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Safety and Efficiency of Umbilical Cord-derived Mesenchymal Stem Cells(UC-MSC) in Patients With Alzheimer's Disease (SEMAD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Affiliated Hospital to Academy of Military Medical Sciences
Sponsor:
Collaborator:
Peking University Third Hospital
Information provided by (Responsible Party):
Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier:
NCT01547689
First received: March 5, 2012
Last updated: May 9, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention Phase
Alzheimer's Disease
Biological: Human Umbilical Cord Derived MSC
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Affiliated Hospital to Academy of Military Medical Sciences:

Primary Outcome Measures:
  • Number of participants with adverse event [ Time Frame: 10 weeks from post-administration ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 30
Study Start Date: March 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed 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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01547689

Contacts
Contact: Hu Chen, M.D., Ph.D. +86-010-6694-7108 chenhu217@yahoo.com.cn
Contact: Bin Zhang, M.D., Ph.D. +86-010-6694-7125 zb307ctc@163.com

Locations
China
Department of Hematopoietic Stem Cell Transplantation Recruiting
Beijing, China, 100071
Contact: Bin Zhang, M.D., Ph.D.    +86-010-6694-7125    zb307ctc@163.com   
Sponsors and Collaborators
Affiliated Hospital to Academy of Military Medical Sciences
Peking University Third Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Affiliated Hospital to Academy of Military Medical Sciences
ClinicalTrials.gov Identifier: NCT01547689     History of Changes
Other Study ID Numbers: 307-CTC-MSC-001, 2011AA020114
Study First Received: March 5, 2012
Last Updated: May 9, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 20, 2014