Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study — ACIST  

Alzheimer Disease Clinical Trial

Official title: Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study

Status Enrolling by invitation

Clinical Trial Summary

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.

Clinical Trial Description

Cognition is the process of generating thoughts, recalling memories, processing information, and higher order associations including social interactivity that all take place in the brain. It requires sufficient health and interactivity of neurons in the brain including their ability to form and maintain synaptic connections.

Cognitive impairment results from the loss of these abilities. ACIST will test the hypothesis that the delivery of Bone Marrow Derived Stem Cells (BMSC) via the methods in the study with or without the addition of Near Infrared Light will improve cognition through the ability of BMSC to positively affect the health and function of neurons and the brain.

Patients enrolling with cognitive impairment will require assessment with the Mini-Mental Status Exam (MMSE). A score of 24 or less will be required. Progressive dementias such as Alzheimer's Disease (ALZ) show a decline of 2 to 4 points per year on MMSE. The goal for ACIST in progressive and stable dementia will be stability over the 1 year follow up and ideally an improvement of 3 points on MMSE.

Patients enrolling with Autism Spectrum Disorder (ASD) will be required to be adults (over 18 years of age) and to have a score on the Autism Spectrum Quotient of 20 or above. The goal will be a decrease of 5 or more on the scale over the 1 year follow up period. ;

Related Conditions & MeSH terms

• Alzheimer Dementia
• Alzheimer Disease
• Autism
• Autism Spectrum Disorder
• Autistic Behavior
• Autistic Disorder
• Autistic Disorder, Current or Active State
• Brain Diseases
• Brain Injuries
• Brain Injuries, Traumatic
• CADASIL
• Chronic Traumatic Encephalopathy
• Cognitive Dysfunction
• Dementia
• Dementia, Mixed
• Dementia, Multi-Infarct
• Dementia, Vascular
• Huntington's Dementia
• LATE Limbic-predominant Age-related TDP-43 Encephalopathy
• Lewy Body Dementia With Behavioral Disturbance (Disorder)
• Lewy Body Disease
• Parkinson-Dementia Syndrome
• Problem Behavior
• Syndrome
• Traumatic Brain Injury
• Vascular Dementia
• Wernicke Encephalopathy
• Wernicke Korsakoff Syndrome

• NCT number: NCT03724136
• Study type: Interventional
• Source: MD Stem Cells
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 24, 2018
• Completion date: July 31, 2025