Stem Cell Therapy for Alcoholism and Depression

(Alaunus Trial)

Recruiting at1 trial location

Overseen by Ihsan Salloum, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: Joshua M Hare

Trial Summary

What is the purpose of this trial?

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.

Research Team

Ihsan Salloum, MD

Principal Investigator

University of Texas Rio Grande Valley School of Medicine

Eligibility Criteria

This trial is for adults aged 18-75 with Alcohol Use Disorder and Major Depression who want to reduce or stop drinking. They must have had a depressive episode during sobriety, show signs of inflammation, and agree to stop antidepressants for the study. Excluded are those with autoimmune diseases, current infections like HIV/hepatitis, recent drug trials participation, acute suicidality, certain psychiatric disorders or substance abuse (except mild cannabis), cancer history within 3 years (with exceptions), or medication affecting alcohol consumption.

Inclusion Criteria

Provide written informed consent

Meet Diagnostic and Statistical Manual of Mental Disorder-5 criteria for Alcohol Urge Questionnaire and recurrent unipolar major depression

Have a history of a depressive episode during a period of one-month abstinence

Exclusion Criteria

Positive urine screens for drugs of abuse other than cannabis at baseline

Inability to read or understand study forms or informed consent

Prior history of a suicide attempt within the past year

Treatment Details

Interventions

• Allogeneic Human Mesenchymal Stem Cells (Stem Cell Therapy)
• Placebo (Other)

Trial Overview The trial tests the safety of allogeneic human mesenchymal stem cells (allo-hMSCs) compared to a placebo in treating individuals with both Alcohol Use Disorder and Major Depression. Participants will be randomly assigned to receive either the stem cell treatment or a placebo infusion.

Participant Groups

Group I: allogeneic human mesenchymal stem cells (allo-hMSCs) Experimental Treatment 1 Intervention

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.

Group II: Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Joshua M Hare

Lead Sponsor

Trials

17

Recruited

430+

Ihsan Salloum

Lead Sponsor

Trials

1

Recruited

80+

Ihsan M Salloum, MD, MPH

Lead Sponsor

Trials

1

Recruited

80+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Dr. George F. Koob

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Chief Executive Officer since 2014

PhD in Neurobiology from the Scripps Research Institute

Dr. Patricia Powell

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Chief Medical Officer since 2015

MD from an accredited institution