Clinical trial of the safety, efficacy and feasibility of implantable spinal cord neurostimulator system for the treatment of limb motor dysfunction after stroke

Start Date23 Sep 2024

Sponsor / Collaborator

Changshu No. 2 People's Hospital

NCT06337474

/ RecruitingEarly Phase 1IIT

An Exploratory Clinical Study of the Safety and Efficacy of CD19 Chimeric Antigen Receptor NK Cell Injections for the Treatment of Refractory Primary Immune Thrombocytopenia

A single arm, open-label pilot study is designed to determine the safety and effectiveness of CD19 CAR NK cells (KN5501) in patients with refractory immune thrombocytopenia. 9 patients are planned to be enrolled in the dose-escalation trial (9×10^9 cells, 13.5×10^9 cells). The primary objective of the study is to evaluation of the safety and feasibility of KN5501 for the treatment of relapsed/refractory B-cell related autoimmune diseases. The secondary objective is to evaluate evaluation of KN5501 for the treatment of refractory immune thrombocytopenia. The exploratory objective is to evaluate expansion, persistence and ability to deplete CD19 positive B cells of KN5501 in patients with refractory immune thrombocytopenia.

Start Date30 Aug 2024

Sponsor / Collaborator

Changshu No. 2 People's Hospital

[+1]

100 Clinical Results associated with Changshu No. 2 People's Hospital

0 Patents (Medical) associated with Changshu No. 2 People's Hospital

569

Literatures (Medical) associated with Changshu No. 2 People's Hospital

31 Dec 2025·Annals of Medicine

Impact of 30 mL/kg fluid resuscitation completed within one hour on elderly septic shock patient

Article

Author: Min, YePing ; Gu, Tijun ; Liu, Fujing ; Jin, Fang ; Zhang, Lingling

OBJECTIVEThis study aimed to investigate the prognostic impact of completing 30 mL/kg fluid resuscitation within 1 h in elderly septic shock patients.METHODSThis was a multicenter prospective observational cohort study. We applied logistic regression to assess the impact of completing 30 mL/kg fluid resuscitation within 1 h on respiratory support escalation including new-onset mechanical ventilation, bilevel positive airway pressure (BiPAP), and high-flow nasal cannula (HFNC) as well as heart failure (HF). We plotted Kaplan-Meier (K-M) curves to evaluate survival in patients completing 30 mL/kg fluid resuscitation within 1 h. We performed mediation analyses to determine the influence of HF on mortality associated with completing 30 mL/kg fluid resuscitation within 1 h.RESULTSCompleting 30 mL/kg fluid resuscitation within 1 h increased the odds ratios of new-onset BiPAP (adjusted OR = 3.411; 95% confidence interval (CI) = [1.526, 7.620]) and HFNC (adjusted OR = 2.576; 95% CI = [1.252, 5.297]) within 24 h as well as the odds ratio of HF (adjusted OR = 2.291; 95% CI = [1.266, 4.149]). The adjusted K-M curve showed that patients completing 30 mL/kg fluid resuscitation within 1 h had higher 30-d mortality than those completing it over longer periods. The mediation effect suggested that completing 30 mL/kg fluid resuscitation within 1 h could be fatal primarily because it increased the risk of HF.CONCLUSIONFor elderly patients with septic shock, completing 30 ml/kg of fluid resuscitation within 1 h ought to be more cautious, particularly considering the patient's cardiac function and overall clinical status.

01 Jul 2025·Biochemical Pharmacology

A novel IgD-FcδR blocker, IgD-Fc-Ig fusion protein, effectively alleviates abnormal activation of T cells the disease progression in systemic lupus erythematosus

Article

Author: Yan, Shangxue ; Ling, Xi ; Xu, Nuo ; Wang, Yueye ; Dong, Manling ; He, Jingjing ; Wei, Wei ; Guo, Tingting ; Jiang, Li ; Li, Tao ; Zhang, Jing ; Liu, Danyan ; Wu, Tiantian ; Zhao, Jiemin ; Wu, Yujing ; Chen, Mengqin

Systemic lupus erythematosus (SLE) is a chronic, multi-organ autoimmune disease with complex pathogenesis and unclear causes. Elevated levels of IgD have been observed in the peripheral blood of SLE patients, suggesting a potential role for IgD through its interaction with the IgD Fc receptor (FcδR). This study aimed to explore the impact of IgD on T cell function in SLE and evaluate the therapeutic potential of targeting the IgD-FcδR pathway using an IgD-Fc-Ig fusion protein. In SLE patients, biomarkers such as BAFF, ESR, anti-dsDNA and SLEDAI-2k, which are used to assess disease activity and clinical presentations, were significantly correlated with sIgD levels. As an IgD-FcδR blocker, IgD-Fc-Ig effectively suppressed the activation and proliferation of CD4⁺ T cells stimulated by IgD, restored the balance between Th17 and Treg cell subsets, and reduced the expression and interaction of phosphorylated Lck (p-Lck) and JAK2 (p-JAK2). Moreover, in vivo study demonstrated that IgD-Fc-Ig may also ameliorates disease manifestations in MRL/lpr mice with lupus nephritis. IgD-Fc-Ig could reduce serum IgD levels, proteinuria level and the kidney deposition of immune complex C3, ameliorate histopathological changes in kidney and spleen tissue. Additionally, it reversed the state of excessive activation and imbalance of Th17/Treg cell subsets, reduced cytokine levels, and downregulated p-JAK2 and p-STAT3 expression. In conclusion, our study revealed a correlation between abnormally increased sIgD and SLE pathogenesis, IgD-FcδR-Lck-JAK2-STAT3 may act as an important mechanism contributing to T cell activation in SLE. IgD-Fc-Ig fusion protein may represent a promising targeted therapy for SLE.

01 Apr 2025·Drug Research

Fragment-Based Drug Discovery of KIF11 Inhibitors for Glioblastoma Treatment: Molecular Insights and Therapeutic Potential

Article

Author: Naseer, Qais Ahmad ; Chen, Shengxia ; Khan, Muhammad Ajmal ; Xuexian, Cao ; Yimai, Deng

Graphical AbstractFragment based novel drug identification and its validation through use of molecular dynamics and simulations.

100 Deals associated with Changshu No. 2 People's Hospital

100 Translational Medicine associated with Changshu No. 2 People's Hospital

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