investigational New Drug Application ; Immunomodulation |
| مستخلص: | 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. (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.) |
| فهرسة مساهمة: | Keywords: GvHD; HSCT; QC; UC-MSCs; clinical trials; stem cell transplantation |
| تواريخ الأحداث: | Date Created: 20220527 Date Completed: 20230714 Latest Revision: 20230718 |
| رمز التحديث: | 20231215 |
| DOI: | 10.2174/1574888X17666220520155212 |
| PMID: | 35619293 |
| قاعدة البيانات: | MEDLINE |
| تدمد: | 2212-3946 |
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| DOI: | 10.2174/1574888X17666220520155212 |