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临床试验/JPRN-jRCTb030210237
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

发起方
Ohtake Takayasu

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