Allogeneic Human Mesenchymal Stem Cell Infusion vs Placebo in Alcohol Use Disorder and Major Depression.

Korábbi kezelés

• 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.
• Positive urine screens for any drug of abuse other than cannabis at baseline.
• Prior history of a suicide attempt, within the past year.
• Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.

Más betegség

• 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.
• Active medical condition that could cause or exacerbate depressive symptoms (e.g., hypothyroidism, anemia).
• Medical conditions with known autoimmune or inflammatory mechanisms including any chronic allergic condition.
• 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.
• 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.

Laborértékek

• 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.)
• Any evidence of current infection including serum positive for HIV, hepatitis BsAg or Viremic hepatitis.
• Be serum positive for HIV, hepatitis BsAg or Viremic hepatitis C.

Életkor

• First major depressive episode after 50 years of age.

Egyéb

• Acute suicidality.
• Being enrolled in an alcohol treatment program (self-help groups participation such as Alcoholics Anonymous or Dual Diagnosis self-help are allowed).
• Currently pregnant or breast-feeding.

• 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.
• 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).