Study |
Baseline MMSE |
N |
M:F |
Mean age ± SD |
Types of SCT |
Cell density |
Where cells derived |
Transplantation zone |
Intervention-outcome measurement interval |
Outcome assessment scales |
Summary of results |
Cognitive outcomes |
Kim et al.2424. Kim HJ, Seo SW, Chang JW, Lee JI, Kim CH, Chin J, et al. Stereotactic brain injection of human umbilical cord blood mesenchymal stem cells in patients with Alzheimer’s disease dementia: a phase 1 clinical trial. Alzheimers Dement (N Y). 2015;1(2):95-102. https://doi.org/10.1016/j.trci.2015.06.007 https://doi.org/10.1016/j.trci.2015.06.0...
|
16.6±4.1 |
9 |
6:3 |
61.6±6.9 |
human UC-MSCs |
(3, 6)×1066. Rasi Marzabadi L, Fazljou SMB, Araj-Khodaei M, Sadigh-Eteghad S, Naseri A, Talebi M. Saffron reduces some inflammation and oxidative stress markers in donepezil-treated mild-to-moderate Alzheimer’s Disease patients: a randomized double-blind placebo-control trial. J Herb Med. 2022;34:100574. https://doi.org/10.1016/j.hermed.2022.100574 https://doi.org/10.1016/j.hermed.2022.10...
cells |
umbilical cord blood |
bilateral hippocampi and right precuneus |
4, 12 weeks, and 24 months |
ADAS-Cog, S-IADL, MMSE, PiB-PET, FDG-PET, CSF biomarkers, brain CT and MRI |
In the 12-week follow-up, wound pain (100%), headache (44.4%), dizziness (33.3%), delirium (33.3%), nausea (22.2%), and back pain (22.2%) were the most common adverse events, none of which were extended to 24 months. There were no structural abnormalities or immunological reactions. |
Changes in ADAS-Cog, in the low-dose group, were 5.3±3.5 (week 12) and 20.0±9.9 (month 24); in the high-dose group, they were 3.5±5.6 (week 12) and 8.6±13.1 (month 24). Changes in S-IADL, in the low-dose group, were 1.7±4.0 (week 12) and 19.5±6.4 (month 24); in the high-dose group, they were 1.2±5.9 (week 12) and 12.0±6.0 (month 24). Changes in MMSE, in the low-dose group, were -1.7±0.6 (week 12) and -9.5±0.7 (month 24); in the high-dose group, they were 0.5±2.1 (week 12) and -8.4±5.6 (month 24). |
Duma et al.2323. Duma C, Kopyov O, Kopyov A, Berman M, Lander E, Berman S, et al. Human intracerebroventricular (ICV) injection of autologous, non-engineered, adipose-derived stromal vascular fraction for neurodegenerative disorders: a 3-year phase 1 study of 113 injections in 31 patients. Stereotact Funct Neurosurg. 2019;97(suppl 1):111.
|
Various |
10 |
6:4 |
75.5±11.6 |
ADSVF |
3.5–20 cc containing 4.05×1055. Majidazar R, Rezazadeh-Gavgani E, Sadigh-Eteghad S, Naseri A. Pharmacotherapy of Alzheimer’s disease: an overview of systematic reviews. Eur J Clin Pharmacol. 2022;78(10):1567-87. https://doi.org/10.1007/s00228-022-03363-6 https://doi.org/10.1007/s00228-022-03363...
to 6.2×1077. Vo TS, Vo TTBC, Vo TTTN. Characterization and heath effects of saffron utilizing in disease treatment and prevention: a review. J Res Clin Med. 2021;9(1):28. https://doi.org/10.34172/jrcm.2021.028 https://doi.org/10.34172/jrcm.2021.028...
cells/cc |
liposuction |
Intracerebroventricular (Ommaya reservoir implantation) |
2 to 36 months |
MPI, RBANS, NeuroQuant® volumetric MRI, CSF biomarkers |
There was no complication other than mild headache, or pain at the surgical sites, for less than 24 hours. Over eight months, 30% showed an improvement in CSF markers. Hippocampal volume increased in one of four assessed AD patients after 2 years of follow-up. |
Over eight months, 80% of AD patients had stable or improved cognitive function, assessed by MPI. |
Kim et al.2222. Kim HJ, Cho KR, Jang H, Lee NK, Jung YH, Kim JP, et al. Intracerebroventricular injection of human umbilical cord blood mesenchymal stem cells in patients with Alzheimer’s disease dementia: a phase I clinical trial. Alzheimers Res Ther. 2021;13(1):154. https://doi.org/10.1186/s13195-021-00897-2 https://doi.org/10.1186/s13195-021-00897...
