Proposed Stroke Recovery Pilot Clinical Study ProtocolBiolectrical Stimulation and Micro Infusion Pump Delivery Stem Cell Based Composition for Treating Ischemic Stroke (BMIPS)
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CerebraCell a Leonhard’s Launchpads Co.
Information provided by (Responsible Party):
Study Details & Description
Condition or Disease:
Device: Deep Brain Bioelectric Stimulation (19+ bioelectric signals) = SDF1, IGF1, EGF, HGF, PDGF, VEGF, HIF1a, CXCL5, eNOS, follistatin, tropoelastin, selected ILs. SDF-1 and PDGF are stem cell homing signals. IGF1 will be expressed the longest duration in this sequence.
Device: Micro Infusion Pump
Biologic: CC-15 Brain Regeneration Cocktail Composition comprised of stem cells, growth factors, exosomes, micro RNAs, amniotic fluid, PRF, selected alkaloids including tetraharmine, nutrient engineered hydrogel and brain matrix. Growth factor supplements include SDF1, IGF1, PDGF, GDF-10 and GDF-11.
The proposed study is a safety and feasibility study intended to provide preliminary data to design a future pilot study. The objective of this study is to document the safety and patient outcomes of electrical stimulation + micro infusion of a stem cell + growth factor based cocktail into he dentate nucleus area for the management of chronic, moderate to severe upper extremity hemiparesis due to ischemic stroke.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||12 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Electrical Stimulation and Micro Infusion Pump Delivery of Stem Cell Based Cocktail Into the Dentate Nucleus Area (BMIPS) for Improvement of Upper Extremity Hemiparesis Due to Ischemic Stroke: A Safety and Feasibility Study|
|Study Start Date :||June 2018|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||July 2019|
Arms and Interventions
Experimental: Electrical Stimulation
This is a single arm study and all subjects will receive electrical stimulation and micro infusion pump delivery of the CC- 15 stem cell + growth factor based cocktail.
Device: Deep Brain Stimulation
Electrical stimulation of the dentate nucleus area of the cerebellum.
Device: Micro Infusion Pump
Biologic: CC-15 stem cell + growth factor based cocktail
Primary Outcome Measures:
Adverse Events [ Time Frame: 18 Months ]
Incidence of all serious adverse events
Information from the National Library of Medicine
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|Ages Eligible for Study:||25 Years to 75 Years (Adult, Senior)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- One-time stroke that occurred 1-3 years ago (i.e. index stroke 12-36 months)
- Stroke due to a blocked blood vessel (i.e. unilateral MCA stroke)
- Moderate to severe weakness in one arm (i.e. unilateral upper-extremity hemiparesis)
- Seizures since time of stroke (i.e. seizures or seizure disorder)
- Unable to have an MRI (i.e. contraindicated for MRI)
Contact: Dr. Leslie Miller, Chief Medical Officer email firstname.lastname@example.org
Sponsors and Collaborators
CerebraCell a Leonhardt’s Launchpad co.
Principal Investigator: TBD
|Responsible Party:||CerebraCell a Leonhardt’s Launchpad by Cal-X Stars Business Accelerator, Inc. company|
|Other Study ID Numbers:|
|First Posted:||March 21, 20918|
|Last Update Posted:||March 21, 20189|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
Keywords provided by CerebraCell a Leonhardt‘s Launchpads co,.
Deep Brain Stimulation
Additional relevant MeSH terms:
Central Nervous System Diseases
|Nervous System Diseases
Signs and Symptoms