Working...
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 : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
MD Stem Cells

Tracking Information
First Submitted Date  ICMJE October 25, 2018
First Posted Date  ICMJE October 30, 2018
Last Update Posted Date June 3, 2019
Actual Study Start Date  ICMJE October 24, 2018
Estimated Primary Completion Date October 24, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03724136 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 26, 2018)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study
Official Title  ICMJE Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • 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
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Active Comparator: Arm 1
    Intravenous Bone Marrow Stem Cell (BMSC) Fraction
    Intervention: Procedure: Intravenous Bone Marrow Stem Cell (BMSC) Fraction
  • Active Comparator: Arm 2
    Intravenous Bone Marrow Stem Cell (BMSC) Fraction combined with Near Infrared Light exposure .
    Interventions:
    • Procedure: Intravenous Bone Marrow Stem Cell (BMSC) Fraction
    • Procedure: Near Infrared Light
  • Active Comparator: Arm 3
    Intravenous Bone Marrow Stem Cell (BMSC) Fraction combined with Intranasal topical Bone Marrow Stem Cell (BMSC) Fraction.
    Interventions:
    • Procedure: Intravenous Bone Marrow Stem Cell (BMSC) Fraction
    • Procedure: Intranasal Topical Bone Marrow Stem Cell (BMSC) Fraction
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 26, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 24, 2022
Estimated Primary Completion Date October 24, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Steven Levy, MD 203-423-9494 stevenlevy@mdstemcells.com
Listed Location Countries  ICMJE United Arab Emirates,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03724136
Other Study ID Numbers  ICMJE MDSC-ACIST
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party MD Stem Cells
Study Sponsor  ICMJE MD Stem Cells
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeffrey Weiss, MD The Healing Institute
Study Director: Steven Levy, MD MD Stem Cells
PRS Account MD Stem Cells
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP