Major Depressive DisorderPhase 1/2AlaunusNCT03265808
Allogeneic Human Mesenchymal Stem Cell Infusion vs Placebo in Alcohol Use Disorder and Major Depression.
A Phase 1/2 study testing allogeneic human mesenchymal stem cells (allo-hMSCs) in people with Major Depressive Disorder and Alcohol Use Disorder, run by Ihsan M Salloum, MD, MPH at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Major Depressive Disorder, Alcohol Use Disorder
- What is being tested?
- allogeneic human mesenchymal stem cells (allo-hMSCs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2018to 30 Jul 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent.
- Subjects age >18 and <75 years at the time of signing the Informed Consent Form.
- Diagnostic and Statistical Manual of Mental Disorder-5 criteria for Alcohol Urge Questionnaire (moderate or severe defined as meeting 4 or more of the 11 criteria) AND a concurrent Diagnostic and Statistical Manual of Mental Disorder-5 recurrent unipolar major depression with HRSD-25 score of 18 or above.
- A history of a depressive episode occurring or persisting during a period of one-month abstinence.
- Participants should express the desire to reduce or stop alcohol consumption, report 28 or more standard drinks (SD) per week for males or 21 for females over four weeks during the 90 days preceding study enrollment.
- Increased inflammation ([serum C-reactive protein] ≥3.0 mg/L.
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- Agree to taper and discontinue antidepressant medications during the 12-week trial.
- Able to provide informed consent and comply with study procedures.
- Able to read English and understand study instruments.
- Entry criteria for depression and alcohol use disorder (moderate or severe) will be established using the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders (SCID) for categorical diagnosis.
- Have a score of ≥18 on the Hamilton Depression Rating Scale for Depression (HAM-D).
Who cannot join
- Acute suicidality.
- Any lifetime history of bipolar disorder, schizophrenia, or schizoaffective disorder.
- Active psychotic disorder, eating disorder, or substance use disorder except for alcohol and tobacco or "mild" cannabis use disorder within 6 months of enrollment.
- Any lifetime history of autoimmune or immunodeficiency syndrome.
- Treatment with any psychotropic (including hypnotic), steroidal, or anti-inflammatory medication (including NSAIDs) within 2 weeks of treatment randomization (6 weeks for fluoxetine).
- Any current use of medication that affect alcohol consumption such as acamprosate, disulfiram, naltrexone (po or IM), topiramate, or sedative-hypnotics including benzodiazepines or any psychostimulant.
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- Being enrolled in an alcohol treatment program (self-help groups participation such as Alcoholics Anonymous or Dual Diagnosis self-help are allowed).
- Active medical condition that could cause or exacerbate depressive symptoms (e.g., hypothyroidism, anemia).
- Currently pregnant or breast-feeding.
- Lack of use of a reliable means of contraception methods. (Female subjects of childbearing potential must undergo a serum or urine pregnancy test at screening and within 36 hours prior to infusion.)
- First major depressive episode after 50 years of age.
- Any evidence of current infection including serum positive for HIV, hepatitis BsAg or Viremic hepatitis.
- Medical conditions with known autoimmune or inflammatory mechanisms including any chronic allergic condition.
- Positive urine screens for any drug of abuse other than cannabis at baseline.
- Inability to read or understand study forms or informed consent or the presence of any other conditions or factors, which in the opinion of the investigator would make the patient unsuitable for study participation.
- Prior history of a suicide attempt, within the past year.
- Have hypersensitivity to dimethyl sulfoxide (DMSO).
- Have a clinical history of malignancy within 3 years (i.e., subjects with prior malignancy must be disease free for 3 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ or cervical carcinoma.
- Be serum positive for HIV, hepatitis BsAg or Viremic hepatitis C.
- Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Rio Grande Valley School of Medicine
Harlingen, Texas, 78550
About this study
Official title: A Phase I/II, Prospective, Randomized, Double-Blind, PlAcebo-ControLled Trial to EvAluate the Efficacy of Allogeneic HUman Mesenchymal Stem Cell InfusioN Versus Placebo in Subjects With Alcohol Use Disorder and Major DepreSsion.(ALAUNUS)
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.
Read the detailed description
This is a randomized, double-blind placebo-controlled study of allogeneic human mesenchymal stem cell in subjects with comorbid Alcohol Use Disorder And Major Depression (AUD-MD). 80 subjects will be randomized (1:1) to active treatment vs. placebo an followed weekly for 12 weeks and then every 3 months for 12 months.
