LipodystrophiesPhase 1LipAgeNCT02034786
Safety Study of Filler Agent Composed of Autologous Mesenchymal Stem Cells and Hyaluronic Acid
A Phase 1 study testing Adipose tissue collection and Transdermal injection in people with Lipodystrophies and Aesthetics Procedure, run by Cryopraxis Criobiologia Ltda. at 1 site in Brazil.
Trial summary
Lipodystrophies are part of a clinically heterogeneous group of disorders characterized by loss (lipoatrophies) and / or accumulation of fat, which usually results in a change of normal tissue surface. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lipodystrophies, Aesthetics Procedure
- What is being tested?
- Adipose tissue collection and Transdermal injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2015to Jun 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female over 18 years;
- Signature of the ICF;
- Suitable for the following preoperative laboratory tests results: complete blood count, coagulation, biochemistry, electrocardiogram, hepatogram and β-human chorionic gonadotropin (hCG) for women of childbearing age.
Who cannot join
- Patients unable to undergo surgery liposuction with Klein technique as those with severe cardiovascular disease, severe coagulation disorders including thrombophilia and pregnancy;
- Patients with limited understanding of the procedure;
- Pregnant or lactating;
- Under 18 years;
- Immunosuppressed;
- Lack of signature of the ICF;
- Use of drugs;
- Patients with preoperative results considered inadequate.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Federal de Bonsucesso
Rio de Janeiro, Rio de Janeiro
Paulo RC Souza, M.D, +55212561-0182, faseb@faseb.org.br
Paulo RC Souza, M.D
About this study
Official title: Phase I Study of a Filler Agent Composed of Mesenchymal Stem Cells Obtained From Autologous Adipose Tissue Associated With Hyaluronic Acid
Lipodystrophies are part of a clinically heterogeneous group of disorders characterized by loss (lipoatrophies) and / or accumulation of fat, which usually results in a change of normal tissue surface. Millions of plastic and reconstructive surgeries are performed annually to repair soft tissue defects due to trauma, tumor resection and congenital defects. Surgical options for lipoatrophy, the lipodystrophy type characterized by subcutaneous adipose tissue atrophy, include: Transfer of autologous fat, Dermis - fat graft, Skin flaps and Commercially available fillers.
Currently, the most commonly filler agent used for the lipodystrophy treatment is polymethylmethacrylate, considered permanent and with a history of short- and medium-term adverse effects. Biocompatible and temporary filler agents such as hyaluronic acid, polylactic acid and collagen have been used for over 25 years for cosmetic purposes and in lipoatrophies. More recently, the use of autologous fibroblasts proved to be efficient solving acne scars and enabling dermis regeneration. Studies in mice showed that the combination of pre - adipocytes with a biomaterial is much more effective in tissue reconstitution than the injection of adipose tissue only, providing volume and also stimulating cell proliferation and differentiation with increased production of extracellular matrix.
This project aims a phase I clinical trial of a filler agent, composed of mesenchymal stem cells derived from autologous adipose tissue associated with hyaluronic acid.
Read the detailed description
Open, controlled and randomized study. The intervention performed in this study will be the transdermal injection of the filler agent in patients undergoing elective cosmetic liposuction procedure, with legal age and without any of the exclusion criteria items. Patients will be evaluated according to the parameters for a total period of 12 months.
Individuals in the control group will have transdermal injection of hyaluronic acid and will be evaluated with the same parameters used for the study group and also for the same period.
In this study, 25 volunteers attended at Dermatologic Service of the Bonsucesso Federal Hospital (HFB) will be included.
The research subjects will be evaluated preliminarily regarding inclusion and exclusion criteria of the study and the procedure will only be performed after the signing of the Informed Consent Form (ICF).
The efficacy and safety study will be conducted following Good Laboratory and Clinics Practices.
Patients who meet the study eligibility criteria will be randomly assigned to one of the two treatment groups: Test or Control.
The first follow-up visit will occur in the first month post-procedure. Subsequent consultations will be held at 3, 6 and 12 months after the procedure.
- Conditions
- Lipodystrophies, Aesthetics Procedure
- Being tested
- Adipose tissue collection, Transdermal injection
- Keywords
- Mesenchymal stem cell, Hyaluronic acid, Adipose Tissue, Filler Agent
- Medical subject headings
- Lipodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adipose tissue collectionProcedure or surgery
Only the patients selected for the Test Group will go through the procedure. The adipose tissue collection will occur in an elective surgery liposuction, in patients who meet the inclusion criteria, after signing the informed consent form. Thus, the material that would be disposed after surgery will be donated to the study.
The material for the study will be collected by the tumescent liposuction technique, which involves the removal of subcutaneous fat under local anesthesia.
Transdermal injectionBiological
Transdermal injection of the filler agent composed of mesenchymal stem cells derived from autologous adipose tissue associated with hyaluronic acid.
Transdermal injectionProcedure or surgery
Transdermal injection of hyaluronic acid only.
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Adipose tissue collection and Transdermal injection of the filler agent, composed of mesenchymal stem cells derived from the autologous adipose tissue, associated with hyaluronic acid. Receives: Procedure: Adipose tissue collection; Biological: Transdermal injection |
| Control | Active comparator | Transdermal injection of hyaluronic acid only. Receives: Procedure: Transdermal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events Analysis
Proportion of patients with non-serious and serious adverse events in the first 12 months after the intervention.
Measured: Every visit over the first 12 months after intervention
Secondary outcomes (1)
Efficacy Analysis
Difference of volume increase, captured by images, between control and study group at different times after the intervention (1, 3, 6 and 12 months).
