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临床试验/NCT05154591
NCT05154591已完成1 期

Chronic Kidney Disease of Unknown Cause (CKDu) Treated With Directed Local Intra-arterial Infusion of Autologous Stromal Vascular Fraction (SVF) Cells.

Samuel Vilchez, PhD1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2018年1月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
18
试验地点
1
主要终点
Preliminary evidence of efficacy

研究概览

简要总结

This is an interventional study to treat 18 patients with chronic kidney disease of unknown cause (CKDu), formerly known as Mesoamerican nephropathy (MeN), with autologous adipose tissue-derived stromal vascular fraction (SVF) cells transplanted by intra-arterial injection both kidneys.

This study assesses: (1) safety and tolerability, (2) preliminary evidence of efficacy, (3) exploratory evidence of clinical effects.

详细描述

Patients under go 24 hours of preoperative hydration combined with N-actyl cysteine 300 mg IV for prevention of nephrotoxicity. Under general anesthesia 200-300 cc of lipoaspirate is collected into a sterile processing cannister (GID SFV-1, Louisville, CO, USA). The tissue is washed and dissociated with collagenase (Worthington CLS-1, Lakewood, NJ, USA) at a concentration of 200 CDU/ml of total volume for 50 minutes at 39°C. This is followed by inactivation using 40 cc of human serum albumin. SVF cells are separated via centrifugation for 10 minutes at 800 g. The cell pellet is extracted and resuspended in Harmann solution with an aliquot (10 µl) removed for counting and viability assessment of resulting total nucleated cells (YNC) through and image cytometer (ADAM MC, Portsmouth NH, USA).

Femoral artery catheterization is performed permitting advancement of a 100 cc balloon-tip catheter into the renal artery under fluoroscopic control, with position confirmation using 1 cc of OrtoRay® 320 contrast diluted 1:4 with Hartmann solution. SVF cells are then admixed with 200 cc Hartmann solution warmed to 37°C and in fused using a DRE infusion pump (DRE Medical, Louisville, KY, USA) over a 15 minute period with constant agitation. On the 1st pos-operative day creatinine and glomerular filtration rate are checked and the patient is discharged.

Follow-up studies include clinical assessment, chemistries, and renal ultrasound to assess intra-parenchymal renal volume, renal blood flow distribution, and hilar artery vascular resistance.

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

盲法说明

  • Open label for surgeons and radiologists
  • Closed label for pathologists and nephrologists

入排标准

年龄范围
30 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Mesoamerican nephropathy
  • Stages 3 and 4
  • No other renal disease
  • No essential hypertension

排除标准

  • Significant abnormalities in laboratory tests that contraindicate surgical procedures.
  • Acute pathology or complications of significant chronic pathologies in the 6 months prior to study entry, including, but not limited to:
  • Medical history of deep vein thrombosis Uncontrolled hypertension Active infection Reduced cardiac ejection fraction Hepatitis B, C or HIV Diabetes treated with insulin or glucose lowering agents Anemia (Hb <9 g/dL) History of cancer Severe depression (Beck scale) Autoimmune disease

结局指标

主要结局

Preliminary evidence of efficacy

时间窗: Assessment of changes between day 7 and month 36 post intervention.

Improvement in clinical parameter of GFR as compared with historical age and stage-matched controls.

Incidence of treatment related adverse events

时间窗: 36-months follow-up post intervention.

Documentation of adverse events

次要结局

  • Renal blood flow.(Up to month 12 post intervention.)
  • Kidney volume.(Up to month 12 post intervention.)
  • Renal arterial resistive index.(Up to month 12 post intervention.)

研究者

发起方
Samuel Vilchez, PhD
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Samuel Vilchez, PhD

Professor

National Autonomous University of Nicaragua

研究点 (1)

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