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

Recruiting

This study will evaluate the use of autologous bone marrow-derived stem cells and near infrared light to improve cognitive impairment in Alzheimer's and related dementias and to improve behavior and socialization issues in adult autism spectrum disorder.

Minimum Age Maximum Age Gender Healthy Volunteers
18 Years N/A All No
October 24, 2018
October 24, 2022
100

  • Documented cognitive impairment or diagnosis of disease associated with cognitive impairment
  • If under current medical therapy (drug or surgical treatment), must be stable on that treatment and unlikely to have reversal of the associated cognitive impairment as a result of the treatment
  • Have the potential for improvement with the study treatment and be at minimal risk of any potential harm from the procedure
  • Be medically stable and able to be medically cleared by primary care physician or a licensed primary care practitioner for the procedure
  • Participants enrolling with cognitive impairment will have a Mini-Mental Status Examination score of 24 or less (mild, moderate, or severe dementia)

  • Not able to undergo a neurological exam and evaluation to document the pathology
  • Not able or willing to undergo followup neurological exams with the investigators or own neurologists
  • Not able to provide informed consent (or have a designated responsible party who can provide consent)
  • Not medically stable
  • Procedure may pose significant risk of harm to participant's health or neurological function
  • Women of childbearing potential must not be pregnant and should refrain from becoming pregnant for 3 months after

Participants will undergo intraveneous delivery of self-derived bone marrow stem cells and may also undergo near infrared light treatment or intranasal topical bone marrow stem cell treatment. Researchers will test the ability of the stem cell treatment, with or without infrared light, to positively affect the health and function of neurons and the brain.

Name City State Zip Status Primary Contact
The Healing Institute
Margate Florida 33063 Recruiting Steven Levy, MD
203-423-9494
stevenlevy@mdstemcells.com

MD Stem Cells

Name Role Affiliation
Jeffrey Weiss, MD Principal Investigator The Healing Institute
Steven Levy, MD Study Director MD Stem Cells

Name Phone Email
Steven Levy, MD 203-423-9494 stevenlevy@mdstemcells.com

NCT03724136

Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study