Measured: 1, 3, 6 and 12 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startMar 2015
- Primary completionMay 2016 (estimated)
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LipodystrophiesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cryopraxis Criobiologia Ltda.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hospital Federal de Bonsucesso
- Responsible party
- Sponsor
- Investigators
- Paulo RC Souza, M.D, Principal investigator, Dermatology Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02034786
- Sponsor's protocol ID
- Cryo 394.191
- Other IDs
- 394.191
- Acronym
- LipAge
- Status last verified
- Feb 2015
- First submitted
- 10 Jan 2014
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of a Filler Agent Composed of Mesenchymal Stem Cells Obtained From Autologous Adipose Tissue Associated With Hyaluronic Acid
- ClinicalTrials.gov ID
- NCT02034786
- Acronym / sponsor ID
- LipAge / Cryo 394.191
- Conditions
- Lipodystrophies, Aesthetics Procedure
- Keywords
- Mesenchymal stem cell, Hyaluronic acid, Adipose Tissue, Filler Agent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Cryopraxis Criobiologia Ltda.Industry (pharma, biotech, devices)
- Collaborators
- Hospital Federal de Bonsucesso
- Study start
- Mar 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Jun 2016 (estimated)
- First posted
- 13 Jan 2014 (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.
Lipodystrophies are part of a clinically heterogeneous group of disorders characterized by loss (lipoatrophies) and / or accumulation of fat, which usually results in a change of normal tissue surface. Millions of plastic and reconstructive surgeries are performed annually to repair soft tissue defects due to trauma, tumor resection and congenital defects. Surgical options for lipoatrophy, the lipodystrophy type characterized by subcutaneous adipose tissue atrophy, include: Transfer of autologous fat, Dermis - fat graft, Skin flaps and Commercially available fillers.
Currently, the most commonly filler agent used for the lipodystrophy treatment is polymethylmethacrylate, considered permanent and with a history of short- and medium-term adverse effects. Biocompatible and temporary filler agents such as hyaluronic acid, polylactic acid and collagen have been used for over 25 years for cosmetic purposes and in lipoatrophies. More recently, the use of autologous fibroblasts proved to be efficient solving acne scars and enabling dermis regeneration. Studies in mice showed that the combination of pre - adipocytes with a biomaterial is much more effective in tissue reconstitution than the injection of adipose tissue only, providing volume and also stimulating cell proliferation and differentiation with increased production of extracellular matrix.
This project aims a phase I clinical trial of a filler agent, composed of mesenchymal stem cells derived from autologous adipose tissue associated with hyaluronic acid.
Detailed description
Open, controlled and randomized study. The intervention performed in this study will be the transdermal injection of the filler agent in patients undergoing elective cosmetic liposuction procedure, with legal age and without any of the exclusion criteria items. Patients will be evaluated according to the parameters for a total period of 12 months.
Individuals in the control group will have transdermal injection of hyaluronic acid and will be evaluated with the same parameters used for the study group and also for the same period.
In this study, 25 volunteers attended at Dermatologic Service of the Bonsucesso Federal Hospital (HFB) will be included.
The research subjects will be evaluated preliminarily regarding inclusion and exclusion criteria of the study and the procedure will only be performed after the signing of the Informed Consent Form (ICF).
The efficacy and safety study will be conducted following Good Laboratory and Clinics Practices.
Patients who meet the study eligibility criteria will be randomly assigned to one of the two treatment groups: Test or Control.
The first follow-up visit will occur in the first month post-procedure. Subsequent consultations will be held at 3, 6 and 12 months after the procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Procedure: Adipose tissue collection, Biological: Transdermal injectionAdipose tissue collection and Transdermal injection of the filler agent, composed of mesenchymal stem cells derived from the autologous adipose tissue, associated with hyaluronic acid. |
| Control | Active comparator | Procedure: Transdermal injectionTransdermal injection of hyaluronic acid only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female over 18 years;
- Signature of the ICF;
- Suitable for the following preoperative laboratory tests results: complete blood count, coagulation, biochemistry, electrocardiogram, hepatogram and β-human chorionic gonadotropin (hCG) for women of childbearing age.
Key exclusion criteria (8 listed)
- Patients unable to undergo surgery liposuction with Klein technique as those with severe cardiovascular disease, severe coagulation disorders including thrombophilia and pregnancy;
- Patients with limited understanding of the procedure;
- Pregnant or lactating;
- Under 18 years;
- Immunosuppressed;
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 |
|---|---|---|
| Adipose tissue collectionOnly the patients selected for the Test Group will go through the procedure. The adipose tissue collection will occur in an elective surgery liposuction, in patients who meet the inclusion criteria, after signing the informed consent form. Thus, the material that would be disposed after surgery will be donated to the study. The material for the study will be collected by the tumescent liposuction technique, which involves the removal of subcutaneous fat under local anesthesia. | Procedure or surgery | Test |
| Transdermal injectionTransdermal injection of the filler agent composed of mesenchymal stem cells derived from autologous adipose tissue associated with hyaluronic acid. | Biological | Test |
| Transdermal injectionTransdermal injection of hyaluronic acid only. | Procedure or surgery | Control |
Primary outcome
Adverse Events Analysis
Time frame: Every visit over the first 12 months after intervention
Proportion of patients with non-serious and serious adverse events in the first 12 months after the intervention.
1 secondary outcome
Efficacy Analysis
Time frame: 1, 3, 6 and 12 months after the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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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.
Paulo RC Souza, M.D principal investigator
Dermatology Service
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 Adipose tissue collection and Transdermal injection in people with Lipodystrophies and Aesthetics Procedure, run by Cryopraxis Criobiologia Ltda. 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 3 inclusion and 8 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 4 Feb 2015. 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?
Contact Paulo RC Souza, M.D (+55212561-0182, faseb@faseb.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events Analysis (time frame: Every visit over the first 12 months after intervention). 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 4 Feb 2015.