Stem Cell Therapy for Alcoholism and Depression

(Alaunus Trial)

Recruiting at 1 trial location

Overseen By Maria Herrera

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Joshua M Hare

Must not be taking: Psychotropics, Steroids, NSAIDs, others

Disqualifiers: Bipolar, Schizophrenia, Autoimmune, others

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

80 Participants Needed

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.

Will I have to stop taking my current medications?

Yes, you will need to stop taking antidepressant medications during the 12-week trial. Additionally, you cannot be on any psychotropic, steroidal, or anti-inflammatory medications within 2 weeks of starting the trial, and certain medications affecting alcohol consumption are also not allowed.

What data supports the effectiveness of the treatment Allogeneic Human Mesenchymal Stem Cells for alcoholism and depression?

Research shows that mesenchymal stem cells (MSCs) can significantly reduce alcohol consumption and prevent relapse in animal models, with effects lasting several weeks. These cells help by reducing inflammation in the brain, which is linked to alcohol use disorders. ^{1 2 3 4 5}

Is stem cell therapy safe for humans?

Research on mesenchymal stem cells (MSCs) in animal models suggests they may be safe, as they have been used to treat conditions like alcohol use disorders and depression without reported safety issues. However, these studies were conducted on animals, so more research is needed to confirm safety in humans. ^{1 2 6 7 8}

How is stem cell therapy different from other treatments for alcoholism and depression?

Stem cell therapy for alcoholism and depression is unique because it uses allogeneic human mesenchymal stem cells, which have anti-inflammatory properties that can reduce neuroinflammation and oxidative stress associated with chronic alcohol intake. This approach targets the underlying biological processes that perpetuate alcohol consumption and relapse, offering a novel mechanism compared to traditional treatments. ^{1 2 3 7 9}

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single administration of allogeneic hMSCs or placebo via peripheral intravenous infusion

12 weeks

Weekly visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Every 3 months

Treatment Details

Interventions

• Allogeneic Human Mesenchymal Stem Cells
• Placebo

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+

References

1. England pubmed.ncbi.nlm.nih.gov

Intravenous administration of anti-inflammatory mesenchymal stem cell spheroids reduces chronic alcohol intake and abolishes binge-drinking. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Activated mesenchymal stem cell administration inhibits chronic alcohol drinking and suppresses relapse-like drinking in high-alcohol drinker rats. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Intracerebral Stem Cell Administration Inhibits Relapse-like Alcohol Drinking in Rats. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Transplantation of mesenchymal stem cells causes long-term alleviation of schizophrenia-like behaviour coupled with increased neurogenesis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Allo-reactivity of mesenchymal stem cells in rhesus macaques is dose and haplotype dependent and limits durable cell engraftment in vivo. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Use of human mesenchymal stem cell treatment to prevent anhedonia in a rat model of traumatic brain injury. [2019]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Placenta-Derived Mesenchymal-like Adherent Stromal Cells as an Effective Cell Therapy for Cocaine Addiction in a Rat Model. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Cell encapsulation enhances antidepressant effect of the mesenchymal stem cells and counteracts depressive-like behavior of treatment-resistant depressed rats. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Gene and cell therapy on the acquisition and relapse-like binge drinking in a model of alcoholism: translational options. [2021]