- Conditions
- Major Depressive Disorder, Alcohol Use Disorder
- Being tested
- allogeneic human mesenchymal stem cells (allo-hMSCs), Placebo
- Keywords
- stem cells
- Medical subject headings
- Depressive Disorder, Major, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic human mesenchymal stem cells (allo-hMSCs)Drug
Single administration of allogeneic hMSCs: 100 x 106 (100 million) allo-hMSCs of cells delivered via a single peripheral intravenous infusion.
PlaceboDrug
Placebo administration consisting of 1% human albumin serum in Plasma-Lyte A delivered via a single peripheral intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| allogeneic human mesenchymal stem cells (allo-hMSCs) | Experimental | 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. Receives: Drug: allogeneic human mesenchymal stem cells (allo-hMSCs) |
| Placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incident of treatment emergent-serious adverse events
Incidence of any treatment-emergent serious adverse events, defined as a composite of acute suicidality and hospitalization for suicide attempts.
Measured: One month post-infusion
Secondary outcomes (13)
Change in serum concentrations of high sensitivity C-reactive protein.
Change in serum concentrations of high sensitivity C-reactive protein. A serum sample will be collected to assess the change.
Measured: Baseline, 12 weeks
Change in serum concentrations of inflammatory biomarkers
Change in serum concentrations of inflammatory biomarkers, such as in TNF alpha and interleukin-6. A serum sample will be collected to assess the change.
Measured: Baseline, 12 weeks
Change in depressive symptoms as assessed by MADRS
Montgomery and Asberg Depression Rating Scale (MADRS) is a ten item questionnaire with a total score ranging from 0-60 with a higher score indicating higher depressive symptoms.
Measured: Baseline, 12 weeks
Change in Depressive symptoms as assessed by CGI
Clinical Global Improvement (CGI) is rated on a 7 point scale ranging from 1 (very much improved) to 7 (very much worse).
Measured: Baseline, 12 weeks
Change in quantity of alcohol use as assessed by TLFB
30-day self report Timeline Follow Back (TLFB) questionnaire will be used to assess daily alcohol use.
Measured: Baseline, 12 weeks
Change in frequency of alcohol use as assessed by TLFB
30-day self report Timeline Follow Back (TLFB) questionnaire will be used to assess frequency of daily alcohol use.
Measured: Baseline, 12 weeks
Change in Anhedonia as measured by SHAPS
Snaith Hamilton Pleasure Scale (SHAPS) is a 14 item questionnaire with a total score ranging from 0-56 with a higher score indicating increased anhedonic symptoms.
Measured: Baseline, 12 weeks
Change in cravings as assessed by AUQ
Alcohol Urge Questionnaire (AUQ) is an 8 item questionnaire with total score ranging from 8-56 with a high score indicating increased cravings .
Measured: Baseline, 12 weeks
Change in cravings as assessed by OCDS
Obsessive-Compulsive Drinking Scale (OCDS) is a 14 item questionnaire ranging from 0-56 with a higher score indicating increase cravings.
Measured: Baseline, 12 weeks
Change in cognition as assessed by BAC-A
Brief Assessment of Cognition for Affective Disorders (BAC-A) includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3.
Measured: Baseline, 12 weeks
Change in functioning as assessed by UPSA-B
University of California of San Diego (UCSD) Performance Based Skills Assessment (UPSA-B) questionnaire has a total score from 0-100 with a higher score indication better functioning.
Measured: Baseline, 12 weeks
Change in functioning as assessed by GAF
Global Assessment of Functioning (GAF) questionnaire has a total score ranging from 1-100 with a higher score indicating of daily activities.
Measured: Baseline, 12 weeks
Change in quality of life as assessed by QOLI
Quality of Life Index (QOLI) questionnaire has a total score ranging from 10-100 with a higher score indicating higher quality of life.
