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

Expanded access is currently available for this treatment.

Verified June 2011 by Osiris Therapeutics

First Received on September 23, 2008. Last Updated on June 15, 2011 History of Changes

Sponsor:	Osiris Therapeutics
Collaborator:	Quintiles
Information provided by:	Osiris Therapeutics
ClinicalTrials.gov Identifier:	NCT00759018

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:

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 106 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: Kelly Selmanoff, MS	443-545-1811	kselmanoff@osiris.com
Contact: Michelle Marcelino	443-535-1810	mmarcelino@osiris.com

Show 24 Study Locations

Sponsors and Collaborators

Osiris Therapeutics

Quintiles

More Information

No publications provided

Responsible Party:	Lode Debrabandere, Ph.D, Senior Vice President, Therapeutics, Osiris Therapeutics, Inc.
ClinicalTrials.gov Identifier:	NCT00759018 History of Changes
Other Study ID Numbers:	275
Study First Received:	September 23, 2008
Last Updated:	June 15, 2011
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 February 07, 2012