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A Study on the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSCs treatment group | Experimental | Human umbilical cord mesenchymal stem cells injection is a human expanded umbilical cord mesenchymal stem cells suspension |
|
| Placebo-control group | Placebo Comparator | Saline solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Human umbilical cord mesenchymal stem cells injection | Biological | Pahse 1: Patients will be enrolled into one of three cohorts to receive single injection of human umbilical cord mesenchymal stem cells injection(5×10^5 cells × vascular surface area (cm²), 2.5×10^6 cells × vascular surface area (cm²), 5×10^6 cells × vascular surface area (cm²)). Phase 2: Based on the data obtained from Phase 1, the investigator will select one dose cohort to conduct study. |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | Phase1: Exploration of dose-limiting toxicity (DLT) and the optimal dose for the phase 2 after the admistration of human umbilical cord mesenchymal stem cells injection. | Day 28 |
| Evaluating the efficacy of human umbilical cord mesenchymal stem cells injection in preventing stenosis | Phase2: Observation the primary patency rate and secondary patency rate of the AVF after administration of human umbilical cord mesenchymal stem cells | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Primary patency rate and secondary patency rate | Observation the primary patency rate and secondary patency rate of the AVF after surgery. | 1 year |
| Incidence of infection complications | Observation the incidence of infection complications after AVF surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianhua Dong | Contact | 02580864326 | dongjianhua007@126.com |
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Phase 1 was a a prospective, single-arm, open-label study. Phase 2 was a prospective, randomized, placebo-controlled, and dose-escalation study.
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|
| saline solution | Other | Phase 2: Saline solution will be given at the same quantity and following the same schedule |
|
| 1 year |
| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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