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Alzheimer DiseasePhase 1/2NCT04388982

the Safety and the Efficacy Evaluation of Allogenic Adipose MSC-Exos in Patients With Alzheimer's Disease

A Phase 1/2 study testing low dosage MSCs-Exos administrated for nasal drip, mild dosage MSCs-Exos administrated for nasal drip and high dosage MSCs-Exos administrated for nasal drip in people with Alzheimer Disease, run by Ruijin Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Evaluate the Safety and Efficacy of Exosomes Derived from Allogenic Adipose Mesenchymal Stem Cells（MSCs-Exos）in Subjects with Alzheimer's disease. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Alzheimer Disease
What is being tested?
low dosage MSCs-Exos administrated for nasal drip, mild dosage MSCs-Exos administrated for nasal drip and high dosage MSCs-Exos administrated for nasal drip
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
1 siteChina
Study dates
1 Jul 2020to Aug 2022
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects themselves and their legal representatives (or their immediate family members) voluntarily received the treatment and signed the consent form before this study;
  • Age ≧ 50 years, males and females;
  • Subjects diagnosed with Patients with mild or moderate Alzheimer's disease, based on the NIA/AA(2011).
  • The Mini-Mental Status Examination (MMSE) score was 10-24 (inclusive);
  • Modified Hachinski Ischemic Scale (MHIS) score was ≦ 4;
  • Suspension of cognitive-enhancing drugs and marketed therapeutic drugs such as ginkgo, high-dose vitamin E, lecithin, estrogen, non-steroidal anti-inflammatory drugs (NSAIDs), Donepezil, Memantine, etc ;
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  • Based on medical history, physical examination, vital signs, laboratory tests and 12-lead electrocardiogram (ECG) results, subjects are generally in good condition;
  • Subjects can walk independently or receive outpatient follow-up with assistive devices (wheelchairs, walkers or crutches), while the subject's vision and hearing (allowing glasses and / or hearing aids) do not affect the follow-up procedure;
  • The subject has an identified and reliable caregiver who must also meet the following conditions:
  • In the hospital, caregiver can independently read and understand relevant research documents, and can do necessary communication with the investigator; (2) Caregiver can follow clinical research procedures and ensure that accurate information about the status of the subject can be provided during the study; (3) Caregiver live with the subject; or take care of the subject no less than 3 days a week and no less than 2 hours a day; 10. Female subjects with fertility (including women of childbearing age and women less than 1 year after menopause) were required to take effective contraception throughout the study. At the same time, urine pregnancy tests were negative during screening.

Who cannot join

  • The subjects with more serious allergic constitution;
  • Received allogeneic mesenchymal progenitor cell therapy or its derived exosomes;
  • Laboratory test (any item meets): neutrophil absolute number < 1.0 × 109 / L, platelet count < 100 × 109 / L, serum albumin < 30g / L, serum creatinine > upper limit of normal value range, total bilirubin, alanine aminotransferase, aspartate aminotransferase > upper limit of 2 times of normal value range;
  • The subject has serious and poorly controlled concomitant diseases, such as (but not limited to) cardiovascular, cerebrovascular, liver, kidney, lung, endocrine and other system diseases;
  • Severe Alzheimer's Disease;
  • Severe depression;
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  • The subjects suffered from Parkinson's disease, multiple cerebral infarction, vascular dementia, Huntington's disease, hydrocephalus, progressive supranuclear paralysis, multiple sclerosis, epilepsy, mental retardation or major history of brain injury (with or without persistent neurological impairment) or known brain structural abnormalities;
  • The subject has an history malignant tumor；
  • The subject has severe generalized infectious diseases in the 3 months prior to this trial.;
  • The subject has contraindication of MRI, included but not only: the subject installed heart pacemaker, defibrillator, heart bracket, heart valve prosthesis, metal clip after aneurysm surgery, drug infusion device implanted in vivo, any electronic device implanted in the body (nerve stimulator, bone growth stimulator) endovascular coil, strainer, ECG monitor, metal suture, shrapnel or sand of body, plate fixation and steel nail after fracture surgery, artificial cochlea, middle ear shift plant, metallic intraocular foreign body etc; the subject is a claustrophobia, critical ill patient and so on.
  • The subject tests positive for: HIV, HBV, HCV and treponema pallidum;
  • The subject has history of alcoholism, drug abuse, or mental illness in the 10 years prior to this trial.
  • The subject has participated in any other clinical trial in the 6 months prior to this trial;
  • The female subjects are pregnant, lactating or pregnant in the past half a year;
  • The subject has any other unsuitable condition (such as factors reducing the follow-up compliance) to be determined by the investigator.

