Craniofacial MicrosomiaNCT03806361
Fat Grafts With Adipose-derived Regenerative Cells for Soft Tissue Reconstruction in Children
A study testing Fat grafts supplemented with ADRC and Structural fat grafting in people with Craniofacial Microsomia, run by Hospital Sirio-Libanes at 1 site in Brazil.
Trial summary
Although first reports of the clinical use of adipose-derived regenerative cells (ADRC) suggest that this approach may be feasible and effective for soft tissue augmentation, there is a lack of randomized, controlled clinical trials in the literature. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Craniofacial Microsomia
- What is being tested?
- Fat grafts supplemented with ADRC and Structural fat grafting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 10 Jan 2019to 10 Jan 2021
- Phase
- Interventional
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Unilateral craniofacial microsomia
- 10 to 18 years old
- Phenotype: (M0, M1 or M2) and (S1 or S2) according to the OMENS-Plus classification
Who cannot join
- Previous facial soft tissue surgery
- Absence of fat donor site
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Municipal Infantil Menino Jesus
São Paulo, São Paulo, 01329-010
About this study
Official title: Fat Grafts Supplemented With Adipose-derived Regenerative Cells for Soft Tissue Reconstruction in Children With Craniofacial Microsomia
Although first reports of the clinical use of adipose-derived regenerative cells (ADRC) suggest that this approach may be feasible and effective for soft tissue augmentation, there is a lack of randomized, controlled clinical trials in the literature. Hence, this study aimed to investigate whether a novel protocol for isolation of ADRC and their use in combination with fat tissue improve the long-term retention of the grafts in paediatric patients with craniofacial microsomia.
Read the detailed description
To overcome problems associated with fat grafting, such as unpredictable clinical results and a low rate of graft survival, many innovative efforts and refinements of surgical techniques have been reported. For example, condensation of living tissue and removal of unnecessary components have been performed by centrifugation, filtration or gravity sedimentation; external mechanical force has been used to expand the recipient tissue as well as the overlying skin envelope; and a recent experimental study has suggested that repeated local injections of erythropoietin might enhance retention of grafted fat.
Based on the finding that aspirated fat tissue contains a much smaller number of adipose-derived regenerative cells (ADRC) compared with intact tissue and that these cells play pivotal roles in the adipose tissue remodeling after lipoinjection, the supplementation of fat grafts with stromal vascular fraction isolated from adipose portion of liposuction aspirates has been proposed as a method to compensate its relative deficiency of ADRC.
In the literature, there are at least three experimental studies demonstrating that supplementation of adipose progenitor cells enhances the volume or weight of surviving adipose tissue, and first reports of the clinical use of ADRC suggest that this approach may be feasible and effective for soft tissue augmentation.
However, since these studies represent level of evidence IV, which correspond to the publication of case series, there is a lack of randomized, controlled clinical trials comparing this method to current standard techniques.
Hence, this study aimed to fill this gap by investigating whether a novel protocol for isolation of ADRC and their use in combination with fat tissue improve the long-term retention of the grafts in paediatric patients with craniofacial microsomia.
- Conditions
- Craniofacial Microsomia
- Being tested
- Fat grafts supplemented with ADRC, Structural fat grafting
- Medical subject headings
- Goldenhar Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fat grafts supplemented with ADRCProcedure or surgery
Isolation of ADRC from fat aspirates and its use for supplementation of fat grafts.
Structural fat graftingProcedure or surgery
Fat grafts without supplementation of ADRC
| Study group | Role | What they receive |
|---|---|---|
| With ADRC | Experimental | Supplementation of fat grafts with ADRC Receives: Procedure: Fat grafts supplemented with ADRC |
| Structural | Active comparator | Structural fat grafting Receives: Procedure: Structural fat grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric analysis of both hemifaces
Preoperative and 1, 3 and 6-months postoperative 3D-photogrammetry will be performed for volumetric measurements of both hemifaces using Vectra H1 software. Volumetric augmentation will be noticed for each patient by comparing the change between volumes of affected and unaffected hemifaces in the preoperative and 1, 3 and 6 months postoperative periods, which will be considered the retention volume. The percentage of fat graft survival will be determined as a ratio of the retention volume to the preoperative difference between volumes of affected and unaffected hemifaces.
