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

Expanded access is no longer available for this treatment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00759018
First Posted: September 25, 2008
Last Update Posted: October 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast International Sàrl )
  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. ( Mesoblast International Sàrl ):

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

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759018


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

Responsible Party: Mesoblast International Sàrl
ClinicalTrials.gov Identifier: NCT00759018     History of Changes
Other Study ID Numbers: 275
First Submitted: September 23, 2008
First Posted: September 25, 2008
Last Update Posted: October 22, 2015
Last Verified: October 2015

Keywords provided by Mesoblast, Ltd. ( Mesoblast International Sàrl ):
GVHD
Prochymal
Graft vs Host Disease

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