CIRM RFA-13-06: CIRM Alpha Stem Cell Clinics Network: Alpha Stem Cell Clinics
Nomination per School: One
Proposals may not be submitted directly by the PI; nominations are submitted by the School’s Research Dean’s Office.
LOI: December 16, 2013 (Required)
Internal Deadline: November 25, 2013
External Deadline: Invitations for applications will be sent mid-January, 2014
Award Information: Anticipated Amount: $55 million to support up to five awards for a funding period of up to five years. Given the urgency of CIRM’s mission, all approved applications are expected to be initiated within three months of a grant start date that is indicated on a signed Notice of Grant Award (NGA) and must be initiated within six months of approval and authorization for funding by the Application Review Subcommittee of the Independent Citizen’s Oversight Committee (ICOC), CIRM’s Governing Board.
Materials to Office of Research: Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt).CV – (4 pages maximum)
Purpose: Under this RFA, up to five California medical institutions will be funded for up to five years to form and operate an Alpha Stem Cell Clinic within that given institution. These 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. These activities would be integrated into the larger CASC network, utilizing efficient and standardized methods to accomplish the goals and activities detailed below.
Funds from this RFA shall be used to leverage already existing assets at the awarded Institution, including expertise, capabilities, infrastructure, resources and assets resident within their state-of-the-art medical centers. The Applicant Institution must be committed to the formation and sustainability of the Alpha Stem Cell Clinic. It should be well positioned to attract and support high quality stem cell clinical activities with a variety of candidate stem cell products, involving a range of disease targets. The Applicant will provide a sustainability plan for the Alpha Stem Cell Clinic to continue to provide for operating expenses beyond the period of CIRM funding support.
This RFA will fund a core Alpha Stem Cell Clinic team for each site, consisting of a Program Director (PD) and staff consisting, at minimum, of a Study Coordinator and a Patient Care Coordinator. To be eligible for this Award, the Alpha Stem Cell Clinic
Applicant must provide evidence that at least two Lead Clinical Trials will be conducted at the Alpha Stem Cell Clinic (see Section II, “Lead Clinical Trials” for a full description). The clinical trials themselves will not be funded directly by this RFA; however, the scope, quality and relevance of the proposed Lead Clinical Trials to the CIRM mission will be used as criteria to evaluate the Alpha Stem Cell Clinics application. (See Sections VIII Review Criteria and Section IX B Application Submission Instructions). As described in Section II, the Alpha Stem Cell Clinic 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. In addition, as part of the CASC Network, the Alpha Stem Cell Clinic will provide access to CIMC support, including information and data management, consulting services, and independent patient education counselors as described below and in RFA13-07.
To promote accelerated learning and shared knowledge, the Alpha Stem Cell Clinics and the clinical trial investigators/sponsors entering these clinics will contribute to the CIMC informational resources. For a description of the CIMC see RFA 13-07.