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

NCT01725698 | Unknown Phase 1

• 1 other identifier: SCNONUNION12
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Union

Outcome Measures

Primary Outcomes (1)

• RADIOGRAPHIC UNION SCALE (RUST Score) as a measure of bone union

  plain radiograps will be taken to determine whether the bone has healed.

  Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years

Secondary Outcomes (1)

• Visual analog scale as the measure of clinical union

  Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years

Study Arms (1)

Stemcell

EXPERIMENTAL

Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant

Drug: Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant

Interventions

Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant DRUG

Stemcell

Eligibility Criteria

• Age: 17 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• subjects with critical size defect of bone

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

University of Indonesia, National University of Singapore

Jakarta, Singapore, Indonesia, Singapore, 14430, Indonesia

Location

Related Publications (1)

• Dilogo IH, Phedy P, Kholinne E, Djaja YP, Fiolin J, Kusnadi Y, Yulisa ND. Autologous mesenchymal stem cell implantation, hydroxyapatite, bone morphogenetic protein-2, and internal fixation for treating critical-sized defects: a translational study. Int Orthop. 2019 Jun;43(6):1509-1519. doi: 10.1007/s00264-019-04307-z. Epub 2019 Feb 12.

  PMID: 30747273 DERIVED

MeSH Terms

Interventions

Drug Implants

Intervention Hierarchy (Ancestors)

Delayed-Action Preparations; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: November 14, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 14, 2012

Record last verified: 2012-11

Locations

ID (1)