Neurologic Stem Cell Surgery

This is a concise how-to of successfully treating previously poorly or untreatable neurologic conditions with stem cell therapies. The text examines the IRB approved protocols of NEST (Neurologic Bone Marrow Derived Stem Cell Treatment Study), SCiExVr (Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study), and ACIST (Alzheimer’s and Cognitive Impairment Stem Cell Treatment Study). The discussion focuses on the protocols and informed consents and may be used as a template for specialists to develop clinical trials utilizing stem cell based therapy. Other potential noninvasive treatments for brain injury are also discussed. Neurologic Stem Cell Surgery, the sister text to the recently published Retinal and Optic Nerve Stem Cell Surgery, is an invaluable reference for all physicians with an interest in the development of stem cell based treatments. Contents Introduction 1: ClinicalTrials.gov Listings Neurologic Bone Marrow Derived Stem Cell Treatment Study (NEST) Introduction Objectives Methods/Design Type of Research Neurologic Treatment Arms Randomization Withdrawal Anesthesia BMSC Collection and Preparation Post-procedure Neurologic Exams Trial Status Initial Results Discussion References Informed Consent and Permission Neurologic Bone Marrow Derived Stem Cell Treatment Study NEST Study Introduction Background Terms of the Study Reproductive Information for Females Benefits/Outcomes of Treatment Description of Procedure Follow-up Exams Alternative Treatments Medical Treatments and Costs Treatment Location Acceptance of Risks Medical Clearance Anesthesia Treatment Procedure Preoperative Neurologic Exam Treatment Location Treatment Procedure Possible Side Effects/Complications Post-procedure Neurologic Exams Collection and Use of Data Confidentiality of Records Available Information Termination Participant Statement and Authorization Protocol Title Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study Working Title SCiExVR Study Principal Investigator Sub-Investigators Study Director Primary Site Supplemental Sites Introduction Type of Research Purpose and Objective of the Study Background of the Study Background of the Neurologic Stem Cell Treatment Study (NEXT or NEST) Participant Selection Inclusions Restrictions Study Design/Method/Procedures Summary of Research Design Preoperative Neurologic Exam Treatment Location Randomization Treatment Procedure Anesthesia BMSC Collection and Preparation Neurologic Treatment Performance of Injections of Adult Stem Cell Material Possible Side Effects/Complications General Bone Marrow Aspiration Spinal Cord Treatment Post-procedure Neurologic Exams Collection and Use of Data Analysis of Study Results Monitoring Storage of Data Confidentiality of Data Risk/Benefit Assessment Risks General Bone Marrow Aspiration Neurologic Treatment Prevention of Risks Adverse Events Serious Adverse Event Unanticipated Adverse Event Anticipated Adverse Event Benefits Participant Recruitment and Informed Consent Recruitment Length of Study Informed Consent/Assent BMSC References Arm 3. Exoskeleton Background Phoenix Device Description (For Example) Device Usage Anticipated Risk/Benefits Subject Conditions Inclusion Criteria Exclusion Criteria Study Protocol Arm 3 References Literature References Virtual Reality ASIA Scoring Diagram Informed Consent and Permission Stem Cell Spinal Cord Injury Exoskeleton and Virtual Reality Treatment Study SCiExVR Treatment Study Introduction Background Terms of the Study Reproductive Information for Females Benefits/Outcome of Treatment Description of Procedures Follow-up Exams Alternative Treatments Medical Treatments and Costs Treatment Location Acceptance of Risks Medical Clearance Anesthesia Treatment Procedure Preoperative Neurologic Exam Treatment Location Treatment Procedure Possible Side Effects/Complications Post-procedure Neurologic Exams Collection and Use of Data Confidentiality of Records Available Information Termination Participant Statement and Authorization Protocol Title Alzheimer’s and Cognitive Impairment Stem Cell Treatment Study ACIST Study Principal Investigator Sub-Investigators Study Director Primary Site Supplemental Site Introduction Type of Research Purpose and Objective of the Study Background of the Study Participant Selection Inclusions Restrictions Study Design/Method/Procedures Summary of Research Design Preoperative Neurologic Exam Treatment Location Treatment Procedure Anesthesia BMSC Collection and Preparation Neurologic Treatment Performance of Injections of Adult Stem Cell Material Possible Side Effects/Complications General Bone Marrow Aspiration Neurologic Treatment Post-procedure Neurologic Exams Collection and Use of Data Analysis of Study Results Monitoring Storage of Data Confidentiality of Data Risk/Benefit Assessment Risks General Bone Marrow Aspiration Neurologic Treatment Prevention of Risks Adverse Events Serious Adverse Event Unanticipated Adverse Event Anticipated Adverse Event Benefits Participant Recruitment and Informed Consent Recruitment Length of Study Informed Consent/Assent References Publications Near Infrared Light / WARP 10 Application Informed Consent and Permission Alzheimer’s Autism and Cognitive Impairment Stem Cell Treatment Study Introduction ACIST Study Cost Background Terms of the Study Reproductive Information for Females Benefits/Outcome of Treatment Description of Procedure Pre-op and Follow-up Neurologic Exams Alternative Treatments Medical Treatments and Costs Treatment Location Acceptance of Risks Medical Clearance Anesthesia Treatment Procedure Preoperative Neurologic Exam Treatment Location Treatment Procedure: 1. Anesthesia BMSC Collection and Preparation Neurologic Treatment Possible Side Effects/Complications General Bone Marrow Aspiration Neurologic Treatment Post-procedure Neurologic Examinations Collection and Use of Data Confidentiality of Records Available Information Termination Participant Statement and Authorization 2: Procedure – Additional Patient Explanation 3: Some Thoughts Quantitative Assessment Bone Marrow Aspirate Separation Bibliography 4: Other Treatment Modalities Light Questions PBM for Acute Stroke NEST-1 NEST-2 NEST-3 Traumatic Brain Injury (TBI) Dementia Transcranial Magnetic Stimulation (TMS) Problems Repetitive TMS (rTMS) Transcranial Direct Current Stimulation (tDCS) Transcranial Doppler Sonography (TCD) Hyperbaric Oxygen [22–26] Neurofeedback [27] Virtual Reality [28, 29] External Stimulation [34] References Index