NCT04388982

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

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
BIOLOGICAL	low dosage MSCs-Exos administrated for nasal drip	Dosage：5μg MSCs-Exos,Total volume： 1ml Frequency：Twice a week Duration：12 weeks
BIOLOGICAL	mild dosage MSCs-Exos administrated for nasal drip	Dosage：10μg MSCs-Exos,Total volume： 1ml Frequency：Twice a week Duration：12 weeks
BIOLOGICAL	high dosage MSCs-Exos administrated for nasal drip	Dosage：20μg MSCs-Exos,Total volume： 1ml Frequency：Twice a week Duration：12 weeks

Timeline

• Start date: 2020-07-01
• Primary completion: 2021-08-01
• Completion: 2022-08-01
• First posted: 2020-05-15
• Last updated: 2021-06-25

Locations

1 site across 1 country: China