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Stem Cell Therapy

Stem Cell Therapy for Alcoholism and Depression (Alaunus Trial)

Q: Are geriatric patients welcome in this research project?

According to the eligibility requirements for this study, participants must be aged between 18-75. There are currently 370 trials underway for individuals under 18 and 1343 for seniors above 65 years old.

Q: Are there any specific qualifications that participants must meet in order to join this clinical trial?

28 people total will be accepted into this trial for major depressive disorder. The following are key criteria that participants must meet: a desire to taper and discontinue antidepressant medications over the 12-week study, a history of <a href="https://www.withpower.com/clinical-trials/depression">depression</a> during one month of abstinence, 28 or more standard drinks per week for males/21 for females over four weeks in the 90 days prior to enrollment, moderate or severe alcohol use disorder as defined by the SCID and 4 or more out of 11 diagnostic criteria from the DSM-5.

Q: Can people with the condition still participate in this research?

Unfortunately, this specific study is not looking for new candidates at the moment. It was first posted on March 18th, 2018 and had its last update on November 14th, 2022. There are nearly two-thousand other trials that are actively recruiting patients though.

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 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.

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

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

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 more

Alaunus 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 / 2Eligibility criteria met

Find a Location

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

802 Previous Clinical Trials

1,365,365 Total Patients Enrolled

424 Trials studying Alcoholism

985,788 Patients Enrolled for Alcoholism

Media Library

Allogeneic Human Mesenchymal Stem Cells (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03265808 — Phase 1 & 2

Alcoholism Research Study Groups: allogeneic human mesenchymal stem cells (allo-hMSCs), Placebo

Alcoholism Clinical Trial 2023: Allogeneic Human Mesenchymal Stem Cells Highlights & Side Effects. Trial Name: NCT03265808 — Phase 1 & 2

Allogeneic Human Mesenchymal Stem Cells (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03265808 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are geriatric patients welcome in this research project?

"According to the eligibility requirements for this study, participants must be aged between 18-75. There are currently 370 trials underway for individuals under 18 and 1343 for seniors above 65 years old."

Answered by AI

Are there any specific qualifications that participants must meet in order to join this clinical trial?

"28 people total will be accepted into this trial for major depressive disorder. The following are key criteria that participants must meet: a desire to taper and discontinue antidepressant medications over the 12-week study, a history of depression during one month of abstinence, 28 or more standard drinks per week for males/21 for females over four weeks in the 90 days prior to enrollment, moderate or severe alcohol use disorder as defined by the SCID and 4 or more out of 11 diagnostic criteria from the DSM-5."

Answered by AI

Can people with the condition still participate in this research?

"Unfortunately, this specific study is not looking for new candidates at the moment. It was first posted on March 18th, 2018 and had its last update on November 14th, 2022. There are nearly two-thousand other trials that are actively recruiting patients though."

Answered by AI