Alzheimer’s Autism and Cognitive Impairment Stem Cell Treatment Study

Brief Title

Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study

Official Title

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

Interventional


Primary Outcome

Mini-Mental Status Exam (MMSE)

Secondary Outcome

 Activities of Daily Living

Condition

Alzheimer Disease

Intervention

Intravenous Bone Marrow Stem Cell (BMSC) Fraction

Study Arms / Comparison Groups

 Arm 1
Description:  Intravenous Bone Marrow Stem Cell (BMSC) Fraction

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

100

Start Date

October 24, 2018

Completion Date

October 24, 2023

Primary Completion Date

October 24, 2022

Eligibility 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.
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Steven Levy, MD, 203-423-9494, [email protected]

Location Countries

United Arab Emirates

Location Countries

United Arab Emirates

Administrative Informations


NCT ID

NCT03724136

Organization ID

MDSC-ACIST


Responsible Party

Sponsor

Study Sponsor

MD Stem Cells


Study Sponsor

Steven Levy, MD, Study Chair, MD Stem Cells


Verification Date

February 2021