Trial ID | NCT01547689 | NCT02054208 | NCT02600130 | NCT02912169 | NCT02833792 | NCT02672306 | NCT02899091 |
---|---|---|---|---|---|---|---|
Date | 03/2012 to 12/2016 | 02/2014 to 02/2018 | 11/2015 to 10/2019 | 11/2015 to 12/2017 | 06/2016 to 06/2018 | 05/2016 to 10/2019 | 09/2016 to 06/2018 |
Study design | Phase I/II Safety and efficacy Intervention Single group open-label | Phase I/II Safety and efficacy Intervention Randomized Double-blind Placebo-controlled | Phase I Safety and efficacy Intervention Randomized Double-blind Placebo-controlled | Phase I/II Safety and efficacy Intervention Non-randomized Single group Open-label Multi-centre | Phase II Safety and efficacy Intervention Randomized Single-blind Placebo-controlled Multi-centre | Phase I/II Safety and efficacy Intervention Randomized Double-blind Placebo-controlled | Phase I/II Safety and efficacy Intervention Randomized Double-blind Placebo-controlled |
Stage | Active | Recruiting | Recruiting | Recruiting | Recruiting | Not yet recruiting | Not yet recruiting |
Cell type | hUCB-MSCs | hUCB-MSCs | hBM-MSCs | hAD-SVF | hBM-MSCs | hUCB-MSCs | hPD-MSCs |
Inclusion criteria | Age 50–85 Probable AD K-MMSE 3–20 | Age 50–85 Probable AD K-MMSE 18–26 Amyloid+ PIB/florbetaben-PET | Age 50–80 Diagnosed AD K-MMSE 18–24 Amyloid+ PET | Age ≥55 Probable AD (NINCDS-ADRDA and DSM IV) | Age 55–80 Mild-moderate AD K-MMSE 12–24 Amyloid+ florbetapir-PET | Age 50–85 Probable AD K-MMSE 3–20 | Age ≥50 Probable AD K-MMSE 10–26 Amyloid+ PET |
Delivery route | Intravenous infusion | Ommaya Reservoir intraventricular injection | Intravenous infusion | Intravenous and intranasal infusion | Intravenous infusion | Intravenous infusion | Intravenous infusion |
Arms | n = 30 Eight infusions once every 2 weeks in the first month of each quarter 2 × 107 cells per infusion | n = 42 Three injections at 4-week intervals Low-dose group: 1 × 107 cells per injection High-dose group: 3 × 107 cells per injection Placebo group: saline | n = 30 Single infusion Low-dose group: 2 × 107 cells High-dose group: 1 × 108 cells Placebo group: Plasmalyte A and 1% human serum albumin | n = 100 Single intravenous infusion or intravenous and intranasal infusion | n = 40 Single infusion Crossover at 6 months post-infusion Group 1: 1.5 × 106 cells/kg bodyweight Group 2: lactated Ringer’s Solution | n = 40 Eight infusions at 2-week intervals Treatment group: 2 × 107 cells per infusion Placebo group: saline | n = 24 Single or repeat (day 0 and week 4) infusions Arm 1: K-MMSE 20–26 Arm 2: K-MMSE 10–19 Group1: 2 × 108 cells Group 2: two infusions of 2 × 108 cells Placebo group: placebo infusion |
Outcome measures | 10 weeks FU No. of adverse events Change from baseline: ADAS-cog, MMSE, CIBIC, ADCS-ADL and CGA-NPI CSF transthyretin, Aβ and tau Blood Thl/Th2 cytokines | 24 weeks FU No. of adverse events Change from baseline: ADAS-cog, S-IADL, K-MMSE, CIBIC, CGA-NPI and CDR CSF biomarkers MRI DTI mapping, PIB-PET and FDG-PET | 30 days FU No. of adverse events 2, 4, 13, 39, and 52 weeks FU Change from baseline: ADAS-cog, MMSE, CGA-NPI and GDS CSF inflammatory markers, Aβ and tau Blood inflammatory and AD biomarkers MRI brain volumetry | 12 months FU No. of adverse events 3 and 6 months FU Change from baseline: FAQ, GDS, MMSE and ADCS-ADL | 18 months FU No. of adverse events Change from baseline: Neurological examinations | 10 weeks FU No. of adverse events Change from baseline: ADAS-cog, MMSE, ADCS-CCGIC, ADCS-ADL and CGA-NPI CSF Aβ and tau Blood Aβ | 48 weeks FU No. of adverse events Change from baseline: ADAS-cog, K-MMSE, GDS, CDR, K-IADL, CGA-NPI, CIBIC and SF-36 CSF Aβ and tau Brain MRI, amyloid-PET, FDG-PET, CMRglc Quantitative ECG |