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Pilot and Exploratory Studies Core (PESC)

Pilot and Exploratory Studies Core (PESC). This Core, led by Robert Clark, MD, seeks to draw investigators into aging research relevant to the theme of the San Antonio OAIC and to promote early stage research that will set the stage for the development of both larger definitive studies and successful grant applications to continue the research project. To advance these goals the core leadership seeks the creation of novel aging research, and manages the application, review, selection, monitoring, and subsequent tracking of pilot proposals.

pepper_pesc1
Robert Clark, MD
Core Leader

The PESC program addresses a critical area within the overall goals of the San Antonio OAIC – the development, testing, and validation of interventions proposed to enhance healthy aging and prevent or slow the progression of aging-associated processes and diseases, using both marmoset models and clinical studies. This overall goal capitalizes on rapidly accumulating data regarding the effects of pharmacologic and non-pharmacologic (e.g. stem cells, gene therapy) interventions on healthspan and lifespan in model organisms. The PESC, and the overall San Antonio OAIC, will move these advances toward clinical use to improve the health, quality of life, and independence of older Americans.

What types of studies does the PESC fund? In keeping with the overall emphasis of the OAIC, the PESC will support studies in marmosets and human subjects. Many of the studies supported will focus on pharmacologic interventions using compounds already in clinical use for other indications. However, we will also consider new molecular entities, stem cell, and gene therapy approaches, and other novel approaches to improve the health and functioning of older people based upon emerging clinical or basic science research.

Pilot Study Announcements and Applications 

Rapid Response Pilot Program

We are soliciting applications for our new Rapid Response Pilot Grants Program for aging-related basic, clinical and translational research. Award size will range from $1,000 to $10,000, dependent on scope of work. In keeping with the overall emphasis of the SA OAIC, the PESC will support studies in either marmosets or human subjects, focusing especially on pharmacologic interventions using compounds already in clinical use for other indications. However, we will also consider new molecular entities, stem cell, and gene therapy approaches, and other novel approaches to improving the health and functioning of older people, based upon emerging clinical or basic science research.

A “rolling applications process” will be used. Applications will be accepted on a rolling basis until allocated funds for this program have been spent. Please see the program description and application requirements at the upper right of this page.

PESC Pilot Program

The application period for the 2017 PESC pilot program has closed, and funded projects will be announced imminently. You may view the 2017 RFA on the upper right of this page for information purposes; the 2018 RFA will be released in Fall 2017.  

SNPRC-OAIC Joint Pilot Grant

The application period for the Southwest National Primate Research Center (SNPRC) and the OAIC  joint pilot grant for projects using nonhuman primates in translational studies of aging is closed. The recipient, Nam Vo, PhD of the University of Pittsburgh School of Medicine, will initiate his project,  “Investigating rapamycin as a therapeutic to mitigate age-dependent intervertebral disc degeneration in marmosets”, once all regulatory approvals are received. The 2016 Joint SNPRC-Pepper Center RFA on the upper right is provided for information purposes. 

Current Projects

Current Pilot Studies (PES) include:

Sara Espinoza, MD

PES-3: “Metformin for preventing frailty in high-risk older adults

Investigators: Sara Espinoza*, MD (PI); Chen-Pin Wang*, PhD (Co-PI); Carlos Lorenzo*, MD; Ralph DeFronzo, MD (* early-stage investigators).

This pilot explores whether metformin in older adults with pre-diabetes prevents or slows the development of frailty.

NAD Modulation to Improve Cognition in Mild Cognitive Impairment (MCI) (Becky Powers, MD, and Miranda Orr, PhD, Co-PIs)

NAD(+) can be synthesized from dietary intake of its precursors, including nicotinamide riboside, a currently available non-prescription nutritional supplement. In this pilot study, they will conduct an eight week, double-blind, randomized, placebo-controlled trial with this supplement. The investigators will then test the efficacy of NAD(+) supplementation on brain function through cognitive assessment and functional MRI.

Effect of Stress-Busting Program on Caregivers’ Quality of Life, Immunology/Stress Biomarkers and Cellular Aging (Lyda Arevalo-Flechas, PhD, PI and Chih-Ko Yeh, DDS, Co-I)

The proposed study examines the differences in quality of life (QoL), stress response, and immune function of Hispanic caregivers of persons with dementia, and  aims to determine whether a caregiver intervention can effectively improve the QoL and immune function of Hispanic caregivers, including the measurement of the biological response to stress as indicated by immunologic and other pertinent protein markers in blood and saliva from the caregivers.

