Clinical Trials in Degenerative Diseases

STUDY PROTOCOL
Year
: 2016  |  Volume : 1  |  Issue : 1  |  Page : 1--8

Safety and efficacy of human umbilical cord-derived mesenchymal stem cells in patients with Alzheimer俟Q製 disease: study protocol for an open-label self-control trial


Jing-wen Niu, Bin Zhang, Hu Chen 
 Department of Hematopoietic Stem Cell Transplantation, Cell and Gene Therapy Center, the 307th Hospital of Chinese People's Liberation Army, Beijing, China

Correspondence Address:
Bin Zhang
Department of Hematopoietic Stem Cell Transplantation, Cell and Gene Therapy Center, the 307th Hospital of Chinese People俟Q製 Liberation Army, Beijing
China
Hu Chen
Department of Hematopoietic Stem Cell Transplantation, Cell and Gene Therapy Center, the 307th Hospital of Chinese People俟Q製 Liberation Army, Beijing
China

Background: Animal model experiments have demonstrated the efficacy and safety of human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) in the treatment of Alzheimer俟Q製 disease. However, the clinical efficacy of hUC-MSCs in the treatment of Alzheimer俟Q製 disease in humans remains unclear. This study protocol for a phase I/II clinical trial was designed to investigate the clinical safety (primary outcome) and efficacy (secondary outcome) of hUC-MSCs in the clinical treatment of Alzheimer俟Q製 disease. Methods/Design: This open-label, self-control, single-center prospective phase I/II clinical trial will be performed at the Department of Hematopoietic Stem Cell Transplantation, Cell and Gene Therapy Center, the 307 th Hospital of Chinese People俟Q製 Liberation Army, China. Thirty patients with moderate to severe Alzheimer俟Q製 disease will be included. The primary outcome is the number of patients who have adverse events at 10 weeks and 1 year after hUM-MSCs therapy. Secondary outcomes include cognitive function, overall clinical status, daily living activities, neuropsychiatric symptoms, blood biochemical Alzheimer俟Q製 disease markers. Discussion: The findings from this trial will provide valuable evidence for the use of hUM-MSCs in the clinical treatment of Alzheimer俟Q製 disease. Trial registration: ClinicalTrial.gov identifier: NCT01547689; registered on 5 March 2012. This study protocol was approved by the Ethics Committee of the 307 th Hospital of Chinese People俟Q製 Liberation Army.


How to cite this article:
Niu Jw, Zhang B, Chen H. Safety and efficacy of human umbilical cord-derived mesenchymal stem cells in patients with Alzheimer's disease: study protocol for an open-label self-control trial.Clin Trials Degener Dis 2016;1:1-8


How to cite this URL:
Niu Jw, Zhang B, Chen H. Safety and efficacy of human umbilical cord-derived mesenchymal stem cells in patients with Alzheimer's disease: study protocol for an open-label self-control trial. Clin Trials Degener Dis [serial online] 2016 [cited 2022 Jan 19 ];1:1-8
Available from: https://www.clinicaltdd.com/article.asp?issn=2542-3975;year=2016;volume=1;issue=1;spage=1;epage=8;aulast=Niu;type=0