WithdrawnPhase 1

Mesenchymal Stem Cells In Cisplatin-Induced Acute Renal Failure In Patients With Solid Organ Cancers

Stopped: 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

Italy0Started 2010-11

Plain-language summary

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.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Serum creatinine concentration.

Timeframe: 15 days post-cisplatin infusion

Trial details

NCT IDNCT01275612

SponsorMario Negri Institute for Pharmacological Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-03-19

View on ClinicalTrials.gov More Solid Tumors trials

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.