Stem Cell Therapy for Alcoholism and Depression

(Alaunus Trial)

Not currently recruiting at 1 trial location

Overseen By Dante M Durand, MD

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of using stem cells to treat individuals with both Alcohol Use Disorder and Major Depression. Researchers aim to determine if stem cell therapy can reduce alcohol consumption and improve mood. Participants will receive either a stem cell treatment (allogeneic human mesenchymal stem cells) or a placebo (a substance with no active medicine) through a single intravenous infusion. Ideal candidates for this trial are those who have been drinking heavily, have ongoing depression, and wish to reduce or stop drinking. As a Phase 1/Phase 2 trial, this research focuses on understanding how the treatment works in people and measuring its effectiveness in an initial, smaller group.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that treatments using donated human stem cells have been explored in various projects. One study focused on patients with frailty, administering these stem cells through an IV drip. The study found that patients generally tolerated the treatment well.

Another study examined similar stem cell treatments for patients with alcohol use disorder and major depression, also focusing on safety. No major safety issues were reported. These findings suggest that these stem cell treatments are usually safe, with no serious side effects noted in these studies.

Since this trial is in its early stages, it is designed to closely monitor safety. Safety remains a top priority, and researchers will carefully track and manage any potential side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for alcoholism and depression?

Unlike traditional treatments for alcoholism and depression, which often include medication and psychotherapy, the new approach using allogeneic human mesenchymal stem cells (allo-hMSCs) offers a unique method by potentially repairing and regenerating damaged tissues in the brain. Researchers are excited about this treatment because allo-hMSCs have anti-inflammatory and neuroprotective properties that could target the root causes of these conditions rather than just alleviating symptoms. Furthermore, this treatment is administered through a single peripheral intravenous infusion, which could provide a more straightforward and less invasive delivery method compared to ongoing medication regimens.

What evidence suggests that this trial's treatments could be effective for Alcohol Use Disorder and Major Depression?

Research has shown that certain donor stem cells, called allo-hMSCs, may help treat alcohol use disorder and major depression. In this trial, some participants will receive allo-hMSCs. Animal studies suggest these cells can lower alcohol use and improve mood by reducing inflammation. Some human studies have also found these stem cells generally safe for similar conditions. Reducing inflammation, measured by a protein called CRP that increases with inflammation, is thought to improve mood and lessen alcohol cravings. While more research is needed, early results are promising for using these stem cells to treat alcoholism and depression. ^{1 3 6 7 8}

Who Is on the Research Team?

Ihsan Salloum, MD

Principal Investigator

University of Texas Rio Grande Valley School of Medicine

Are You a Good Fit for This Trial?

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

I want to cut down or stop drinking alcohol and can specify how much I drink.

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT02065245

NCT02065245 | AllogeneiC Human Mesenchymal Stem ... The purpose of this study is to look at the safety of treatment with stem cells in patients with Frailty. Official Title. A Phase I/II, Randomized, Blinded and ...

2. clinicaltrial.be clinicaltrial.be/fr/details/8461?per_page=100&only_recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Allogeneic Human Mesenchymal Stem Cell Infusion Vs ... This is a randomized, double-blind placebo-controlled study of allogeneic human mesenchymal stem cell in subjects with comorbid Alcohol Use ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03265808/allogeneic-human-mesenchymal-stem-cell-infusion-vs-placebo-in-alcohol-use-disorder-and-major-depression

Allogeneic Human Mesenchymal Stem Cell Infusion Vs ... 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)

4. reporter.nih.gov reporter.nih.gov/search/rjfC6pt7kku7wlPjU0d0-Q/project-details/9380069

Stem Cell Therapy, Inflammation and Treatment Response ... To examine the direct (reduction in CRP and other inflammatory biomarkers) and indirect (reduction in alcohol use and depression) effects of ahMSC therapy on ...

5. withpower.com withpower.com/trial/phase-2-depressive-disorder-2-2018-0d013

Stem Cell Therapy for Alcoholism and Depression 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02675556

Allogeneic Human Mesenchymal Stem Cells (hMSCs) Infusion in ... This is a phase I study, with eight subjects in the pilot phase and eighty (80) subjects fulfilling all inclusion/exclusion criteria's will be randomly ...

7. clinicaltrial.be clinicaltrial.be/fr/details/8461?per_page=100&recruiting=1&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_recruiting=0&only_eligible=0

Allogeneic Human Mesenchymal Stem Cell Infusion Vs ... This is a randomized, double-blind placebo-controlled study of allogeneic human mesenchymal stem cell in subjects with comorbid Alcohol Use ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4914257/

A phase I/II, randomized, blinded and placebo controlled ... This study will determine the safety of intravenous infusion of stem cells and compare phenotypic outcomes in patients with aging frailty. Keywords: aging, ...