Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study

Launched by MD STEM CELLS · Oct 26, 2018

Keywords

ClinConnect Summary

This is a early-stage research study to see if a patient’s own bone marrow stem cells, given through intravenous (IV) infusion, can help with thinking and daily functioning in adults with cognitive problems like Alzheimer’s disease, as well as improve behavior and social skills in adults with autism spectrum disorder. Some participants will also test adding near-infrared light therapy or a nasal, topical stem cell delivery. There are three groups running at the same time, and everyone will have follow-up checks at 1, 3, 6, and 12 months after treatment. No results are available yet, and the study plans to enroll about 100 people with completion expected around July 2025.

Who can join? Adults 18 and older with documented cognitive impairment due to conditions such as Alzheimer’s disease or autism spectrum disorder, whose current treatments are stable, and who can understand and provide informed consent. Participants must be medically stable and able to attend follow-up visits. The study is non-randomized, meaning people are assigned to one of three arms: Arm 1 – IV stem cell infusion; Arm 2 – IV stem cells plus near-infrared light therapy; Arm 3 – IV stem cells plus an intranasal stem cell delivery. The main goals are to see changes in cognitive tests (MMSE) and autism traits (AQ) over 12 months, with additional measures of daily living. The trial is sponsored by MD Stem Cells and is not yet results-ready. Sites include centers in Connecticut, Florida, and Dubai.

Gender

ALL

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.