umbilical cord mesenchymal stem cell therapy (hUC-MSC) / Shenzhen Beike Biotech - LARVOL DELTA

TNFRSF11B-modified umbilical cord mesenchymal stem cells as a novel strategy for bone-related diseases by suppressing osteoclast activity. (PubMed, J Orthop Surg Res) - "This study demonstrates that although TNFRSF11B overexpression does not promote osteogenesis in UCMSCs, it may participate in regulating bone remodeling by inhibiting osteoclast differentiation."

Journal • Oncology • TNFA • TNFRSF11B

A GMP-compliant manufacturing method for Wharton's jelly-derived mesenchymal stromal cells. (PubMed, Stem Cell Res Ther) - "This study offers valuable insights into optimizing the isolation and culture of WJ-MSCs. Our scalable manufacturing processes facilitate the large-scale production of high-quality WJ-MSCs. These findings contribute to the advancement of WJ-MSCs-based therapies in regenerative medicine."

Journal • Stroma

Unveiling the functional heterogeneity of cytokine-primed human umbilical cord mesenchymal stem cells through single-cell RNA sequencing. (PubMed, Cell Biosci) - "These findings contribute to a comprehensive understanding of the inflammatory priming of MSCs, paving the way for their precise treatment in clinical applications."

Heterogeneity • Journal • Immunology • IFNG • IL15 • IL17A • IL4 • IL6 • TNFA

Interleukin-18-primed human umbilical cord-mesenchymal stem cells achieve superior therapeutic efficacy for severe viral pneumonia via enhancing T-cell immunosuppression. (PubMed, Cell Death Dis) - "Notably, IL18-hUCMSC treatment has a superior inhibitory effect on T-cell exudation and proinflammatory cytokine secretion in bronchoalveolar lavage fluid (BALF). Altogether, IL-18 is a promising cytokine that can prime hUC-MSCs to improve the efficacy of precision therapy against viral-induced pneumonia, such as COVID-19."

Journal • Acute Lung Injury • Fibrosis • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases • Transplantation • CCL2 • CXCL12 • IL18 • MMP1 • TGFB1 • VCAM1

Topical and intravenous administration of human umbilical cord mesenchymal stem cells in patients with diabetic foot ulcer and peripheral arterial disease: a phase I pilot study with a 3-year follow-up. (PubMed, Stem Cell Res Ther) - "Based on the current pilot study, the preliminary clinical benefits of hUC-MSCs on DFU healing were shown, including good tolerance, a shortened healing time to 1.5 months and a favorable 3-year amputation-free survival rate. The clinical evidence in the current study suggested a further phase I/II study with a larger patient population and a more rigorous design to explore the efficacy and mechanism of hUC-MSCs on DFU healing."

Journal • P1 data • Cardiovascular • Diabetes • Metabolic Disorders • Peripheral Arterial Disease • Venous Ulcer

Reproductive and Developmental Toxicity Assessment of Human Umbilical Cord Mesenchymal Stem Cells in Rats. (PubMed, Front Cell Dev Biol) - " Based on the results of the studies, the no-observed-adverse-effect levels (NOAELs) are 8.5 × 10/kg for fertility and early embryonic development, 1.2 × 10/kg for maternal toxicity and 2.4 × 10/kg for embryo-fetal development in rats intravenous injected with hUC-MSCs, which are equivalent to 8.5-fold, 12-fold, and 24-fold respectively of its clinical dosage in humans. These findings may provide a rational basis for human health risk assessment of hUC-MSCs."

Journal • Preclinical • Cardiovascular • Pulmonary Embolism • Respiratory Diseases

Human umbilical cord mesenchymal stromal cells attenuate pulmonary fibrosis via regulatory T cell through interaction with macrophage. (PubMed, Stem Cell Res Ther) - "Our study establishes a link between hucMSCs, macrophage, Treg, and PF. It provides new insights into how hucMSCs interact with macrophage during the repair process of bleomycin-induced PF and play its immunoregulation function."

Journal • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • Transplantation • CXCL10 • CXCL9

Human umbilical cord-derived mesenchymal stem cells improve the function of liver in rats with acute-on-chronic liver failure via downregulating Notch and Stat1/Stat3 signaling. (PubMed, Stem Cell Res Ther) - "hUC-MSC transplantation can improve liver function, the degree of fibrosis, and liver damage and promote liver repair in rats with ACLI or ACLF, mediated most likely by inhibiting Notch signaling and reversing the imbalance of the Stat1/Stat3 pathway."

Journal • Preclinical • Fibrosis • Hepatology • Immunology • Liver Cirrhosis • Liver Failure • Transplantation • HGF • IFNG • IL6 • STAT1

Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis (clinicaltrials.gov) - P1; N=20; Not yet recruiting; Sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD

New P1 trial • Biosimilar • Fibrosis • Immunology • Inflammation • Oncology

A Study on Radiation-induced Pulmonary Fibrosis Treated With Clinical Grade Umbilical Cord Mesenchymal Stem Cells (clinicaltrials.gov) - P1; N=14; Active, not recruiting; Sponsor: Jianwu Dai; Recruiting ➔ Active, not recruiting; Trial primary completion date: Dec 2016 ➔ Jul 2017

Enrollment closed • Trial primary completion date • Biosimilar • Fibrosis • Immunology

Characterization of HLA-G and related immunosuppressive effects in human umbilical cord stroma derived stem cells. (PubMed) - "This study confirms the HLA-G-related immunosuppressive property of HUCMSCs, which is more potent than MSCs of other origin. A good tolerance of this mesenchymal stem cell in allogeneic transplantation can thus be anticipated."

Journal • Biosimilar • Graft versus Host Disease • Immunology • Inflammation

Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD

New P1 trial • Biosimilar • Immunology • Inflammation • Oncology • Rheumatoid Arthritis

Randomized Clinical Trial of Intravenous Infusion Umbilical Cord Mesenchymal Stem Cells on Cardiopathy (clinicaltrials.gov) - P1/2; N=30; Completed; Sponsor: Universidad Los Andes, Chile; Recruiting -> Completed

Trial completion • Biosimilar • Myositis

Umbilical Cord Mesenchymal Stem Cells Injection for Ocular Corneal Burn (clinicaltrials.gov) - P1/2; N=100; Not yet recruiting; Sponsor: Guangzhou Saliai Stem Cell Science and Technology Co. Ltd.

New P1/2 trial • Biosimilar • Ophthalmology

Transplantation of insulin-producing cells to treat diabetic rats after 90% pancreatectomy. (PubMed) - "Our results show that UCMSCs can differentiate into islet-like cells in vitro under certain conditions, which can function as IPCs both in vivo and in vitro."

Journal • Biosimilar • Diabetes • Immunology • Inflammation

Therapy for Pneumonia Patients iInfected by 2019 Novel Coronavirus (clinicaltrials.gov) - P=N/A; N=48; Recruiting; Sponsor: Puren Hospital Affiliated to Wuhan University of Science and Technology

Clinical • New trial

Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells for the Treatment of Severe Viral Pneumonian (clinicaltrials.gov) - P1; N=40; Not yet recruiting; Sponsor: Shanghai East Hospital

Clinical • New P1 trial

Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars (clinicaltrials.gov) - P2; N=120; Recruiting; Sponsor: Maternal and Child Health Hospital of Foshan; Trial completion date: Apr 2019 ➔ Apr 2022; Trial primary completion date: Oct 2018 ➔ Oct 2021

Trial completion date • Trial primary completion date

Safety of Umbilical Cord Mesenchymal Stem Cell Local Intramuscular Injection for Treatment of Uterine Scars (clinicaltrials.gov) - P1; N=10; Recruiting; Sponsor: Maternal and Child Health Hospital of Foshan; Trial completion date: Jun 2018 ➔ May 2022; Trial primary completion date: Jan 2018 ➔ Oct 2021

Trial completion date • Trial primary completion date

Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Novel Coronavirus Severe Pneumonia (clinicaltrials.gov) - P=N/A; N=48; Not yet recruiting; Sponsor: Wuhan Union Hospital, China

Clinical • New trial

Effect of Different Transplantation Time for Mesenchymal Stem Cells(MSCs) of Cerebral Infarction Patients (clinicaltrials.gov) - P1/2; N=120; Enrolling by invitation; Sponsor: Shanghai East Hospital; Recruiting ➔ Enrolling by invitation; Initiation date: Sep 2019 ➔ Jan 2019

Clinical • Enrollment status • Trial initiation date

Intracavitary Injection of hUMSCs in Acute Basal Ganglia Hematoma After Stereotactic Aspiration (clinicaltrials.gov) - P2; N=100; Not yet recruiting; Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University; Initiation date: Dec 2019 ➔ Mar 2020

Clinical • Trial initiation date • MRI

Collagen Membrane Combined With HUC-MSCs Transplantation in Patients With Nasal Septum Perforation (clinicaltrials.gov) - P1/2; N=12; Recruiting; Sponsor: Chinese Academy of Sciences; Trial completion date: Dec 2019 ➔ Dec 2020; Trial primary completion date: Dec 2019 ➔ Dec 2020

Clinical • Trial completion date • Trial primary completion date

Clinical Study of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetic Nephropathy (clinicaltrials.gov) - P2; N=54; Recruiting; Sponsor: Shanghai East Hospital

Clinical • New P2 trial

A Study on Pneumoconiosis Treated With Whole-lung Lavage Combined With Mesenchymal Stem Cells (clinicaltrials.gov) - P1; N=80; Completed; Sponsor: Jianwu Dai; Active, not recruiting ➔ Completed

Clinical • Trial completion