[Translation] A clinical trial to evaluate the safety, tolerability and efficacy of intravenous infusion of YFQLXB-UC01 injection in the treatment of decompensated liver cirrhosis

Ⅰ期（单次+多次给药、随机开放、剂量递增）主要目的：评价YFQLXB-UC01注射液在失代偿期肝硬化患者中的安全性和耐受性，确定临床用药的安全剂量。次要目的：评价YFQLXB-UC01注射液在失代偿期肝硬化患者中的初步有效性，为后续临床试验方案设计提供依据。探索性目的：探索YFQLXB-UC01注射液在失代偿期肝硬化患者中的药代动力学特征和免疫原性。探索YFQLXB-UC01注射液在失代偿期肝硬化患者中的药效动力学（PD）特征。 Ⅱ期（多次给药、随机双盲、安慰剂对照）主要目的：评价YFQLXB-UC01注射液在失代偿期肝硬化患者中的初步有效性。次要目的：评价YFQLXB-UC01注射液在失代偿期肝硬化患者中的安全性和耐受性。探索性目的：探索YFQLXB-UC01注射液在失代偿期肝硬化患者中的药代动力学特征和免疫原性。探索YFQLXB-UC01注射液在失代偿期肝硬化患者中的药效动力学（PD）特征

[Translation]

Phase I (single + multiple administration, randomized open, dose escalation) Main purpose: To evaluate the safety and tolerability of YFQLXB-UC01 injection in patients with decompensated cirrhosis and determine the safe dose for clinical use. Secondary purpose: To evaluate the preliminary efficacy of YFQLXB-UC01 injection in patients with decompensated cirrhosis and provide a basis for the design of subsequent clinical trial programs. Exploratory purpose: To explore the pharmacokinetic characteristics and immunogenicity of YFQLXB-UC01 injection in patients with decompensated cirrhosis. To explore the pharmacodynamic (PD) characteristics of YFQLXB-UC01 injection in patients with decompensated cirrhosis. Phase II (multiple administration, randomized double-blind, placebo-controlled) Main purpose: To evaluate the preliminary efficacy of YFQLXB-UC01 injection in patients with decompensated cirrhosis. Secondary purpose: To evaluate the safety and tolerability of YFQLXB-UC01 injection in patients with decompensated cirrhosis. Exploratory purpose: To explore the pharmacokinetic characteristics and immunogenicity of YFQLXB-UC01 injection in patients with decompensated cirrhosis. To explore the pharmacodynamic (PD) characteristics of YFQLXB-UC01 injection in patients with decompensated cirrhosis

Start Date-

Sponsor / Collaborator

Shandong Qilu Cell Therapy Engineering Technology Co., Ltd.

NCT05872659 / RecruitingEarly Phase 1

A Clinical Study to Evaluate the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells Combined With Antiviral Therapy in the Treatment of AIDS Patients With Immune Non-responder

The goal of this clinical trial is to explore the effect of mesenchymal stem cell therapy on immune non-responder patients. The main questions it aims to answer are:
Efficacy of human umbilical cord mesenchymal stem cells combined with antiviral therapy in the treatment of AIDS patients with immune non-response.
Safety of human umbilical cord mesenchymal stem cells combined with antiviral therapy in AIDS patients with immune non-response.
Participants will receive CD4,CD4/CD8, and RNA viral load tests and will be randomly assigned to either saline or mesenchymal stem cell therapy.
Investigators will evaluate the safety and efficacy of mesenchymal stem cell therapy based on examination results.

Start Date16 Apr 2023

Sponsor / Collaborator

Shandong Qilu Cell Therapy Engineering Technology Co., Ltd.

100 Clinical Results associated with Yinfeng Biological Engineering Group Co. Ltd.

0 Patents (Medical) associated with Yinfeng Biological Engineering Group Co. Ltd.

Literatures (Medical) associated with Yinfeng Biological Engineering Group Co. Ltd.

01 Jun 2024·Global Medical Genetics

Comparing Genomic Profiles of ALK Fusion-Positive and ALK Fusion-Negative Nonsmall Cell Lung Cancer Patients

Article

Author: Li, Hongbin ; Liu, Jinfeng ; Yang, Jing ; Xia, Wenchao ; Li, Ling

Abstract Background Anaplastic lymphoma kinase (ALK) fusion events account for 3 to 7% of genetic alterations in patients with nonsmall cell lung cancer (NSCLC). This study aimed to explore the landscape of ALK fusion-positive and ALK fusion-negative in a large cohort of NSCLC patients. Methods The formalin-fixed paraffin-embedded specimens of NSCLC patients who underwent next-generation sequencing from 2020 to 2023 in Yinfeng Gene Technology Co., Ltd. Clinical laboratory were included in this study. Results In the current study, a total of 180 (3.20%) patients tested positive for ALK fusions in 5,622 NSCLC samples. Within the ALK-positive cohort, a total of 228 ALK fusions were identified. Furthermore, five novel ALK fusion partners, including DAB1-ALK, KCMF1-ALK, KIF13A-ALK, LOC643770-ALK, and XDH-ALK were identified. In cases with ALK fusion-positive, TP53 alterations were the most prevalent (26.3%), followed by CDKN2A (8.4%), epidermal growth factor receptor (EGFR, 5.6%), and ALK (5.6%). By contrast, EGFR alterations were most prevalent (51%) in patients with ALK fusion-negative NSCLC, followed by TP53 (42.7%), KRAS (11.6%), and CDKN2A (11.3%). A total of 10 cases where ALK fusion co-occurred with EGFR mutations were also identified. Notably, the ALK fusion positivity rate was higher in younger patients (p < 0.0001) and in female patients (p = 0.0429). Additionally, positive ALK test results were more prevalent in patients with high programmed death-ligand 1 expression, especially when applying a 50% cutoff. Conclusions Collectively, these findings offer valuable genomic insights that could inform the personalized clinical care of patients with NSCLC harboring ALK fusions within the context of precision medicine.

