Table 1.
Current clinical trials on stem cell therapy for Alzheimer’s disease.
| Title | Brief Summary | Intervention in Experimental Arm | Primary Outcome | Status | NCT Number |
|---|---|---|---|---|---|
| Phase 2b, Randomized, Double-Blind, Active-Controlled Study to Assess the Efficacy and Safety of AstroStem, Autologous Adipose Tissue Derived Mesenchymal Stem Cells, in Patients with Alzheimer’s Disease | This is a phase 2b randomized, double-blind, active-controlled study with 2 treatment arms, to compare the efficacy and safety of AstroStem versus donepezil treatment in patients with mild AD. Eligible patients diagnosed with AD within one year of the start of treatment will be enrolled. Patients who are randomized into the treatment group will be administered via intravenously AstroStem and donepezil placebo every 4 weeks from Week 0 to Week 16. | Autologous adipose tissue derived mesenchymal stem cells (AdMSCs) administered intravenously and donepezil placebo. | Change from baseline to Week 28 in the ADAS-Cog score. | Not Yet Recruiting | NCT04482413 |
| Open-Label, Single-Center, Phase I/II Clinical Trial to Evaluate the Safety and the Efficacy of Exosomes Derived from Allogenic Adipose Mesenchymal Stem Cells in Patients with Mild to Moderate Dementia Due to Alzheimer’s Disease | The purpose of this study is to evaluate the safety and efficacy of Exosomes Derived from Allogenic Adipose Mesenchymal Stem Cells(MSCs-Exos)in subjects with mild to moderate dementia due to Alzheimer’s Disease. | Low dosage (5 μg) MSCs-Exos administrated for nasal drip twice a week for 12 weeks. Mild dosage (10 μg) MSCs-Exos administrated for nasal drip twice a week for 12 weeks. High dosage (20 μg) MSCs-Exos administrated for nasal drip twice a week for 12 weeks. |
Number of participants with treatment-related abnormal laboratory values of liver or kidney function. Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) v4.0. |
Recruiting | NCT04388982 |
| Phase I, Prospective, Open-label Trial to Evaluate the Safety, Tolerability and Exploratory Outcomes of Multiple Allogeneic Human Mesenchymal Stem Cells (HMSC) Infusions in Patients with Mild to Moderate Alzheimer’s Disease | The purpose of this interventional research study is to test the safety, possible side effects, and possible effectiveness of human mesenchymal stem cell (HMSC) infusions when given to people with a diagnosis of mild to moderate Alzheimer’s disease. | Participants in the hMSC treatment group will receive a total of 4 doses administered intravenously, once a week, every 13 weeks within a year period. | Incidence of any Treatment-Emergent Serious Adverse Events (TE-SAEs). All adverse events will be evaluated for relationship with the study intervention. | Recruiting | NCT04040348 |
| Alzheimer’s Autism and Cognitive Impairment Stem Cell Treatment Study | The purpose of the study is to evaluate the use of autologous Bone Marrow Derived Stem Cells (BMSC) as a mean to improve cognitive impairment as occurs in Alzheimer’s Disease and other dementias and to improve behavior and socialization issues which occur in adult with autism spectrum disorder. The use of Near Infrared Light, in conjunction with the use of BMSC, will also be assessed. | Intravenous administration of BMSC Fraction (14cc). Intravenous administration of BMSC Fraction (14cc) combined with Near Infrared Light exposure. Intravenous administration of BMSC Fraction (14cc) combined with Intranasal BMSC Fraction. |
Mini-Mental Status Exam (MMSE). The change from pretreatment baseline to each time point (1, 3, 6, and 12 months post-treatment) will be assessed. Autism Spectrum Quotient Exam. The change in scoring from pretreatment baseline to each time point (1, 3, 6, and 12 months post-treatment) will be assessed. |
Recruiting | NCT03724136 |
| Randomized, Double-blind, Placebo-controlled, Phase I / IIa Clinical Trial for Evaluation of Safety and Potential Therapeutic Effect After Transplantation of CB-AC-02 in Patients with Alzheimer’s Disease | The objective of the study is to evaluate the safety and the potential therapeutic effects of intravenous transplantation of placenta-derived mesenchymal stem cells (CB-AC-02) in patients with Alzheimer’ disease in two treatment groups. | Group1: CB-AC-02 administration on day 0. Group2: CB-AC-02 administration on day 0 and on week 4. |
The safety and tolerability of treatment with CB-AC-02 will be assessed by analysis of adverse events, abnormal findings, and standard laboratory tests. | Recruiting | NCT02899091 |
| Phase IIa Study of Allogeneic Human Mesenchymal Stem Cells in Subjects with Mild to Moderate Dementia Due to Alzheimer’s Disease | The purpose of the study is to assess the safety and tolerability of ischemia-tolerant allogeneic human mesenchymal stem cells (hMSCs) administered intravenously versus placebo to subjects with mild to moderate dementia due to Alzheimer’s disease. Secondarily, to assess the preliminary efficacy of hMSCs versus placebo in subjects with Alzheimer’s-related dementia. | Intravenous administration of allogeneic hMSCs and Lactated Riunger’s Solution. | Safety of allogeneic hMSCs administration by assessment of adverse events. | Recruiting | NCT02833792 |