NCT04855955

Brief Summary

This is a single patient emergency expanded access clinical study to assess the safety of administering autologous AdMSCs to an incurable Alzheimer disease patient. The study subject will be evaluated for disease-associated severity according to symptoms, cognitive function, memory, and quality of life.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 30, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 22, 2021

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

First QC Date

March 30, 2021

Last Update Submit

February 5, 2024

Conditions

Keywords

Autologous Adipose-derived Stem Cells (AdMSCs)

Interventions

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • The patient is diagnosed with later stage of Alzheimer Disease with sever cognitive disability.
  • All current anti-Alzheimer medicines cannot prevent disease progression and the patient's mental and physical ability persistently declined
  • Patient's legal guardian and caregiver must voluntarily sign an approved written consent form after ample explanation of the proposed therapy.

You may not qualify if:

  • Current diagnosis of malignancy
  • Renal/liver dysfunction: Exceed two times as normal subject
  • Pregnant or nursing
  • Received other trial drugs within 30 days after participation of this study
  • Experienced major surgery or trauma in the last 14 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Richard L Neel, M.D.

    Little Alsace Urgent Care Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2021

First Posted

April 22, 2021

Last Updated

February 7, 2024

Record last verified: 2024-02