Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
03OST/014
Study information
Scientific title
A multicentre, randomised and comparative clinical study of the efficacy and safety of Ostem™ (autologous cultured osteoblasts) injection to treat fractures
Acronym
Study hypothesis
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
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)
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Phase III
Drug names
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 trial start date
13/05/2006
Overall trial end date
30/01/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
77
Participant 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
Recruitment start date
13/05/2006
Recruitment end date
30/01/2008
Locations
Countries of recruitment
Korea, South
Trial participating centre
Catholic University College of Medicine
Uijeongbu
480-717
Korea, South
Funders
Funder type
Industry
Funder name
SEWON Cellontech Co., Ltd (South Korea)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Korea Health Industry Development Institute (KHIDI) (South Korea) (ref : A04-0012)
Alternative name(s)
KHIDI
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Korea, South
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list