Proposed Stroke Recovery Pilot Clinical Study Protocol

Biolectrical Stimulation and Micro Infusion Pump Delivery Stem Cell Based Composition for Treating Ischemic Stroke (BMIPS)

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Sponsor:
CerebraCell a Leonhard’s Launchpads Co.
Information provided by (Responsible Party):

Study Details & Description

Condition or Disease:

Stroke

Intervention/treatment

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.

Detailed Description:
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 Design

Study Type  : Interventional  (Clinical Trial)
Estimated  Enrollment  : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm

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.

Intervention/treatment

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

Outcome Measures
Primary Outcome Measures:
Adverse Events [ Time Frame: 18 Months ]
Incidence of all serious adverse events

Eligibility Criteria

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
Criteria
Key Inclusion Criteria:
  • 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)
Key Exclusion Criteria:
  • Seizures since time of stroke (i.e. seizures or seizure disorder)
  • Unable to have an MRI (i.e. contraindicated for MRI)

Contacts

Contact: Dr. Leslie Miller, Chief Medical Officer email lmiller@secondheartinc.com

Locations
United States

TBD

Sponsors and Collaborators
CerebraCell a Leonhardt’s Launchpad co.
Investigators
Principal Investigator: TBD

More Information

Responsible Party: CerebraCell a Leonhardt’s Launchpad by Cal-X Stars Business Accelerator, Inc. company 
ClinicalTrials.gov Identifier: TBD 
Other Study ID Numbers:
First Posted: March 21, 20918
Last Update Posted: March 21, 20189 
Last Verified:
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by CerebraCell a Leonhardt‘s Launchpads co,.

Ischemic Stroke
Deep Brain Stimulation
DBS
Physical Therapy
Rehab
Brain Stimulation

Additional relevant MeSH terms:

Stroke
Paresis
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Neurologic Manifestations
Signs and Symptoms

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