Skip to main content
MedPathMedPath Home
Clinical Trials/ISRCTN10637905
ISRCTN10637905
Completed
Not Applicable

A multicentre, randomised and comparative clinical study of the efficacy and safety of Ostem™ (autologous cultured osteoblasts) injection to treat fractures

Individual sponsor (South Korea)0 sites77 target enrollmentMay 22, 2008
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditionsong bone fractureInjury, Occupational Diseases, PoisoningFracture

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
ong bone fracture
Sponsor
Individual sponsor (South Korea)
Enrollment
77
Status
Completed
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
May 22, 2008
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Individual sponsor (South Korea)

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

Similar Trials

Completed
Phase 4
A multi-centre study to compare and evaluate a herbal capsule in patients with hemorrhoidsHealth Condition 1: K649- Unspecified hemorrhoids
CTRI/2017/10/010038Zuventus Healthcare Limited200
Active, not recruiting
Not Applicable
A randomised, comparative, multicentre clinical trial of the immunogenicity and safety of Tdap-IPV vaccine (REPEVAX) and a tetanus monovalent vaccine in healthy adults 18 years of age and olderAntibody responses to tetanus toxoid.MedDRA version: 9.1Level: LLTClassification code 10060308Term: Tetanus antibody positive
EUCTR2008-008724-32-DESanofi Pasteur MSD S.N.C.456
Active, not recruiting
Phase 1
A randomised, comparative, multicentre clinical trial of the immunogenicity and safety of Tdap-IPV vaccine (REPEVAX) and a tetanus monovalent vaccine in healthy adults 18 years of age and older
EUCTR2008-008724-32-FRSanofi Pasteur MSD S.N.C.
Completed
Phase 3
A clinical trial to study the effects of two drugs, Lafutidine and Rabeprazole in the Treatment of heartburn-dominant uninvestigated dyspepsia.
CTRI/2009/091/000913Zuventus Healthcare Ltd202
Completed
Phase 3
A Randomised, Comparative, Multicentre Clinical Trial of the Immunogenicity and Safety of Tdap-IPV Vaccine and a Tetanus Monovalent Vaccine in Healthy Adults 18 Years of Age and OldertetanusA35Other tetanus
DRKS00000180Sanofi Pasteur MSD456