The Combined Effect of Mesenchymal Stem Cell, HA-CaSO4,BMP-2, and Implant in Inducing The Healing of Critical-Sized Bone Defect

This study is not yet open for participant recruitment.
Verified November 2012 by Indonesia University
Sponsor:
Information provided by (Responsible Party):
Ismail Hadisoebroto Dilogo, Indonesia University
ClinicalTrials.gov Identifier:
NCT01725698
First received: November 7, 2012
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

This research is aimed to evaluate the combination of mesenchymal stem cell, HA-CaSO4, BMP-2, and implant in treating critical-sized bone defect.

In the presence of critical-sized bone defect whose defect size is more than 2.5 cm, bone will suffer a healing disturbance. In treating these conditions, the conventional method were vascularised bone grafting and bone transport. But the existing methods of treatment have many weaknesses Vascularized bone graft is a procedure with a high level of difficulty. Hence not every orthopaedic surgeon were able to perform it. It also takes more operating time and its failure rate is also quite high.

Meanwhile, external fixation which is applied with bone transport, was being often complained by the patient in terms of cosmetic and psychologically.

According to diamond concept of bone healing, there are four main factors that influence the bone healing. These factors are osteogenic factor (mesenchymal stem cell), osteconductive factor (HA-CaSO4), osteoinductive factor (bone morphogenetic protein-2) and mechanical component (implant). The potency of each component in fracture healing with/out bone defect has been proved in many studies. The combined effect of these components is often studied as well, but not in critical-sized bone defect.


Condition Intervention Phase
Union
Drug: Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Indonesia University:

Primary Outcome Measures:
  • RADIOGRAPHIC UNION SCALE (RUST Score) as a measure of bone union [ Time Frame: Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years ] [ Designated as safety issue: No ]
    plain radiograps will be taken to determine whether the bone has healed.


Secondary Outcome Measures:
  • Visual analog scale as the measure of clinical union [ Time Frame: Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years ] [ Designated as safety issue: No ]
    We will measure VAS (grade 0-10) to determine the clinical union


Estimated Enrollment: 5
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stemcell
Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant
Drug: Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant

  Eligibility

Ages Eligible for Study:   17 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • subjects with critical size defect of bone

Exclusion Criteria:

  • subjects with patological fracture caused by primary or secondary bone malignancy, imunological deficit, active hepatitis or those who's under immunosuppresant therapy or other therapeutic modality that can interferes with bone healing.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01725698

Locations
Indonesia
University of Indonesia, National University of Singapore Not yet recruiting
Jakarta, Singapore, Indonesia, Singapore, Indonesia, 14430
Contact: Ismail , PhD    +628561961498      
Sponsors and Collaborators
Indonesia University
  More Information

No publications provided

Responsible Party: Ismail Hadisoebroto Dilogo, PhD, Indonesia University
ClinicalTrials.gov Identifier: NCT01725698     History of Changes
Other Study ID Numbers: SCNONUNION12
Study First Received: November 7, 2012
Last Updated: November 8, 2012
Health Authority: Indonesia: Ethics Committee

ClinicalTrials.gov processed this record on April 17, 2014