Overview

Safety and Efficacy of Prochymal for the Salvage of Treatment-Refractory Acute GVHD Patients

Status:
Completed
Trial end date:
2007-02-08
Target enrollment:
0
Participant gender:
All
Summary
This study is designed to evaluate the safety and efficacy of Prochymal(TM) (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) in subjects experiencing treatment-refractory acute GVHD, Grades III-IV, that is refractory to standard first line therapies and at least one second-line therapy.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mesoblast International Sàrl
Mesoblast, Inc.
Treatments:
Remestemcel-l
Criteria
Inclusion Criteria:

- Subjects must be 6 months to 70 years of age inclusive.

- If female and of childbearing age, subjects must be non-pregnant, not breast-feeding,
and use adequate contraception. Male subjects must use adequate contraception.

- Subjects 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.

- Subjects must have minimal renal function as defined by:Calculated creatinine
clearance (CrCl) of > 30 mL/min using the Cockcroft-Gault equation.

- Subject must provide written informed consent and authorization for use and disclosure
of protected health information (PHI).

Exclusion Criteria:

- Subject has uncontrolled alcohol or substance abuse within 6 months of treatment.

- Subject has any underlying or current medical or psychiatric condition that, in the
opinion of the Investigator, would interfere with the evaluation of the subject (e.g.,
uncontrolled infection, right heart failure, pulmonary hypertension, etc.).

- Subject has a clinically significant, unstable arrhythmia.

- Subject has a known allergy to bovine or porcine products.

- Subject is unwilling to sign consent form for the long-term follow-up study, protocol
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