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Clinical Trials/EUCTR2007-004310-14-BE
EUCTR2007-004310-14-BE
Active, not recruiting
Phase 1

Infusion of mesenchymal stem cells as treatment for steroid resistant grade II to IV acute GVHD or poor graft function: a multicenter phase II study

CHU-ULG0 sites120 target enrollmentDecember 10, 2007

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Not specified
Sponsor
CHU-ULG
Enrollment
120
Status
Active, not recruiting
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
December 10, 2007
End Date
TBD
Last Updated
last year
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
CHU-ULG

Eligibility Criteria

Inclusion Criteria

  • Patient eligibility criteria
  • 1\. Male or female of any age.
  • 2\. Previous allogeneic transplantation or autologous transplantation (for part 2 only) of HSC at any time before.
  • 3\. Informed consent given by donor or his/her guardian if of minor age.
  • 4\. Additional criteria for each part of the protocol:
  • Part 1: MSC for steroid\-refractory grade II\-IV acute GVHD
  • \- Acute GVHD refractory to mPDN 2 mg/kg/day or equivalent
  • Part 2: MSC for poor graft function (PGF)
  • \- Cytopenia in 2 or 3 lineages:
  • \- Cytopenia duration \= 2 weeks beyond day 28 after autologous HCT, or day 42 Part 3: MSC \+ DLI for poor donor T\-cell chimerism

Exclusion Criteria

  • 1\. HIV positive.
  • 2\. Active uncontrolled infection at time of scheduled MSC infusion.
  • 3\. Relapsing or progressing malignancy.

Outcomes

Primary Outcomes

Not specified

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