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Stem Cell Therapy
Stem Cell Therapy for Alcoholism and Depression (Alaunus Trial)
Phase 1 & 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one month post-infusion
Awards & highlights
Alaunus Trial 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.Check my eligibility
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.See study design
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.
Alaunus Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 75 years old.
Select...
I agree to stop taking my antidepressants during the trial.
Alaunus Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one month post-infusion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one month post-infusion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incident of treatment emergent-serious adverse events
Secondary outcome measures
Change in Anhedonia as measured by SHAPS
Change in Depressive symptoms as assessed by CGI
Change in cognition as assessed by BAC-A
+10 moreAlaunus 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.
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Who is running the clinical trial?
Joshua M HareLead Sponsor
15 Previous Clinical Trials
329 Total Patients Enrolled
Ihsan SalloumLead Sponsor
National Institute on Alcohol Abuse and Alcoholism (NIAAA)NIH
812 Previous Clinical Trials
1,158,357 Total Patients Enrolled
428 Trials studying Alcoholism
778,277 Patients Enrolled for Alcoholism
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I want to cut down or stop drinking alcohol and can specify how much I drink.I haven't had cancer in the last 3 years, except for certain types.I am between 18 and 75 years old.I have a condition caused by my immune system attacking my body.I have a health condition that could make depression worse.I agree to stop taking my antidepressants during the trial.I have not taken certain medications recently.I am taking medication that affects how much alcohol I drink.My first major depression episode occurred after I turned 50.I do not have any current infections.
Research Study Groups:
This trial has the following groups:- Group 1: allogeneic human mesenchymal stem cells (allo-hMSCs)
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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