Solitary Bone Cysts MedDRA version: 9.1 Level: LLT Classification code 10041309 Term: Solitary bone cyst
Conditions
Interventions
Product Name: Osteogenic Gel I-040302
Product Code: I-040302
Pharmaceutical Form: Gel for injection
Current Sponsor code: TGplPTH1-34
Co
Sponsors
Kuros Biosurgery AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged 6 - =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 > 30mL 9. Patients who have had open curettage or osteosynthesis of the bone cyst 10. Fracture present in the cortical bone surrounding the cyst 11. Evidence of rapid venous drainage from the cyst determined by rapid disappearance of X-ray contrast medium during the surgical process. 12. Suspected or known evidence of allergic reactions towards any of the components of I-040302 13. 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 14. Females of child-bearing potential 15. Participation in another clinical trial within 3 months prior to trial start
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether a single I-040302 implantation at concentrations of 33 µg/mL, 67 µg/mL or 133 µg/mL in a volume of up to 30mL (i.e. delivering doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34 respectively) can improve bone cyst healing at 6 months, versus a single injection of bone marrow aspirate or a single steroid injection.; Secondary Objective: To assess the safety and tolerability of I-040302 To assess the pharmacokinetics of PTH1-34 To assess antibody formation against PTH1-34 and TGp1PTH1-24 To assess the number of recurrent surgical interventions annually until 5 years after study treatment To assess the rate of bone cyst healing annually until 5 years after study treatment To assess the effects of I-040302 on bone growth in the affected limb annually until 5 years after study treatment To evaluate quality of life and functional ability ; Primary end point(s): The primary endpoint of the study is the cyst resolution at 6 months. The cyst resolution (blinded central evaluation) will be defined radiographically (based on MRI and X-ray) using:- • A reduction in Cyst Index of 1 point • 75% or more reduction in cyst volume The extend of cyst resolution at each time-point will be defined and assessed by an independent radiological panel, blinded to the treatment. An analysis of the 6 month cyst healing data will be undertaken once all subjects have completed the 6 month visit. A further analysis will be made after all subjects have completed one and two year follow-up. Thereafter, annual reporting of data from all available subjects will be conducted for 5 years after application of I-040302. Secondary Endpoint(s) • The change in cyst index at 6 months, and annually until 5 years after study treatment, compared to baseline i | — |
Countries
Czech Republic, Slovakia, United Kingdom
Outcome results
None listed