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Stem Cell Therapy
Stem Cells + Light Therapy for Alzheimer's Disease and Autism (ACIST Trial)
N/A
Waitlist Available
Led By Jeffrey Weiss, MD
Research Sponsored by MD Stem Cells
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have documented cognitive impairment or diagnosis of disease associated with cognitive impairment such as Alzheimer's Disease, Autism Spectrum Disorder.
Have documented cognitive impairment or diagnosis of disease associated with cognitive impairment such as Alzheimer's Disease, Autism Spectrum Disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1,3,6,and 12 months post treatment
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether stem cells from patients' own bone marrow can improve cognitive impairment and socialization issues in adults with Alzheimer's or autism. Near-infrared light therapy will also be tested.
Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Potential side effects aren't specified but participants must be at minimal risk of harm from BMSC treatment as assessed by investigators. Medical clearance is required indicating they can undergo the procedure safely.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with a condition that affects my thinking, like Alzheimer's or Autism.
Select...
I have been diagnosed with a condition like Alzheimer's or Autism that affects my thinking.
Select...
I am over 18 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1,3,6,and 12 months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1,3,6,and 12 months post treatment
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Autism Spectrum Quotient Exam
Mini-Mental Status Exam (MMSE)
Secondary study objectives
Activities of Daily Living
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
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 CellsLead Sponsor
5 Previous Clinical Trials
1,390 Total Patients Enrolled
Steven Levy, MDStudy ChairMD Stem Cells
4 Previous Clinical Trials
1,340 Total Patients Enrolled
Jeffrey Weiss, MDPrincipal InvestigatorCoral Springs
4 Previous Clinical Trials
1,340 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor believes BMSC treatment could help me with minimal risk.I can undergo a full neurological exam to check my brain function.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.My doctor agrees I can safely undergo a medical procedure.I (or my designated decision-maker) can understand and consent to medical procedures.My current treatment for my condition is stable and not expected to reverse my cognitive issues.I am willing and able to attend follow-up neurological exams as required.I am over 18 years old.My doctor believes BMSC treatment could help me with minimal risk.My current treatment for my condition is stable and not expected to reverse my cognitive issues.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1
- Group 2: Arm 2
- Group 3: Arm 3
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Autism Spectrum Disorder Patient Testimony for trial: Trial Name: NCT03724136 — N/A