A phase III clinical trial for the two months safety and efficacy evaluation of Ostem™ (autologous cultured osteoblasts) in patients with fracture

Completed

• Conditions: ong bone fracture; Injury, Occupational Diseases, Poisoning; Fracture

• Registration Number: ISRCTN10637905
• Lead Sponsor: Individual sponsor (South Korea)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-22
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

1. Long bone fracture (femur, tibia, radius, ulna, humerus) patients
2. Aged 15 and 65 years, either sex
3. Approximately six weeks after the first open or closed reduction, the score of callus formation was lower than 3 points
4. Individuals who have completed a written consent form

Exclusion Criteria

1. Patient who is oversensitive to bovine protein
2. Patients with a known history of anaphylaxis to gentamicin
3. Patients with acute infection in bone defects
4. Patients who have communicable disease (positive reaction against human immunodeficiency virus [HIV], hepatitis C virus [HCV], hepatitis B virus [HBV], cytomegalovirus [CMV], syphilis, human T-lymphotropic virus [HTLV])
5. Patients diagnosed by the investigators to have psychological disorders
6. Patients whose score of callus formation was higher than 4 points

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference of Callus Formation Score for two months after autologous cultured osteoblast injection.

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures