Allogeneic Human Mesenchymal Stem Cell Infusion vs Placebo in Alcohol Use Disorder and Major Depression.

NCT03265808 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: 201706741R01AA024933-01A1
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to look at the safety of a study treatment with stem cells in Alcohol Use Disorder And Major Depression (AUD-MD) subjects.

Conditions

Major Depressive Disorder; Alcohol Use Disorder

Keywords

stem cells

Outcome Measures

Primary Outcomes (1)

• Incident of treatment emergent-serious adverse events

  Incidence of any treatment-emergent serious adverse events, defined as a composite of acute suicidality and hospitalization for suicide attempts.

  One month post-infusion

Secondary Outcomes (13)

• Change in serum concentrations of high sensitivity C-reactive protein.

  Baseline, 12 weeks

• Change in serum concentrations of inflammatory biomarkers

  Baseline, 12 weeks

• Change in depressive symptoms as assessed by MADRS

  Baseline, 12 weeks

• Change in Depressive symptoms as assessed by CGI

  Baseline, 12 weeks

• Change in quantity of alcohol use as assessed by TLFB

  Baseline, 12 weeks

Study Arms (2)

allogeneic human mesenchymal stem cells (allo-hMSCs)

EXPERIMENTAL

Participants will be treated with a single administration of allogeneic hMSCs: 100 x 10\^6 (100 million) allo-hMSCs of cells delivered via a single peripheral intravenous infusion.

Drug: allogeneic human mesenchymal stem cells (allo-hMSCs)

Placebo

PLACEBO COMPARATOR

Participants will be treated with a placebo administration consisting of 1% human albumin serum in Plasma-Lyte A delivered via a single peripheral intravenous infusion.

Drug: Placebo

Interventions

allogeneic human mesenchymal stem cells (allo-hMSCs) DRUG

Single administration of allogeneic hMSCs: 100 x 106 (100 million) allo-hMSCs of cells delivered via a single peripheral intravenous infusion.

allogeneic human mesenchymal stem cells (allo-hMSCs)

Placebo DRUG

Placebo administration consisting of 1% human albumin serum in Plasma-Lyte A delivered via a single peripheral intravenous infusion.

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide written informed consent.
• Subjects age \>18 and \<75 years at the time of signing the Informed Consent Form.
• Diagnostic and Statistical Manual of Mental Disorder-5 criteria for Alcohol Urge Questionnaire (moderate or severe defined as meeting 4 or more of the 11 criteria) AND a concurrent Diagnostic and Statistical Manual of Mental Disorder-5 recurrent unipolar major depression with HRSD-25 score of 18 or above.
• A history of a depressive episode occurring or persisting during a period of one-month abstinence.
• Participants should express the desire to reduce or stop alcohol consumption, report 28 or more standard drinks (SD) per week for males or 21 for females over four weeks during the 90 days preceding study enrollment.
• Increased inflammation (\[serum C-reactive protein\] ≥3.0 mg/L.
• Agree to taper and discontinue antidepressant medications during the 12-week trial.
• Able to provide informed consent and comply with study procedures.
• Able to read English and understand study instruments.
• Entry criteria for depression and alcohol use disorder (moderate or severe) will be established using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID) for categorical diagnosis.
• Have a score of ≥18 on the Hamilton Depression Rating Scale for Depression (HAM-D).

You may not qualify if:

• Acute suicidality.
• Any lifetime history of bipolar disorder, schizophrenia, or schizoaffective disorder.
• Active psychotic disorder, eating disorder, or substance use disorder except for alcohol and tobacco or "mild" cannabis use disorder within 6 months of enrollment.
• Any lifetime history of autoimmune or immunodeficiency syndrome.
• Treatment with any psychotropic (including hypnotic), steroidal, or anti-inflammatory medication (including NSAIDs) within 2 weeks of treatment randomization (6 weeks for fluoxetine).
• Any current use of medication that affect alcohol consumption such as acamprosate, disulfiram, naltrexone (po or IM), topiramate, or sedative-hypnotics including benzodiazepines or any psychostimulant.
• Being enrolled in an alcohol treatment program (self-help groups participation such as Alcoholics Anonymous or Dual Diagnosis self-help are allowed).
• Active medical condition that could cause or exacerbate depressive symptoms (e.g., hypothyroidism, anemia).
• Currently pregnant or breast-feeding.
• Lack of use of a reliable means of contraception methods. (Female subjects of childbearing potential must undergo a serum or urine pregnancy test at screening and within 36 hours prior to infusion.)
• First major depressive episode after 50 years of age.
• Any evidence of current infection including serum positive for HIV, hepatitis BsAg or Viremic hepatitis.
• Medical conditions with known autoimmune or inflammatory mechanisms including any chronic allergic condition.
• Positive urine screens for any drug of abuse other than cannabis at baseline.
• Inability to read or understand study forms or informed consent or the presence of any other conditions or factors, which in the opinion of the investigator would make the patient unsuitable for study participation.

Sponsors & Collaborators

• Ihsan M Salloum, MD, MPH: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

University of Texas Rio Grande Valley School of Medicine

Harlingen, Texas, 78550, United States

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Alcoholism

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Ihsan Salloum, MD

  University of Texas Rio Grande Valley School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 16, 2017
• First Posted: August 29, 2017
• Study Start: March 18, 2018
• Primary Completion: July 30, 2025
• Study Completion: July 30, 2025
• Last Updated: January 9, 2026

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)