A phase III clinical trial for the two months safety and efficacy evaluation of Ostem™ (autologous cultured osteoblasts) in patients with fracture
| ISRCTN | ISRCTN10637905 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10637905 |
| Secondary identifying numbers | 03OST/014 |
- Submission date
- 14/05/2008
- Registration date
- 22/05/2008
- Last edited
- 22/05/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Kim Seok-Jung
Scientific
Scientific
Catholic University College of Medicine
Uijeongbu St. Mary's Hospital, Kumoh-dong
Uijeongbu
480-717
Korea, South
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A multicentre, randomised and comparative clinical study of the efficacy and safety of Ostem™ (autologous cultured osteoblasts) injection to treat fractures |
| Study objectives | To accelerate fracture healing, ultrasound and other diverse treatment methods have recently been introduced. In particular, cell therapy suggests a new treatment approach. When using Ostem™ (autologous cultured osteoblasts) rather than bone grafts, problems may develop in the donor area in general autologous bone grafts and immunological problems may develop in allograft, although problems involving the spread of disease are less frequent and a faster patient recovery may be achieved when using Ostem™ (autologous cultured osteoblasts). The hypothesis for this trial is that patients who implant Ostem™ (autologous cultured osteoblasts) will improve. |
| Ethics approval(s) | Ethics approval received from the following institutional review boards: 1. Catholic University College of Medicine (Uijeongbu St. Marys Hospital) on 9th March 2006 (ref: UCMC06MT001) 2. Yonsei University College of Medicine on 13th December 2006 (ref: 3-2006-0066) 3. Catholic University College of Medicine (St. Pauls Hospital) on 5th December 2006 (ref: PCMC06MT011) 4. Inje University College of Medicine on 29th December 2006 (ref: 06-33) 5. Dankook University College of Medicine on 22th January 2007 (ref: 2006-36) 6. Konyang University College of Medicine on 24th January 2007 (ref: 06-17) 7. Catholic University College of Medicine (Kangnam St. Marys Hospital) on 16th May 2007 (ref: KCMC06Mt174) |
| Health condition(s) or problem(s) studied | Long bone fracture |
| Intervention | All patients will receive standardised first fracture surgery (closed or open reduction). At enrolment patients are randomised to receive either injection (intervention group) or observation (control group). Intervention group: approximately eight weeks after the first open or closed reduction, this group will receive Ostem™ (autologous cultured osteoblasts) Control group: approximately eight weeks after the first open or closed reduction, this group will be observed but no other treatments performed. Total duration of follow-up for both treatment arms is two months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | Ostem™ (autologous cultured osteoblasts) |
| Primary outcome measure | Difference of Callus Formation Score for two months after autologous cultured osteoblast injection. |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 13/05/2006 |
| Completion date | 30/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 77 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 13/05/2006 |
| Date of final enrolment | 30/01/2008 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Catholic University College of Medicine
Uijeongbu
480-717
Korea, South
480-717
Korea, South
Sponsor information
Individual sponsor (South Korea)
Other
Other
c/o Ms Su-Young Lee
802 Wooyoung Techno Center, 273-15
Seongsu 2ga 3-Dong
Seongdong-Gu
Seoul
133-831
Korea, South
Funders
Funder type
Industry
SEWON Cellontech Co., Ltd (South Korea)
No information available
Korea Health Industry Development Institute (KHIDI) (South Korea) (ref : A04-0012)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- KHIDI
- Location
- Korea, South
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
