Condition category
Injury, Occupational Diseases, Poisoning
Date applied
14/05/2008
Date assigned
22/05/2008
Last edited
22/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Kim Seok-Jung

ORCID ID

Contact details

Catholic University College of Medicine
Uijeongbu St. Mary's Hospital
Kumoh-dong
Uijeongbu
480-717
Korea
South

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. Mary’s 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. Paul’s 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. Mary’s 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 measures

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

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

Sponsor information

Organisation

Individual sponsor (South Korea)

Sponsor details

c/o Ms Su-Young Lee
802 Wooyoung Techno Center
273-15
Seongsu 2ga 3-Dong
Seongdong-Gu
Seoul
133-831
Korea
South

Sponsor type

Other

Website

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

Federal/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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes