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

Bone Cysts Clinical Trial

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 Young Adults With Solitary Bone Cysts

Status Withdrawn

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00459641
Study type	Interventional
Source	Kuros Biosurgery AG
Contact
Status	Withdrawn
Phase	Phase 2
Start date	December 2012
Completion date	July 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT04737590` - Bioactive Glass or Allogenic Bone in Pediatric Bone Cysts	N/A
Completed	`NCT03076138` - Gene-activated Bone Substitute for Maxillofacial Bone Regeneration	N/A
Enrolling by invitation	`NCT05075148` - Aneurysmal Bone Cyst Imaging After Interventional Radiology Treatment
Recruiting	`NCT05880628` - Evaluation of Faisability, Safety and Effectiveness and of Discogel in Patients With Aneurysmal and Simple Bone Cysts