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

Expanded access is currently available for this treatment.
Verified August 2014 by Mesoblast, Ltd.
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )
ClinicalTrials.gov Identifier:
NCT00759018
First received: September 23, 2008
Last updated: August 29, 2014
Last verified: August 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Elizabeth Burke 212-880-2060

  Show 27 Study Locations
Sponsors and Collaborators
Mesoblast International Sàrl
  More Information

No publications provided

Responsible Party: Mesoblast, Ltd. ( Mesoblast International Sàrl )
ClinicalTrials.gov Identifier: NCT00759018     History of Changes
Other Study ID Numbers: 275
Study First Received: September 23, 2008
Last Updated: August 29, 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 October 23, 2014