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

Expanded access is currently available for this treatment.
Verified October 2012 by Osiris Therapeutics
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Osiris Therapeutics
ClinicalTrials.gov Identifier:
NCT00759018
First received: September 23, 2008
Last updated: October 10, 2012
Last verified: October 2012
History of Changes
  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
 Drug: Prochymal®

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

Further study details as provided by Osiris Therapeutics:

Intervention Details:
    Drug: Prochymal®
    Patients will be treated with Prochymal® twice per week at a dose of 2 x 10 hMSC/kg (actual body weight) for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart.
    Other Name: 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: Farrell Newman 443-545-4910 fnewman@osiris.com
Contact: Michelle Marcelino 443-545-1810 mmarcelino@osiris.com

  Show 28 Study Locations
Sponsors and Collaborators
Osiris Therapeutics
Quintiles
  More Information

No publications provided

Responsible Party: Osiris Therapeutics
ClinicalTrials.gov Identifier: NCT00759018     History of Changes
Other Study ID Numbers: 275
Study First Received: September 23, 2008
Last Updated: October 10, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Osiris Therapeutics:
GVHD
Prochymal
Graft vs Host Disease

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

ClinicalTrials.gov processed this record on May 19, 2013