- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01725698
The Combined Effect of Mesenchymal Stem Cell, HA-CaSO4,BMP-2, and Implant in Inducing The Healing of Critical-Sized Bone Defect
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Förväntat)
Fas
- Fas 1
Kontakter och platser
Studieorter
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-
Indonesia, Singapore
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Jakarta, Singapore, Indonesia, Singapore, Indonesien, 14430
- University of Indonesia, National University of Singapore
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: Stemcell
Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
RADIOGRAPHIC UNION SCALE (RUST Score) as a measure of bone union
Tidsram: Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years
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plain radiograps will be taken to determine whether the bone has healed.
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Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Visual analog scale as the measure of clinical union
Tidsram: 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
|
Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Förväntat)
Avslutad studie (Förväntat)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- SCNONUNION12
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