Trial locations and contacts

1 site in 1 country.

Gang Wang, MD,PhD contact

086-021-64370045

wg11424@rjh.com.cn

China1 site, 1 recruiting

  • Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200000

    Xinyi Xie, MD, 18616817612, Xiexy0619@163.com

    Recruiting

Other trials in China

About this study

Official title: Open-Label, Single-Center, Phase I/Ⅱ Clinical Trial to Evaluate the Safety and the Efficacy of Exosomes Derived From Allogenic Adipose Mesenchymal Stem Cells in Patients With Mild to Moderate Dementia Due to Alzheimer's Disease

Evaluate the Safety and Efficacy of Exosomes Derived from Allogenic Adipose Mesenchymal Stem Cells（MSCs-Exos）in Subjects with Alzheimer's disease.

Read the detailed description

To date, the main pathological characteristics of AD patients are the accumulation of β-amyloid (Aβ) into senile plaques, the abnormal aggregation of intracellular Tau protein to form neuron fiber tangles (NFT) and neuron death. There are still no effective treatments to prevent, halt, or reverse Alzheimer's disease.

Exosomes are naturally occurring nanosized vesicles and comprised of natural lipid bilayers with the abundance of adhesive proteins that readily interact with cellular membranes. These vesicles have a content that includes cytokines and growth factors, signaling lipids, mRNAs, and regulatory miRNAs. Exosomes are involved in cell-to-cell communication, cell signaling, and altering cell or tissue metabolism at short or long distances in the body, and can influence tissue responses to injury, infection, and disease.

The purpose of this single center, open label, phase I/Ⅱ clinical trial, therefore, is to explore the safety and efficacy of the exosomes derived from allogenic adipose mesenchymal stem cells (MSCs-Exos) in the treatment of mild to moderate dementia due to Alzheimer's Disease.

Being tested
low dosage MSCs-Exos administrated for nasal drip, mild dosage MSCs-Exos administrated for nasal drip, high dosage MSCs-Exos administrated for nasal drip
Medical subject headings
Alzheimer Disease

What participants receive

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

  • low dosage MSCs-Exos administrated for nasal dripBiological

    Dosage：5μg MSCs-Exos,Total volume： 1ml Frequency：Twice a week Duration：12 weeks

  • mild dosage MSCs-Exos administrated for nasal dripBiological

    Dosage：10μg MSCs-Exos,Total volume： 1ml Frequency：Twice a week Duration：12 weeks

  • high dosage MSCs-Exos administrated for nasal dripBiological

    Dosage：20μg MSCs-Exos,Total volume： 1ml Frequency：Twice a week Duration：12 weeks

Study groups in NCT04388982
Study groupRoleWhat they receive
MSCs-Exos Dosage 1ExperimentalMSCs-Exos. low-dose group
Receives: Biological: low dosage MSCs-Exos administrated for nasal drip
MSCs-Exos Dosage 2ExperimentalMSCs-Exos mid-dose group
Receives: Biological: mild dosage MSCs-Exos administrated for nasal drip
MSCs-Exos Dosage 3ExperimentalMSCs-Exos high-dose group
Receives: Biological: high dosage MSCs-Exos administrated for nasal drip

What is being measured

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

  1. Number of participants with treatment-related abnormal laboratory values of Liver or kidney function

    Measured: 12 weeks

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    Measured: 12 weeks

Secondary outcomes (14)

  1. Cognitive function

    ADAS-cog (Alzheimer 's disease assessment scale-cognitive section) consists of 12 items. Maximum value is 70 and higher score means a worse congnitive condition.

