Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2025-12-26 @ 11:12 PM
NCT ID:
NCT01275612
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01275612
Study Brief:
Protocol Section:
NCT01275612