solizmestrocel (UMC119-06) / Xuanjie - LARVOL DELTA

A Phase I, Open-Label, Dose-Escalation Study to Evaluate the Safety and Tolerability of Intravenous UMC119-06 in Acute Ischemic Stroke Patients (ESOC 2025) - P1 | "Despite the small sample size of six participants, trends toward positive outcomes were observed in the mRS, NIHSS, Barthel Index, and infarct volume. At the end of visit, 4 out of 6 subjects had mRS scores 0-1. 5 subjects had an infarct volume of 0 mL by day 30, while the remaining subject achieved 0 mL by day 90."

Clinical • Late-breaking abstract • Cardiovascular • Ischemic stroke • IL6 • TNFA

Late Breaking Abstract - The interim analysis result of allogeneic umbilical cord mesenchymal stem cells administration to moderate COPD patients: an open-label, dose escalation, Phase I study. (ERS 2023) - P1 | "All the subjects had ameliorated or remained in the same grade in mMRC dyspnea scale. The interim analysis result demonstrated that UMC119-06 is feasible, safe and promising therapeutic for COPD.; Cell and molecular biology; Physiology; Public health; General respiratory patient care; Pulmonary rehabilitation; Imaging"

Clinical • Late-breaking abstract • P1 data • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Pulmonary Emphysema • Respiratory Diseases

Mesenchymal Stem Cells for The Treatment of Acute Respiratory Distress Syndrome (ARDS) (clinicaltrials.gov) - P1 | N=18 | Not yet recruiting | Sponsor: Meridigen Biotech Co., Ltd. | Trial completion date: Dec 2023 ➔ Sep 2025 | Trial primary completion date: Dec 2022 ➔ Sep 2024

Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

Mesenchymal Stem Cells for The Treatment of Acute Ischemic Stroke (clinicaltrials.gov) - P1 | N=9 | Recruiting | Sponsor: Meridigen Biotech Co., Ltd. | Trial completion date: Dec 2023 ➔ Dec 2025 | Trial primary completion date: Dec 2022 ➔ Dec 2023

Trial completion date • Trial primary completion date • Cardiovascular • Ischemic stroke

Mesenchymal Stem Cells for The Treatment of Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P1 | N=9 | Active, not recruiting | Sponsor: Meridigen Biotech Co., Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2023 ➔ Jun 2024 | Trial primary completion date: Mar 2022 ➔ Dec 2023

Enrollment closed • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Xuanjie Stem Cell and Shuanghe Hospital start the treatment of severe patients with new coronary pneumonia [Google translation] (China Times) - "Xuanjie Stem Cell (4724) said on the 10th that it will work with Shuanghe Hospital to obtain emergency approval from the Food and Drug Administration (TFDA) for 100 doses of new allogeneic umbilical cord mesenchymal stem cell drug UMC119-06 for the treatment of severely ill patients with new coronary pneumonia, hoping to reduce the new crown Pneumonia severe death rate. Xuanjie’s new allogeneic umbilical cord mesenchymal stem cell drug UMC119-06 participated in the 'CDE can Help' project approval of the Drug Inspection Center. It was notified on June 4 that the TFDA urgently approved the kindness of Shuanghe Hospital to provide emergency patients for the project application therapy."

New trial • Infectious Disease • Novel Coronavirus Disease

Xuanjie Stem Cell announced that it has obtained new drug authorization. The new general manager is Wu Shiyang, the chief operating officer of Hugui Industrial [Google translation] (ETtoday) - "During the meeting, it approved the acquisition of UMC119-06, a new drug for allogeneic umbilical cord mesenchymal stem cells, and its application in chronic obstructive pulmonary disease (COPD) and acute respiratory distress (ARDS)....Xuanjie Stem Cell stated that it will obtain the allogeneic umbilical cord mesenchymal stem cell new drug UMC119-06 pharmaceutical and therapeutic technology authorization from Orilitia Biopharma Limited in Hong Kong....The rights in Japan, South Korea, Malaysia, Singapore, Thailand, Vietnam, Taiwan, Indonesia, the Philippines and other regions are exclusively authorized to Xuanjie Stem Cell."

Licensing / partnership • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Mesenchymal Stem Cells for The Treatment of Knee Osteoarthritis (KOA). (clinicaltrials.gov) - P1; N=6; Not yet recruiting; Sponsor: Meridigen Biotech Co., Ltd.

Clinical • New P1 trial • Immunology • Osteoarthritis • Pain • Rheumatology • MRI

Mesenchymal Stem Cells for The Treatment of Acute Respiratory Distress Syndrome (ARDS) (clinicaltrials.gov) - P1; N=18; Not yet recruiting; Sponsor: Meridigen Biotech Co., Ltd.; Trial completion date: Dec 2022 ➔ Dec 2023; Trial primary completion date: Dec 2021 ➔ Dec 2022

Clinical • Trial completion date • Trial primary completion date • Acute Respiratory Distress Syndrome • Pulmonary Disease • Respiratory Diseases

Mesenchymal Stem Cells for The Treatment of Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P1; N=9; Recruiting; Sponsor: Meridigen Biotech Co., Ltd.; Trial completion date: Dec 2022 ➔ Dec 2023; Trial primary completion date: Mar 2021 ➔ Mar 2022

Clinical • Trial completion date • Trial primary completion date • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

Mesenchymal Stem Cells for The Treatment of Acute Ischemic Stroke (clinicaltrials.gov) - P1; N=9; Recruiting; Sponsor: Meridigen Biotech Co., Ltd.; Trial completion date: Dec 2022 ➔ Dec 2023

Clinical • Trial completion date • Cardiovascular • Ischemic stroke • MRI

Miracle Stem Cell 2/Reverse the plight of no cure [Google translation] (CTWANT Company) - "Xuanjie Pharmaceutical's new human umbilical cord stem cell drug UMC119-06 for the treatment of COPD phase I clinical trial was reviewed by the US FDA and Taiwan's Ministry of Health and Welfare at the end of 2019 and was approved for implementation. In June last year, a clinical acceptance was initiated with Shuanghe Hospital to evaluate the safety, tolerability and preliminary efficacy of UMC119-06. The first subject has been accepted and is continuing to be recruited."

Review • Chronic Obstructive Pulmonary Disease • Respiratory Diseases

Mesenchymal Stem Cells for The Treatment of Chronic Obstructive Pulmonary Disease (clinicaltrials.gov) - P1; N=9; Recruiting; Sponsor: Meridigen Biotech Co., Ltd.; Active, not recruiting ➔ Recruiting; Initiation date: Mar 2020 ➔ Jun 2020

Clinical • Enrollment open • Trial initiation date • Chronic Obstructive Pulmonary Disease • Respiratory Diseases