Translating Stem Cells: A New Professional Education Course

Stem Cell Clinical Trials Course at UCSD Extension

This course focuses on practical application of the principles of translating stem cell-based therapies, especially those in early development and in phase 1 studies. Students will acquire skills to translate these interventions from the bench to the bedside by designing a trial. Differences between drug development and stem cell-based therapies will be highlighted

The UC San Diego CIRM Alpha Stem Cell Clinic is committed to educating patients and professionals, including study staff. We are pleased to invite all clinical research professionals, from coordinators to physicians, to enroll in Translating Stem Cells (CLRE-237).

This 20 hour course is offered via CTRI CREST program. The course may also count as an elective in the MAS program, but applicants do not necessarily need to be enrolled in either the CREST nor MAS program to take this course!

Enrollment period is currently closed. Please contact CTRI CREST program with questions, and click here to apply.

Click this downloadable flyer for more information about the course. The sections below have additional details.

Highlights of the Stem Cell Translation course

  • 20 hours of face-to-face interaction (2 units; course CLRE-237)
  • Once weekly on Mondays: April 2 – June 11, 2018
  • 4 p.m. – 6 p.m.
  • Location: UC San Diego Extension, UCC, 6256 Greenwich Drive, Room 111 San Diego, CA 92122
  • Topics: defining translation, study design, regulatory compliance, ethical considerations, endpoint and statistical planning, differences between Phase I and beyond, unique aspects of stem cell studies
  • Final project: individually design a rational, ethical clinical trial for a cell-based therapy
  • Grade based on participation, homework and a final exam/individual project
  • Build the cost into your upcoming grants! The cost is $1,500 for non-MAS or non-CREST seekers. For MAS or CREST members, the cost is about $575. This cost may be allowable by federal or state grants.

Syllabus

This course will consist of twenty hours of face-to-face interaction with lecture and exercises. An overarching assignment to design a cell base therapy translational study will be turned in at the end of
the course. A typical lecture will teach concepts that are linked to practical applications in translational stem cell therapeutics. Lectures will provide context through expert guest speakers. The grade of the course will come from participation, homework assignment and a final exam.

Course Purpose
This course, focused on the practical application of the principles of translating Stem Cell based therapies that focuses on the early development and phase 1 studies required to translate these
interventions from the bench to the bedside. This course will highlight the unique aspects of stem cell based therapies compared to drug development.

Learning Objectives
By the end of this course, the student should be able to:
1. Understanding to bench to bedside concept
2. Understanding the process of development of new stem cell based therapies
3. Determining the preclinical work needed to support first-in-human studies
4. Articulate the rationale and objectives for a stem cell study
5. Identify and describe the appropriate study design and methods
6. Select a study population and methods for their recruitment and selection of study subjects for a stem cell study
7. Select outcome measures for safety and efficacy
8. Design a monitoring plan to protect both participants and the scientific and ethical integrity of the study
9. Determine methods of data collection, sample size and analysis plan

Course Structure
This course will have 10 weekly 2 hour sessions. Each session will have assigned background reading. Each session will have a 1 hour lecture and 1 hour of class exercises. Each lecture will be given by an expert in the field who has direct experience with developing stem cell therapeutics from basic science to clinical trials.

Course Materials/Textbooks
There is no required textbook for this course as there is no existing textbook for stem cell based clinical trials. Materials will be provided by the lecturer from current literature and guidance documents in the field of stem cell therapy.

Course Evaluation
Grades will be determined by participation in classes (10%), a written assignment (40%) and a final exam (50%). Grades will be scaled according to the class performance for A+, A, A-, B+, B, B-, C+, C, C-, D, F.

Assignment
Design a first –in-human clinical trail for a cell therapy, cell targeted therapy, or gene therapy. A well designed
protocol should include the following:
• safety and proof-of-concept information to justify the risks of the proposed trial; choice of study population;
• study design

dose(s) to be administered and justification for dosing;

clinical issues related to any invasive administration procedures;

the treatment plan for the control group, if one is proposed;

safety monitoring plan, including long-term follow-up and any special safety assessments;

stopping rules;

trial endpoints.

Cost

$1,5700 for all students. Registration fees not included, and vary upon student status and UCSD affiliation.

How to Enroll and Who to Contact

ADMINISTRATION: The Alpha Clinic is closely involved in the course, however it is offered and administered through the CTRI CREST Program. Please enroll via the CREST program website.

CERTIFICATION: Participants taking only this course will not receive a CREST/MAS certificate. This course may be applied to CREST or MAS certificates.

COST: Applicable fees and tuition are collected by the program. Fees vary based on UC San Diego affiliation and CREST or MAS certificate status. Keep in mind: tuition/fees may be allowable by federal or state grants.

QUESTIONS: Please contact CTRI CREST program with questions and for assistance enrolling. Registration is due by April 30, 2018.

Course Co-Directors

Sheldon Morris, MD, MPH, shmorris@ucsd.edu

Catriona Jamieson, MD, PhD, cjamieson@ucsd.edu

Program Manager MAS in Clinical Research

Tam Nguyen, ttn018@ucsd.edu

Program Manager CREST

Seble Chernet, schernet@ucsd.edu

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