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Alzheimer's DiseasePhase 1/2SEMADNCT01547689

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

A Phase 1/2 study testing Human Umbilical Cord Derived MSC in people with Alzheimer's Disease, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 to 85 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Human Umbilical Cord Derived MSC
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
Mar 2012to Dec 2016
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Department of Hematopoietic Stem Cell Transplantation

    Beijing, 100071

Other trials in China

About this study

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

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).

Read the 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.

Being tested
Human Umbilical Cord Derived MSC
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Human Umbilical Cord Derived MSCBiological

    Also called 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

Study groups in NCT01547689
Study groupRoleWhat they receive
Human Umbilical Cord Derived MSCExperimentalNot described
Receives: Biological: Human Umbilical Cord Derived MSC

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 10 weeks from post-administration

Secondary outcomes (1)

  1. 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.

    Measured: 10 weeks from post-administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2012 (estimated)
  2. Study startMar 2012
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01547689
Sponsor's protocol ID
307-CTC-MSC-001
Other IDs
2011AA020114
Acronym
SEMAD
Status last verified
Feb 2016
First submitted
5 Mar 2012
Last updated
22 Feb 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Human Umbilical Cord Derived MSC in people with Alzheimer's Disease, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with adverse event (time frame: 10 weeks from post-administration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01547689.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2016.

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