Clinical trial · Interventional
Mesenchymal Stem Cells In Cisplatin-Induced Acute Renal Failure In Patients With Solid Organ Cancers
Ex-Vivo Expanded Mesenchymal Stem Cells To Repair The Kidney And Improve Function In Cisplatin-Induced Acute Renal Failure In Patients With Solid Organ Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Patients evaluated so far could not be enrolled because they did not meet the primary criterion of acute renal failure provided by the study protocol
Summary
Brief summary (as posted)
This is a pilot, explorative, study to test the feasibility and safety of systemic infusion of donor ex-vivo expanded Mesenchymal Stem Cells to repair the kidney and improve function in patients with solid organ cancers who develop acute renal failure after chemotherapy with cisplatin.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Kidney Injury | — | UNRESOLVED | — |
| Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mesenchymal stromal cell infusion | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cell therapy
- interventionNames
- Biological: Mesenchymal stromal cell infusion
Primary outcomes (1)
- measure
- Serum creatinine concentration.
- timeFrame
- 15 days post-cisplatin infusion
- description
- To evaluate the rate of renal function loss up to 15 days post-cisplatin infusion.
Secondary outcomes (2)
- measure
- Neutrophil gelatinase-associated lipocalin (NGAL)
- timeFrame
- At days 0,2,5,7,12,15,18 and 30.
- measure
- N-acetyl-p- D glucosaminidase enzyme (NAG)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female patients * Requiring cisplatin therapy (\>80mg/m2) against advanced head and neck carcinoma, non-small cell lung cancer stage IIIB/IV, bladder transitional cell carcinoma locally advanced or metastatic, which are not amenable to surgical resection or ablation with curative intent * An Eastern Cooperative Oncology Group performance status (ECOG PS) \<2 * Normal renal, hepatic and bone marrow function * Physician's assessment of life expectancy: 4-10 months * Aged \> 18 years * Evidence of acute renal injury as assessed by percent increase of NGAL concentration in spot urine \> 3500% over baseline values at day 2 post-cisplatin infusion * Written informed consent Exclusion Criteria: * Specific contraindication to MSC infusion * Serious concomitant diseases not adequately responding to specific therapy * Symptomatic brain metastases * Pregnancy * Previous cisplatin infusion
References
Publications (0)
Data not yet available