Alzheimer Disease Clinical Trial
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
NCT number | NCT04855955 |
Other study ID # | CTXSP0001 |
Secondary ID | |
Status | No longer available |
Phase | |
First received | |
Last updated |
Verified date | February 2024 |
Source | Celltex Therapeutics Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Expanded Access |
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.
Status | No longer available |
Enrollment | 0 |
Est. completion date | |
Est. primary completion date | |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Celltex Therapeutics Corporation |
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