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Stem Cell Therapy

Stem Cell Therapy for Alcoholism and Depression (Alaunus Trial)

Phase 1 & 2

Waitlist Available

Led By Dante M Durand, MD

Research Sponsored by Joshua M Hare

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects age >18 and <75 years at the time of signing the Informed Consent Form

Agree to taper and discontinue antidepressant medications during the 12-week trial

Must not have

Medical conditions with known autoimmune or inflammatory mechanisms

Current use of medications affecting alcohol consumption

Timeline

Screening 3 weeks

Treatment Varies

Follow Up one month post-infusion

Summary

This trial will study the safety of stem cell therapy in people with AUD-MD.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include reactions related to stem cell infusion such as discomfort at the injection site, fever, chills, headache or nausea. There could also be an immune response causing symptoms similar to flu-like illness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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I agree to stop taking my antidepressants during the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a condition caused by my immune system attacking my body.

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I am taking medication that affects how much alcohol I drink.

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My first major depression episode occurred after I turned 50.

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I do not have any current infections.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ one month post-infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~one month post-infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and one month post-infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incident of treatment emergent-serious adverse events

Secondary study objectives

Change in Anhedonia as measured by SHAPS

Change in Depressive symptoms as assessed by CGI

Change in cognition as assessed by BAC-A

+10 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: allogeneic human mesenchymal stem cells (allo-hMSCs)Experimental Treatment1 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: PlaceboPlacebo Group1 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.

0 / 6Eligibility criteria met