|
21.1±3.82 |
9 |
3:6 |
62.7±7.93 |
human UC-MSCs |
(1-3)×1077. Vo TS, Vo TTBC, Vo TTTN. Characterization and heath effects of saffron utilizing in disease treatment and prevention: a review. J Res Clin Med. 2021;9(1):28. https://doi.org/10.34172/jrcm.2021.028 https://doi.org/10.34172/jrcm.2021.028...
cells/2 mL [three repeated injections] |
umbilical cord blood |
Intracerebroventricular (Ommaya reservoir implantation) |
4,8, 12, 52, 104 weeks |
ADAS-Cog, S-IADL, MMSE, NPI, CIBIC-Plus, CSF biomarkers, MRI, PiB-PET or florbetaben PET |
Fever (100%), headache (77.8%), nausea (55.6%), vomiting (44.4%), myalgia or chills (22.2%), paresthesia on both arms and legs (22.2%) were the most commonly reported adverse events, all of which subsided within 36 hours. There were also three serious adverse events in two participants which required an extended hospitalization. |
Changes in ADAS-Cog, in the low-dose group were 0.7±4.0, and in the high-dose group, were 2.3±5.0 (week 12) Changes in S-IADL, in the low-dose group were 2.0±2.0, and in the high-dose group were 1.5±3.0 (week 12) Changes in MMSE, in the low-dose group, were 0.0±2.0, and, in the high-dose group were 0.7±1.6 (week 12). Changes in NPI, in the low-dose group, were 1.3±2.3, and, in the high-dose group, were -1.7±5.8 (week 12). |
Myeong et al. 2121. Myeong SH, Kim H, Lee NK, Hwang JW, Kim HJ, Jang H, et al. Intracerebroventricular administration of human umbilical cord blood-derived mesenchymal stem cells induces transient inflammation in a transgenic mouse model and patients with Alzheimer’s disease. Biomedicines. 2022;10(3):563. https://doi.org/10.3390/biomedicines10030563 https://doi.org/10.3390/biomedicines1003...
|
21.6±1.39 |
6 (+3 placebo) |
5:4 |
63.4±3.64 |
human UC-MSCs |
3×1077. Vo TS, Vo TTBC, Vo TTTN. Characterization and heath effects of saffron utilizing in disease treatment and prevention: a review. J Res Clin Med. 2021;9(1):28. https://doi.org/10.34172/jrcm.2021.028 https://doi.org/10.34172/jrcm.2021.028...
cells/2 mL |
umbilical cord blood |
Intracerebroventricular (Ommaya reservoir implantation) |
24 hours |
CSF pro-inflammatory cytokine |
Injection was associated with increased CSF levels of TNF-α, IL-1β, IL-6, and CRP; however, bacterial culture results were negative. |
- |
Brody et al.2525. Brody M, Agronin M, Herskowitz BJ, Bookheimer SY, Small GW, Hitchinson B, et al. Results and insights from a phase I clinical trial of Lomecel-B for Alzheimer’s disease. Alzheimers Dement. 2023;19(1):261-73. https://doi.org/10.1002/alz.12651 https://doi.org/10.1002/alz.12651...
|
20.45±1.46, 20.60±2.06, 20.70±2.26 |
25 (+ 8 placebo) |
17:16 |
71.2±8.4 |
Lomecel-B |
(2-10)×1077. Vo TS, Vo TTBC, Vo TTTN. Characterization and heath effects of saffron utilizing in disease treatment and prevention: a review. J Res Clin Med. 2021;9(1):28. https://doi.org/10.34172/jrcm.2021.028 https://doi.org/10.34172/jrcm.2021.028...
cells |
Bone marrow |
single intravenous infusion |
13, 26, 52 weeks |
MMSE, ADAS-Cog-11, ADCS-ADL, ADRQL, GDS, NPI, QOL-AD, Trail Making Test, plasma biomarkers, MRI |
There was only one treatment-emergent serious adverse event. The incidence of adverse events was lower in each Lomecel-B treatment arm. There were no amyloid-related imaging abnormalities. |
Low-dose (but not high-dose) Lomecel-B arm was significantly better than the placebo at week 13 by 2.69±1.39 points in MMSE. Lomecel-B arms appeared more stable in ADAS-Cog-11, and the difference at week 26 between placebo and low-dose Lomecel-B arms, while not significant, was 5.68±3.66. |