Dementia of the Alzheimer's Type Clinical Trial
Official title:
Open-Label, Single-Center, Phase 1 Clinical Trial to Evaluate the Safety and the Efficacy of NEUROTSTEM®-AD in Patients With Dementia of the Alzheimer's Type
The primary purpose of this study is to evaluate the safety and the tolerability of NEUROSTEM®-AD (Human Umbilical Cord Blood Derived Mesenchymal Stem Cells) and to assess the maximum tolerated dose (MTD). This study is also to investigate the efficacy of this study drug in patients with dementia of Alzheimer's type.
Most of the treatments for Alzheimer disease are chemical drug that is designed to
temporarily increase acetylcholine, based on the cholinergic hypothesis. These drugs can
improve the symptoms but is not able to inhibit the disease progression. New drugs from the
disease have been developed but they have not been successful yet.
Mesenchymal stem cells (MSC) are capable of differentiating into various tissues. Due to the
characteristics of the cells it has been widely investigated in tissue regeneration. In
addition, the paracrine effect of MSC in microenvironment has been recently reported. MSC
has been developed as an immunomodulation cell therapy product because it has been known
that it does not cause immunological rejection in allo- and xeno-transplantation. Clinical
studies showed that umbilical cord blood-derived MSC is immunologically stable and not
toxic.
This study is to evaluate the safety and the tolerability of NEUROSTEM®-AD (Human Umbilical
Cord Blood Derived Mesenchymal Stem Cells) and to assess the maximum tolerated dose (MTD).
This study is also to investigate the efficacy of this study drug in patients with dementia
of Alzheimer's type.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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Phase 3 | |
| Completed |
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Phase 2 |