NCT03724136: ACIST

Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study

ENROLLING BY INVITATION NA Last updated 15 April 2024

What this trial tests

NA trial testing Intravenous Bone Marrow Stem Cell (BMSC) Fraction in Alzheimer Disease in 100 participants. Enrolling by invitation.

Timeline

24 October 2018

Primary endpoint
31 July 2025

31 July 2025

Quick facts

Lead sponsor	MD Stem Cells
Phase	NA
Status	ENROLLING BY INVITATION
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	100
Start date	24 October 2018
Primary completion	31 July 2025
Estimated completion	31 July 2025
Sites	3 locations across United States, United Arab Emirates

Drugs / interventions tested

• Intravenous Bone Marrow Stem Cell (BMSC) Fraction
• Intranasal Topical Bone Marrow Stem Cell (BMSC) Fraction
• Near Infrared Light

Conditions studied

• Alzheimer Disease — all drugs for Alzheimer Disease →
• Alzheimer Dementia — all drugs for Alzheimer Dementia →
• Vascular Dementia — all drugs for Vascular Dementia →
• Lewy Body Disease — all drugs for Lewy Body Disease →

Sponsor

MD Stem Cells

Who can join

18 and older, any sex, with Alzheimer Disease or Alzheimer Dementia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of the study is to evaluate the use of autologous Bone Marrow Derived Stem Cells (BMSC) as a means to improve cognitive impairment as occurs in Alzheimer's Disease and other dementias and to improve behavior and socialization issues which occur in adult Autism Spectrum Disorder. The use of Near Infrared Light, in conjunction with the use of BMSC, will also be assessed.

Publications & conference data

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

1. Stem cell therapy for Alzheimer's disease.
   Liu XY, Yang LP, Zhao L. · · 2020 · cited 106× · PMID 32952859 · DOI 10.4252/wjsc.v12.i8.787
2. Neurodegeneration and Neuro-Regeneration-Alzheimer's Disease and Stem Cell Therapy.
   Vasic V, Barth K, Schmidt MHH. · · 2019 · cited 90× · PMID 31480448 · DOI 10.3390/ijms20174272
3. Imaging of intranasal drug delivery to the brain.
   Veronesi MC, Alhamami M, Miedema SB, Yun Y, et al · · 2020 · cited 63× · PMID 32211216
4. Recent Advances in Intranasal Administration for Brain-Targeting Delivery: A Comprehensive Review of Lipid-Based Nanoparticles and Stimuli-Responsive Gel Formulations.
   Koo J, Lim C, Oh KT. · · 2024 · cited 57× · PMID 38414526 · DOI 10.2147/ijn.s439181
5. Stem Cell Transplantation Therapy and Neurological Disorders: Current Status and Future Perspectives.
   Rahman MM, Islam MR, Islam MT, Harun-Or-Rashid M, et al · · 2022 · cited 51× · PMID 35053145 · DOI 10.3390/biology11010147
6. The Use of Stem Cells as a Potential Treatment Method for Selected Neurodegenerative Diseases: Review.
   Cecerska-Heryć E, Pękała M, Serwin N, Gliźniewicz M, et al · · 2023 · cited 39× · PMID 37027074 · DOI 10.1007/s10571-023-01344-6
7. Nasal delivery of neurotherapeutics <i>via</i> nanocarriers: Facets, aspects, and prospects.
   Rajput A, Pingale P, Dhapte-Pawar V. · · 2022 · cited 29× · PMID 36176429 · DOI 10.3389/fphar.2022.979682
8. New idea to promote the clinical applications of stem cells or their extracellular vesicles in central nervous system disorders: Combining with intranasal delivery.
   Li Y, Wu H, Jiang X, Dong Y, et al · · 2022 · cited 28× · PMID 35967290 · DOI 10.1016/j.apsb.2022.04.001