ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03724136
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : December 4, 2018
Sponsor:
Information provided by (Responsible Party):
MD Stem Cells

Brief 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.

Condition or disease Intervention/treatment Phase
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 Procedure: Intravenous Bone Marrow Stem Cell (BMSC) Fraction Procedure: Intranasal Topical Bone Marrow Stem Cell (BMSC) Fraction Procedure: Near Infrared Light Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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
Official Title: Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study
Actual Study Start Date : October 24, 2018
Estimated Primary Completion Date : October 24, 2021
Estimated Study Completion Date : October 24, 2022


Arm Intervention/treatment
Active Comparator: Arm 1
Intravenous Bone Marrow Stem Cell (BMSC) Fraction
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.

Active Comparator: Arm 2
Intravenous Bone Marrow Stem Cell (BMSC) Fraction combined with Near Infrared Light exposure .
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: 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.

Active Comparator: Arm 3
Intravenous Bone Marrow Stem Cell (BMSC) Fraction combined with Intranasal topical Bone Marrow Stem Cell (BMSC) Fraction.
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.




Primary Outcome Measures :
  1. Mini-Mental Status Exam (MMSE) [ Time Frame: 1,3,6 and 12 months post treatment. ]
    In cognitive impairment patients this standard cognitive function test will be administered. The change from pretreatment baseline to each time point post treatment will be assessed.

  2. Autism Spectrum Quotient Exam [ Time Frame: 1,3,6 and 12 months post treatment. ]
    Patients with Autism Spectrum Disorder (ASD) or Autism will undergo testing with the Autism Spectrum Quotient (AQ) Exam, an autism assessment for adults. The change in scoring from pretreatment baseline to each time point post treatment will be assessed.


Secondary Outcome Measures :
  1. Activities of Daily Living [ Time Frame: 1,3,6,and 12 months post treatment ]
    The patients, friends and family will describe changes in abilities to function on a day to day basis.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03724136


Contacts
Contact: Steven Levy, MD 203-423-9494 stevenlevy@mdstemcells.com

Locations
United States, Florida
The Healing Institute Recruiting
Margate, Florida, United States, 33063
Contact: Steven Levy, MD    203-423-9494    stevenlevy@mdstemcells.com   
United Arab Emirates
Euro-Arabian Hospital Recruiting
Dubai, Sharjah, United Arab Emirates
Contact: Steven Levy, MD    203-423-9494    stevenlevy@mdstemcells.com   
Sponsors and Collaborators
MD Stem Cells
Investigators
Principal Investigator: Jeffrey Weiss, MD The Healing Institute
Study Director: Steven Levy, MD MD Stem Cells

Additional Information:
Publications:

Responsible Party: MD Stem Cells
ClinicalTrials.gov Identifier: NCT03724136     History of Changes
Other Study ID Numbers: MDSC-ACIST
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by MD Stem Cells:
Dementia
Alzheimer's Disease
CADASIL
Autism Spectrum Disorder
Adult Autism
High Functioning Autism
Asperger's Syndrome
CTE
TBI

Additional relevant MeSH terms:
Autistic Disorder
Autism Spectrum Disorder
Disease
Syndrome
Alzheimer Disease
Brain Injuries
Dementia
Cognitive Dysfunction
Brain Injuries, Traumatic
Child Development Disorders, Pervasive
Brain Diseases
Dementia, Vascular
Lewy Body Disease
Problem Behavior
CADASIL
Dementia, Multi-Infarct
Chronic Traumatic Encephalopathy
Korsakoff Syndrome
Wernicke Encephalopathy
Parkinson Disease
Supranuclear Palsy, Progressive
Pathologic Processes
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Craniocerebral Trauma
Trauma, Nervous System