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

Status:

NO_LONGER_AVAILABLE

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

Lead Sponsor:

Mesoblast, Inc.

Conditions:

Graft vs Host Disease

Graft-Versus-Host Disease

Eligibility:

All Genders

2-17 years

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.

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...

Eligibility Criteria

Inclusion

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.

Exclusion

Key Trial Info

Start Date :

Trial Type :

EXPANDED_ACCESS

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00759018

Last Update

March 9 2020

Active Locations (27)

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Page 1 of 7 (27 locations)

Phoenix Children's Hospital

Phoenix, Arizona, United States, 85016

Children's Hospital of Orange County

Orange, California, United States, 92868

UCSF

San Francisco, California, United States, 94143