UnionPhase 1NCT01725698
The Combined Effect of Mesenchymal Stem Cell, HA-CaSO4,BMP-2, and Implant in Inducing The Healing of Critical-Sized Bone Defect
A Phase 1 study testing Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant in people with Union, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Union
- What is being tested?
- Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteIndonesia
- Study dates
- Nov 2012to Dec 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- subjects with critical size defect of bone
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
University of Indonesia, National University of Singapore
Jakarta, Singapore, Indonesia, Singapore, 14430
Ismail, PhD, +628561961498
About this study
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.
Read more
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
- Being tested
- Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and ImplantDrug
| Study group | Role | What they receive |
|---|---|---|
| Stemcell | Experimental | Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant Receives: Drug: Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
RADIOGRAPHIC UNION SCALE (RUST Score) as a measure of bone union
plain radiograps will be taken to determine whether the bone has healed.
Measured: 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
We will measure VAS (grade 0-10) to determine the clinical union
Measured: Before surgery, after surgery, week 4 , 8, 12, 16, 20, 24 up to 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for UnionStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismail Hadisoebroto Dilogo, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01725698
- Sponsor's protocol ID
- SCNONUNION12
- Status last verified
- Nov 2012
- First submitted
- 7 Nov 2012
- Last updated
- 14 Nov 2012
- Results posted
- No
Publications
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.
PubMed 30747273
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined Effect of Mesenchymal Stem Cell, HA-CaSO4,BMP-2, and Implant in Inducing The Healing of Critical-Sized Bone Defect
- ClinicalTrials.gov ID
- NCT01725698
- Acronym / sponsor ID
- SCNONUNION12
- Conditions
- Union
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 14 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stemcell | Experimental | Drug: Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and ImplantMesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- subjects with critical size defect of bone
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant | Drug | Stemcell |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2012.
- Derived from this study: PubMed 30747273Dilogo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant in people with Union, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01725698, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2012.