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WithdrawnNCT00459641Updated Jul 17, 2012

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

A Phase 2 interventional study of I-040302 and Standard of Care in Bone Cysts, sponsored by Kuros Biosurgery AG. Withdrawn. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2012-07-17.

Sponsored by Kuros Biosurgery AG · Phase 2, Interventional, and Treatment

Why this study was withdrawn
Stopped before any site initiation or any recruitment due to change in overall product development plan
Phase
Phase 2
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
6 Years to 16 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Bone Cysts

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Keywords

  • Osteogenic Gel
  • Solitary Bone Cysts
03

In context

Bone Cysts

18 studies on the registry are indexed under Bone Cysts; 5 are open to participants now.

Browse Bone Cysts studies →

Lead sponsor

Kuros Biosurgery AG is the lead sponsor of 12 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    1

    I-040302 doses of up to 1 mg, 2 mg or 4 mg of TGplPTH1-34

    Drug: I-040302

  • Active comparator
    2

    Standard of care (bone marrow aspirate or steroids)

    Other: Standard of Care

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

    Also known as: Bone marrow aspirate or steroids

06

What researchers measure

Primary outcomes

  1. Radiographic images

    Time frame: At 6 months and throughout the study

Secondary outcomes

  1. Blood parameters

    Time frame: At 6 months and throughout the study

  2. Vital signs

    Time frame: At 6 months and throughout the study

  3. Questionnaires of life questionnaire

    Time frame: At 6 months and throughout the study

  4. Pharmacoeconomic evaluation

    Time frame: At 6 months and throughout the study

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 17, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00459641
Lead sponsor
Kuros Biosurgery AG
Responsible party
Sponsor
First posted
Apr 12, 2007
Start date
Dec 2012
Primary completion
Jun 2014 (estimated)
Completion
Jul 2019 (estimated)
Last update
Jul 17, 2012

Study contacts

Virginia Jamieson, MD
study director · Kuros Biosurgery AG, Technoparkstrasse 1, CH-8005 Zurich

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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Discussion

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