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.
Author(s): Jeffrey N. Weiss
Publisher: Springer
Year: 2021
Language: English
Pages: 138
City: Cham
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
