NCT02065245已完成1 期
A Phase I/II, Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Patients With Aging Frailty
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Incidence of Any Treatment Emergent - Serious Adverse Events (TE-SAEs)
研究概览
简要总结
The purpose of this study is to look at the safety of treatment with stem cells in patients with Frailty.
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
- 60 Years 至 95 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 greater than or equal to 60 and less than or equal to 95 years at the time of signing the Informed Consent Form.
- •Show signs of frailty apart from a concomitant condition as assessed by the Investigator with a frailty score of 4 to 7 using the Clinical Frailty Scale
- •Female subjects with an Follicle-stimulating hormone (FSH) equal to or > 25.8 milli-international units (mIU) /mL (milliliter), if not currently on hormone replacement therapy.
排除标准
- •Score of less than or equal to 24 on the Mini Mental State Examination (MMSE)
- •Inability to perform any of the assessments required for endpoint analysis (report safety or tolerability concerns, perform pulmonary function tests, undergo blood draws, read and respond to questionnaires.
- •Active listing (or expected future listing) for transplant of any organ.
- •Clinically important abnormal screening laboratory values, including but not limited to: hemoglobin <8 g/dl, white blood cell count <3000/mm3, platelets<80,000/mm3, international normalized ratio (INR) > 1.5 not due to a reversible cause (i.e. Coumadin), aspartate transaminase, alanine transaminase, or alkaline phosphatase > 3 times upper limit of normal, total bilirubin > 1.5 mg/dl.
- •Serious comorbid illness that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study. Including, but not limited to: HIV, advanced liver or renal failure, class III/IV congestive heart failure, myocardial infarction, unstable angina, or cardiac revascularization within the last six months, or severe obstructive ventilatory defect.
- •Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.
- •Be an organ transplant recipient.
- •Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma, squamous cell carcinoma, melanoma in situ or cervical carcinoma if recurrence occurs.
- •Have a non-pulmonary condition that limits lifespan to < 1 year.
- •Have a history of drug or alcohol abuse within the past 24 months.
- •Be serum positive for HIV, hepatitis B Surface Antigen (BsAg) or Viremic hepatitis C.
- •Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
- •Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female patients must undergo a blood or urine pregnancy test at screening and within 36 hours prior to infusion.
- •Have hypersensitivity to dimethyl sulfoxide (DMSO)
结局指标
主要结局
Incidence of Any Treatment Emergent - Serious Adverse Events (TE-SAEs)
时间窗: One Month post infusion
Incidence of any treatment-emergent serious adverse events (SAE), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities. * Serum chemistry: chloride, bicarbonate, blood urea nitrogen (BUN), creatinine, glucose, calcium, aspartate aminotransferase (AST), alanine aminotransferase (ALT), total bilirubin (fractionate if total \>1.5 times normal), alkaline phosphatase, albumin, * Hematology (Complete blood count): hemoglobin, hematocrit, platelets, white blood cells (WBC), WBC differential
次要结局
- Change in Quality of Life (QoL) as Measured by the EQ-5D-3L Overall Health Status Scale.(At baseline and 6 month follow-up visit.)
- Change in Frailty as Assessed by CHAMPS Questionnaire(At baseline and 6 month follow-up visit.)
- Change in Quality of Life (QoL) as Measured by the SF-36 Questionnaire(At baseline and 6 month follow-up visit.)
- Change in Weight(At baseline and 6 month follow-up visit.)
- Change in Quality of Life (QoL) as Measured by the EQ-5D-3L Questionnaire(At baseline and 6 month follow-up visit.)
- Change in Slowing of Mobility as Measured by 4 Meter Gait Speed Test(At baseline and 6 month follow-up visit.)
- Change in Ejection Fraction (EF)(At baseline and 6 month follow-up visit.)
- Change in Inflammatory Markers(At baseline and 6 month follow-up visit.)
- Change in Slowing of Mobility as Measured by SPPB(At baseline and 6 month follow-up visit.)
- Change in Diminished Hand Grip Strength(At baseline and 6 month follow-up visit.)
- Change in Exhaustion as Measured by the MFI Questionnaire(At baseline and 6 month follow-up visit.)
- Change in Quality of Life (QoL) as Measured by the ICECAP Questionnaire(At baseline and 6 month follow-up visit.)
- Change in Inflammatory Markers Levels(At baseline and 6 month follow-up visit.)
- Change in Inflammatory Marker D-dimer Levels(At baseline and 6 month follow-up visit.)
- Change in Sense of Smell as Measured by UPSIT(At baseline and 6 month follow-up visit.)
- Death(Up to 12 months.)
研究者
研究点 (2)
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