Review Article

Mesenchymal Stem Cell Therapy for Alzheimer’s Disease

Table 2

Clinical trials of MSCs in humans with AD.

NCTStageCell typeStudy designPhaseParticipantsRouteInterventionFindings

NCT01297218CompletedHuman UCB-MSCsOpen-label, single-center study191 single I.C. infusion250,000 UCB-MSCs per 5 μL per 1 entry site, 3 million cells per brain.
500,000 UCB-MSCs per 5 μL per 1 entry site, 6 million cells per brain.
The stereotactic injection of UCB-MSCs into the hippocampus and precuneus is feasible, safe, and well tolerated. However, a single injection of UCB-MSCs was not effective in altering the AD pathophysiological process [54, 55].
NCT01696591UnknownHuman UCB-MSCsLong-term follow-up study of NCT01297218Same as NCT01297218 [56]
NCT02054208CompletedHuman UCB-MSCsDouble-blind, single-center study1/2a453 I.V.T. infusions UCB-MSCs/2 mL
UCB-MSCs/2 mL
Placebo
Not yet published results [57].
NCT03172117RecruitingHuman UCB-MSCsLong-term follow-up study of NCT02054208Same as NCT02054208 [61]
NCT03117738CompletedAutologous human AD-MSCsRandomized, double-blind, placebo-controlled, parallel-group comparison study1/2219 I.V. infusions AD-MSCs
Placebo
Not yet published results [58].
NCT04228666WithdrawnAutologous human AD-MSCsOpen-label, nonrandomized study1/2a244 I.V. infusions AD-MSCsN/A [59]
NCT02600130Active, not recruitingLMSCsRandomized, placebo-controlled study1331 single I.V. infusion20 million LMSCs
100 million LMSCs
Placebo
N/A [60]
NCT04855955AvailableAutologous human AD-MSCsSingle patient emergency expanded access studyN/A1N/AN/AN/A [62]
NCT02833792RecruitingHuman MSCsMulticenter, randomized, single-blind, placebo-controlled, crossover study2a401 single I.V. infusion1.5 million MSCs per kilogram body weight
Placebo
N/A [63]
NCT04040348RecruitingAllogeneic human UCB-MSCsProspective open-label study164 I.V. infusions100 million UCB-MSCsN/A [64]
NCT04388982RecruitingAllogenic AD-MSCs-ExosSingle-center, open-label study1/2924 nasal drip infusions.5 μg MSCs-Exos/1 mL
10 μg MSCs-Exos/1 mL
20 μg MSCs-Exos/1 mL
N/A [65]
NCT02899091RecruitingP-MSCsRandomized, double-blind, placebo-controlled study1/2a241 and 2 I.V. infusions. P-MSCs
Placebo
N/A [66]
NCT04684602RecruitingHuman UCB-MSCsMulticenter, prospective, open-label clinical study1/25,0001 single infusion via condition-specific route of administration.N/AN/A [67]
NCT04482413Not yet recruitingAutologous AD-MSCsRandomized, double-blind, active-controlled study2b804 I.V. infusions AD-MSCs/20 mL
Placebo
N/A [68]
NCT01547689UnknownHuman UCB-MSCsOpen-label, single-center, self-control study1/2308 I.V. infusions20 million UCB-MSCs ( UCB-MSCs per kg)N/A [69]
NCT02672306UnknownHuman UCB-MSCsMulticenter, randomized, double-blind, placebo-controlled study1/2168 I.V. infusions20 million UCB-MSCs per subject ( UCMSCs per kg)
Placebo
N/A [70]

AD-MSCs: adipose tissue-derived mesenchymal stem cells; AD-MSCs-Exos: adipose tissue-derived mesenchymal stem cells exosomes; AM-MSCs: amniotic mesenchymal stem cells; BM-MSCs: bone marrow-derived mesenchymal stem cells; I.C.: intracerebral; I.C.V.: intracerebroventricular; I.N.: intranasal; I.V.: intravenous; I.V.T.: intraventricular; P-MSCs: placenta-derived mesenchymal stem cells; UCB-MSCs: umbilical cord blood-derived mesenchymal stem cells; WJ-MSCs: Wharton’s Jelly mesenchymal stem cells.