Neurologic Bone Marrow Derived Stem Cell Treatment Study

Trial ID: NCT02795052

Interventional - Phase Unknown - Recruiting

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/

Conditions

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

Interventions

• Intravenous and Intranasal BMSC

Eligibility

Inclusion criteria

• 1. Have documented functional damage to the central or peripheral nervous system unlikely to improve with present standard of care.
• 2. Be at least 6 months post-onset of the disease.
• 3. 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 neurologic functional damage as a result of the ongoing pharmacologic or surgical treatment.
• 4. In the estimation of Dr. Weiss and the neurologists have the potential for improvement with BMSC treatment and be at minimal risk of any potential harm from the procedure.
• 5. Be over the age of 18 and capable of providing informed consent.
• 6. 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. This will include the ability to cooperate with the exam.
• 2. Patients must be capable and willing to undergo follow up neurologic exams with the sub-investigators or their own neurologists as outlined in the protocol.
• 3. Patients must be capable of providing informed consent.
• 4. In the estimation of Dr. Weiss 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.

Sponsor

MD Stem Cells

Source: ClinicalTrials.gov

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