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Alzheimer's Autism and Cognitive Impairment Stem Cell Treatment Study

NCT03724136 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-04-15

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease
  • Alzheimer Dementia
  • Vascular Dementia
  • Lewy Body Disease
  • Lewy Body Dementia With Behavioral Disturbance (Disorder)
  • Dementia, Mixed
  • Parkinson-Dementia Syndrome
  • Chronic Traumatic Encephalopathy
  • Huntington's Dementia
  • Wernicke Korsakoff Syndrome
  • Traumatic Brain Injury
  • Dementia, Multi-Infarct
  • Autism
  • Autism Spectrum Disorder
  • Autistic Behavior
  • Autistic Disorder, Current or Active State
  • Cadasil
  • LATE Limbic-predominant Age-related TDP-43 Encephalopathy

Interventions

PROCEDURE

Intravenous Bone Marrow Stem Cell (BMSC) Fraction

14 cc of BMSC fraction separated from bone marrow aspirate and filtered with 150 micron filter and administered intravenously.

PROCEDURE

Intranasal Topical Bone Marrow Stem Cell (BMSC) Fraction

Approximately 1 cc of BMSC fraction separated from bone marrow aspirate and administered to the nasal mucosa topically.

PROCEDURE

Near Infrared Light

Near Infrared Light will be administered using an FDA cleared medical device on the preoperative day and the first postoperative day as tolerated to the general area of the frontal bone.

Sponsors & Collaborators

  • MD Stem Cells

    lead INDUSTRY

Principal Investigators

  • Steven Levy, MD · MD Stem Cells

  • Jeffrey Weiss, MD · Coral Springs

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-24
Primary Completion
2025-07-31
Completion
2025-07-31

Countries

  • United States
  • United Arab Emirates

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03724136 on ClinicalTrials.gov