I. Background
Acute ischemic stroke leading to infarction of brain tissue is the most significant vascular central nervous system (CNS) disorder in industrial nations and remains the leading cause of adult disability. The Bentsen Stroke Center (BSC) was created to meet the critical need to develop therapeutic strategies for the treatment of stroke. One focus of the BSC is to develop cell-based therapeutics, including the use of certain populations of stem cells, to reduce secondary brain injury and to enhance recovery after ischemic stroke.
The Bentsen Stroke Center (BSC) will be physically embedded within the Center for Stem Cell Biology and Regenerative Medicine (SCBRM) at the Institute of Molecular Medicine (IMM). This arrangement will allow investigators working in the BSC to benefit both from the intellectual environment of the SCBRM and from the infrastructure associated with the Center.
II. Purpose and Criteria
Applications will be accepted from all full-time members of the Medical School faculty at any level of seniority interested in advancing the study and therapeutic outcomes of regenerative medicine and stroke. Support from the BSC for individual faculty investigators can be up to a total of $1 million over a three-year period. (The average disbursements from the Center will be limited to $1M per year.) Bentsen Investigators will retain their primary faculty appointment in a Medical School Department but be granted adjunct appointments in the SCBRM, the formal academic and administrative home of the Bentsen Center. Funds may be used for direct costs such as faculty salary, technical support personnel, stipends for graduate students and postdoctoral fellows, supplies, and equipment.
The research program of Bentsen Investigators should encompass one or more of the specific aims of the Center as outlined below:
1.Determine which stem cells are the most appropriate for regenerative therapy.
2. Determine the significance/relevance in patients of blood-derived stem cells, bone marrow derived stem cells, endothelial progenitor cells (EPC) and MSC.
3. Determine the mechanism(s) of action of specific stem cell types in recovery from stroke.
4. Define appropriate endpoints, surrogate markers for success (especially imaging) in patients.
5. Define optimal multimodal therapy for patients.
6. Examine role of stem cell therapy for intracerebral hemorrhage.
7. Examine the application of stem cell therapy to other types of brain injury. Such disorders include, but are not limited to, traumatic brain injury, spinal cord injury, peripheral nerve injury, neurodegenerative disease, and multiple sclerosis.
III. Submission Requirements
Each Application must include:
a) A letter (one page limit, 11 point font) from the investigator, which briefly summarizes the investigator’s plans and demonstrates how the project fits with the goals of the Center. The letter should also describe what other efforts are, have been or will be made to obtain funding for the project.
b) If a resubmission of a prior BSC Investigator Program application, a 1-2 page response to the prior review critique(s) should be provided. In particular, it should detail how the Scientific Plan (and Budget if addressed in the critique) has been modified in this revised application. Note: Modified sections of the budget and Scientifc Plan (items e and f below) should be highlighted in some manner (e.g. underlined or italicized).
c) Applicant’s NIH-Style Biographical Sketch (2 pages maximum) on NIH Form PHS398.
d) Other Support (no page limit) to include a description of other support from all external and internal funding sources including, but not limited to, grants, contracts, endowments, gift accounts, departmental reserves, and departmental start-up funds and the amounts and dates covered by such support.
e) Budget and Budget Justification (three page limit). The budget pages should be in NIH style and include the major categories of all expenses as well as a detailed budget justification and the percentage effort that key personnel will devote to the project. No indirect costs will be provided with an award. For multi-year proposals, estimates for those years and appropriate justification of expenses should be provided.
f) Scientific Plan (maximum of six pages including illustrations and legends) to include:
(1) Specific Aims (no more than one page), (2) Background and Significance (no more than two pages), (3) Experimental plan (no more than three pages), and (4) References (without page limit). Appendix material of any kind will not be accepted. Font size, line spacing and margins of the Scientific Plan should follow NIH Guidelines.
g) A letter of support from the investigator’s chairperson, which includes an approval of the Principal Investigator's percentage effort devoted to the project.
IV. Review Criteria
The Scientific Review Board of the Bentsen Stroke Center will evaluate the applications according to the following criteria:
1. Scientific Merit and Innovation
2. Project Consistency with Center’s goals
3. Collaborative Potential
4. Potential for leading to multiple grant applications (R01) in Years 2 or 3, and to a program project or center grant in years 3 or 4
5. Potential for leading to the initiation of Phase I / IIA clinical trials in which newly developed cell therapies are tested in stroke patients.
V. Deadline
Grant applications may be submitted by the 15th of February or the 15th of August and will be reviewed by the Scientific Review Board.
The major goal of the BSC is to build a team of researchers with common interests. To help achieve this goal all recipients of awards will be expected to attend monthly meetings during which time investigators report on their progress and on matters related to the goals of the Center. The BSC will also run a funded seminar program thematically related to the work in the Center. All investigators and their scientific staff will be expected to attend.
The Scientific Review Board will require a yearly progress report and a final report at the end of the term of the award if it exceeds one year. Continuation of funding for multi-year awards will be dependent on suitable progress. Awards will be made with the understanding that investigators will submit a R01 or its equivalent within two or three years after initial receipt of BSC funding. Investigators will also be expected to participate in a planned PPG or Center grant during or soon after Year 3 of the initiation of the Program.
Please submit all application material in .pdf format to the Bentsen Scientific Review Board at msresearchcommittee@uth.tmc.edu.
