Identification of Patient Barriers and Success Predicting Metrics for a Clinical Trial Testing Blood Derived Autologous Angiogenic Cell Precursor Therapy in Patients With Critical Limb Ischemia (ACP-CLI)

Regeneration of destroyed arteries using the patient’s own stem cells is an innovative new treatment for Peripheral Artery Disease, that is currently being tested in humans in a Phase II trial. Throughout clinical studies, there has been an issue efficiently recruiting patients and clinical trial sites. Recruitment is recognized as a key determinant of success for clinical trials. Thus, the purpose of this project is developing an effective and efficient patient and site recruitment plan for the Phase III clinical trial. This will be done by analyzing the metrics obtained from the Phase II trial as well as conducting a literature search. Additionally, the metric analysis and literature search will allow for the identification of study designs and the development of the framework for the Phase III clinical trial. These research projects will be completed alongside the creation of a metrics dashboard which is an invaluable tool in companies wishing to be efficient, organized and to make well informed, accurate decisions. The failure of a clinical trial has many scientific, ethical and financial implications thus the goals of this project is to develop methods and plans to aid in the success of the clinical development of ACP-01.

Faculty Supervisor:

Janice Braun

Student:

Partner:

Hemostemix Inc.

Discipline:

Life Sciences

Sector:

Professional, scientific and technical services

University:

University of Calgary

Program: