Bone Cysts
Conditions
Keywords
Osteogenic Gel, Solitary Bone Cysts
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.
Interventions
DRUGI-040302
doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34
OTHERStandard of Care
Bone marrow aspirate or steroids
Sponsors
Kuros Biosurgery AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
Inclusion criteria
1. Subjects 6 - 16 years of age 2. 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 3. 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 4. Subjects with bone cyst volumes \< 30 mL 5. Subjects must be appropriately communicative to verbalise pain. 6. Subjects must be able to understand and be willing to comply with the protocol procedures. 7. Subjects who have provided written informed consent to participate in the study 8. The legally authorised representative of the child must give written informed consent after the child has agreed to participate in the study.
Exclusion criteria
1. A history of/or presence of active cancer 2. Family history of retinoblastoma 3. Indication of aneurysmal bone cyst on MRI, cyst aspiration or histology 4. Possible presence of osteosarcoma or uncertain histology 5. Systemic or localised infection at time of surgery 6. Evidence of immune-suppression 7. Evidence of hypercalcemia 8. Cyst volume \> 30 mL 9. Fracture present in the cortical bone surrounding the cyst 10. Evidence of rapid venous drainage from the cyst determined by rapid disappearance of X-ray contrast medium during the surgical process. 11. Suspected or known evidence of allergic reactions towards any of the components of I-040302 12. 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 13. Pregnant or lactating females 14. Participation in another clinical trial within 3 months prior to trial start
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic images | At 6 months and throughout the study |
Secondary
| Measure | Time frame |
|---|---|
| Blood parameters | At 6 months and throughout the study |
| Vital signs | At 6 months and throughout the study |
| Questionnaires of life questionnaire | At 6 months and throughout the study |
| Pharmacoeconomic evaluation | At 6 months and throughout the study |
Outcome results
None listed