To evaluate the safety of the stromal cell infusion June 2001 [clinicaltrials_resource:d499ad03204bd6401253ddc5e7cdbcb3]
This is a pilot study of infusions of ex vivo expanded, gene marked donor bone marrow stromal cells following allogeneic bone marrow transplantation. The study is a within patient dose escalation safety evaluation. It is believed that this patient population may benefit from these donor stromal cell infusions.
As the stromal cells will be obtained from the original stem cell donor, no conditioning is required.
Patients will receive two infusions of mesenchymal cells (MSC) approximately 14 to 21 days apart unless there is unacceptable toxicity after the first infusion. The first dose of cells to be given will be 1x10^6 MSC/kg and the second dose of cells will be 5x10^6 MSC/kg. The patients will be followed for approximately 28 days following the second infusion for any toxicity. Only after all six patients have safely completed both infusions will we consider 5 x 10^6 MSC/kg a safe dose of allogeneic mesenchymal stem cells for infusion.
clinicaltrials_vocabulary:primary outcome [clinicaltrials_vocabulary:clinicaltrials_vocabulary:primary-outcome]
To evaluate the safety of the stromal cell infusion June 2001 [clinicaltrials_resource:d499ad03204bd6401253ddc5e7cdbcb3]
This is a pilot study of infusions of ex vivo expanded, gene marked donor bone marrow stromal cells following allogeneic bone marrow transplantation. The study is a within patient dose escalation safety evaluation. It is believed that this patient population may benefit from these donor stromal cell infusions.
As the stromal cells will be obtained from the original stem cell donor, no conditioning is required.
Patients will receive two infusions of mesenchymal cells (MSC) approximately 14 to 21 days apart unless there is unacceptable toxicity after the first infusion. The first dose of cells to be given will be 1x10^6 MSC/kg and the second dose of cells will be 5x10^6 MSC/kg. The patients will be followed for approximately 28 days following the second infusion for any toxicity. Only after all six patients have safely completed both infusions will we consider 5 x 10^6 MSC/kg a safe dose of allogeneic mesenchymal stem cells for infusion.
Bio2RDF identifier
d499ad03204bd6401253ddc5e7cdbcb3
Bio2RDF namespace
clinicaltrials_resource
Bio2RDF uri
http://bio2rdf.org/clinicaltrials_resource:d499ad03204bd6401253ddc5e7cdbcb3
measure [clinicaltrials_vocabulary:measure]
To evaluate the safety of the stromal cell infusion
time frame [clinicaltrials_vocabulary:time-frame]
description
This is a pilot study of infus ...... hymal stem cells for infusion.
identifier
clinicaltrials_resource:d499ad03204bd6401253ddc5e7cdbcb3
title
To evaluate the safety of the stromal cell infusion June 2001
@en
type
label
To evaluate the safety of the ...... 9ad03204bd6401253ddc5e7cdbcb3]
@en