Neurologic Stem Cell Treatment Study

ConditionsNeurologic 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

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorMD Stem Cells

About this trial

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/

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Have documented functional damage to the central or peripheral nervous system unlikely to improve with present standard of care.

Be at least 6 months post-onset of the disease.

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.

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.

Disqualifiers

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.

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.

Patients must be capable of providing informed consent.

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. .

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

500 Participants

are divided into 1 treatment group

Group A: Arm 1- Intravenous and Intranasal BMSCOther 1 intervention

Trial outcomes

Primary outcomes

Change in Neurologic Function

Neurologic function from prior to treatment (0 month) and the change in neurologic function at 1,3,6 and 12 months post treatment will be compared to pretreatment using the Neuro-QOL (Neurology Quality of Life) questionnaire. The scales of the Neuro-QOL assess the following Outcome Measures: Communication, Social Roles and Activities ,Anxiety , Depression, Emotional and Behavioral Dyscontrol, Lower Extremity Function (Mobility), Positive Affect and Well-Being, Sleep Disturbance, Upper Extremity Function ( Fine Motor, ADL/Activities of Daily Living) , Stigma , Satisfaction with Social roles and Activities, Cognitive Function. The scale for each question ranges from 1 to 5 with 1 being the most impairment and 5 being no impairment; higher numbers are better. The scale can range from 5 indicating no impairment to 45 for significant impairment. Each scale will be recorded and presented as separate Outcome Measurements.

Time frame

0,1,3,6 and 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

MD Stem Cells

Lead sponsor

Source ClinicalTrials.gov

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