Alpha Stem Cell Clinics
RFA 13-06: CIRM Alpha Stem Cell Clinics Network: Alpha Stem Cell Clinics
RFA 13-06 is one of two RFAs released as part of the CIRM Alpha Stem Cell Clinics (CASC) Network Initiative. The overall goal of the initiative is to accelerate therapeutic development and delivery of stem cell therapies by providing a high-quality, efficient infrastructure to support clinical research emanating from CIRM’s funding pipeline as well as non-CIRM funded investigator- or industry-sponsored trials.
The CASC Initiative consists of two linked Requests for Applications (RFAs) that will be co-released:
- RFA13-06: Alpha Stem Cell Clinics Sites: Up to five clinical sites located in or affiliated with existing academic medical centers.
- RFA13-07: Coordinating and Information Management Center (CIMC): One coordinating center to facilitate the efficiency and effectiveness of the network of clinical sites across California. (See RFA13-07)
The Alpha Stem Cell Clinics will provide critical operational support for the conduct of clinical trials for investigational stem cell therapies and will operate as a center of excellence for approved stem cell therapies. They will provide focused resources and expertise in clinical research with novel stem cell-based products, and an array of critical clinical operations support and patient care coordination personnel and resources. These activities would be integrated into the larger CASC network, utilizing efficient and standardized methods to accomplish its goals and activities.
Please see the RFA for full details.
RFA 13-06: CIRM Alpha Stem Cell Clinics Awards [pdf]
CIRM conducted a webinar for prospective applicants on Tuesday, November 5, 2013 to address questions about both RFA 13-06 and 13-07 and the application process. Click the following links for a recording of the webinar and supplemental materials:
Appendix A Alpha Stem Cell Clinics Concept Statement [pdf]
Appendix B Alpha Stem Cell Clinics: Delivering a New Kind of Medicine [pdf]
Appendix C The Alpha Stem Cell Clinic: A Model for Evaluating and Delivering Stem Cell-Based Therapies [pdf]
Submission of an application for a CIRM Alpha Stem Cell Clinics Awards involves a two-step process. A Program Director may only submit one LOI for this RFA and only one LOI will be accepted from each Institution. In addition to the Authorized Organizational Official (AOO) authorization, each LOI must be signed by an Authorized Executive Officer (AEO) who is an organizational official (e.g. Vice-Chancellor, Dean, etc.) with the authority, to nominate the institution’s sole candidate for this award. An eligible applicant must first submit a Letter of Intent (LOI) to CIRM following the instructions below. In the second step of the process, eligible applicants will submit a full application.
LOI Submission Instructions:
The Letter of Intent (LOI) must be submitted via the CIRM Grants Management Portal, as follows:
- Go to the Grants Management Portal (https://grants.cirm.ca.gov) and log in with your existing CIRM Username and Password. If you do not have a Username, click on the "New User" link and follow the instructions to create a CIRM Username and password.
- After logging in, click on the "Menu" tab. Select the link labeled "Open Programs". Under the section labeled "RFAs and Programs Open for Applications", click on the “Start a Letter of Intent” link located in the "RFA 13-06 CIRM Alpha Stem Cell Clinics Awards: Letter of Intent" section.
- Select the Applicant Institution from the dropdown menu (or select “other” and enter the institution name if it is not listed.) Complete the LOI by following the posted instructions.
- The “Done with Letter of Intent” button becomes enabled when all sections are complete. Select this button to complete your LOI submission. Once this button has been selected, you will no longer be able to make changes to your LOI.
- To ensure the process is complete, click on the "Menu" tab and select "Your Submitted Applications" from the drop down list. Your submission for the RFA 13-06 CIRM Alpha Stem Cell Clinics Awards: Letter of Intent should appear in the table labeled “Your Submitted Applications”.
The LOI must be received by CIRM no later than 5:00 pm (PST) on December 16, 2013 via the CIRM Grants Management Portal. No exceptions to this deadline will be made.
Application Instructions and Forms:
Only those applicants that submitted an LOI that was accepted by CIRM may submit an application. Applicants will be notified by CIRM if they are eligible to submit an application and application forms will be available on the CIRM website https://grants.cirm.ca.gov in mid-January 2014.
The application for RFA 13-06 consists of 6 parts:
Part A: Application Information Form (Web-based form)
Part B: Alpha Stem Cell Clinic Proposal (MS Word template)
Part C: Biographical Sketches for Key Personnel (MS Word template)
Part D: Activity Based Budget (Web-based form)
Part E: Documentation
Part F: Licenses and agreements
All applicable parts of the Application for RFA 13-06: CIRM Alpha Stem Cell Clinics Awards must be submitted together and received by CIRM no later than 5:00 PM PDT on March 14, 2014 via the CIRM Grants Management Portal. It is the applicant’s responsibility to meet this deadline; no exceptions will be made.
|Schedule of CIRM Deadlines and Reviews||Date|
|Letters of Intent due||5:00 pm (PST), December 16, 2013|
|Invitations for Applications sent out by CIRM||mid-January, 2014|
|Applications due||5:00 pm (PDT), March 14, 2014|
|Scientific Review of Applications by Grants Working Group (GWG)||Spring 2014|
|Review and Approval by ICOC||Summer 2014|
|Earliest Funding of Awards||Fall 2014|
No exceptions will be made to the indicated deadlines.
For information about the review process for this RFA:
Gilberto R. Sambrano, Ph.D.
Associate Director, Review
California Institute for Regenerative Medicine
Phone: (415) 396-9103
For information about this RFA:
Maria T. Millan, M.D.
California Institute for Regenerative Medicine
Phone: (415) 396-9801