Shandong Qilu Cell Therapy Engineering Technology Co., Ltd., founded in 2011 and part of the Shandong YinFeng Biological Group, specializes in cellular technology development, clinical research, and cell therapy product registration. With a focus on stem and immune cell technologies, the company engages in clinical research, translational services, CAR-T cell products, adult cell storage, and novel cell-derived products, providing personalized treatment solutions. It is one of the few high-tech enterprises in the cellular technology sector encompassing the entire industry chain from upstream to downstream R&D.

Tags

Respiratory Diseases

Digestive System Disorders

Immune System Diseases

Biological products

Mesenchymal stem cell therapy

CAR-T

Disease domain score

A glimpse into the focused therapeutic areas

Technology Platform

Most used technologies in drug development

Targets

Most frequently developed targets

Disease Domain	Count

Immune System Diseases	2
Hemic and Lymphatic Diseases	1
Infectious Diseases	1
Neoplasms	1

Top 5 Drug Type	Count

CAR-T	1
Mesenchymal stem cell therapy	1
Biological products	1

Top 5 Target	Count

CD19(B-lymphocyte antigen CD19)	1

Drugs associated with Shandong Qilu Cell Therapy Engineering Technology Co., Ltd.

YFQLXB-UC01

Target-

Mechanism-

Active Org.

Shandong Qilu Cell Therapy Engineering Technology Co., Ltd.

Originator Org.

Shandong Qilu Cell Therapy Engineering Technology Co., Ltd.

Active Indication

Decompensated cirrhosis of liver [+1]

Inactive Indication-

Drug Highest PhasePhase 1/2

First Approval Ctry. / Loc.-

First Approval Date-

Human umbilical cord mesenchymal stem cells(Shandong Qilu Cell Therapy Engineering Technology)

Target-

Mechanism-

Active Org.

Shandong Qilu Cell Therapy Engineering Technology Co., Ltd.

Originator Org.

Shandong Qilu Cell Therapy Engineering Technology Co., Ltd.

Active Indication

Acquired Immunodeficiency Syndrome [+3]

Inactive Indication-

Drug Highest PhaseEarly Phase 1

First Approval Ctry. / Loc.-

First Approval Date-

IL-6/IFN-γ KD CD19 targeted CAR-T(Shandong Qilu Cell Therapy Engineering Technology)

Target

CD19

Mechanism

CD19 inhibitors

Active Org.

Shandong Qilu Cell Therapy Engineering Technology Co., Ltd.

Originator Org.

Shandong Qilu Cell Therapy Engineering Technology Co., Ltd.

Active Indication

B-Cell Prolymphocytic Leukemia [+1]

Inactive Indication-

Drug Highest PhasePreclinical

First Approval Ctry. / Loc.-

First Approval Date-

Clinical Trials associated with Shandong Qilu Cell Therapy Engineering Technology Co., Ltd.

CTR20241765 / Not yet recruitingPhase 1/2

一项评价YFQLXB-UC01注射液静脉输注治疗失代偿期肝硬化的安全性、耐受性及有效性临床试验

[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 Shandong Qilu Cell Therapy Engineering Technology Co., Ltd.

0 Patents (Medical) associated with Shandong Qilu Cell Therapy Engineering Technology Co., Ltd.

Literatures (Medical) associated with Shandong Qilu Cell Therapy Engineering Technology Co., Ltd.

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 Nov 2022·Free Radical Biology and Medicine

Exosomes derived from human umbilical cord mesenchymal stem cells ameliorate experimental non-alcoholic steatohepatitis via Nrf2/NQO-1 pathway

Article

Author: Luo, Yuxin ; Yang, Shuangshuang ; Yu, Jun ; Guo, Jinbo ; Song, Jia ; Zhang, Xiaolan ; Song, Yiran ; Li, Chenyang ; Kang, Yaxing

