Neurostem (human umbilical cord blood derived allogeneic mesenchymal stem cells) / Medipost - 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

Intravitreal allogeneic mesenchymal stem cells: a non-randomized phase II clinical trial for acute non-arteritic optic neuropathy. (PubMed, Stem Cell Res Ther) - P2 | "Besides the development of an epiretinal membrane in one patient, the intravitreal application of allogeneic BM-MSCs appeared to be intraocularly well tolerated. Consequently, not only NA-AION but also BM-MSCs deserve more clinical investigational resources and a larger randomized multicenter trial that would provide stronger evidence both about safety and the potential therapeutic efficacy of intravitreally injected allogeneic BM-MSCs in acute NA-AION."

Journal • P2 data • Cataract • Inflammation • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pain • Retinal Disorders

Exploratory Efficacy Study of NEUROSTEM® in Subjects Who Control Group of NEUROSTEM® (clinicaltrials.gov) - P=N/A; N=9; Not yet recruiting; Sponsor: Samsung Medical Center

Clinical • New trial • Alzheimer's Disease • CNS Disorders • CGA, CHGA

Will the domestic pharmaceutical company develop ’new dementia’ speed up?…[Google translation] (Consumer News) - "Medipost is developing 'Neurostem'...as a treatment for Alzheimer's dementia. In September 2013, it was approved for domestic awards 1 and 2a, and the test was finished in January of this year...In clinical results, the statistical significance between the placebo group and neurostem group was not confirmed in the variable amount of ADAS-Cog, the primary efficacy endpoint....Medipost plans to re-analyze the clinical data results to reconfirm the possibility of a treatment for dementia....'We confirmed the findings that the secretion of the expected therapeutic efficacies increased, but it was difficult to confirm the presence or absence of cognitive improvement within a relatively short clinical trial period....We plan to proceed with development.'"

P1 data • P2a data • Alzheimer's Disease • CNS Disorders

Safety and Exploratory Efficacy Study of NEUROSTEM® Versus Placebo in Patients With Alzheimer's Disease (clinicaltrials.gov) - P1/2; N=46; Completed; Sponsor: Medipost Co Ltd.; Recruiting ➔ Completed; Trial completion date: Jul 2019 ➔ Dec 2019; Trial primary completion date: Jul 2019 ➔ Dec 2019

Trial completion • Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders • CGA, CHGA

Follow-up Study of Safety and Efficacy in Subjects Who Completed NEUROSTEM® Phase-I/IIa Clinical Trial. (clinicaltrials.gov) - P1/2; N=45; Recruiting; Sponsor: Medipost Co Ltd.

New P1/2 trial • Alzheimer's Disease • Biosimilar • CNS Disorders

Medipost completes trials of stem cell therapy in Korea to treat Alzheimer’s (Pulse News) - "Medipost Co., a Korean stem cell therapy company, announced on Monday it has completed phase 1 and 2a clinical trials to evaluate its investigational stem cell drug to treat Alzheimer’s disease."

Trial completion