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

CTXSP0001

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.

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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

{'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'individual': True}}

2024-02-07