Safety and Efficiency of Umbilical Cord-derived Mesenchymal Stem Cells(UC-MSC) in Patients With Alzheimer's Disease (SEMAD)
|Alzheimer's Disease||Biological: Human Umbilical Cord Derived MSC||Phase 1 Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Open-Label, Single-Center, Self Control, Phase Ⅰ/Ⅱ Clinical Trial to Evaluate the Safety and the Efficacy of UC-MSC in Patients With Alzheimer's Disease|
- Number of participants with adverse event [ Time Frame: 10 weeks from post-administration ]All subjects: Follow-up a year Number of participants with adverse event, number of participants with normal range of vital signs and laboratory examination Indexes of safety evaluation: symptom or sign, laboratory examination, adverse reaction rate
- Changes from the baseline in Alzheimer' s Disease Assessment Scale-cognitive subscale(ADAS-Cog) at 10 weeks post-dose [ Time Frame: 10 weeks from post-administration ]Changes from the baseline in ADAS-cog, Clinician's Interview-Based Impression of Change(CIBIC), mini-mental state examination（MMSE), CIBIC-plus, Activity of Daily Living Scales(ADL), Neuropsychiatric Inventory(NPI), serum transthyretin, amyloid beta and tau in cerebrospinal fluid, Thl/Th2 cytokines in the peripheral blood.
|Study Start Date:||March 2012|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
|Experimental: Human Umbilical Cord Derived MSC||
Biological: Human Umbilical Cord Derived MSC
20 million cells per subject（0.5×10^6 UC-MSCs per kg ） intravenous injection Infusion number:8 (Once every two weeks in the first month of each quarter) Time interval: two and a half months
Other Name: Other Name: UC-MSC
To date, most AD patients who seek treatment already have neuritic plaques, neurofibrillary tangles, and neurodegeneration. At this stage of the disease, perhaps a multi-faceted approach to halt the toxicity of amyloid-β peptides and promote cell survival and/or replace lost cells would be most beneficial.Most of the treatments for Alzheimer disease are chemical drug which can improve the symptoms but is not able to inhibit the disease progression.
Mesenchymal stem cells (MSCs) are multipotent cells that are being clinically explored as a new therapeutic for treating a variety of immune-mediated diseases.Preclinical studies of the mechanism of action suggest that the therapeutic effects afforded by MSC transplantation are short-lived and related to dynamic, paracrine interactions between MSCs and host cells.Clinical trials of MSCs thus far have shown no adverse reactions to allogeneic versus autologous MSC transplants. Clinical studies showed that umbilical cord derived MSC is immunologically stable and not toxic.
This study is to evaluate the safety and the tolerability of UC-MSC (Human Umbilical Cord-Derived Mesenchymal Stem Cell).This study is also to investigate the efficacy of this treatment in patients with Alzheimer's disease.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01547689
|Department of Hematopoietic Stem Cell Transplantation|
|Beijing, China, 100071|
|Study Chair:||Hu Chen, M.D., Ph.D.||Department of Hematopoietic Stem Cell Transplantation, Affiliated Hospital to Academy of Military Medical Sciences|
|Study Director:||Bin Zhang, M.D. Ph.D.||Department of Hematopoietic Stem Cell Transplantation, Affiliated Hospital to Academy of Military Medical Sciences|
|Principal Investigator:||Dongsheng Fan, M.D.||Department of Neurology,Peking University Third Hospital|