Clinical Trial VICCPED0921
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.
- Protocol No. VICCPED0921
- Open Date: 05/01/2009
- Staging: Phase I
- Age Group: Children
- Scope: National
- Objective: Allow pediatric patients who have failed to respond to steroid treatment for acute GVHD expanded access to Prochymal.
- Disease Sites: Pediatrics; Leukemia
- Therapies: Molecular Targeted Agents / Immunotherapy / Biologics
- Drugs: Prochymal
- Participating Institutions: Vanderbilt University
- National Clinical Trial ID: NCT00759018
- Secondary Protocol No: 275
|Ages Eligible for Study:||2 Months to 17 Years|
|Genders Eligible for Study:||Both|
• 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.