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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Ismail Hadisoebroto Dilogo, Indonesia University.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01725698
First Posted: November 14, 2012
Last Update Posted: November 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ismail Hadisoebroto Dilogo, Indonesia University
  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: Intervention Model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Ismail Hadisoebroto Dilogo, 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 ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   17 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Ismail Hadisoebroto Dilogo, PhD, Indonesia University
ClinicalTrials.gov Identifier: NCT01725698     History of Changes
Other Study ID Numbers: SCNONUNION12
First Submitted: November 7, 2012
First Posted: November 14, 2012
Last Update Posted: November 14, 2012
Last Verified: November 2012