Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Autistic Disorder, Current or Active State
- Alzheimer Dementia
- Alzheimer Disease
- Vascular Dementia
- Autism
- Autism Spectrum Disorder
- Autistic Behavior
- CADASIL
- Chronic Traumatic Encephalopathy
- Traumatic Brain Injury
- Wernicke Korsakoff Syndrome
- Dementia, Mixed
- Dementia, Multi-Infarct
- LATE Limbic-predominant Age-related TDP-43 Encephalopathy
- Lewy Body Dementia With Behavioral Disturbance (Disorder)
- Parkinson-Dementia Syndrome
- Huntington's Dementia
- Lewy Body Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients will be assigned to one of 3 arms with monitoring and retesting at 1,3,6 and 12 months following treatment.Masking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 main...
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.
Tracking Information
- NCT #
- NCT03724136
- Collaborators
- Not Provided
- Investigators
- Study Chair: Steven Levy, MD MD Stem Cells Principal Investigator: Jeffrey Weiss, MD Coral Springs
Get Well Soon