Neurologic Stem Cell Treatment Study

Part of paid clinical trials in Westport, Connecticut.

Sponsor
MD Stem Cells
Study ID
NCT02795052
Status
Recruiting

Conditions

  • ALS
  • Alzheimer Disease
  • Amyotrophic Lateral Sclerosis
  • Cadasil
  • Cerebral Hemorrhage
  • Cerebral Infarction
  • Cerebral Ischemia
  • Cerebral Stroke
  • Chronic Traumatic Encephalopathy
  • Cognitive Impairment
  • Dementia
  • Diabetic Neuropathies
  • Frontotemporal Dementia
  • Lewy Body Disease
  • Lewy Body Variant of Alzheimer Disease
  • MSA - Multiple System Atrophy
  • Multi-System Degeneration
  • Nervous System Diseases
  • Neurodegenerative Diseases
  • Neurologic Disorders
  • Neurological Disorders
  • Neuropathy
  • Parkinson
  • Progressive Supranuclear Palsy
  • Stroke
  • Traumatic Brain Injury

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Intravenous and Intranasal BMSC — PROCEDURE
    Autologous Bone Marrow Derived Stem Cells provided intravenous and intranasal (lower 1/3 of nose)

Study Details

This is a human clinical study involving the isolation of autologous bone marrow derived stem cells (BMSC) and transfer to the vascular system and inferior 1/3 of the nasal passages in order to determine if such a treatment will provide improvement in neurologic function for patients with certain neurologic conditions. http://mdstemcells.com/nest/

Key Dates

Start date
Jun 30, 2016
Status verified
Apr 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Arm 1- Intravenous and Intranasal BMSC
    Intervention- Autologous bone marrow aspiration and separation of Bone Marrow Derived Stem Cell (BMSC) fraction then provided intravenously and intranasally (lower 1/3 of nasal passages).

Primary Outcome Measure

Change in Neurologic Function [ Time Frame: 0,1,3,6 and 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
MD Stem CellsWestportConnecticut06880
Steven Levy, MD, Study Director
203-423-9494
203-423-9494
MD Stem CellsCoral SpringsFlorida33065
Steven Levy, MD, Study Director
203-423-9494
203-423-9494
Steven Levy, MD (SUB_INVESTIGATOR)
Jeffrey Weiss, MD (PRINCIPAL_INVESTIGATOR)

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