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

Primary Purpose

Alzheimer's Disease

Status

Unknown status

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

Human Umbilical Cord Derived MSC

About this trial

This is an interventional treatment trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Hematopoietic Stem Cell Transplantation

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Human Umbilical Cord Derived MSC

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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.

Full Information

NCT ID

NCT01547689

First Posted

March 5, 2012

Last Updated

February 18, 2016

Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Collaborators

Peking University Third Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01547689

Brief Title

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

Acronym

SEMAD

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2012 (undefined)

Primary Completion Date

December 2016 (Anticipated)

Study Completion Date

December 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Affiliated Hospital to Academy of Military Medical Sciences

Collaborators

Peking University Third Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Alzheimer's Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Human Umbilical Cord Derived MSC

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

Human Umbilical Cord Derived MSC

Other Intervention Name(s)

Other Name: UC-MSC

Intervention Description

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 Outcome Measure Information:

Title

Number of participants with adverse event

Description

Time Frame

10 weeks from post-administration

Secondary Outcome Measure Information:

Title

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

Description

Time Frame

10 weeks from post-administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hu Chen, M.D., Ph.D.

Organizational Affiliation

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

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Bin Zhang, M.D. Ph.D.

Organizational Affiliation

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

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Dongsheng Fan, M.D.

Organizational Affiliation

Department of Neurology,Peking University Third Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Hematopoietic Stem Cell Transplantation

City

Beijing

ZIP/Postal Code

100071

Country

China

12. IPD Sharing Statement

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

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