Arteriovenous Fistula Stenosis
Conditions
Brief summary
A Study on the Safety and Efficacy of Human Umbilical Cord Mesenchymal Stem Cells in Preventing Arteriovenous Fistula Stenosis
Interventions
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.
OTHERsaline solution
Phase 2: Saline solution will be given at the same quantity and following the same schedule
Sponsors
Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Phase 1 was a a prospective, single-arm, open-label study. Phase 2 was a prospective, randomized, placebo-controlled, and dose-escalation study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Diabetic nephropathy with estimated glomerular filtration rate (eGFR) \< 15 mL/min·1.73m²; 2. Requirement for creation of primary forearm cephalic vein-radial artery autologous arteriovenous fistula ; 3. Vessel criteria: cephalic vein diameter ≥ 2.0 mm (after tourniquet inflation) and radial artery diameter ≥ 1.5 mm; 4. Subject agrees to comply with the study treatment plan and visit schedule, is voluntarily enrolled, and has provided written informed consent.
Exclusion criteria
1. Patients with conditions unsuitable for AVF, including surgical site infection, uncontrolled heart failure, malignant tumor, or hypotension; 2. Patients with stenosis or adjacent lesions in the proximal upper extremity vessels or central veins that affect arterial inflow or venous outflow; 3. Patients with a history of pacemaker implantation; 4. Patients with known hypersensitivity to human serum albumin, human platelet lysate, gentamicin sulfate, anesthetic agents, or other related products; 5. Positive for hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum antibody, or human immunodeficiency virus antibody; 6. Subjects who have participated in, are currently participating in, or plan to participate in other interventional clinical trials within 30 days prior to screening or during the study period; 7. Any other conditions deemed inappropriate by the investigator for enrollment in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dose-limiting toxicity (DLT) | Day 28 | 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. |
| Evaluating the efficacy of human umbilical cord mesenchymal stem cells injection in preventing stenosis | 3 months | Phase2: Observation the primary patency rate and secondary patency rate of the AVF after administration of human umbilical cord mesenchymal stem cells |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency rate and secondary patency rate | 1 year | Observation the primary patency rate and secondary patency rate of the AVF after surgery. |
| Incidence of infection complications | 1 year | Observation the incidence of infection complications after AVF surgery |
Contacts
CONTACTJianhua Dong
Outcome results
None listed