THERAPEUTIC EVIDENCE OF UMBILICAL CORD
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Affiliations
1 Department of Neonatology, The First Affiliated Hospital of Xi'an Jiaotong University, No.277 West Yanta Road, Xi'an, 710061, Shaanxi, People's Republic of China. 2 Affiliated Taihe Hospital of Hubei University of Medicine, No. 32 Southern Renmin Road, Shiyan, 422000, Hubei, People's Republic of China. 3 Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, 38163, USA. 4 Shenzhen Beike Biotechnology Co., Ltd, No. 18 Keyuan Road, Hi-Tech Industrial Park South Area, Shenzhen, 518057, People's Republic of China. 5 Shiyan đô thị Disabled Persons' Federation, No. 12 Beijing Road, Shiyan, 422000, Hubei, People's Republic of China. 6 Department of Neonatology, The First Affiliated Hospital of Xi'an Jiaotong University, No.277 West Yanta Road, Xi'an, 710061, Shaanxi, People's Republic of China. Liuli918163.com.
PMID: 32014055 miễn phí PMC article
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Randomized Controlled Trial
Therapeutic evidence of umbilical cord-derived mesenchymal stem cell transplantation for cerebral palsy: a randomized, controlled trial
Jiaowei Guet al. Stem Cell Res Ther. 2020.
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Stem Cell Res Ther
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. 2020 Feb 3;11(1):43.
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doi: 10.1186/s13287-019-1545-x.
Authors
Jiaowei Gu 1 2 ,Li Huang 2 ,Che Zhang 1 2 ,Yong Wang 2 ,Ruibo Zhang 2 ,Ziliang Tu 2 ,Hengdong Wang 2 ,Xihui Zhou 1 ,Zhousheng Xiao 3 ,Zegan Liu 2 ,Xiang Hu 4 ,Zunchen Ke 5 ,Dabin Wang 2 ,Li Liu 6
Affiliations
1 Department of Neonatology, The First Affiliated Hospital of Xi'an Jiaotong University, No.277 West Yanta Road, Xi'an, 710061, Shaanxi, People's Republic of China. 2 Affiliated Taihe Hospital of Hubei University of Medicine, No. 32 Southern Renmin Road, Shiyan, 422000, Hubei, People's Republic of China. 3 Department of Medicine, University of Tennessee Health Science Center, Memphis, TN, 38163, USA. 4 Shenzhen Beike Biotechnology Co., Ltd, No. 18 Keyuan Road, Hi-Tech Industrial Park South Area, Shenzhen, 518057, People's Republic of China. 5 Shiyan đô thị Disabled Persons' Federation, No. 12 Beijing Road, Shiyan, 422000, Hubei, People's Republic of China. 6 Department of Neonatology, The First Affiliated Hospital of Xi'an Jiaotong University, No.277 West Yanta Road, Xi'an, 710061, Shaanxi, People's Republic of China. Liuli918163.com.
PMID: 32014055
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Abstract
Background: Cerebral palsy (CP) is a syndrome of childhood movement and posture disorders. Clinical evidence is still limited và sometimes inconclusive about the benefits of human umbilical cord mesenchymal stem cells (hUC-MSCs) for CP. We conducted a randomized trial to lớn evaluate the safety and efficacy of hUC-MSC transplantation concomitant with rehabilitation in patients with CP.
Methods: Eligible patients were allocated into the hUC-MSC group and control group. In addition to rehabilitation, the patients in the hUC-MSC group received four transfusions of hUC-MSCs intravenously, while the control group received a placebo. Adverse events (AEs) were collected for safety evaluation in the 12-month follow-up phase. Primary endpoints were assessed as activities of daily living (ADL), comprehensive function assessment (CFA), và gross motor function measure (GMFM) scales. In addition, cerebral metabolic activity was detected by 18F-FDG-PET/CT to lớn explore the possible mechanism of the therapeutic effects. Primary endpoint data were analyzed by ANOVA using SPSS version 20.0.
Results: Forty patients were enrolled, và 1 patient withdrew informed consent. Therefore, 39 patients received treatments and completed the scheduled assessments. No significant difference was shown between the 2 groups in AE incidence. Additionally, significant improvements in ADL, CFA, và GMFM were observed in the hUC-MSC group compared with the control group. In addition, the standard uptake value of 18F-FDG was markedly increased in 3 out of 5 patients from the hUC-MSC group at 12 months after transplantation.
Conclusions: Our clinical data showed that hUC-MSC transplantation was safe và effective at improving the gross motor & comprehensive function of children with CP when combined with rehabilitation. Recovery of cerebral metabolic activity might play an essential role in the improvements in brain function in patients with CP. The therapeutic window, transfusion route, and dosage in our study were considerable for reference in clinical application.
Trial registration: Chictr.org.cn, ChiCTR1800016554. Registered 08 June 2018-retrospectively registered. The public title was "Randomized trial of umbilical cord-derived mesenchymal stem cells for cerebral palsy."
Keywords: Activities of daily living; Cell transplantation; Cerebral palsy; Clinical trial; Mesenchymal stem cells; Umbilical cord.
Xem thêm: Các Cụ Ơi Có Nên Mua Kia Morning Si 2016, Kia Morning 2016 Cũ Có Đáng Mua
Flow chart for the study procedure. The patients received four transfusions after randomization & completed four scheduled visits at 1 month (51 ± 7 days), 3 months (111 ± 7 days), 6 months (201 ± 7 days), & 12 months (381 ± 15 days) after the last dose. ADL, activities of daily living; CFA, comprehensive function assessment; ECG, electrocardiogram; GMFM, gross motor function measure; hUC-MSCs, human umbilical cord blood mesenchymal stem cells; MRI, magnetic resonance imaging; 18F-FDG PET/CT, 18F-fluorodeoxyglucose positron emission tomography/computed tomography
