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2019 Project Identification Committee
Call for Proposals: Pre-App (Closed)

 

Dear colleagues,

We are writing to solicit proposals to accelerate clinical trials of novel stem cell related therapies for a range of human disorders, including cancer indications. We anticipate to provide 40% co-funding*, administrative and other relevant support to clinical trials of novel stem cell related therapies.

*The Sanford Stem Cell Clinical Center at UC San Diego Health offers funding for direct costs specifically related to the clinical trials. No overhead costs can be paid with Sanford Center funds.

What activities will we support?

  • All activities necessary for the conduct and completion of a Phase 1, Phase 2, or Phase 3 clinical trial with a single therapeutic candidate
  • Manufacturing of product to supply the proposed clinical trial
For this call for proposals, Sanford Stem Cell Clinical Center will not support studies for therapeutic candidate discovery, preclinical IND-enabling activities, and studies to remove a clinical hold by the FDA.

Eligibility

  • PI must be a UCSD physician knowledgeable about cell and regenerative medicine with experiences in clinical trials.
  • UCSD must be the primary clinical trial site.
  • Project team must include at least one investigator credentialed in cell and regenerative medicine at UCSD.
  • The therapeutic candidate must meet at least one of the following criteria.
    • A cell therapy where stem cells either compose the therapy or are used to manufacture the cell therapy. Minimally manipulated bone marrow, minimally manipulated cord blood or unmodified hematopoietic stem cells are eligible only if being developed as a novel method of addressing a rare or unmet need unlikely to receive funding from other sources, or provides consistent reporting of patient outcomes and further the development and provision of evidenced-powered care.
    • A gene therapy that targets a stem or somatic cell for its therapeutic effect; and is intended to replace, regenerate, or repair the function of aged, diseased, damaged, or defective cells, tissues, and/or organs; and is being developed for a rare or unmet medical need unlikely to receive funding from other sources.
    • A small molecule or biologic that acts on, or is dependent on, endogenous stem cells for its therapeutic effect, that is dependent on targeting cancer stem cells for its therapeutic effect, that modifies a stem cell product, and is being developed for a rare or unmet need unlikely to receive funding from other sources.
    • A medical device where human stem cell or derivative are a necessary component of the device or are used to manufacture the device. A device that is intended for clinical use with a therapeutic candidate where the stem cell related therapeutic contributes to the therapeutic mechanism of action of the combination product. A device intended to address a critical bottleneck to clinical development or use of a stem cell related treatment, and where testing with a such treatment confirms its clinical safety and efficacy. Or a device where the therapeutic mechanism of action requires the recruitment or incorporation of an endogenous stem cell.
  • Must have an open IND/IDE. Phase 2 trial applicants must have Phase 1 safety data; Phase 3 trial applicants must have Phase 2 efficacy data.
  • Must have a robust plan to secure 60% co-funding from a non-Sanford Stem Cell Clinical Center fund source

Application Details and Submission

We will start with a pre-application process, which is a 2-page written summary with the following information:

  • Proposed PI name
  • Title of project
  • Proposed indication
  • Proposed product and route of administration
  • Scientific evidence for the value of the approach
  • Evidence of regulatory approval by the FDA
  • Length of desired support (start and end date)
  • Estimate costs for the entire clinical trial
  • Plan on co-funding

Pre-Applications must be submitted through the online application system https://sanfordctr.wufoo.com/forms/z19hb6uz1totpux/.

The deadline for pre-applications is May 15, 2019. Selected pre-applications will then be asked to provide a lengthier application with more substantial details.

For inquiries on the pre-application process, please contact Cynthia Kuan, MA, SPHR, Business Operations Manager (c1kuan@ucsd.edu).

Review Information

Applications will be reviewed by an interdisciplinary committee experienced in clinical trial operations and cell and regenerative medicine. We will prioritize projects that anticipate to draw on existing Sanford Center resources (i.e. UC San Diego Health Alpha Stem Cell Clinic recharge service and Advanced Cell Therapy Laboratory recharge service).

We look forward to hearing from our colleagues about interesting projects that we might help with. We appreciate your support.

Sincerely,

Catriona Jamieson, MD, PhD
Director, Sanford Stem Cell Clinical Center
UC San Diego Health
on behalf of the Sanford Stem Cell Clinical Center Project Identification Committee