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

Therapeutic Efficacy of Mesenchymal Stem Cells (MSCs) on Alzheimer's Disease: Review of Clinical Results. (PubMed, Tissue Eng Regen Med) - "The analysis of 17 clinical trials and 5 relevant clinical outcomes showed that MSCs therapy if feasible and generally safe in AD patients. There are indications of potential therapeutic benefits such as improved cognitive function or quality of life measures in some AD patients. However, its therapeutic efficacy has not been proven definitely due to small size of subjects, variations in dosage, MSCs source, and administration scheme (route, timing, and frequency). Larger subject sizes and well-controlled trials are needed to provide more conclusive evidence."

Journal • Review • Alzheimer's Disease • CNS Disorders

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