Overview

This trial is active, not recruiting.

Condition alzheimer's disease
Treatment human umbilical cord derived msc
Phase phase 1/phase 2
Sponsor Affiliated Hospital to Academy of Military Medical Sciences
Collaborator Peking University Third Hospital
Start date March 2012
End date December 2016
Trial size 30 participants
Trial identifier NCT01547689, 2011AA020114, 307-CTC-MSC-001

Summary

The primary purpose of 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 (AD).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
human umbilical cord derived msc Other Name: UC-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

Primary Outcomes

Measure
Number of participants with adverse event
time frame: 10 weeks from post-administration

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 50 years up to 85 years old.

Inclusion Criteria: - Men and women who are age in the range of 50 to 85 - All women: go into menopause - Probable Alzheimer's disease as determined by NINCDS-ADRDA criteria - MMSE score between 3 and 20, both inclusive - Voluntarily participating subject who sign the consent form Exclusion Criteria: - Subject with cancer - Subject with positive test for Human Immunodeficiency Virus(HIV) - Subject who cannot undergo Magnetic Resonance Imaging(MRI), computed tomography(CT) screening - Subject with psychological diseases (i.e. depression, schizophrenia, bipolar disorder, etc) - Subject with dementia caused by other than Alzheimer's disease (i.e. infection of central nervous system, Creutzfeld-Jacob disease, severe head trauma, Pick's disease, Huntington's disease, and Parkinson's disease) - Subject with vascular dementia as determined by the clinical criteria of Design Standards Manual(DSM) IV and the imaging criteria of Erkinjuntii - Subject with severe white matter hyperintensities (WMH); Severe WMH is defined that length of the deep white matter is 25 mm or longer and length of the periventricular capping/banding is 10 mm or longer. - Subject who have had stroke in 3 months. - Subject with severe kidney failure (1.5 mg/dL of serum creatinine or more) Hemoglobin < 9.5 g/dL for men, < 9.0 g/dL for women; Total WBC count < 3000/mm3; Total bilirubin ≥ 3 mg/dL - Subject who is suspect to have active lung diseases based on check X-ray result - Subject who have been excluded in the subject selection process for this study before - A platelet count < 150,000/mm3; Plasma prothrombin time(PT)≥ 1.5; the international normalized ratio (INR) or activated partial thromboplastin time(aPTT)≥ 1.5X control value - Subject who is determined inappropriate by the investigators

Additional Information

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
Principal investigator Dongsheng Fan, M.D.
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Affiliated Hospital to Academy of Military Medical Sciences.