AstroStem (autologous adipose tissue derived mesenchymal stem cells) / K-STEMCELL, Nature Cell - LARVOL DELTA

Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease (clinicaltrials.gov) - P2b | N=100 | Not yet recruiting | Sponsor: Nature Cell Co. Ltd. | Trial completion date: Dec 2023 ➔ Dec 2024 | Trial primary completion date: Dec 2022 ➔ May 2024

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis (clinicaltrials.gov) - P2; N=28; Active, not recruiting; Sponsor: Nature Cell Co. Ltd.; Trial completion date: Mar 2018 ➔ Mar 2019; Trial primary completion date: Sep 2017 ➔ Mar 2018

Clinical • Trial completion date • Trial primary completion date • Immunology • Osteoarthritis • Pain • MRI

A Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease (clinicaltrials.gov) - P1/2; N=60; Recruiting; Sponsor: Nature Cell Co. Ltd.; Trial completion date: Nov 2018 ➔ Jul 2019; Trial primary completion date: Oct 2018 ➔ Jun 2019

Clinical • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • APP • MRI • NRG1

A Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease (clinicaltrials.gov) - P1/2; N=21; Active, not recruiting; Sponsor: Nature Cell Co. Ltd.; Recruiting ➔ Active, not recruiting; N=60 ➔ 21

Clinical • Enrollment change • Enrollment closed • Alzheimer's Disease • CNS Disorders • APP • MRI • NRG1

A Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease (clinicaltrials.gov) - P1/2; N=21; Completed; Sponsor: Nature Cell Co. Ltd.; Active, not recruiting ➔ Completed; Trial primary completion date: Aug 2019 ➔ Jan 2019

Clinical • Trial completion • Trial primary completion date • Alzheimer's Disease • CNS Disorders • APP • MRI • NRG1

A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis (clinicaltrials.gov) - P2; N=28; Completed; Sponsor: Nature Cell Co. Ltd.; Active, not recruiting ➔ Completed

Clinical • Trial completion • Osteoarthritis • Pain • Rheumatology • MRI

A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis (clinicaltrials.gov) - P2; N=45; Recruiting; Sponsor: Nature Cell Co. Ltd.; Trial primary completion date: Mar 2017 ➔ Aug 2017

Clinical • Trial primary completion date • Immunology • Osteoarthritis • Pain • Rheumatology • MRI

A Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease (clinicaltrials.gov) - P1/2; N=60; Recruiting; Sponsor: Nature Cell Co. Ltd.

Clinical • New P1/2 trial • Alzheimer's Disease • CNS Disorders • APP • MRI • NRG1

A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis (clinicaltrials.gov) - P2; N=30; Recruiting; Sponsor: Nature Cell Co. Ltd.; N=45 ➔ 30

Clinical • Enrollment change • Immunology • Osteoarthritis • Pain • Rheumatology • MRI

A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis (clinicaltrials.gov) - P2; N=28; Active, not recruiting; Sponsor: Nature Cell Co. Ltd.; Recruiting ➔ Active, not recruiting

Clinical • Enrollment closed • Osteoarthritis • Pain • Rheumatology • MRI

A Phase 2 Study to Evaluate the Efficacy and Safety of JointStem in Treatment of Osteoarthritis (clinicaltrials.gov) - P2; N=45; Recruiting; Sponsor: Nature Cell Co. Ltd.

Clinical • New P2 trial • Immunology • Inflammation • Osteoarthritis • Pain • Rheumatology • MRI

Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease (clinicaltrials.gov) - P2b; N=80; Not yet recruiting; Sponsor: Nature Cell Co. Ltd.; Initiation date: Dec 2020 ➔ Dec 2021; Trial primary completion date: Dec 2021 ➔ Dec 2022

Clinical • Trial initiation date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Study to Evaluate the Safety and Efficacy of AstroStem in Treatment of Alzheimer's Disease (clinicaltrials.gov) - P2b; N=80; Not yet recruiting; Sponsor: Nature Cell Co. Ltd.

Clinical • New P2b trial • Alzheimer's Disease • CNS Disorders

Nature Cell to launch clinical trial of dementia treatment drug 'Astrostem' in US FDA 2b [Google translation] (E-Today) - "US clinical trials for the development of Alzheimer's dementia treatment using Nature Cell's adult stem cells begin....A protocol for conducting a second-level clinical trial was developed and submitted to the FDA in May, and a protocol revision was submitted in June in response to requests for amendments to the protocol."

Trial status • Alzheimer's Disease • CNS Disorders

Nature Cell to submit clinical IND for phase 2b of Astrostem, an Alzheimer's treatment drug to the US FDA [Google translation] (Pax Economic TV) - "Nature Cell...announced on the 21st that it has submitted the US FDA Phase 2b clinical trial plan (IND) to evaluate the effectiveness and safety of autologous adipose-derived mesenchymal stem cells 'Astrostem' in patients with Alzheimer's disease....'We expect to be able to confirm the effectiveness of Astrostem through the non-inferiority evaluation with Donepezil, a US FDA-approved drug in this clinical trial, and confirm that the safety is similar to or equivalent to a previously approved drug.'"

IND • Alzheimer's Disease • CNS Disorders