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

Expanded access is currently available for this treatment.
Verified April 2014 by Mesoblast, Ltd.
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd.
ClinicalTrials.gov Identifier:
NCT00759018
First received: September 23, 2008
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Graft vs Host Disease
Graft-Versus-Host Disease
Biological: remestemcel-L

Study Type: Expanded Access     What is Expanded Access?
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Mesoblast, Ltd.:

Intervention Details:
    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
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   2 Months to 17 Years
Genders Eligible for Study:   Both
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759018

Contacts
Contact: Elizabeth Burke elizabeth.burke@mesoblast.com

  Show 28 Study Locations
Sponsors and Collaborators
Mesoblast, Ltd.
  More Information

No publications provided

Responsible Party: Mesoblast, Ltd.
ClinicalTrials.gov Identifier: NCT00759018     History of Changes
Other Study ID Numbers: 275
Study First Received: September 23, 2008
Last Updated: April 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mesoblast, Ltd.:
GVHD
Prochymal
Graft vs Host Disease

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on April 22, 2014