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临床试验/NCT02266394
NCT02266394已完成1 期

Hypoxia and Inflammatory Injury in Human Renovascular Hypertension : Phase 1 Trial of Mesenchymal Stem Cell Therapy

Mayo Clinic3 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2014年10月21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
Mayo Clinic
入组人数
42
试验地点
3
主要终点
Change in Kidney function

研究概览

简要总结

Current treatments for ARAS based on restoring blood flow alone have been unsuccessful at recovering kidney function. For this reason we are studying a stem cell product called "mesenchymal stem cells" or MSC. Mesenchymal stem cells (MSC) are grown from a person's own fat tissue (obtained as a fat biopsy) and infused back into the patient's own kidney.

This study is also being done to determine if the MSC infusion prior to percutaneous transluminal renal angioplasty with stenting (PTRA) further enhances changes in single kidney blood flow and restoration of kidney function, as well as to assess the relationship between MSC dose and measures of kidney function.

详细描述

These studies include participation by human subjects using a 3-day inpatient CRU protocol at St. Mary's Hospital. Studies include formal measurement of blood and urinary markers of kidney function, BOLD MR and multidetector CT scanning. Forty-two non-diabetic patients between 40 and 80 years of any race or ethnicity will be recruited. All will have hypertension (defined as BP≥140/90 mmHg or ongoing antihypertensive drug therapy) but will have less than 180 mmHg to be included (with or without drug therapy). These subjects will be free of cardiovascular events within 3 months and will not have implanted electrical devices, such as a pacemaker or defibrillator. All patients will have identified large vessel renovascular disease (RVD) for Aims 1, 2 and 3. At least 10% of these subjects will be of African-American descent (self-identified) and recruited in collaboration with the University of Mississippi under the direction of Dr. Luis Juncos and the University of Alabama under the direction of Dr. David Calhoun. For completion of Aims 2 and 3, a three-day evaluation will be repeated between three and four months later, and ongoing safety and imaging studies will be performed up to 24 months after MSC administration. Participants in these protocols will undergo transvenous kidney biopsy under the direction of Drs. McKusick and Misra and their colleagues in Interventional Radiology. All subjects for these studies will complete the research plan at Mayo Clinic, Rochester, Minnesota.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Creatinine <2.2 mg/dL for Caucasian males, <2.0 Caucasian females,< 2.4 African-American males, <2.1 mg/dL African-American females
  • Hypertension (Systolic BP>155 mm Hg) and/or requirement for two or more antihypertensive medications: no restrictions on antihypertensive agents, although loop diuretics will be changed to diluting site agents (e.g. hydrochlorothiazide, indapamide, metolazone) prior to study.
  • Angiotensin Converting Enzyme (ACE inhibitor) or Angiotensin Receptor Blocker (ARB) therapy maintained or initiated at usual recommended daily dose (equivalent: 40 mg lisinopril) .

排除标准

  • Diabetes requiring insulin or oral hypoglycemic medications (see text)
  • Known allergy to furosemide or iodinated intravenous contrast
  • Pregnancy
  • Recent Cardiovascular event: Myocardial infarction, stroke, congestive heart failure within 3 months
  • Cardiac ejection fraction less than 30%
  • Evidence of hepatitis B or C, or HIV infection
  • requirement for potentially nephrotoxic drugs, e.g. non-steroidal anti-inflammatory drugs
  • Uncontrolled hypertension: SBP >180 mm Hg, despite antihypertensive therapy
  • Kidney transplant
  • Pacemaker, implantable defibrillator or other contraindication to Magnetic resonance imaging
  • Inability to comply with breath-hold for 30 seconds
  • History of deep venous thrombosis within 3 months of enrollment
  • contraindications to renal biopsy including artificial valve requiring continuous anticoagulation

研究组 & 干预措施

Mesenchymal stem cell delivery

Active Comparator

To determine hemodynamic and immunologic changes associated with intra-renal delivery of adipose-derived MSC into human subjects with advanced RVD.

干预措施: Mesenchymal stem cell (Drug)

Mesenchymal stem cell delivery with stent placement

Active Comparator

To test adjunctive delivery of MSC to individuals with advanced RVD undergoing renal artery stenting.

干预措施: Mesenchymal stem cell (Drug)

Mesenchymal stem cell delivery with stent placement

Active Comparator

To test adjunctive delivery of MSC to individuals with advanced RVD undergoing renal artery stenting.

干预措施: Mesenchymal stem cell delivery with stent placement (Procedure)

结局指标

主要结局

Change in Kidney function

时间窗: 3 months

Renal Tissue oxygenation

Safety of Mesenchymal stem cell infusion

时间窗: 2 years

Number of patients with tissue injury markers

次要结局

  • Decrease in Kidney inflammation(3 months)

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

Stephen C. Textor, M.D.

PI

Mayo Clinic

研究点 (3)

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