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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.
The screening test is performed after the clinical trial subject consents in writing to participate in the clinical trial.
Subjects who meet the inclusion/exclusion criteria are registered in the clinical trial, and Cellgram-CKD is injected intravenously by puncturing a vein with a needle. After injecting Cellgram-CKD three times at an interval of 2 weeks (14 days), the subject visits the testing institution at 1 month, 3 months, 6 months, 9 months and 12 months for safety evaluation.
However, since the safety of Cellgram-CKD has not been established, proceed as follows.
In the first 3 subjects who received the investigational product, if no adverse events of Grade 3 or higher according to the NCI-CTCAE related to the investigational product occur 14 days after the 1st and 2nd administration, and 1 month after the 3rd administration, the remaining subjects were sequentially treated. Register as a member and conduct clinical trials.
If an adverse event of Grade 3 or higher according to the NCI-CTCAE standard related to the test drug occurs in two of the first three subjects, the clinical trial is terminated early. is conducted by registering three additional test subjects in the same way as the first.
If one or more of the three subjects develops a Grade 3 or higher adverse event related to the investigational product, the clinical trial is terminated early, and the remaining subjects are treated only if all three subjects do not have a Grade 3 or higher adverse reaction related to the investigational product. Register to continue the clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cellgram-CKD | Experimental | Subjects receive a safety evaluation at 1 month, 3 months, 6 months, 9 months and 12 months after intravenous infusion of Cellgram-CKD 10mL at intervals of 2 weeks (14 days) 3 times. In the case of Cellgram-CKD, a milky white cell suspension solution is filled in a colorless and transparent plastic syringe, and the syringe tip is fixed with an obturator. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cellgram-CKD | Biological | Allogeneic bone marrow-derived mesenchymal stem cell therapy for the treatment of chronic kidney disease |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Changes in BUN |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kim Hyosang | Asan Medical Center Nephrology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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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 |
| 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 |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |