| STUDY PROTOCOL |
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| Year : 2016 | Volume
: 1
| Issue : 1 | Page : 1-8 |
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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
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's Liberation Army, Beijing
China
Hu Chen
Department of Hematopoietic Stem Cell Transplantation, Cell and Gene Therapy Center, the 307th Hospital of Chinese People's Liberation Army, Beijing
China
 Source of Support: None, Conflict of Interest: None  | Check |
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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's disease. However, the clinical efficacy of hUC-MSCs in the treatment of Alzheimer's 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's 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's Liberation Army, China. Thirty patients with moderate to severe Alzheimer's 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's disease markers.
Discussion: The findings from this trial will provide valuable evidence for the use of hUM-MSCs in the clinical treatment of Alzheimer's 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's Liberation Army. |
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