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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04855955
Expanded Access Status : No longer available
First Posted : April 22, 2021
Last Update Posted : May 6, 2022
Sponsor:
Information provided by (Responsible Party):
Celltex Therapeutics Corporation

Study Description
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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.

Condition or disease Intervention/treatment
Alzheimer Disease Drug: Adipose-Derived Mesenchymal Stem Cells

Study Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
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

Resource links provided by the National Library of Medicine


Interventions
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04855955


Sponsors and Collaborators
Celltex Therapeutics Corporation
Investigators
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Principal Investigator: Richard L Neel, M.D. Little Alsace Urgent Care Center
More Information
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Responsible Party: Celltex Therapeutics Corporation
ClinicalTrials.gov Identifier: NCT04855955    
Other Study ID Numbers: CTXSP0001
First Posted: April 22, 2021    Key Record Dates
Last Update Posted: May 6, 2022
Last Verified: December 2020
Keywords provided by Celltex Therapeutics Corporation:
Autologous Adipose-derived Stem Cells (AdMSCs)
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders