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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


Phase 2
6 Years
16 Years
Not Enrolling
Both
Bone Cysts

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Radiographic images

Outcome Time Frame:

At 6 months and throughout the study

Safety Issue:

No

Principal Investigator

Virginia Jamieson, MD

Investigator Role:

Study Director

Investigator Affiliation:

Kuros Biosurgery AG, Technoparkstrasse 1, CH-8005 Zurich

Authority:

Switzerland: Ethikkommission

Study ID:

CS I-040302/01

NCT ID:

NCT00459641

Start Date:

December 2012

Completion Date:

July 2019

Related Keywords:

  • Bone Cysts
  • Osteogenic Gel
  • Solitary Bone Cysts
  • Bone Cysts
  • Cysts

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