Autologous Human Adipose-Derived Mesenchymal Stem Cells in Alzheimer's Disease

February 5, 2024 updated by: Celltex Therapeutics Corporation

Individual Patient Expanded Access Investigation New Drug (IND) Application for Administration of Autologous Human Adipose-Derived Mesenchymal Stem Cells in Alzheimer's Disease

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.

Study Overview

Status

No longer available

Conditions

Intervention / Treatment

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celltex Therapeutics Corporation

Investigators

  • Principal Investigator: Richard L Neel, M.D., Little Alsace Urgent Care Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

March 30, 2021

First Submitted That Met QC Criteria

April 20, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTXSP0001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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