LipodystrophyPhase 1AADSCTPLNCT00715546
Autologous Adipose-Derived Stem Cell Transplantation in Patients With Lipodystrophy
A Phase 1 study testing autologous transplantation of liposuction material enriched with adipose-derived stem cells in people with Lipodystrophy, run by Irmandade Santa Casa de Misericórdia de Porto Alegre at 1 site in Brazil.
Trial summary
The aim of this study is to determine the safety of the autologous transplantation of adipose-derived stem cells in the treatment of lipodystrophies. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Lipodystrophy
- What is being tested?
- autologous transplantation of liposuction material enriched with adipose-derived stem cells
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteBrazil
- Study dates
- Oct 2007to Nov 2011
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- lipodystrophies with necessity of fat grafting
- accept to participate of the study
Who cannot join
- HIV infection
- Metastatic malignancy
- Body mass index < 20 kg/m²
- Other severe systemic disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Irmandade Santa Casa de Misericórdia
Porto Alegre, Rio Grande do Sul
About this study
Official title: Phase 1 Study of Autologous-Derived Stem Cell Transplantation in Patients With Lipodystrophy
The aim of this study is to determine the safety of the autologous transplantation of adipose-derived stem cells in the treatment of lipodystrophies.
- Conditions
- Lipodystrophy
- Being tested
- autologous transplantation of liposuction material enriched with adipose-derived stem cells
- Keywords
- Adipose-derived stem cell, Lipodystrophy
- Medical subject headings
- Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous transplantation of liposuction material enriched with adipose-derived stem cellsProcedure or surgery
Lipoinjection enriched with adipose-derived stem-cells.
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical evaluation of the transplanted area.
Measured: one year
Secondary outcomes (1)
Presence of neovascularization, adipose transplantation reabsorption, tissue viability
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2008 (estimated)
- Study startOct 2007
- Primary completionAug 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipodystrophyStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irmandade Santa Casa de Misericórdia de Porto Alegre
- Sponsor type
- University, hospital or other
- Investigators
- Eduardo M. Chem, MD, Principal investigator, Irmandade Santa Casa de Misericórdia de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00715546
- Sponsor's protocol ID
- ISCMPA 1642/07
- Acronym
- AADSCTPL
- Status last verified
- Mar 2009
- First submitted
- 11 Jul 2008
- Last updated
- 22 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study of Autologous-Derived Stem Cell Transplantation in Patients With Lipodystrophy
- ClinicalTrials.gov ID
- NCT00715546
- Acronym / sponsor ID
- AADSCTPL / ISCMPA 1642/07
- Conditions
- Lipodystrophy
- Keywords
- Adipose-derived stem cell, Lipodystrophy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Irmandade Santa Casa de Misericórdia de Porto AlegreUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 15 Jul 2008 (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 aim of this study is to determine the safety of the autologous transplantation of adipose-derived stem cells in the treatment of lipodystrophies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- lipodystrophies with necessity of fat grafting
- accept to participate of the study
Key exclusion criteria (4 listed)
- HIV infection
- Metastatic malignancy
- Body mass index < 20 kg/m²
- Other severe systemic disease
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 |
|---|---|---|
| autologous transplantation of liposuction material enriched with adipose-derived stem cellsLipoinjection enriched with adipose-derived stem-cells. | Procedure or surgery | – |
Primary outcome
Clinical evaluation of the transplanted area.
Time frame: one year
1 secondary outcome
Presence of neovascularization, adipose transplantation reabsorption, tissue viability
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2011.
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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.
Eduardo M. Chem, MD principal investigator
Irmandade Santa Casa de Misericórdia de Porto Alegre
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 autologous transplantation of liposuction material enriched with adipose-derived stem cells in people with Lipodystrophy, run by Irmandade Santa Casa de Misericórdia de Porto Alegre at 1 site in Brazil.
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 2 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 22 Jun 2011. 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 Brazil. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical evaluation of the transplanted area. (time frame: one 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 22 Jun 2011.