Status:
COMPLETED
Safety and Efficacy of Prochymal for the Salvage of Treatment-Refractory Acute GVHD Participants
Lead Sponsor:
Mesoblast, Inc.
Conditions:
Graft Versus Host Disease
Eligibility:
All Genders
6-70 years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate the safety and efficacy of Prochymal® (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) in participants experiencing treatment-refractory acute GVHD, Grades III-...
Detailed Description
Allogeneic HSCT is used in the treatment of a variety of hematological, myeloproliferative and lymphoproliferative disorders, and malignancies involving solid tumors. Participants receiving HSCT can d...
Eligibility Criteria
Inclusion
- Participants must be 6 months to 70 years of age inclusive.
- If female and of childbearing age, participants must be non-pregnant, not breast-feeding, and use adequate contraception. Male participants must use adequate contraception.
- Participants must have Grade III-IV acute GVHD that has failed to respond to standard first and at least one second-line therapy. Biopsy for confirmation of both skin and gastrointestinal GVHD is not mandatory, but is recommended when feasible. Enrollment should not be delayed awaiting biopsy results.
- Participants must have minimal renal function as defined by: Calculated creatinine clearance (CrCl) of \> 30 milliliters/minute (mL/min) using the Cockcroft-Gault equation.
- Participant must provide written informed consent and authorization for use and disclosure of protected health information (PHI).
Exclusion
- Participant has uncontrolled alcohol or substance abuse within 6 months of treatment.
- Participant has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the participant (e.g., uncontrolled infection, right heart failure, pulmonary hypertension, etc.).
- Participant has a clinically significant, unstable arrhythmia.
- Participant has a known allergy to bovine or porcine products.
- Participant is unwilling to sign consent form for the long-term follow-up study, protocol 271.
Key Trial Info
Start Date :
November 18 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2007
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT00284986
Start Date
November 18 2005
End Date
February 8 2007
Last Update
October 30 2025
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27708