JPRN-jRCTb030210237进行中(未招募)1 期
G-CSF-mobilized peripheral blood-derived autologous CD34+ cell transplantation for patients with chronic kidney disease
Ohtake Takayasu0 个研究点目标入组 4 人开始时间: 2021年8月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 4
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 <= 80age old(—)
- 性别
- All
入选标准
- •1) Patients with chronic kidney disease.
- •2) Patients who are undergoing medical and diet treatment for chronic kidney disease.
- •3) Patients with CKD stage G3b~G4 and progressive kidney dysfunction under standard medical and diet treatment.
- •4) Patients aged 20~80 years old.
- •5) Patients with written informed consent.
排除标准
- •1) Patients without data of kidney function within preceding 12 months.
- •2) Patients who are admitting in hospital.
- •3) Dialysis patients.
- •4) Past history of renal transplantation (both recipient and donor).
- •5) Single kidney or single functioning kidney.
- •6) Patients who underwent contrast media-enhanced imaging test or catheter angiography/intervention within recent 1 month.
- •7) Patients who underwent surgical treatment within recent 1 month.
- •8) Severely damaged cardiac function (EF<25%).
- •9) Allergic reaction to G-CSF, apheresis.
- •10) Allergic reaction to mouse anti CD34 antibody in reagents.
- •11) Malignancy or past history within past 5 years.
- •12) Diabetic proliferating retinopathy.
- •13) Within 3 months from angina pectoris, myocardial infarction, or stroke.
- •14) Leukemia, myeloproliferative disorder, myelodysplastic syndrome, sickle cell anemia.
- •15) Liver cirrhosis.
- •16) Interstitial pneumonia.
- •17) Cerebral arterial aneurysm which need treatment.
- •18) White blood cell count under 3,000/micro L or over 10,000/micro L.
- •19) Platelet count under 50,000/micro L.
- •20) Hemoglobin under 8g/dL.
- •21) AST (GOT) or ALT (GPT) 100 IU/L or over.
- •22) Albumin under 2g/dL.
- •23) Splenomegaly 15 cm or Larger in its longest diameter on CT imaging.
- •24) Pregnant.
- •25) Patient of HBV, HCV, HIV or HTLV1.
- •26) Participant of other clinical study.
- •27) Patients who are judged not to be appropriate to participate in this study.
研究者
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