    Measured: baseline

  2. Cognitive function

    ADAS-cog (Alzheimer 's disease assessment scale-cognitive section) consists of 12 items. Maximum value is 70 and higher score means a worse congnitive condition.

    Measured: 12 weeks

  3. Cognitive function

    ADAS-cog (Alzheimer 's disease assessment scale-cognitive section) consists of 12 items. Maximum value is 70 and higher score means a worse congnitive condition.

    Measured: 24 weeks

  4. Cognitive function

    ADAS-cog (Alzheimer 's disease assessment scale-cognitive section) consists of 12 items. Maximum value is 70 and higher score means a worse congnitive condition.

    Measured: 36 weeks

  5. Cognitive function

    ADAS-cog (Alzheimer 's disease assessment scale-cognitive section) consists of 12 items. Maximum value is 70 and higher score means a worse congnitive condition.

    Measured: 48 weeks

  6. Quality of life evaluation

    Scores of ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) range from 0 to 54 and higher score means a better life quality.

    Measured: baseline

  7. Quality of life evaluation

    Scores of ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) range from 0 to 54 and higher score means a better life quality.

    Measured: 12 weeks

  8. Quality of life evaluation

    Scores of ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) range from 0 to 54 and higher score means a better life quality.

    Measured: 24 weeks

  9. Quality of life evaluation

    Scores of ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) range from 0 to 54 and higher score means a better life quality.

    Measured: 36 weeks

  10. Quality of life evaluation

    Scores of ADCS-ADL (Alzheimer's Disease Cooperative Study Activities of Daily Living) range from 0 to 54 and higher score means a better life quality.

    Measured: 48 weeks

  11. MRI Neuroimaging

    Evaluation of MRI（Magnetic Resonance Imaging)

    Measured: baseline

  12. MRI Neuroimaging

    Evaluation of MRI（Magnetic Resonance Imaging)

    Measured: 48 weeks

  13. PET-CT Neuroimaging

    Evaluation of and PET-CT（Positron Emission Computed Tomography- Computed Tomography)

    Measured: baseline

  14. PET-CT Neuroimaging

    Evaluation of and PET-CT（Positron Emission Computed Tomography- Computed Tomography)

    Measured: 48 weeks

Timeline

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

  1. First posted15 May 2020
  2. Study start1 Jul 2020
  3. Primary completionAug 2021 (estimated)
  4. Study completionAug 2022 (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
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
9 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04388982
Sponsor's protocol ID
CBMG-AD-01
Status last verified
Sep 2020
First submitted
28 Apr 2020
Last updated
25 Jun 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Pala M, Yilmaz SG. Circular RNAs, miRNAs, and Exosomes: Their Roles and Importance in Amyloid-Beta and Tau Pathologies in Alzheimer's Disease. Neural Plast. 2025 Apr 8;2025:9581369. doi: 10.1155/np/9581369. eCollection 2025.

    PubMed 40235521

  • Xie X, Song Q, Dai C, Cui S, Tang R, Li S, Chang J, Li P, Wang J, Li J, Gao C, Chen H, Chen S, Ren R, Gao X, Wang G. Clinical safety and efficacy of allogenic human adipose mesenchymal stromal cells-derived exosomes in patients with mild to moderate Alzheimer's disease: a phase I/II clinical trial. Gen Psychiatr. 2023 Oct 11;36(5):e101143. doi: 10.1136/gpsych-2023-101143. eCollection 2023.

    PubMed 37859748

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing low dosage MSCs-Exos administrated for nasal drip, mild dosage MSCs-Exos administrated for nasal drip and high dosage MSCs-Exos administrated for nasal drip in people with Alzheimer Disease, run by Ruijin Hospital 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 10 inclusion and 15 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 25 Jun 2021. 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?

Contact Gang Wang, MD,PhD (086-021-64370045, wg11424@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with treatment-related abnormal laboratory values of Liver or kidney function (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT04388982, which also lists 2 linked publications.

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 25 Jun 2021.

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