Clinical Trial: Safety and Tolerability of I-040302 in Children and Young Adults With Solitary Bone Cysts

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Phase 2 Randomised, Open-label, Multi-centre Ascending Dose Study of the Efficacy, Safety and Tolerability of I-040302 Versus Control Injection (Bone Marrow Aspirate or Steroids) in Children and You

Brief Summary: This is a randomised, controlled, open-label study of a single intralesional administration of I-040302 or a single bone marrow aspirate or a single steroid injection (methylprednisolone). Subjects will undergo screening with X-ray and magnetic resonance imaging (MRI) in the diagnosis of a solitary bone cyst.

Detailed Summary:
Sponsor: Kuros Biosurgery AG

Current Primary Outcome: Radiographic images [ Time Frame: At 6 months and throughout the study ]

Original Primary Outcome: Radiographic images

Current Secondary Outcome:

  • Blood parameters [ Time Frame: At 6 months and throughout the study ]
  • Vital signs [ Time Frame: At 6 months and throughout the study ]
  • Questionnaires of life questionnaire [ Time Frame: At 6 months and throughout the study ]
  • Pharmacoeconomic evaluation [ Time Frame: At 6 months and throughout the study ]


Original Secondary Outcome:

  • Clinical assessments of the fracture site
  • Blood parameters
  • Vital signs
  • Questionnaires of life
  • Pharmacoeconomic evaluation


Information By: Kuros Biosurgery AG

Dates:
Date Received: April 11, 2007
Date Started: December 2012
Date Completion: July 2019
Last Updated: July 16, 2012
Last Verified: July 2012