Trials Sponsors Conditions Drugs Pricing

Conditions

Acute Kidney Injury Solid Tumors

Keywords

Mesenchymal Stromal CellsSolid tumorsCisplatin therapyAcute kidney injury

Outcome Measures

Primary Outcomes (1)

Serum creatinine concentration.
To evaluate the rate of renal function loss up to 15 days post-cisplatin infusion.
15 days post-cisplatin infusion

Secondary Outcomes (2)

Neutrophil gelatinase-associated lipocalin (NGAL)
At days 0,2,5,7,12,15,18 and 30.
N-acetyl-p- D glucosaminidase enzyme (NAG)
At days 0,2,5,7,12,15,18 and 30.

Study Arms (1)

Cell therapy

EXPERIMENTAL

Biological: Mesenchymal stromal cell infusion

Interventions

Mesenchymal stromal cell infusionBiological

The first 3 patients will receive a single i.v infusion of donor ex-vivo expanded MSC (1 x 106 MSC/kg). If the efficacy outcome of cell treatment is negligible or partial and the procedure is safe, a second group of additional 3 patients will be enrolled. They will be given MSC i.v infusion at higher dose (2 x 106 MSC/kg).Should the therapeutic efficacy of this treatment again negligible or marginal, but still safe, a third group of 3 patients will be enrolled in the study. The dose of cells to be infused will be up-titrated to 5 x 106 MSC/kg.

Cell therapy

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 80 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

Mario Negri Institute for Pharmacological Research
Otherlead

Study Sites (1)

Unit of Oncology - Ospedali Riuniti of Bergamo

Bergamo, BG, 24128, Italy

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

Giuseppe Remuzzi, MD
Department of Immunology and Clinical Transplantation/Mario Negri Institute for Pharmacological Research and Ospedali Riuniti of Bergamo
STUDY CHAIR
Norberto Perico, MD
Mario Negri Institute for Pharmacological Research
PRINCIPAL INVESTIGATOR
Martino Introna, MD
Cell and Gene Therapy Laboratory "G.Lanzani" Bergamo
PRINCIPAL INVESTIGATOR
Alessandro Rambaldi, MD
Unit of Hematology - Ospedali Riuniti of Bergamo
PRINCIPAL INVESTIGATOR

Enrollment

0 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NA
Masking: NONE
Purpose: TREATMENT
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 11, 2011

First Posted

January 12, 2011

Study Start

November 2010

Actual (reported)

Primary Completion

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Cell therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

Cell therapy

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations