NCT02833792

Allogeneic Human Mesenchymal Stem Cells for Alzheimer's Disease

Status unknown Phase 2 Last updated 28 October 2022

What this trial tests

Phase 2 trial testing Human Mesenchymal Stem Cells and Lactated Riunger's Solution in Alzheimer Dementia in 40 participants. Status unknown.

Timeline

1 June 2016

Primary endpoint
30 July 2024

31 December 2024

Quick facts

Lead sponsor	Stemedica Cell Technologies, Inc.
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	single
Primary purpose	treatment
Enrollment	40
Start date	1 June 2016
Primary completion	30 July 2024
Estimated completion	31 December 2024
Sites	1 location across United States

Drugs / interventions tested

• Human Mesenchymal Stem Cells and Lactated Riunger's Solution — full drug profile →
• Placebo

Conditions studied

• Alzheimer Dementia — all drugs for Alzheimer Dementia →

Sponsor

Stemedica Cell Technologies, Inc. — full company profile →

Who can join

Adults 55 to 80, any sex, with Alzheimer Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

STUDY OBJECTIVES

Primary:

To assess the safety and tolerability of ischemia-tolerant allogeneic human mesenchymal stem cells (hMSCs) manufactured by Stemedica versus placebo administered intravenously to subjects with mild to moderate dementia due to Alzheimer's disease.

Secondary:

To assess the preliminary efficacy of hMSCs versus placebo in subjects with Alzheimer's-related dementia, as evidenced by neurologic, functional, and psychiatric endpoints.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Alzheimer's disease drug development pipeline: 2019.
   Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2019 · cited 485× · PMID 31334330 · DOI 10.1016/j.trci.2019.05.008
2. Alzheimer's disease drug development pipeline: 2018.
   Cummings J, Lee G, Ritter A, Zhong K. · · 2018 · cited 402× · PMID 29955663 · DOI 10.1016/j.trci.2018.03.009
3. Alzheimer's disease drug development pipeline: 2022.
   Cummings J, Lee G, Nahed P, Kambar MEZN, et al · · 2022 · cited 369× · PMID 35516416 · DOI 10.1002/trc2.12295
4. Alzheimer's disease drug development pipeline: 2020.
   Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2020 · cited 350× · PMID 32695874 · DOI 10.1002/trc2.12050
5. Alzheimer's disease drug development pipeline: 2023.
   Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2023 · cited 326× · PMID 37251912 · DOI 10.1002/trc2.12385
6. Alzheimer's disease drug development pipeline: 2021.
   Cummings J, Lee G, Zhong K, Fonseca J, et al · · 2021 · cited 312× · PMID 34095440 · DOI 10.1002/trc2.12179
7. Pathological mechanisms and therapeutic strategies for Alzheimer's disease.
   Ju Y, Tam KY. · · 2022 · cited 260× · PMID 34380884 · DOI 10.4103/1673-5374.320970
8. Alzheimer's disease drug development pipeline: 2017.
   Cummings J, Lee G, Mortsdorf T, Ritter A, et al · · 2017 · cited 258× · PMID 29067343 · DOI 10.1016/j.trci.2017.05.002