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Trial record 3 of 4 for:    salloum | Miami, Florida, U.S.

Allogeneic HUman Mesenchymal Stem Cell InfusioN Versus Placebo in Subjects With Alcohol Use Disorder and Major DepreSsion. (Alaunus)

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ClinicalTrials.gov Identifier: NCT03265808
Recruitment Status : Recruiting
First Posted : August 29, 2017
Last Update Posted : May 7, 2019
Sponsor:
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Joshua M Hare, University of Miami

Tracking Information
First Submitted Date  ICMJE August 16, 2017
First Posted Date  ICMJE August 29, 2017
Last Update Posted Date May 7, 2019
Actual Study Start Date  ICMJE March 18, 2018
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
treatment emergent-serious adverse events [ Time Frame: One month post-infusion ]
Incidence (at one-month post infusion) of any treatment-emergent serious adverse events, defined as a composite of acute suicidality and hospitalization for suicide attempts.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03265808 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 25, 2017)
  • Reduction of Inflammation [ Time Frame: Assessed at 12 weeks ]
    Reduction of Inflammation: Change in serum concentrations of high sensitivity C-reactive protein. A serum sample will be collected to assess the change.
  • Reduction of Inflammation [ Time Frame: Assessed at 12 weeks ]
    Reduction of Inflammation: 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.
  • Reduction in Depressive Symptoms [ Time Frame: Assessed at 12 weeks ]
    Reduction in Depressive Symptoms due to change in MADRS.
  • Reduction in Depressive Symptoms [ Time Frame: Assessed at 12 weeks ]
    Reduction in Depressive Symptoms due to change in Global clinical functioning (CGI).
  • Reduction of alcohol use [ Time Frame: Assessed at 12 weeks ]
    Reduction of alcohol use using the clinician administered measures of the severity of alcohol use (TLFB-% heavy drinking days)
  • Reduction in Anhedonia [ Time Frame: Assessed at 12 weeks ]
    Reduction in Anhedonia (depression related features) due to change in SHAPS.
  • Improvements in quality of life [ Time Frame: Assessed at 12 weeks ]
    Improvements in craving, cognition, functioning and quality of life as indicated by changes in the Alcohol Urge Questionnaire.
  • Improvements in quality of life [ Time Frame: Assessed at 12 weeks ]
    Improvements in craving, cognition, functioning and quality of life as indicated by changes in the Obsessive-Compulsive Drinking Scale.
  • Improvements in quality of life [ Time Frame: Assessed at 12 weeks ]
    Improvements in craving, cognition, functioning and quality of life as indicated by changes in the Brief Assessment of Cognition for Affective Disorders.
  • Improvements in quality of life [ Time Frame: Assessed at 12 weeks ]
    Improvements in craving, cognition, functioning and quality of life as indicated by changes in the UCSD Performance Based Skills Assessment.
  • Improvements in quality of life [ Time Frame: Assessed at 12 weeks ]
    Improvements in craving, cognition, functioning and quality of life as indicated by changes in the Global Assessment of Functioning questionnaire.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Allogeneic HUman Mesenchymal Stem Cell InfusioN Versus Placebo in Subjects With Alcohol Use Disorder and Major DepreSsion.
Official Title  ICMJE A Phase I/II, Prospective, Randomized, Double-Blind, PlAcebo-ControLled Trial to EvAluate the Potential Efficacy of Allogeneic HUman Mesenchymal Stem Cell InfusioN Versus Placebo in Subjects With Alcohol Use Disorder and Major DepreSsion.
Brief Summary Eighty (80) subjects with Alcohol Use Disorder and Comorbid Major Depression, fulfilling all inclusion/exclusion criteria's will be randomly assigned to receive allogeneic human Mesenchymal stem cells or placebo in a 1:1 blinded fashion.
Detailed Description

Eighty (80) subjects fulfilling all inclusion/exclusion criteria's will be randomly assigned to receive allogeneic hMSCs or placebo in a 1:1 blinded fashion.

Forty (40) subjects 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.

Forty (40) subjects will be treated with a placebo administration consisting of 1% human albumin serum in Plasma-Lyte A delivered via a single peripheral intravenous infusion.

The Allo-hMSCs will be supplied from an allogeneic human mesenchymal stem cell source or commercial grade bone marrow product and will be manufactured by the University of Miami.

The study will last approximately 14 months with six follow-up visits, which will occur every 2 weeks at 2, 4, 6, 8, 10, and 12 weeks following treatment infusion and then at 6, 9 and 12 months.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Subjects will be randomized in a 1:1 blinded fashion
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Major Depression
  • Alcohol Use Disorder
Intervention  ICMJE
  • Drug: allogeneic human mesenchymal stem cells (allo-hMSCs)
    Forty (40) subjects will be treated with a single administration of allogeneic hMSCs: 100 x 106 (100 million) allo-hMSCs of cells delivered via a single peripheral intravenous infusion.
    Other Names:
    • allo-hMSCs
    • stem cells
  • Drug: Placebo
    Forty (40) subjects will be treated with a placebo administration consisting of 1% human albumin serum in Plasma-Lyte A delivered via a single peripheral intravenous infusion.
Study Arms  ICMJE
  • Experimental: allogeneic human mesenchymal stem cells (allo-hMSCs)
    Forty (40) subjects 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.
    Intervention: Drug: allogeneic human mesenchymal stem cells (allo-hMSCs)
  • Placebo Comparator: Placebo
    Forty (40) subjects will be treated with a placebo administration consisting of 1% human albumin serum in Plasma-Lyte A delivered via a single peripheral intravenous infusion.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 25, 2017)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 2026
Estimated Primary Completion Date February 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Provide written informed consent.
  2. Subjects age >18 and <75 years at the time of signing the Informed Consent Form.
  3. 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.
  4. A history of a depressive episode occurring or persisting during a period of one-month abstinence.
  5. 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.
  6. Increased inflammation ([serum C-reactive protein] ≥3.0 mg/L.
  7. Agree to taper and discontinue antidepressant medications during the 12-week trial.
  8. Able to provide informed consent and comply with study procedures.
  9. Able to read English and understand study instruments.
  10. 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.
  11. Have a score of ≥18 on the Hamilton Depression Rating Scale for Depression (HAM-D).

Exclusion Criteria:

  1. Acute suicidality.
  2. Any lifetime history of bipolar disorder, schizophrenia, or schizoaffective disorder.
  3. Active psychotic disorder, eating disorder, or substance use disorder except for alcohol and tobacco or "mild" cannabis use disorder within 6 months of enrollment.
  4. Any lifetime history of autoimmune or immunodeficiency syndrome.
  5. Treatment with any psychotropic (including hypnotic), steroidal, or anti-inflammatory medication (including NSAIDs) within 2 weeks of treatment randomization (6 weeks for fluoxetine).
  6. 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.
  7. Being enrolled in an alcohol treatment program (self-help groups participation such as Alcoholics Anonymous or Dual Diagnosis self-help are allowed).
  8. Active medical condition that could cause or exacerbate depressive symptoms (e.g., hypothyroidism, anemia).
  9. Currently pregnant or breast-feeding.
  10. 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.)
  11. First major depressive episode after 50 years of age.
  12. Any evidence of current infection including serum positive for HIV, hepatitis BsAg or Viremic hepatitis.
  13. Medical conditions with known autoimmune or inflammatory mechanisms including any chronic allergic condition.
  14. Positive urine screens for any drug of abuse other than cannabis at baseline.
  15. 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.
  16. Prior history of a suicide attempt, within the past year.
  17. Have hypersensitivity to dimethyl sulfoxide (DMSO).
  18. 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.
  19. Be serum positive for HIV, hepatitis BsAg or Viremic hepatitis C.
  20. Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joshua M Hare, MD 305-243-5579 JHare@med.miami.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03265808
Other Study ID Numbers  ICMJE 20170674
1R01AA024933-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Joshua M Hare, University of Miami
Study Sponsor  ICMJE Joshua M Hare
Collaborators  ICMJE National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators  ICMJE
Principal Investigator: Ihsan Salloum, MD University of Miami
PRS Account University of Miami
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP