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Clinical Trials/EUCTR2008-007869-23-IT
EUCTR2008-007869-23-IT
Active, not recruiting
Not Applicable

Mesenchymal Stromal Cells (MSC) for the treatment of severe (grade II-IV) steroid-resistant Graft Versus Host Disease (GVHD): a phase I trial - MSC-GvHD

AZIENDA OSPEDALIERA SAN GERARDO DI MONZA0 sitesJuly 23, 2009
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ConditionsGraft versus Host disease GvHD steroid resistant

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Graft versus Host disease GvHD steroid resistant
Sponsor
AZIENDA OSPEDALIERA SAN GERARDO DI MONZA
Status
Active, not recruiting
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 23, 2009
End Date
TBD
Last Updated
14 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
AZIENDA OSPEDALIERA SAN GERARDO DI MONZA

Eligibility Criteria

Inclusion Criteria

  • •1\. Informed consent. 2\. Patients between 2 and 65 years of age 3\. Patients are required to meet the following inclusion criteria: Any patient that has undergone allogeneic stem cell transplantation with steroid refractory grades II\-IV acute GvHD either occurring post transplant, or induced by donor lymphocyte infusions (DLI) or T\-cell add back, or chronic steroid refractory GVHD in acute phase. a) Steroids have been given, for instance metilprednisolone 2 mg/kg/day, for at least 72h in case of progressive acute GvHD, 5 days in case of stable acute GVHD (grade II to IV) or chronic GvHD in active phase. b) Despite this treatment, the patient has unresponsive GvHD after 5 days, or progressive acute GvHD after 72 hours.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes
  • •F.1\.2\.1 Number of subjects for this age range
  • •F.1\.3 Elderly (\>\=65 years) no
  • •F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

  • •1\. Inability to obtain informed consent. 2\. Patients/subjects with documented uncontrolled EBV, CMV or fungal infection 3\. Patients in poor clinical conditions with life expectancy of less than 30 days.

Outcomes

Primary Outcomes

Not specified

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