The clinical trial investigating the safety in the treatment of osteonecrosis of the femoral head with a local application of recombinant human bFGF gelatin hydrogel for bone regeneration and preventing the femoral head collapse.

The clinical trial investigating the safety in the treatment of osteonecrosis of the femoral head with a local application of recombinant human bFGF gelatin hydrogel for bone regeneration and preventing the femoral head collapse. - The clinical application of recombinant human bFGF gelatin hydrogel for osteonecrosis of the femoral head.

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009250

Enrollment

Registered

2012-11-02

Start date

2013-03-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteonecrosis of the femoral head

Interventions

The local application of recombinant human bFGF gelatin hydrogel into the femoral head of osteonecrosis.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients diagnosed with stage-1 or stage-2 osteonecrosis of the femoral head. The affected femoral head of osteonecrosis can be considered suitable for the treatment with the local administration of bFGF gelatin hydrogel. The adequate function of major organs is preserved.

Exclusion criteria

Exclusion criteria: Patients with Osteonecrosis of the femoral head who had been operated of the affected femoral head. BMI over 30. Serious complications including uncontrolled diabetes, serious hypertension, severe heart diseases and severe pulmonary diseases etc. Malignancies treated within 5 years not including carcinoma in situ and intramucosal carcinoma. Judged inappropriate with the reason for mental disorder or mental status by the treating physician Active infection Under treating diabetic retinopathy including preproliferative diabetic retinopathy and proliferative diabetic retinopathy. Gelatin allergy Drug allergy considered not to be suitable with this study. receiving systemic corticosteroids over 10mg dosage of Prednisolone.

Design outcomes

Primary

Measure	Time frame
Presence of adverse events	—

Secondary

Measure	Time frame
Periodical assessment of clinical outcomes (VAS pain score, UCLA activity score, Harris Hip Score). Radiological assessment of the stage of osteonecrosis and the repaired femoral head using MRI.	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026