The Combined Effect of Mesenchymal Stem Cell, HA-CaSO4,BMP-2, and Implant in Inducing The Healing of Critical-Sized Bone Defect
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|ClinicalTrials.gov Identifier: NCT01725698|
Recruitment Status : Unknown
Verified November 2012 by Ismail Hadisoebroto Dilogo, Indonesia University.
Recruitment status was: Not yet recruiting
First Posted : November 14, 2012
Last Update Posted : November 14, 2012
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 or disease||Intervention/treatment||Phase|
|Union||Drug: Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Study Start Date :||November 2012|
|Estimated Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2014|
Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant
|Drug: Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant|
- 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.
- 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
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
|University of Indonesia, National University of Singapore||Not yet recruiting|
|Jakarta, Singapore, Indonesia, Singapore, Indonesia, 14430|
|Contact: Ismail , PhD +628561961498|