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临床试验/NCT04063215
NCT04063215已完成1 期

A Clinical Trial to Determine the Safety and Efficacy of Hope Biosciences Autologous Mesenchymal Stem Cell Therapy for the Treatment of Traumatic Brain Injury and Hypoxic-Ischemic Encephalopathy

Hope Biosciences LLC1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2020年1月1日最近更新:
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适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
24
试验地点
1
主要终点
Vital Signs (Respiratory Rate)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on brain structure, neurocognitive/functional outcomes, and neuroinflammation after subacute and chronic neurological injury in adults.

详细描述

This study aims to determine the safety of HB-adMSC infusion and treatment effects of HB-adMSC infusion on global gray and/or white matter, as well as structural integrity of GM and WM regions of interest in the corpus callous and corticospinal tracts as measured by fractional anisotropy (FA) and mean diffusivity (MD) in specific regions known to correlate with specific neurocognitive deficits in patients after neurological injury.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 55 Years（Adult）
性别
All
接受健康志愿者
否

入选标准

  • •adults between 18 and 55 years of age
  • •documented head injury with functional neurological damage to the central nervous system unlikely to improve with present standard of care approaches
  • •a Glasgow Outcome Scale-Extended (GOS-E) score > 2 and ≤ 6
  • •onset or diagnosis of the injury or disease process greater than 6 months
  • •ability to obtain consent from the subject of their legally authorized representative (LAR)
  • •ability to speak English or Spanish *required for validated neurocognitive outcome testing) -

排除标准

  • •known history of:
  • •intellectual deficiency or psychiatric conditions likely to invalidate our ability to assess changes in cognition or behavior,
  • •recently treated infection,
  • •renal disease or altered renal function (screening serum creatinine > 1.5 mg/dL),
  • •hepatic disease or altered liver function (screening SGPT > 150 U/L or T. Bilirubin >1.3 mg/dL),
  • •immunosuppression (screening WBC < 3, 000 cells/ml),
  • •chemical or ETOH dependency that in the opinion of the investigator would preclude participation in the study,
  • •acute or chronic lung disease requiring significant medication, oxygen supplementation, or mechanical ventilation,
  • •bleeding disorders including immune-mediated heparin-induced thrombocytopenia,
  • •known sensitivity to heparin, Lovenox, and pork products,
  • •individuals with mechanical prosthetic heart valves.
  • •individuals who have received a stem cell treatment.
  • •Normal brain CT/MRI exam
  • •Spinal deformity, spinal surgery (including repeated epidural or spinal punctures), or spinal cord injury diagnosed by CT/MR or clinical exam
  • •diagnosed with a genetic or metabolic disorder related to the neurologic condition
  • •other acute or chronic medical conditions that, in the opinion of the investigator, may increase the risks associated with study participation
  • •for women of child bearing potential, a positive pregnancy test at the screening visit, or, for both women and men, unwillingness to comply with acceptable methods of birth control during the study
  • •participation in a concurrent interventional study
  • •inability to undergo the diagnostic tests (PET/DT-MRI) or unwilling/unable to cooperate with the diagnostic tests and outcome assessments
  • •unwilling or unable to return for follow-up study visits -

研究组 & 干预措施

HB-adMSC

Experimental

HB-adMSCs will be infused three times spaced 14 days apart (Week 0, Week 2, Week 4)

干预措施: HB-adMSCs (Biological)

结局指标

主要结局

Vital Signs (Respiratory Rate)

时间窗: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Respiratory Rate

Vital Signs (Temperature)

时间窗: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Temperature

Vital Signs (Systolic Blood Pressure)

时间窗: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Systolic Blood Pressure

Vital Signs (Diastolic Blood Pressure)

时间窗: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Diastolic Blood Pressure

Vital Signs (Pulse Rate)

时间窗: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Pulse Rate

Vital Signs (Oxygen Saturation)

时间窗: Screening/Pre-Infusion (Visit 1), Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56)

Mean and Standard Deviation of Vital Signs at Visits 1, 3, 6, and 7 for Oxygen Saturation

Vital Signs Change From Baseline (Diastolic Blood Pressure)

时间窗: Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)

Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Diastolic Blood Pressure

Vital Signs Change From Baseline (Systolic Blood Pressure)

时间窗: Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)

Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Systolic Blood Pressure

Vital Signs Change From Baseline (Pulse Rate)

时间窗: Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)

Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Pulse Rate

Vital Signs Change From Baseline (Oxygen Saturation)

时间窗: Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)

Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Oxygen Saturation

Vital Signs Change From Baseline (Respiratory Rate)

时间窗: Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)

Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Respiratory Rate

Vital Signs Change From Baseline (Temperature)

时间窗: Infusion 1/Baseline (Visit 3 - Week 0), Infusion 2 (Visit 4 - Week 2), Infusion 3 (Visit 5 - Week 4)

Mean and Standard Deviation of Vital Signs Change from Baseline at Visits 3, 4, and 5 for Temperature

次要结局

  • Interleukin 4(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Interleukin 2(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Interleukin 1-beta(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Interferon Gamma-induced Protein 10 (IP-10)(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Tumor Necrosis Factor Alpha(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Monocyte Chemoattractant Protein-1 (MCP-1)(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Interleukin Protein-17A (IL-17a)(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Interleukin 6(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Interleukin 10(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • IFN-gamma(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • IL-12p70(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • IL-8(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Free Active TGF-Beta1(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Glasgow Outcome Scale-Expanded (GOS-E) Functional Outcomes(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Disability Rating Scale (DRS) Functional Outcomes(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Galveston Orientation and Amnesia Test Neuropsychological Outcomes(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Brief Symptoms Inventory 18 (BSI 18) SOM T Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Brief Symptoms Inventory 18 (BSI 18) DEP T Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Brief Symptoms Inventory 18 (BSI 18) Anxiety (ANX) T Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Brief Symptoms Inventory 18 (BSI 18) Global Severity Index (GSI) T Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • TBI Quality of Life Questionnaires (TBI-QOL SF) - Cognition - General Concerns T Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • TBI Quality of Life Questionnaires (TBI-QOL SF) - Communication T Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • TBI Quality of Life Questionnaires (TBI-QOL SF) - Independence T Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • TBI Quality of Life Questionnaires (TBI-QOL SF) - Mobility T Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • TBI Quality of Life Questionnaires (TBI-QOL SF) - Satisfaction With SRA T Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • TBI Quality of Life Questionnaires (TBI-QOL SF) - Upper Extremity/ADL T Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • NIH Toolbox - Cognition: Pattern Comparison Processing Speed Test T Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • NIH Toolbox - Cognition: Picture Vocabulary Test T Scores(Infusion 1/Baseline (Visit 3 - Week 0) and 1 year Post-Infusion (Visit 7 - Week 56))
  • NIH Toolbox - Cognition: Dimensional Change Card Sort Test T Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • NIH Toolbox - Cognition: Franker Inhibitory Control and Attention Test T Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • NIH Toolbox - Cognition: List Sorting Working Memory Test T Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test T Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • NIH Toolbox - Motor: 9-hole Pegboard Dexterity Test Non-Dominant Hands T Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Rey Auditory Verbal Learning Test (RAVLT) Delay T Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Rey Auditory Verbal Learning Test (RAVLT) Trials 1-5 T Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Wechsler Adult Intelligence Scale - IV: Coding Scaled Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Wechsler Adult Intelligence Scale - IV: Symbol Search Scaled Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Wechsler Adult Intelligence Scale - IV: Processing Speed Index/Composite Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • Controlled Oral Word Association Test (COWAT) Total Scaled Scores(Infusion 1/Baseline (Visit 3 - Week 0), 6 months Post-Infusion (Visit 6 - Week 28), 1 year Post-Infusion (Visit 7 - Week 56))
  • MRI Structural Measures - Global White Matter(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Global Gray Matter(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Global Corpus Callosum Matter(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Hippocampus (Bilateral)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Amygdala (Bilateral)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Thalamus (Bilateral)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Caudate (Bilateral)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Putamen (Bilateral)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Pallidum (Bilateral)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Insula (Bilateral)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Hippocampus (Left)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Hippocampus (Right)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Amygdala (Left)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Amygdala (Right)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Thalamus (Left)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Thalamus (Right)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Caudate (Left)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Caudate (Right)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Putamen (Left)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Putamen (Right)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Pallidum (Left)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Pallidum (Right)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Insula (Left)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))
  • MRI Structural Measures - Insula (Right)(Infusion 1/Baseline (Visit 3 - Week 0) and 6 months Post-Infusion (Visit 6 - Week 28))

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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