ADR-001 / Shionogi, Rohto Pharma - LARVOL DELTA

Safety and Tolerability of ADR-001 Therapy for Immunoglobulin A Nephropathy. (PubMed, Kidney360) - P1 | "The safety and tolerability of adipose-derived mesenchymal stem cells are acceptable for patients with immunoglobulin A nephropathy."

Journal • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Renal Disease

Safety and Tolerability of adipose-derived mesenchymal stem cell "ADR-001" in the Treatment of Immunoglobulin A Nephropathy (ERA-EDTA 2024) - P1 | "The safety and tolerability of ADR-001, an adipose-derived MSC, were confirmed. Furthermore, the efficacy of ADR-001 is strongly expected."

Clinical • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Inflammation • Renal Disease

An Follow-Up Study of Liver Cirrhosis (clinicaltrials.gov) - P=N/A | N=19 | Completed | Sponsor: Rohto Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Feb 2024 ➔ Oct 2023

Trial completion • Trial completion date • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis

A Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19) (clinicaltrials.gov) - P2 | N=15 | Completed | Sponsor: Rohto Pharmaceutical Co., Ltd. | Recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

A Study of ADR-001 in Patients With Liver Cirrhosis (clinicaltrials.gov) - P1/2 | N=21 | Completed | Sponsor: Rohto Pharmaceutical Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Sep 2023 ➔ Apr 2023

Trial completion • Trial completion date • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis

The Clinical Trial of ADR-001 for IgA Nephropathy (clinicaltrials.gov) - P1 | N=9 | Completed | Sponsor: Nagoya University | Active, not recruiting ➔ Completed | Trial primary completion date: Jan 2022 ➔ Nov 2022

Trial completion • Trial primary completion date • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease

An Follow-Up Study of Liver Cirrhosis (clinicaltrials.gov) - P=N/A | N=21 | Recruiting | Sponsor: Rohto Pharmaceutical Co., Ltd. | Trial completion date: Jun 2023 ➔ Feb 2024 | Trial primary completion date: Dec 2022 ➔ Oct 2023

Trial completion date • Trial primary completion date • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis

A Study of ADR-001 in Patients With Liver Cirrhosis (clinicaltrials.gov) - P1/2 | N=27 | Recruiting | Sponsor: Rohto Pharmaceutical Co., Ltd. | Trial completion date: Dec 2022 ➔ Sep 2023 | Trial primary completion date: Jun 2022 ➔ Jul 2023

Trial completion date • Trial primary completion date • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis

A Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19) (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Rohto Pharmaceutical Co., Ltd. | Trial completion date: Sep 2022 ➔ May 2023 | Trial primary completion date: Sep 2022 ➔ May 2023

Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

Protocol for a Phase 1, Open-Label, Multiple-Center, Dose-Escalation Study to Evaluate the Safety and Tolerability of ADR-001 in the Treatment of Immunoglobulin A Nephropathy. (PubMed, Front Med (Lausanne)) - P1 | "Following the administration of ADR-001 to patients with IgA nephropathy, the respective percentages of patients with adverse events, asymptomatic pulmonary emboli, clinical remission, partial remission, urine protein remission, hematuria remission, their time to remission, changes in urine protein, hematuria, and glomerular filtration rate will be determined. This study will evaluate the safety and tolerability of ADR-001 and confirm its therapeutic efficacy in adult patients with refractory IgA nephropathy."

Journal • P1 data • Cardiovascular • Glomerulonephritis • IgA Nephropathy • Immunology • Infectious Disease • Inflammation • Lupus Nephritis • Nephrology • Pulmonary Embolism • Renal Disease

A Study of ADR-001 in Patients With Liver Cirrhosis (clinicaltrials.gov) - P1/2 | N=27 | Recruiting | Sponsor: Rohto Pharmaceutical Co., Ltd. | Trial completion date: Dec 2021 ➔ Dec 2022 | Trial primary completion date: Dec 2021 ➔ Jun 2022

Trial completion date • Trial primary completion date • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis

An Follow-Up Study of Liver Cirrhosis (clinicaltrials.gov) - P=N/A | N=21 | Recruiting | Sponsor: Rohto Pharmaceutical Co., Ltd. | Trial completion date: Jun 2022 ➔ Jun 2023 | Trial primary completion date: Dec 2021 ➔ Dec 2022

Trial completion date • Trial primary completion date • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis

The Clinical Trial of ADR-001 for IgA Nephropathy (clinicaltrials.gov) - P1; N=9; Active, not recruiting; Sponsor: Nagoya University; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Glomerulonephritis • IgA Nephropathy • Lupus Nephritis • Nephrology • Renal Disease

A Study of ADR-001 in Patients With Liver Cirrhosis (clinicaltrials.gov) - P1/2; N=27; Recruiting; Sponsor: Rohto Pharmaceutical Co., Ltd.; N=15 ➔ 27; Trial completion date: Dec 2019 ➔ Dec 2021; Trial primary completion date: Dec 2019 ➔ Dec 2021

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis

A Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19) (clinicaltrials.gov) - P2; N=20; Recruiting; Sponsor: Rohto Pharmaceutical Co., Ltd.; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

A Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19) (clinicaltrials.gov) - P2; N=20; Not yet recruiting; Sponsor: Rohto Pharmaceutical Co., Ltd.

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

An Exploratory Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (clinicaltrials.gov) - P1; N=6; Completed; Sponsor: Rohto Pharmaceutical Co., Ltd.; Not yet recruiting ➔ Completed; Trial completion date: Dec 2021 ➔ Feb 2021; Trial primary completion date: Dec 2021 ➔ Feb 2021

Clinical • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

An Follow-Up Study of Liver Cirrhosis (clinicaltrials.gov) - P=N/A; N=21; Recruiting; Sponsor: Rohto Pharmaceutical Co., Ltd.; N=15 ➔ 21; Trial completion date: Jul 2021 ➔ Jun 2022; Trial primary completion date: Jul 2021 ➔ Dec 2021

Clinical • Enrollment change • Trial completion date • Trial primary completion date • Fibrosis • Gastroenterology • Hepatology • Immunology • Liver Cirrhosis

An Exploratory Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (clinicaltrials.gov) - P1; N=6; Not yet recruiting; Sponsor: Rohto Pharmaceutical Co., Ltd.

Clinical • New P1 trial • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

The Clinical Trial of ADR-001 for IgA Nephropathy (clinicaltrials.gov) - P1; N=12; Recruiting; Sponsor: Nagoya University; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Glomerulonephritis • Nephrology • Renal Disease

Rohto Pharmaceutical : to begin stem cell clinical test for COVID-19 in August (Market Screener) - "Rohto Pharmaceutical Co. said Tuesday it will begin a clinical trial in August using stem cells for a potential treatment for patients severely ill with COVID-19....It will administer mesenchymal stem cells derived from adipose tissue from a donor to patients with severe cases of COVID-19....The trial is expected to run through December...it will apply for the launch of the test to the health ministry in late June. Under the plan, six COVID-19 patients who need to be on mechanical ventilators will receive an intravenous injection of the cells once a week for a total of four times."

New trial • Infectious Disease • Novel Coronavirus Disease

The Clinical Trial of ADR-001 for IgA Nephropathy (clinicaltrials.gov) - P1; N=12; Not yet recruiting; Sponsor: Nagoya University

Clinical • New P1 trial