REGEND001 / Regend Therap - LARVOL DELTA

A Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy on Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P2 | N=23 | Completed | Sponsor: Regend Therapeutics | Active, not recruiting ➔ Completed | Trial completion date: Jul 2025 ➔ Mar 2025

Trial completion • Trial completion date • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Autologous P63+ lung progenitor cell transplantation in idiopathic pulmonary fibrosis: a phase 1 clinical trial. (PubMed, Elife) - "National High Level Hospital Clinical Research Funding (2022-PUMCH-B-108), National Key Research and Development Plan (2024YFA1108900, 2024YFA1108500), Jiangsu Province Science and Technology Special Project Funding (BE2023727), National Biopharmaceutical Technology Research Project Funding (NCTIB2023XB01011), Non-profit Central Research Institute Fund of Chinese Academy of Medical Science (2020-PT320-005), and Regend Therapeutics. Chinese clinical trial registry: CTR20210349."

Journal • P1 data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • Transplantation • TP63

Treatment of Chronic Obstructive Pulmonary Disease (COPD) with Diffusion Capacity Defect by REGEND001 Cell Therapy (clinicaltrials.gov) - P2 | N=58 | Active, not recruiting | Sponsor: Regend Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy on Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P2 | N=23 | Active, not recruiting | Sponsor: Regend Therapeutics | Recruiting ➔ Active, not recruiting

Enrollment closed • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • CEACAM5 • CK19 • CRP • KRT19

Efficacy of the Entire Papilla Preservation Technique With and Without the Use of L-PRF as a Regenerative Material for the Treatment of Infrabony Defects (clinicaltrials.gov) - P=N/A | N=30 | Recruiting | Sponsor: Universidad de los Andes, Chile

New trial

[PREPRINT] Autologous P63+ lung progenitor cell transplantation in idiopathic pulmonary fibrosis: a phase 1 clinical trial (medRxiv) - P1 | N=12 | CTR20210349 | "We treated 12 patients with ascending doses of cells: 0.6x, 1x, 2x and 3.3x 106 cells/kg bodyweight. The data revealed that P63+ basal progenitor cell was safe and well tolerated at all doses, with no dose-limiting toxicity or cell therapy-related severe adverse events observed. Patients in the three higher dose groups showed statistically significant improvement of lung gas transfer function as well as exercise ability after REGEND001 therapy. Resolution of honeycomb lesion was also observed in patients of higher dose groups."

P1 data • Preprint • Idiopathic Pulmonary Fibrosis • Pulmonary Disease

Autologous transplantation of P63+ lung progenitor cells (REGEND001) for idiopathic pulmonary fibrosis therapy: phase I clinical trial (ERS 2024) - "REGEND001 was safe in all participants and showed efficacy potential in the 1 x 106 cell/kg bodyweight dose group.These data strongly support further clinical evaluation of REGEND001 as a therapeutic product in IPF patients."

Clinical • P1 data • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • Transplantation • TP63

Autologous transplantation of P63+ lung progenitor cells in patients with bronchiectasis: a randomized, single-blind, controlled trial (ERS 2024) - "In patients with bronchiectasis, transplantation of REGEND001 was associated with increased lung gas exchange function, reduction of bronchiectasis severity scores and improved quality of life."

Clinical • Bronchiectasis • Genetic Disorders • Immunology • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases • Transplantation • TP63

Treatment of Idiopathic Pulmonary Fibrosis (IPF) by REGEND001 (clinicaltrials.gov) - P1 | N=12 | Completed | Sponsor: Regend Therapeutics | Phase classification: P1/2 ➔ P1

Phase classification • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

A Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy on Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Regend Therapeutics | Trial completion date: Dec 2024 ➔ Jul 2025 | Initiation date: Oct 2023 ➔ Jun 2023 | Trial primary completion date: Jul 2024 ➔ Jan 2025

Trial completion date • Trial initiation date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • CEACAM5 • CK19 • CRP • KRT19

Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Diffusion Capacity Defect by REGEND001 Cell Therapy (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Regend Therapeutics | Trial completion date: Jun 2024 ➔ Dec 2025 | Trial primary completion date: Dec 2023 ➔ Jun 2025

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

A Clinical Study to Evaluate the Efficacy and Safety of REGEND001 Cell Therapy on Idiopathic Pulmonary Fibrosis (IPF) (clinicaltrials.gov) - P2 | N=20 | Recruiting | Sponsor: Regend Therapeutics

New P2 trial • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases

Treatment of Idiopathic Pulmonary Fibrosis(IPF) by REGEND001 (clinicaltrials.gov) - P1/2 | N=12 | Completed | Sponsor: Regend Therapeutics | Recruiting ➔ Completed | N=24 ➔ 12 | Trial completion date: Sep 2024 ➔ Jun 2023 | Trial primary completion date: Mar 2023 ➔ Jun 2023

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • CEACAM5 • CK19 • KRT19

Clinical Efficacy and Safety of Autologous Lung Stem Cell Transplantation in Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P1/2 | N=10 | Completed | Sponsor: Shanghai East Hospital | Recruiting ➔ Completed | N=20 ➔ 10

Enrollment change • Trial completion • Bone Marrow Transplantation • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • Transplantation

Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases (clinicaltrials.gov) - P1/2 | N=15 | Completed | Sponsor: Shanghai East Hospital | Recruiting ➔ Completed | N=10 ➔ 15

Enrollment change • Trial completion • Bone Marrow Transplantation • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Transplantation

Treatment of Idiopathic Pulmonary Fibrosis(IPF) by REGEND001 (clinicaltrials.gov) - P1/2 | N=24 | Recruiting | Sponsor: Regend Therapeutics

New P1/2 trial • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • CEACAM5 • CK19 • KRT19

Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Pulmonary Diffusion Dysfunction by REGEND001 (clinicaltrials.gov) - P2 | N=50 | Recruiting | Sponsor: Regend Therapeutics

New P2 trial • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases • CEACAM5 • CK19 • KRT19

Clinical Efficacy and Safety of Autologous Lung Stem Cell Transplantation in Patients With Idiopathic Pulmonary Fibrosis (clinicaltrials.gov) - P1/2 | N=20 | Recruiting | Sponsor: Shanghai East Hospital | Trial completion date: Oct 2021 ➔ Oct 2023 | Trial primary completion date: Apr 2021 ➔ Apr 2023

Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Fibrosis • Idiopathic Pulmonary Fibrosis • Immunology • Pulmonary Disease • Respiratory Diseases • Transplantation

Autologous Lung Stem Cell Transplantation in Patients With Interstitial Lung Diseases (clinicaltrials.gov) - P1/2 | N=10 | Recruiting | Sponsor: Shanghai East Hospital | Trial completion date: Oct 2021 ➔ Oct 2023 | Trial primary completion date: Apr 2021 ➔ Apr 2023

Trial completion date • Trial primary completion date • Bone Marrow Transplantation • Interstitial Lung Disease • Pulmonary Disease • Respiratory Diseases • Transplantation