Service Description

We are leveraging the resources and knowledge of the USC Stem Cell Translational Research Committee, which is a team of established investigators dedicated to further expanding translational research in USC Stem Cell laboratories. This committee provides investigators with guidance in the translation of their research findings to promote clinical translation and to accelerate the advancement of regenerative medicine.

Areas of support include: 

  • Initial consultation on clinical needs and proposed solutions 
  • Advice on possible funding mechanisms for translational research projects 
  • Review of specific aims and milestones 
  • Guidance in identifying key personnel, staffing needs and USC support teams 

This service is for USC and CHLA investigators only. To request support, please contact us at a-clinic@usc.edu. 

 

Support Services for Cell and Gene Therapies

The USC+CHLA Alpha Clinic, and its eight network partners across California, provide infrastructure and education support to advance gene and cell therapy clinical trials. Here is an overview of the various regulatory support services available to USC and CHLA investigators that aim to develop gene and cell therapies.

Clinical Trial Support

Clinical study navigation, onboarding protocol evaluation, sponsor-PI matching assistance with resources, and intake procedure support

Community Engagement/DEI

Concept development, working with referral sites, and preparation of educational materials for providers and patients

Education

Spring Course: Cell and Gene Therapy Development – Translating Basic Research into Clinical Applications (SCRM 599)

Manufacturing

Assistance with process development, cell and vector manufacturing, quality control and assurance, and cryostorage

Pipeline Development

Consultations, support for the development of gene and stem cell therapies, including general resources and proposal preparation support

Regulatory/ IND Support

Navigation and managerial support in regulatory affairs, consultations with regulatory experts, including proposal review, pre-IND meeting preparation, and IND packages