NCT03265808已完成1 期
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)
Ihsan M Salloum, MD, MPH1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2018年3月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Incident of treatment emergent-serious adverse events
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
- •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.
研究组 & 干预措施
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.
干预措施: allogeneic human mesenchymal stem cells (allo-hMSCs) (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Incident of treatment emergent-serious adverse events
时间窗: One month post-infusion
Incidence of any treatment-emergent serious adverse events, defined as a composite of acute suicidality and hospitalization for suicide attempts.
次要结局
- Change in serum concentrations of high sensitivity C-reactive protein.(Baseline, 12 weeks)
- Change in serum concentrations of inflammatory biomarkers(Baseline, 12 weeks)
- Change in depressive symptoms as assessed by MADRS(Baseline, 12 weeks)
- Change in Depressive symptoms as assessed by CGI(Baseline, 12 weeks)
- Change in quantity of alcohol use as assessed by TLFB(Baseline, 12 weeks)
- Change in frequency of alcohol use as assessed by TLFB(Baseline, 12 weeks)
- Change in cravings as assessed by AUQ(Baseline, 12 weeks)
- Change in Anhedonia as measured by SHAPS(Baseline, 12 weeks)
- Change in cravings as assessed by OCDS(Baseline, 12 weeks)
- Change in cognition as assessed by BAC-A(Baseline, 12 weeks)
- Change in functioning as assessed by UPSA-B(Baseline, 12 weeks)
- Change in functioning as assessed by GAF(Baseline, 12 weeks)
- Change in quality of life as assessed by QOLI(Baseline, 12 weeks)
研究者
Ihsan M Salloum, MD, MPH
Professor
University of Texas Rio Grande Valley
研究点 (1)
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