Status:
WITHDRAWN
Safety and Tolerability of I-040302 in Children and Young Adults With Solitary Bone Cysts
Lead Sponsor:
Kuros Biosurgery AG
Conditions:
Bone Cysts
Eligibility:
All Genders
6-16 years
Phase:
PHASE2
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 wi...
Eligibility Criteria
Inclusion
- Subjects 6 - 16 years of age
- Diagnostic evidence of unicameral bone cysts based on one or more of a combination of any of the following methods:
- Cyst fluid examination
- Plain radiographs
- MRI
- Subjects with the following types of cysts:
- Intact cysts that are either growing or at risk of fracture, requiring surgical intervention
- Persistence of a cyst cavity following cyst fracture that has received conservative treatment/s to repair the fracture
- Persistence of a cyst cavity despite repeated interventions
- Subjects with bone cyst volumes \< 30 mL
- Subjects must be appropriately communicative to verbalise pain.
- Subjects must be able to understand and be willing to comply with the protocol procedures.
- Subjects who have provided written informed consent to participate in the study
- The legally authorised representative of the child must give written informed consent after the child has agreed to participate in the study.
Exclusion
- A history of/or presence of active cancer
- Family history of retinoblastoma
- Indication of aneurysmal bone cyst on MRI, cyst aspiration or histology
- Possible presence of osteosarcoma or uncertain histology
- Systemic or localised infection at time of surgery
- Evidence of immune-suppression
- Evidence of hypercalcemia
- Cyst volume \> 30 mL
- Fracture present in the cortical bone surrounding the cyst
- Evidence of rapid venous drainage from the cyst determined by rapid disappearance of X-ray contrast medium during the surgical process.
- Suspected or known evidence of allergic reactions towards any of the components of I-040302
- Known clinically significant organ or systemic diseases such that, in the opinion of the investigator, the significance of the disease will compromise the subject's participation in the study
- Pregnant or lactating females
- Participation in another clinical trial within 3 months prior to trial start
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00459641
Start Date
December 1 2012
End Date
July 1 2019
Last Update
July 17 2012
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