MedTrace Logo

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

NCT01275612 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2018-03-21

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

Mesenchymal stromal cell infusion

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.

Sponsors & Collaborators

  • Mario Negri Institute for Pharmacological Research

    lead OTHER

Principal Investigators

  • Giuseppe Remuzzi, MD · Department of Immunology and Clinical Transplantation/Mario Negri Institute for Pharmacological Research and Ospedali Riuniti of Bergamo

  • Norberto Perico, MD · Mario Negri Institute for Pharmacological Research

  • Martino Introna, MD · Cell and Gene Therapy Laboratory "G.Lanzani" Bergamo

  • Alessandro Rambaldi, MD · Unit of Hematology - Ospedali Riuniti of Bergamo

  • Carlo Tondini, MD · Unit of Oncology - Ospedali Riuniti of Bergamo

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2018-03-19
Completion
2018-03-19

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01275612 on ClinicalTrials.gov