NCT01547689

Brief 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

March 5, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 8, 2012

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 22, 2016

Status Verified

February 1, 2016

Enrollment Period

4.8 years

First QC Date

March 5, 2012

Last Update Submit

February 18, 2016

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • Number of participants with adverse event

    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

    10 weeks from post-administration

Secondary Outcomes (1)

  • Changes from the baseline in Alzheimer' s Disease Assessment Scale-cognitive subscale(ADAS-Cog) at 10 weeks post-dose

    10 weeks from post-administration

Study Arms (1)

Human Umbilical Cord Derived MSC

EXPERIMENTAL
Biological: Human Umbilical Cord Derived MSC

Interventions

Human Umbilical Cord Derived MSCBIOLOGICAL

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

Also known as: Other Name: UC-MSC
Human Umbilical Cord Derived MSC

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Hematopoietic Stem Cell Transplantation

Beijing, 100071, China

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Hu Chen, M.D., Ph.D.

    Department of Hematopoietic Stem Cell Transplantation, Affiliated Hospital to Academy of Military Medical Sciences

    STUDY CHAIR

  • Bin Zhang, M.D. Ph.D.

    Department of Hematopoietic Stem Cell Transplantation, Affiliated Hospital to Academy of Military Medical Sciences

    STUDY DIRECTOR

  • Dongsheng Fan, M.D.

    Department of Neurology,Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2012

First Posted

March 8, 2012

Study Start

March 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 22, 2016

Record last verified: 2016-02

Locations

CN(1)