Trial Summary
What is the purpose of this trial?
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.
Research Team
SL
Steven Levy, MD
Principal Investigator
MD Stem Cells
JW
Jeffrey Weiss, MD
Principal Investigator
Coral Springs
Eligibility Criteria
This trial is for adults over 18 with cognitive impairments or diagnoses like Alzheimer's, various dementias, Autism Spectrum Disorder, and other brain diseases. They should be stable on current treatments and have potential to benefit from BMSC treatment without significant risk. Pregnant women or those who may become pregnant within 3 months post-treatment are excluded.Inclusion Criteria
My doctor believes BMSC treatment could help me with minimal risk.
I have been diagnosed with a condition that affects my thinking, like Alzheimer's or Autism.
I have been diagnosed with a condition like Alzheimer's or Autism that affects my thinking.
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Exclusion Criteria
I can undergo a full neurological exam to check my brain function.
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
Women of childbearing age must not be pregnant at the time of treatment and should refrain from becoming pregnant for 3 months post-treatment
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Treatment Details
Interventions
- Intranasal Topical Bone Marrow Stem Cell (BMSC) Fraction (Stem Cell Therapy)
- Intravenous Bone Marrow Stem Cell (BMSC) Fraction (Stem Cell Therapy)
- Near Infrared Light (Procedure)
Trial OverviewThe study tests autologous Bone Marrow Derived Stem Cells (BMSC) administered intravenously and topically through the nose, along with Near Infrared Light therapy. It aims to improve cognitive function in dementia and behavior in adult autism.
Participant Groups
3Treatment groups
Active Control
Group I: Arm 1Active Control1 Intervention
Intravenous Bone Marrow Stem Cell (BMSC) Fraction
Group II: Arm 2Active Control2 Interventions
Intravenous Bone Marrow Stem Cell (BMSC) Fraction combined with Near Infrared Light exposure .
Group III: Arm 3Active Control2 Interventions
Intravenous Bone Marrow Stem Cell (BMSC) Fraction combined with Intranasal topical Bone Marrow Stem Cell (BMSC) Fraction.
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Who Is Running the Clinical Trial?
MD Stem Cells
Lead Sponsor
Trials
6
Recruited
1,500+