OverweightNCT01218945
Development of Bone Grafts Using Adipose Derived Stem Cells and Different Scaffolds
An observational study of Overweight, run by University of Zurich at 1 site in Switzerland.
Trial summary
The repair of large osseous defects remains still unsolved. Aim of this study is to isolate and cultivate fat-derived progenitor cells and differentiation into osteoblasts. Therefore, our research idea is to pre-engineer large synthetic bone grafts and study the vascularization process in vivo. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Overweight
- What is being tested?
- Cell Culture
- Type of treatment
- Surgery or procedure
- How many people
- 33 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2009to Dec 2012
- Phase
- Observational
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted for reconstructive surgery
Who may be able to join
- German-speaking patients aged 18-70 admitted to the Clinic of Reconstructive surgery for reconstructive surgery and fat-excision.
Who cannot join
- Drug-abuse, neoplasia and metabolic disorders
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Clinic of Reconstructive Surgery
Zurich, Canton of Zurich, 8091
About this study
Official title: Development of Bone Grafts Using Adipose Derived Stem Cells and Different Scaffolds: Impact of Pre-engineered Capillaries in Critical Size Grafts
The repair of large osseous defects remains still unsolved. Aim of this study is to isolate and cultivate fat-derived progenitor cells and differentiation into osteoblasts. Therefore, our research idea is to pre-engineer large synthetic bone grafts and study the vascularization process in vivo.
- Conditions
- Overweight
- Being tested
- Cell Culture
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell CultureProcedure or surgery
Aim of this study is to isolate and cultivate fat-derived progenitor cells and differentiation into osteoblasts. Therefore, our research idea is to pre-engineer large synthetic bone grafts and study the vascularization process in vivo.
| Study group | Role | What they receive |
|---|---|---|
| Fat Removal | Patients undergoing surgical fat removal Receives: Procedure: Cell Culture |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2010 (estimated)
- Study startNov 2009
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maurizio Calcagni, MD, Principal investigator, University Hospital Zurich, Clinic of Reconstructive Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01218945
- Sponsor's protocol ID
- Bone-ZH09
- Status last verified
- Jun 2013
- First submitted
- 29 Sep 2010
- Last updated
- 19 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Bone Grafts Using Adipose Derived Stem Cells and Different Scaffolds: Impact of Pre-engineered Capillaries in Critical Size Grafts
- ClinicalTrials.gov ID
- NCT01218945
- Acronym / sponsor ID
- Bone-ZH09
- Conditions
- Overweight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 11 Oct 2010 (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 repair of large osseous defects remains still unsolved. Aim of this study is to isolate and cultivate fat-derived progenitor cells and differentiation into osteoblasts. Therefore, our research idea is to pre-engineer large synthetic bone grafts and study the vascularization process in vivo.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fat Removal | – | Procedure: Cell CulturePatients undergoing surgical fat removal |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted for reconstructive surgery
Key inclusion criteria (1 listed)
- German-speaking patients aged 18-70 admitted to the Clinic of Reconstructive surgery for reconstructive surgery and fat-excision.
Key exclusion criteria (1 listed)
- Drug-abuse, neoplasia and metabolic disorders
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 |
|---|---|---|
| Cell CultureAim of this study is to isolate and cultivate fat-derived progenitor cells and differentiation into osteoblasts. Therefore, our research idea is to pre-engineer large synthetic bone grafts and study the vascularization process in vivo. | Procedure or surgery | Fat Removal |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2013.
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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.
Maurizio Calcagni, MD principal investigator
University Hospital Zurich, Clinic of Reconstructive Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Overweight, run by University of Zurich at 1 site in Switzerland.
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: finished, as of the sponsor's last update on 19 Jun 2013. 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 Switzerland. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 19 Jun 2013.