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

NCT04388982 | Unknown Phase 1

• 1 other identifier: CBMG-AD-01
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (2)

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

  12 weeks

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

  12 weeks

Secondary Outcomes (14)

• Cognitive function

  baseline

• Cognitive function

  12 weeks

• Cognitive function

  24 weeks

• Cognitive function

  36 weeks

• Cognitive function

  48 weeks

Other Outcomes (1)

• Changes of AD biomarkers

  baseline and 48 weeks

Study Arms (3)

MSCs-Exos Dosage 1

EXPERIMENTAL

MSCs-Exos. low-dose group

Biological: low dosage MSCs-Exos administrated for nasal drip

MSCs-Exos Dosage 2

EXPERIMENTAL

MSCs-Exos mid-dose group

Biological: mild dosage MSCs-Exos administrated for nasal drip

MSCs-Exos Dosage 3

EXPERIMENTAL

MSCs-Exos high-dose group

Biological: high dosage MSCs-Exos administrated for nasal drip

Interventions

low dosage MSCs-Exos administrated for nasal drip BIOLOGICAL

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

MSCs-Exos Dosage 1

mild dosage MSCs-Exos administrated for nasal drip BIOLOGICAL

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

MSCs-Exos Dosage 2

high dosage MSCs-Exos administrated for nasal drip BIOLOGICAL

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

MSCs-Exos Dosage 3

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 ;
• 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:
• (1) 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Ruijin Hospital: lead
• Shanghai AbelZeta Ltd.: collaborator

Study Sites (1)

Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

Related Publications (2)

• 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.

  PMID: 40235521 DERIVED

• 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.

  PMID: 37859748 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Gang Wang, MD,PhD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Xiaoling Gao, PhD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gang Wang, MD,PhD

CONTACT

086-021-64370045; wg11424@rjh.com.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2020
• First Posted: May 15, 2020
• Study Start: July 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: August 1, 2022
• Last Updated: June 25, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)