CIRM Alpha Clinic Nurse Symposium Agenda
Day 1
Regenerative Medicine Overview
Module 1: Nursing Considerations for Cellular Therapy Delivery
Routes of administration (including associated timelines)
- Donor apheresis & GMP manufacturing
- Competencies of nurses who cover cellular therapies
- CRN perspective
Module 2: Toxicity Assessment and Management
- CRS
- ICANS
- Longer-term toxicities, short vs. long-term effects
- Tocilizumab (and others)
Module 3: Cellular Therapy Patient Journey
- Patient/family/caregiver education
- Multidisciplinary team efforts
- Patient perspective with Q & A
Day 2
Keynote:
Stem Cell Gene Therapy for Sickle Cell Anemia
Don Kohn, MD, UCLA
Introduction to CIRM Clinical Trials
Module 4: Types of Regenerative Medicine Therapies
- Stem cells for neuromotor/neuromuscular disorders
- Gene therapy
- Cardiosphere-derived stem cells (CDC)
Module 5: Cellular Therapy Clinical Trial Framework
- Differentiating between study and SOC patients
- Roles and responsibilities of clinical trial team members
- Out-of-spec/single subject IND (compassionate care)
- Minimizing protocol deviations (regulatory compliance)
Module 6: Nursing Considerations for Cellular Therapy Delivery
- Instituting new approved therapies
- Product handling and administration
- Role of stem cell lab
- Role of chain of custody and chain of identity
- Outpatient management