Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Prochymal Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHD

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )
ClinicalTrials.gov Identifier:
NCT00759018
First received: September 23, 2008
Last updated: January 5, 2015
Last verified: January 2015

September 23, 2008
January 5, 2015
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Complete list of historical versions of study NCT00759018 on ClinicalTrials.gov Archive Site
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Prochymal Expanded Access Treatment for Pediatric Patients Who Have Failed Steroids for Acute GVHD
Expanded Access of Prochymal (Ex-vivo Cultured Adult Human Mesenchymal Stem Cells) Infusion for the Treatment of Pediatric Patients Who Have Failed to Respond to Steroid Treatment for Acute GVHD

This protocol allows for the treatment of pediatric patients, male and female, between the ages of 2 months and 17 years. Patients must have failed steroid treatment for Grade B-D acute GVHD.

For the treatment of pediatric patients who have failed to respond to steroid treatment for acute graft-versus-host disease (GVHD). Failing steroid treatment for acute GVHD is defined as any Grade B-D (IBMTR grading) of acute GVHD that is not improving after at least 3 days of methylprednisolone (≥ 1 mg/kg/day) or equivalent.

Patients will be treated with Prochymal twice per week at a dose of 2 x 10^6 hMSC/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.

Expanded Access
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  • Graft vs Host Disease
  • Graft-Versus-Host Disease
Biological: remestemcel-L
Patients will be treated with Prochymal® twice per week at a dose of 2 x 10^6 hMSC/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.
Other Names:
  • Prochymal®
  • Ex-vivo Cultured Adult Human Mesenchymal Stem Cells
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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Inclusion Criteria:

  • Patients must be 2 months to 17 years of age, inclusive
  • Patients who have failed to respond to steroid treatment for Grades B-D acute GVHD
  • Patient must not have a known allergy to bovine or porcine products
  • Patient must not have received a transplant for a solid tumor disease.
  • Patient must not have evidence of a pulmonary infiltrate or diffuse alveolar hemorrhage and is likely to require more than 2L of oxygen via face mask or an estimated FiO2 of 28% via other delivery methods in order to sustain an O2 saturation of 92% during the next 3 days.
Both
2 Months to 17 Years
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Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00759018
275
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Mesoblast, Ltd. ( Mesoblast International Sàrl )
Mesoblast International Sàrl
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Mesoblast, Ltd.
January 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP