# Stem Cell Therapy, Inflammation and Treatement Response in Alcholoism-Depression Comobidity

> **NIH NIH R01** · UNIVERSITY OF TEXAS RIO GRANDE VALLEY · 2020 · $618,005

## Abstract

Abstract
Alcohol use disorder (AUD) with comorbid major depression (MD) is among the most frequent and serious
conditions encountered in clinical practice, for which effective treatment interventions are currently limited.
Activation of pro-inflammatory cytokines and pathways are emerging as key pathophysiological factors in the
etiology of both alcoholism and major depression. Although immune and inflammatory mechanisms have been
studied to a considerable extent in alcoholism and major depression separately, patients with co-occurring
alcoholism and major depression are most likely to exhibit substantial inflammation. Pro-inflammatory
mechanisms appear to play a bidirectional role in both depression and alcoholism and may underlie the limited
treatment response reported in clinical trials. The lack of previously effective treatments demands new
intervention modalities and different treatment targets targeting mechanisms underlying such comorbidity. We
hypothesize that increased inflammation in these patients represents a major factor fostering decreased
treatment response.
Thus, patients with comorbid AUD and MD represent an ideal group to test the effect of a
potent anti-inflammatory intervention. We propose to use allogeneic human mesenchymal stem cell (ahMSC)
therapy, a highly novel treatment pioneered at the University of Miami Miller School of Medicine, to treat a variety
of inflammatory conditions. This treatment has been shown to be safe and well-tolerated in a variety of medical
disorders and exerts a robust and sustained anti-inflammatory effect. We plan to test the effects of ahMSCs on
inflammation and on alcohol and depression outcomes in patients with comorbid AUD and recurrent MD (AUD-
MD) preselected for the presence of high inflammatory markers (hsCRP>3 mg/L). Our study has the following
Specific Aims: Aim 1. To examine the effects of a single ahMSC infusion on inflammation, as assessed by C-
Reactive Protein (CRP) concentrations in a 12-week randomized, placebo-controlled trial in 80 MD-AUD patients
(40 active infusion, 40 placebo) all preselected for the presence of inflammation. Aim 2. To examine the effects
of the reduction in CRP and other inflammatory markers associated with ahMSC therapy on clinician-
administered measures of the severity of alcohol use (TLFB-% heavy drinking days) and depression (MADRS)
and global clinical functioning (CGI). Aim 3. To examine the direct (reduction in CRP and other inflammatory
biomarkers) and indirect (reduction in alcohol use and depression) effects of ahMSC therapy on secondary study
outcomes including, craving, cognition, everyday functioning and perceived quality of life. Aim 4. Our exploratory
aim includes assessment of the mediating role of childhood trauma and assessment of the persistence of
treatment effects over the one year follow-up period, with collection of blood samples to explore the role of
inflammation related-polymorphisms and epigenetics in treatment response. If succes...

## Key facts

- **NIH application ID:** 10187777
- **Project number:** 7R01AA024933-04
- **Recipient organization:** UNIVERSITY OF TEXAS RIO GRANDE VALLEY
- **Principal Investigator:** IHSAN M SALLOUM
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $618,005
- **Award type:** 7
- **Project period:** 2020-07-01 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10187777

## Citation

> US National Institutes of Health, RePORTER application 10187777, Stem Cell Therapy, Inflammation and Treatement Response in Alcholoism-Depression Comobidity (7R01AA024933-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10187777. Licensed CC0.

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