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Safety and Efficacy of Mesenchymal Stromal Cells (Amimestrocel ) in Diabetic Kidney Disease

Study acronym: MSC-DKD-001
StatusRecruiting
PhasePhase 2
Started2025-06-09
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 14, 2026 (before its estimated August 15, 2026 completion). Its status may not reflect the trial's current state.
Trial flagged as At Risk
Primary completion moved at least 3 months later May 15, 2026 → Aug 15, 2026
See other at-risk trials from Chinese PLA General Hospital

Amendment history

2026-07-12
Study Status, Arms and Interventions v5
Primary completion pushed: 2026-05-15 → 2026-08-15
2026-03-23
Study Status, Outcome Measures, Eligibility v4
Eligibility criteria-2 characters
Inclusion Criteria: - Men and women who are ≥ 4518 and ≤ 80 years old. Diagnosed with type 2 diabetes mellitus [...] -hour urine protein quantification is continuously ≥ 3.5 g, andor the urine albumin-to-creatinine ratio (UACR) > 1000 mg/g. The estimated glomerular filtration rate (eGFR) ≥ 2015 ml/min/1.73m² (calculated according to the CKD-EPI formula) [...]
Secondary endpointsdetails revised at 10 of 12 entries
2025-09-05
Study Status, Contacts/Locations v3
Study sitesdetails revised at 3 of 6 sites
2025-07-02
Study Status, Contacts/Locations v2
Study sites1→6
2025-06-26
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2025-05-15→confirmed 2025-06-09
Study sitesdetails revised at 1 of 1 site
2025-05-11
Original filing
This trial is to evaluate the efficacy and safety of umbilical cord-derived mesenchymal stromal cells (Amimestrocel ) in study subjects with progressive diabetic kidney disease (DKD), to investigate whether Amimestrocel can improve renal function or proteinuria of DKD patients.
Trial Details
NCT Number NCT06969807
Lead Sponsor Chinese PLA General Hospital
Conditions Diabetic Kidney Disease (DKD)
Enrollment 120 participants
Start Date 2025-06-09
Primary Completion 2026-08-15 (estimated)
Study Completion 2028-05-15 (estimated)
Updated on ClinicalTrials.gov 2026-07-14