KCT0006783
Recruiting
未知
An open label, single-center, phase 1 study to evaluate the safety of Allogeneic bone marrow derived mesenchymal stem cell in patients with Chronic Kidney Disease
ConditionsDiseases of the genitourinary system
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Diseases of the genitourinary system
- Sponsor
- Asan Medical Center
- Enrollment
- 10
- Status
- Recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Male or female between the ages of 19 and 79
- •2\. Those diagnosed with CKD stage 3b or 4 \[eGFR 15 \- 44 ml/min/1\.73 m2] within 1 year before screening
- •3\. Those who voluntarily participated in the clinical trial and signed the Informed consent form
Exclusion Criteria
- •1\. Those with severe cardiovascular disease (angina, myocardial infarction, unstable arrhythmia, heart failure, etc.) at the screening visit
- •2\. Those with the following medical history/comorbidities
- •A. Gentamicin hypersensitivity reaction
- •B. Solid cancer or malignant blood disease within 5 years prior to screening
- •C. Clinically significant cognitive disorder, dementia or psychiatric disorder
- •D. Alcohol or drug abuse
- •E. Severe respiratory disease (COPD, asthma, pneumonia, pulmonary embolism, pneumothorax, etc.)
- •G. Systemic autoimmune disease
- •3\. Those whose test results fall under the following at the screening visit
- •A. Pathogenic microorganism test (Hbs Ag, HCV Ab, HIV Ab, Syphilis) positive
Outcomes
Primary Outcomes
Not specified
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