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

MD Stem Cells

Status: Invitation-only

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

Treatments: Procedure: Intranasal Topical Bone Marrow Stem Cell (BMSC) Fraction; Procedure: Near Infrared Light; Procedure: Intravenous Bone Marrow Stem Cell (BMSC) Fraction

Study type: Interventional

Funder types: Industry

Identifiers

NCT03724136

MDSC-ACIST

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Have documented cognitive impairment or diagnosis of disease associated with cognitive impairment such as Alzheimer's Disease, Autism Spectrum Disorder.
2. If under current medical therapy (pharmacologic or surgical treatment) for the condition be considered stable on that treatment and unlikely to have reversal of the associated cognitive impairment as a result of the ongoing pharmacologic or surgical treatment.
3. In the estimation of the investigator have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.
4. Be over the age of 18
5. Be medically stable and able to be medically cleared by their primary care physician or a licensed primary care practitioner for the procedure. Medical clearance means that in the estimation of the primary care practitioner, the patient can reasonably be expected to undergo the procedure without significant medical risk to health.

Exclusion criteria

1. All patients must be capable of an adequate neurologic examination and evaluation to document the pathology.
2. Patients must be capable and willing to undergo follow up neurologic exams with the the investigators or their own neurologists as outlined in the protocol.
3. Patients or their designated responsible party for medical decisions must be capable of providing informed consent. Cognitive or memory impairment does not necessarily mean the patient is incapable of giving informed consent. They may simply need more time to process or repetition of the content of the consent to reach understanding and provide informed consent.
4. In the estimation of the investigator the BMSC collection and treatment will not present a significant risk of harm to the patient's general health or to their neurologic function.
5. Patients who are not medically stable or who may be at significant risk to their health undergoing the procedure will not be eligible.
6. Women of childbearing age must not be pregnant at the time of treatment and should refrain from becoming pregnant for 3 months post treatment.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 3 patient groups

Arm 1

Active Comparator group

Description:

Intravenous Bone Marrow Stem Cell (BMSC) Fraction

Treatment:

Procedure: Intravenous Bone Marrow Stem Cell (BMSC) Fraction

Arm 2

Active Comparator group

Description:

Intravenous Bone Marrow Stem Cell (BMSC) Fraction combined with Near Infrared Light exposure .

Treatment:

Procedure: Near Infrared Light

Procedure: Intravenous Bone Marrow Stem Cell (BMSC) Fraction

Arm 3

Active Comparator group

Description:

Intravenous Bone Marrow Stem Cell (BMSC) Fraction combined with Intranasal topical Bone Marrow Stem Cell (BMSC) Fraction.

Treatment:

Procedure: Intravenous Bone Marrow Stem Cell (BMSC) Fraction

Procedure: Intranasal Topical Bone Marrow Stem Cell (BMSC) Fraction