Skip to Content

Vanderbilt-Ingram Cancer CenterVanderbilt-Ingram Cancer Center

 

Learn More

VICC toll-free number 1-877-936-8422

Clinical Trial VICCPED0921

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.

Principal Investigator(s)

Jennifer Domm

Details

  • 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

Description

None Provided.

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.