Back to resultsAutologous Human Adipose-Derived Mesenchymal Stem Cells in Alzheimer's Disease
Primary Purpose
Alzheimer Disease
Status
No longer available
Phase
Locations
Study Type
Expanded Access
Intervention
Adipose-Derived Mesenchymal Stem Cells
Sponsored by
About this trial
This is an expanded access trial for Alzheimer Disease focused on measuring Autologous Adipose-derived Stem Cells (AdMSCs)
Eligibility Criteria
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
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT04855955
First Posted
March 30, 2021
Last Updated
May 3, 2022
Sponsor
Celltex Therapeutics Corporation
1. Study Identification
Unique Protocol Identification Number
NCT04855955
Brief Title
Autologous Human Adipose-Derived Mesenchymal Stem Cells in Alzheimer's Disease
Official Title
Individual Patient Expanded Access Investigation New Drug (IND) Application for Administration of Autologous Human Adipose-Derived Mesenchymal Stem Cells in Alzheimer's Disease
Study Type
Expanded Access
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltex Therapeutics Corporation
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Autologous Adipose-derived Stem Cells (AdMSCs)
7. Study Design
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Adipose-Derived Mesenchymal Stem Cells
10. Eligibility
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard L Neel, M.D.
Organizational Affiliation
Little Alsace Urgent Care Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Autologous Human Adipose-Derived Mesenchymal Stem Cells in Alzheimer's Disease
We'll reach out to this number within 24 hrs