BACKGROUNDNo approved effective therapy for non-alcoholic steatohepatitis (NASH) is currently available. Exosomes derived from mesenchymal stem cells (MSCs) perform the functions such as inhibiting inflammation, anti-oxidative stress, regulating immunity, but it is not clear whether human umbilical cord mesenchymal stem cells (hUC-MSCs) exosomes protect against NASH through Nrf2/NQO-1 pathway. Therefore, this study was conducted to investigate the effects of hUC-MSCs exosomes on NASH through Nrf2/NQO-1 pathway in vivo and in vitro.METHODSC57BL/6J male mice were fed with high fat and high cholesterol diet (HFHC) and methionine choline deficiency diet (MCD). Mice were treated with or without hUC-MSCs exosomes by tail intravenous injection. The liver histology, lipid metabolism and oxidative stress were evaluated. HepG2 and AML12 cells were incubated with palmitic acid (PA) and MCD conditioned medium, respectively. Then the therapeutic effect of hUC-MSCs exosomes in steatotic cells was evaluated. To elucidate the signaling pathways, the Nrf2-specific blocker ML385 was applied to intervene in vitro.RESULTSIn NASH models, hUC-MSCs exosomes attenuated steatosis in hepatocytes, altered the abnormal expression of lipid-related genes including SREBP-1c, PPAR-α, Fabp5, CPT1α, ACOX and FAS, suppressed the hepatic inflammatory responses by decreasing the expression of F4/80⁺ macrophages, CD11c⁺ macrophages as well as the content of TNF-α and IL-6. hUC-MSCs exosomes also inhibited oxidative stress by reducing the level of MDA, CYP2E1 and ROS, increasing the activity of SOD and GSH in hepatocytes. Notably, hUC-MSCs exosomes enhanced the protein ratio of p-Nrf2/Nrf2 and the protein expression of NQO-1. Moreover, in vitro, the therapeutic effects of hUC-MSCs exosomes on lipid deposition and ROS were reversed by ML385. Also, ML385 reduced the protein expression of p-Nrf2 and NQO-1 in vitro.CONCLUSIONNrf2/NQO-1 antioxidant signaling pathway may play a key role in the treatment of NASH by hUC-MSCs exosomes.

01 Dec 2021·Stem Cell Research & TherapyQ2 · MEDICINE

A novel therapeutic approach for inflammatory bowel disease by exosomes derived from human umbilical cord mesenchymal stem cells to repair intestinal barrier via TSG-6

Q2 · MEDICINE

ArticleOA

Author: Zhang, Xiaolan ; Yang, Shaopeng ; Liang, Xiaonan ; Song, Jia ; Luo, Yuxin ; Ma, Heran ; Tan, Yi ; Liu, Airu ; Li, Chenyang

AbstractBackgroundExosomes as the main therapeutic vectors of mesenchymal stem cells (MSC) for inflammatory bowel disease (IBD) treatment and its mechanism remain unexplored. Tumor necrosis factor-α stimulated gene 6 (TSG-6) is a glycoprotein secreted by MSC with the capacities of tissue repair and immune regulation. This study aimed to explore whether TSG-6 is a potential molecular target of exosomes derived from MSCs (MSCs-Exo) exerting its therapeutic effect against colon inflammation and repairing mucosal tissue.MethodsTwo separate dextran sulfate sodium (DSS) and 2,4,6-trinitrobenzenesulfonic acid (TNBS)-induced IBD mouse models were intraperitoneally administered MSCs-Exo extracted from human umbilical cord MSC (hUC-MSC) culture supernatant. Effects of MSCs-Exo on intestinal inflammation, colon barrier function, and proportion of T cells were investigated. We explored the effects of MSCs-Exo on the intestinal barrier and immune response with TSG-6 knockdown. Moreover, recombinant human TSG-6 (rhTSG-6) was administered exogenously and colon inflammation severity in mice was evaluated.ResultsIntraperitoneal injection of MSCs-Exo significantly ameliorated IBD symptoms and reduced mortality rate. The protective effect of MSCs-Exo on intestinal barrier was demonstrated evidenced by the loss of goblet cells and intestinal mucosa permeability, thereby improving the destruction of tight junctions (TJ) structures and microvilli, as well as increasing the expression of TJ proteins. Microarray analysis revealed that MSCs-Exo administration downregulated the level of pro-inflammatory cytokines and upregulated the anti-inflammatory cytokine in colon tissue. MSCs-Exo also modulated the response of Th2 and Th17 cells in the mesenteric lymph nodes (MLN). Reversely, knockdown of TSG-6 abrogated the therapeutic effect of MSCs-Exo on mucosal barrier maintenance and immune regulation, whereas rhTSG-6 administration showed similar efficacy to that of MSCs-Exo.ConclusionsOur findings suggested that MSCs-Exo protected against IBD through restoring mucosal barrier repair and intestinal immune homeostasis via TSG-6 in mice.

100 Deals associated with Shandong Qilu Cell Therapy Engineering Technology Co., Ltd.

100 Translational Medicine associated with Shandong Qilu Cell Therapy Engineering Technology Co., Ltd.

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Pipeline

Pipeline Snapshot as of 27 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

Other

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
IL-6/IFN-γ KD CD19 targeted CAR-T(Shandong Qilu Cell Therapy Engineering Technology) ( CD19 )	B-Cell Prolymphocytic Leukemia More	Preclinical
Adipose-derived stem cells(Shandong Qilu Cell Therapy Engineering Technology)	Arthritis More	Pending
NK Cell(Shandong Qilu Cell Therapy Engineering Technology)	Non-Small Cell Lung Cancer More	Pending

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