NCT03724136

Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: MD Stem Cells · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
PROCEDURE	Intravenous Bone Marrow Stem Cell (BMSC) Fraction	14 cc of BMSC fraction separated from bone marrow aspirate and filtered with 150 micron filter and administered intravenously.
PROCEDURE	Intranasal Topical Bone Marrow Stem Cell (BMSC) Fraction	Approximately 1 cc of BMSC fraction separated from bone marrow aspirate and administered to the nasal mucosa topically.
PROCEDURE	Near Infrared Light	Near Infrared Light will be administered using an FDA cleared medical device on the preoperative day and the first postoperative day as tolerated to the general area of the frontal bone.

Timeline

• Start date: 2018-10-24
• Primary completion: 2025-07-31
• Completion: 2025-07-31
• First posted: 2018-10-30
• Last updated: 2024-04-15

Locations

3 sites across 2 countries: United States, United Arab Emirates