Proposed Stroke Recovery Pilot Clinical Study Protocol
Biolectrical Stimulation and Micro Infusion Pump Delivery Stem Cell Based Composition for Treating Ischemic Stroke (BMIPS)The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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 |
- 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)
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 |