Healing of FracturePhase 1NCT01626625
Mesenchymal Stem Cells; Donor and Role in Management and Reconstruction of Nonunion Fracture
A Phase 1 study testing stem cells + hydroxy apatite and autograft taken from iliac crest in people with Healing of Fracture, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
The investigators hypothesized that mesenchymal stem cells can be isolated from fracture site, iliac crest, and tibial crest, and can be expanded to be used in the management of nonunion fracture. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Healing of Fracture
- What is being tested?
- stem cells + hydroxy apatite and autograft taken from iliac crest
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndonesia
- Study dates
- Apr 2010to Jan 2016
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- athropic nonunion fracture of the long bone
Who cannot join
- immunocompromise,
- active infection,
- pathological fracture,
- ongoing hormonal therapy
Trial locations and contacts
1 site in 1 country.
Phedy Phe, MD contact
Ismail HD, PhD contact
About this study
The investigators hypothesized that mesenchymal stem cells can be isolated from fracture site, iliac crest, and tibial crest, and can be expanded to be used in the management of nonunion fracture.
- Conditions
- Healing of Fracture
- Being tested
- stem cells + hydroxy apatite, autograft taken from iliac crest
- Keywords
- nonunion, stem cells, autograft, hydroxyapatite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stem cells + hydroxy apatiteDrug
patient will be transplanted with stem cells and hydroxyapatite
autograft taken from iliac crestOther
patient will be transplanted with autograft
| Study group | Role | What they receive |
|---|---|---|
| stem cells | Experimental | stem cells + hydroxy apatite Receives: Drug: stem cells + hydroxy apatite |
| autograft | Active comparator | Not described Receives: Other: autograft taken from iliac crest |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing of fracture
radiological union
Measured: 1 year
Secondary outcomes (1)
VAS
visual analogue scale
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2012 (estimated)
- Study startApr 2010
- Primary completionApr 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healing of FractureStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 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
- NCT01626625
- Sponsor's protocol ID
- NONUNISTEM1
- Status last verified
- Jun 2012
- First submitted
- 12 Jun 2012
- Last updated
- 25 Jun 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stem Cells; Donor and Role in Management and Reconstruction of Nonunion Fracture
- ClinicalTrials.gov ID
- NCT01626625
- Acronym / sponsor ID
- NONUNISTEM1
- Conditions
- Healing of Fracture
- Keywords
- nonunion, stem cells, autograft, hydroxyapatite
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 25 Jun 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.
The investigators hypothesized that mesenchymal stem cells can be isolated from fracture site, iliac crest, and tibial crest, and can be expanded to be used in the management of nonunion fracture.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stem cells | Experimental | Drug: stem cells + hydroxy apatitestem cells + hydroxy apatite |
| autograft | Active comparator | Other: autograft taken from iliac crest |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- athropic nonunion fracture of the long bone
Key exclusion criteria (4 listed)
- immunocompromise,
- active infection,
- pathological fracture,
- ongoing hormonal therapy
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 |
|---|---|---|
| stem cells + hydroxy apatitepatient will be transplanted with stem cells and hydroxyapatite | Drug | stem cells |
| autograft taken from iliac crestpatient will be transplanted with autograft | Other | autograft |
Primary outcome
healing of fracture
Time frame: 1 year
radiological union
1 secondary outcome
VAS
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2012.
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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.
Phedy Phe, MD contact
Ismail HD, PhD contact
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 stem cells + hydroxy apatite and autograft taken from iliac crest in people with Healing of Fracture, 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 4 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 25 Jun 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?
Contact Phedy Phe, MD (phedy@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
healing of fracture (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jun 2012.