Chronic Kidney Disease stage4 Clinical Trial
Official title:
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
Verified date | March 2024 |
Source | Pharmicell Co., Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 10 |
Est. completion date | September 21, 2023 |
Est. primary completion date | September 21, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years to 79 Years |
Eligibility | 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 - Those with a history of renal transplantation - Those who have received dialysis within 3 months prior to the screening visit or who are planning to undergo dialysis during the clinical trial period - Pregnant, lactating, or planning during clinical trials - Those who do not agree to comply with the contraceptive method specified in this protocol during the clinical trial period - Those who are receiving drugs that are expected to affect the results of this clinical trial when judged by the investigator - Those who participated in other interventional clinical trials within 4 weeks prior to the screening visit and received investigational products/medical devices for investigational use or received procedures - Those who have or are planning to administer other cell therapy products - Those who are judged by the investigator to be inappropriate to participate in this clinical trial |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Pharmicell Co., Ltd. |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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) | The primary endpoint is an adverse event, and the level of the adverse event (AE) is analyzed according to the Common Terminology Criteria for Adverse Event (CTCAE) (version 5.0). | Adverse events are collected from the first administration of the investigational product to 12 months after the third administration of the investigational product. | |
Secondary | Changes in eGFR | Changes in eGFR after 1, 3, 6, 9, and 12 months of administration of the investigational product compared to the baseline | 1, 3, 6, 9, and 12 months of administration of the investigational product | |
Secondary | Changes in BUN | Changes in BUN after 1, 3, 6, 9, and 12 months of administration of the investigational product compared to the baseline | 1, 3, 6, 9, and 12 months of administration of the investigational product | |
Secondary | Changes in Creatinine | Changes in Creatinine after 1, 3, 6, 9, and 12 months of administration of the investigational product compared to the baseline | 1, 3, 6, 9, and 12 months of administration of the investigational product |
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