Identifying Frailty and Determining Outcomes: Setting the Baseline at UHS and STVHCS (Paula Shireman, MD, PI and Sara Espinoza MD, Co-I)

Frailty is an important predictor of outcome after surgical procedures that is not routinely assessed. Practical measures of frailty must be easy to incorporate into busy clinics with minimal disruption of patient flow and be accompanied by acceptance by the clinic staff as an important component of patient care. Given the changing US demographics, providing patient-centered, cost-effective care for the geriatric population is a national
priority. Identification of frailty is the necessary, first step to improving outcomes. The aims of this proposal are:

1) Determine the association of ethnicity and socioeconomic status on the effectiveness of RAI-A scores in predicting post-operative morbidity and mortality

2) Implement RAI and grip strength screening in Vascular Surgery clinics at the STVHCS and UHS

Pilot study on the use of senolytics in older patients with idiopathic pulmonary fibrosis  (Anoop Namibar, MD, PI)

Mayo Clinic and UTHSCSA investigators will conduct parallel pilot studies on the potential use of these senolytic agents in older subjects with IPF and CAVD.  The investigators propose the following Specific Aims:

Aim 1: To characterize drug treatment and general disease phenotypes of patients with IPF and CAVD in the UT Health clinical practice.

Aim 2: To determine the safety and tolerability of senolytic drugs in older  (60+ years) patients with IPF.

Marmoset gut microbiome and aging (Corinna Ross, PhD, PI and Kelly Reveles, DPharm, PhD, Co-I)

The specific aims of this proposal are: 1) To characterize the microbiome of young and old marmosets 2) To perform fecal transplants from young to old marmosets and characterize the change in microbiome and to determine whether the transplanted microbiome is stably maintained over the course of 6 months. The data from this pilot examination will contribute to the rapidly expanding knowledge we have regarding marmoset health and aging as well as contribute to future applications for long term investigation of health span interventions to the NIA.

Completed Projects

Completed Pilot Studies  include:

PES-1: “Pilot study evaluating the pharmacokinetics and tolerability of metformin and acarbose in the marmoset”

Investigators: Elizabeth Fernandez*, PhD and Marty Javors, PhD (* early-stage investigator). This pilot explores whether marmosets tolerate treatment with either metformin or acarbose, and whether therapeutic blood levels of metformin are achievable in marmosets.

PES-2: “Methylene blue enhancement of fMRI brain activity, memory, and cognition in healthy aging and MCI”

Investigators: Peter Fox, MD; Donald Royall, MD, PhD; Francisco Gonzalez-Lima, PhD; Pavel Rodriguez*, MD; Andrew Bresnen*, PhD; Juan Gutierrez, MD (* early-stage investigators). This study explores whether methylene blue (MB) treatment enhances brain memory and cognitive function in elderly patients without and with mild cognitive impairment (MCI).

PES-4: “Lentiviral-mediated delivery of GDF11 in the marmoset”

Investigator: Senlin Li, MD. This study explores whetherl GDF (growth differentiation factor) 11, expressed from a transgene and secreted by blood cells, leads to the rejuvenation of brain, skeletal muscle, and heart of marmosets.

PES-5: “mTOR inhibition in older subjects: Immune, cognitive and functional consequences”

Investigators: Dean Kellogg, MD, PhD; Ellen Kraig, PhD. This pilot explores whether treatment of elderly people with rapamycin and acarbose is safe, and whether such treatment mitigates immunologic, cognitive, and physical function phenotypes of aging.

A novel gene therapy to retard motor neuron degenerative disease and sarcopenia (Qitao Ran, PhD and Corinna Ross, PhD, Co-PIs)

The investigators seek to develop an adeno-associated viral vector expressing the Gpx4 gene, and then to test the effectiveness of transducing spinal motor neurons with the Gpx4 adeno-associated viral vector in retarding ALS and sarcopenia in mice and marmosets.

For information about human subject studies at UTHSCSA, you may visit:

http://vpr.uthscsa.edu/findastudy/

http://research.uthscsa.edu/irb/informationforparticipants.shtml