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

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ClinicalTrials.gov Identifier: NCT00759018
Expanded Access Status : No longer available
First Posted : September 25, 2008
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Mesoblast, Ltd. ( Mesoblast, Inc. )

Study Description
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Brief Summary:
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 or disease Intervention/treatment
Graft vs Host Disease Graft-Versus-Host Disease Biological: remestemcel-L

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 hematopoietic stem cells (hMSC)/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.

Study Design
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Study Type : 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 the National Library of Medicine


Interventions
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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
Eligibility Criteria
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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 sign an informed consent form (ICF) before any protocol-related procedures, including any pre-treatment procedures, are performed.
  • Since patients being treated with Prochymal® under this protocol are under 18, a parental signature of informed consent will be required.
  • Patients must be 2 months to 17 years of age, inclusive.
  • Patients must have failed to respond to steroid treatment for Grades B-D acute GVHD • Failure to respond to steroid treatment for acute GVHD is defined as any Grade B-D acute GVHD that is not improving after at least 3 days of methylprednisolone (≥1 milligram per kilogram per day [mg/kg/day]) or equivalent.

Exclusion criteria:

  • Patient must not have a known allergy to bovine or porcine products.
  • Patient must not have received a transplant for a solid tumor disease.
  • Patients must not have evidence of a pulmonary infiltrate or diffuse alveolar hemorrhage and must be unlikely to require more than 2 liters (L) of oxygen via face mask or an estimated fraction of inspired oxygen (FiO2) of 28% via other delivery methods in order to sustain an O2 saturation of 92% during the next 3 days.
Contacts and Locations
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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


Locations
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Sponsors and Collaborators
Mesoblast, Inc.
Investigators
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Study Director: Mahboob Rahman Mesoblast, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mesoblast, Inc.
ClinicalTrials.gov Identifier: NCT00759018    
Other Study ID Numbers: 275
First Posted: September 25, 2008    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020
Keywords provided by Mesoblast, Ltd. ( Mesoblast, Inc. ):
GVHD
Prochymal
Graft vs Host Disease
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Remestemcel-l
 Anti-Inflammatory Agents
Antiviral Agents
Anti-Infective Agents