Clinical Trial to Evaluate Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cell in Chro… (NCT05042206) | Clinical Trial Compass
CompletedPhase 1
Clinical Trial to Evaluate Safety of Allogeneic Bone Marrow Derived Mesenchymal Stem Cell in Chronic Kidney Disease
South Korea10 participantsStarted 2021-11-24
Plain-language summary
This clinical trial is an open, single-center, phase 1 clinical trial to evaluate the safety of allogeneic bone marrow-derived mesenchymal stem cell injection in patients with chronic kidney disease.
The purpose is to evaluate the safety for 12 months after administration of Cellgram-CKD 3 times in 10 patients with chronic kidney disease.
Who can participate
Age range19 Years – 79 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female between the ages of 19 and 79
* Those diagnosed with CKD stage 3b or 4 \[eGFR 15 - 44 ml/min/1.73 m2\] within 1 year before screening
* Those who voluntarily participated in the clinical trial and signed the Informed consent form
Exclusion Criteria:
* Those with severe cardiovascular disease (angina, myocardial infarction, unstable arrhythmia, heart failure, etc.) at the screening visit
* 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.) F. Stroke G. Systemic autoimmune disease
* Those whose test results fall under the following at the screening visit A. Pathogenic microorganism test (Hbs Ag, HCV Ab, HIV Ab, Syphilis) positive B. Uncontrolled hypertension (systolic blood pressure \>190 mmHg or diastolic blood pressure \>100 mmHg) or hypotension (systolic blood pressure \<90 mmHg or diastolic blood pressure \<50 mmHg) C. AST and ALT ≥ upper limit of normal x 3.0 D. Total bilirubin ≥ upper limit of normal x 1.5
* At screening, those who have the following treatment history A. Those who are being treated for severe systemic infection B. Those who have been treated with immunosuppressant within 28 days prior to screening
* T…
What they're measuring
1
Incidence of adverse event, and the level of the adverse event (AE) analyzed according to the Common Terminology Criteria for Adverse Event (CTCAE) (version 5.0)
Timeframe: Adverse events are collected from the first administration of the investigational product to 12 months after the third administration of the investigational product.