01 Oct 2023·International journal of molecular medicine

Human umbilical cord mesenchymal stem cell‑derived exosomes improve ovarian function in natural aging by inhibiting apoptosis.

Article

Author: Tan, Yi ; Liu, Yibin ; Huang, Xianghua ; Li, Zhongkang ; Li, Qian ; Du, Yanfang ; Zhang, Jingkun ; Zhang, Huihui ; Tian, Yanpeng ; Yang, Shuangshuang ; Shi, Wenxin ; Yang, Tao

Prolonging the reproductive lifespan is beneficial for preserving the physical and psychological health of women. The transplantation of mesenchymal stem cell (MSC)‑derived exosomes (MSC‑Exos) has been reported to be a promising regenerative therapeutic strategy for restoring the function of aging ovaries. The present study thus evaluated the therapeutic efficacy of exosomes derived from human umbilical cord‑MSCs (hUCMSC‑Exos) in a mouse model of natural ovarian aging (NOA), and further investigated the role of exosomal microRNAs (miRNAs/miRs) in the mechanisms of this creative therapy. Specifically, following the administration of hUCMSC‑Exos in mice with NOA, ovarian function was found to improve, as indicated by the restoration of follicle numbers and hormone levels. These exosomes were found to exhibit the ability to inhibit PTEN expression and suppress apoptosis both in vivo and in vitro. Subsequently, miRNA sequencing of the exosomes was performed, following which bioinformatics analysis was used to identify the highly expressed miRNAs that are capable of targeting PTEN expression. Through high‑throughput sequencing and molecular analyses, miR‑21‑5p was found to be the highest in ranking in terms of expression, suggesting that hUCMSC‑Exos can preserve ovarian function by suppressing PTEN expression to inhibit apoptosis by delivering miR‑21‑5p. On the whole, the results of the present study suggest that the application of exosomes can be used to restore ovarian function in mice with NOA. These positive findings also suggest that the transplantation of exosomes derived from MSCs holds promise as an agent against ovarian aging.

01 Sep 2023·Asian Journal of Andrology

A novel loss-of-function variant in PNLDC1 inducing oligo-astheno-teratozoospermia and male infertility

Article

Author: Wang, Xiong ; Du, Zhao-Li ; Tan, Yue-Qiu ; Zhao, Si-Yi ; Meng, Lan-Lan ; He, Wen-Bin

Male infertility is a major reproductive disorder, which is clinically characterized by highly heterogeneous phenotypes of abnormal sperm count or quality. To date, five male patients with biallelic loss-of-function (LOF) variants of PARN-like ribonuclease domain-containing exonuclease 1 (PNLDC1) have been reported to experience infertility with nonobstructive azoospermia. The aim of this study was to identify the genetic cause of male infertility with oligo-astheno-teratozoospermia (OAT) in a patient from a Chinese Han family. Whole-exome and Sanger sequencing analyses identified a homozygous LOF variant (NM_173516.2, c.142C>T, p.Gln48Ter) in PNLDC1. Hematoxylin and eosin staining revealed that the spermatozoa of the patient with OAT had an irregular head phenotype, including microcephaly, head tapering, and globozoospermia. Consistently, peanut agglutinin staining of the spermatozoa revealed a complete or partial loss of the acrosome. Furthermore, the disomy rate of chromosomes in the patient’s spermatozoa was significantly increased compared with that of a fertile control sample. We reported an LOF variant of the PNLDC1 gene responsible for OAT.

100 Deals associated with Yinfeng Biological Engineering Group Co. Ltd.

100 Translational Medicine associated with Yinfeng Biological Engineering Group Co. Ltd.

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Pipeline

Pipeline Snapshot as of 23 Nov 2024

The statistics for drugs in the Pipeline is the current organization and its subsidiaries are counted as organizations,Early Phase 1 is incorporated into Phase 1, Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3

Preclinical

Phase 1 Clinical

Phase 2 Clinical

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Current Projects

Drug(Targets)	Indications	Global Highest Phase

YFQLXB-UC01	Decompensated cirrhosis of liver More	Phase 2 Clinical
Human umbilical cord mesenchymal stem cells(Shandong Qilu Cell Therapy Engineering Technology)	Disorder of immune reconstitution More	Phase 1 Clinical
AB-110	Hematologic Neoplasms More	Phase 1
IL-6/IFN-γ KD CD19 targeted CAR-T(Shandong Qilu Cell Therapy Engineering Technology) ( CD19 )	B-Cell Prolymphocytic Leukemia More	Preclinical
CD133 Targeted CAR-Macrophage(Qilu Pharmaceutical/Shandong Xingrui Biotechnology/Yinfeng Biological Engineering Group/Shandong University) ( CD133 )	Glioblastoma More	Preclinical

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