Measured: Baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start18 Mar 2018
- Primary completion30 Jul 2025
- Study completion30 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ihsan M Salloum, MD, MPH
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Sponsor-investigator, Ihsan M Salloum, MD, MPH, University of Texas Rio Grande Valley
- Investigators
- Ihsan Salloum, MD, Principal investigator, University of Texas Rio Grande Valley School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265808
- Sponsor's protocol ID
- 20170674
- Other IDs
- 1R01AA024933-01A1
- Acronym
- Alaunus
- Status last verified
- Jan 2025
- First submitted
- 16 Aug 2017
- Last updated
- 9 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II, Prospective, Randomized, Double-Blind, PlAcebo-ControLled Trial to EvAluate the Efficacy of Allogeneic HUman Mesenchymal Stem Cell InfusioN Versus Placebo in Subjects With Alcohol Use Disorder and Major DepreSsion.(ALAUNUS)
- ClinicalTrials.gov ID
- NCT03265808
- Acronym / sponsor ID
- Alaunus / 20170674
- Conditions
- Major Depressive Disorder, Alcohol Use Disorder
- Keywords
- stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Ihsan M Salloum, MD, MPHUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- 18 Mar 2018 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 30 Jul 2025 (actual)
- First posted
- 29 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a randomized, double-blind placebo-controlled study of allogeneic human mesenchymal stem cell in subjects with comorbid Alcohol Use Disorder And Major Depression (AUD-MD). 80 subjects will be randomized (1:1) to active treatment vs. placebo an followed weekly for 12 weeks and then every 3 months for 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| allogeneic human mesenchymal stem cells (allo-hMSCs) | Experimental | Drug: allogeneic human mesenchymal stem cells (allo-hMSCs)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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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 may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Provide written informed consent.
- Subjects age >18 and <75 years at the time of signing the Informed Consent Form.
- Diagnostic and Statistical Manual of Mental Disorder-5 criteria for Alcohol Urge Questionnaire (moderate or severe defined as meeting 4 or more of the 11 criteria) AND a concurrent Diagnostic and Statistical Manual of Mental Disorder-5 recurrent unipolar major depression with HRSD-25 score of 18 or above.
- A history of a depressive episode occurring or persisting during a period of one-month abstinence.
- Participants should express the desire to reduce or stop alcohol consumption, report 28 or more standard drinks (SD) per week for males or 21 for females over four weeks during the 90 days preceding study enrollment.
Key exclusion criteria (20 listed)
- Acute suicidality.
- Any lifetime history of bipolar disorder, schizophrenia, or schizoaffective disorder.
- Active psychotic disorder, eating disorder, or substance use disorder except for alcohol and tobacco or "mild" cannabis use disorder within 6 months of enrollment.
- Any lifetime history of autoimmune or immunodeficiency syndrome.
- Treatment with any psychotropic (including hypnotic), steroidal, or anti-inflammatory medication (including NSAIDs) within 2 weeks of treatment randomization (6 weeks for fluoxetine).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| allogeneic human mesenchymal stem cells (allo-hMSCs)Single administration of allogeneic hMSCs: 100 x 106 (100 million) allo-hMSCs of cells delivered via a single peripheral intravenous infusion. | Drug | allogeneic human mesenchymal stem cells (allo-hMSCs) |
| PlaceboPlacebo administration consisting of 1% human albumin serum in Plasma-Lyte A delivered via a single peripheral intravenous infusion. | Drug | Placebo |
Primary outcome
Incident of treatment emergent-serious adverse events
Time frame: One month post-infusion
Incidence of any treatment-emergent serious adverse events, defined as a composite of acute suicidality and hospitalization for suicide attempts.
13 secondary outcomes
Change in serum concentrations of high sensitivity C-reactive protein.
Time frame: Baseline, 12 weeks
Change in serum concentrations of inflammatory biomarkers
Time frame: Baseline, 12 weeks
Change in depressive symptoms as assessed by MADRS
Time frame: Baseline, 12 weeks
Change in Depressive symptoms as assessed by CGI
Time frame: Baseline, 12 weeks
Change in quantity of alcohol use as assessed by TLFB
Time frame: Baseline, 12 weeks
Change in frequency of alcohol use as assessed by TLFB
Time frame: Baseline, 12 weeks
Change in Anhedonia as measured by SHAPS
Time frame: Baseline, 12 weeks
Change in cravings as assessed by AUQ
Time frame: Baseline, 12 weeks
Change in cravings as assessed by OCDS
Time frame: Baseline, 12 weeks
Change in cognition as assessed by BAC-A
Time frame: Baseline, 12 weeks
Change in functioning as assessed by UPSA-B
Time frame: Baseline, 12 weeks
Change in functioning as assessed by GAF
Time frame: Baseline, 12 weeks
Change in quality of life as assessed by QOLI
Time frame: Baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ihsan Salloum, MD principal investigator
University of Texas Rio Grande Valley School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing allogeneic human mesenchymal stem cells (allo-hMSCs) in people with Major Depressive Disorder and Alcohol Use Disorder, run by Ihsan M Salloum, MD, MPH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incident of treatment emergent-serious adverse events (time frame: One month post-infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.