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Investigational drug(s) / intervention(s)
Intravenous and Intranasal BMSC
Intravenous and Intranasal BMSC: Autologous Bone Marrow Derived Stem Cells provided intravenous and intranasal (lower 1/3 of nose)
Study summary
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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Change in Neurologic Function — 0,1,3,6 and 12 months 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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