Measured: Preoperative, 1 month postoperative, 3 months postoperative and 6 months postoperative
Secondary outcomes (1)
Number of viable cells
Immediately after the surgical procedure the number of viable cells isolated before and after the supplementation of the grafts will be counted using the trypan blue dye exclusion assay in a Neubauer chamber using the light microscope Nikon Eclipse TS100 (Nikon Instruments Inc., NY, USA). Next, immunophenotype characterization of cell populations on passage 1 will be done by flow cytometric analysis with the anti-human antibodies CD29, CD31, CD45, CD90, CD73 and CD105 (Becton, Dickinson and Company, NJ, USA) in a Guava EasyCyte flow cytometer running the Guava Express Plus software (Guava Technologies Hayward, CA, USA).
Measured: Intraoperative and immediate postoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2019
- Study start10 Jan 2019
- Primary completion10 Jan 2021
- Study completion10 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Craniofacial MicrosomiaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, clinical trial with 2 parallel comparison groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Sirio-Libanes
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniela S Tanikawa, Hospital Sirio-Libanes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03806361
- Sponsor's protocol ID
- Hospital Sirio Libanes
- Status last verified
- Oct 2021
- First submitted
- 9 Jan 2019
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fat Grafts Supplemented With Adipose-derived Regenerative Cells for Soft Tissue Reconstruction in Children With Craniofacial Microsomia
- ClinicalTrials.gov ID
- NCT03806361
- Acronym / sponsor ID
- Hospital Sirio Libanes
- Conditions
- Craniofacial Microsomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Hospital Sirio-LibanesUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 10 Jan 2021 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 16 Jan 2019 (actual)
- 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.
Although first reports of the clinical use of adipose-derived regenerative cells (ADRC) suggest that this approach may be feasible and effective for soft tissue augmentation, there is a lack of randomized, controlled clinical trials in the literature. Hence, this study aimed to investigate whether a novel protocol for isolation of ADRC and their use in combination with fat tissue improve the long-term retention of the grafts in paediatric patients with craniofacial microsomia.
Detailed description
To overcome problems associated with fat grafting, such as unpredictable clinical results and a low rate of graft survival, many innovative efforts and refinements of surgical techniques have been reported. For example, condensation of living tissue and removal of unnecessary components have been performed by centrifugation, filtration or gravity sedimentation; external mechanical force has been used to expand the recipient tissue as well as the overlying skin envelope; and a recent experimental study has suggested that repeated local injections of erythropoietin might enhance retention of grafted fat.
Based on the finding that aspirated fat tissue contains a much smaller number of adipose-derived regenerative cells (ADRC) compared with intact tissue and that these cells play pivotal roles in the adipose tissue remodeling after lipoinjection, the supplementation of fat grafts with stromal vascular fraction isolated from adipose portion of liposuction aspirates has been proposed as a method to compensate its relative deficiency of ADRC.
In the literature, there are at least three experimental studies demonstrating that supplementation of adipose progenitor cells enhances the volume or weight of surviving adipose tissue, and first reports of the clinical use of ADRC suggest that this approach may be feasible and effective for soft tissue augmentation.
However, since these studies represent level of evidence IV, which correspond to the publication of case series, there is a lack of randomized, controlled clinical trials comparing this method to current standard techniques.
Hence, this study aimed to fill this gap by investigating whether a novel protocol for isolation of ADRC and their use in combination with fat tissue improve the long-term retention of the grafts in paediatric patients with craniofacial microsomia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, controlled, clinical trial with 2 parallel comparison groups
| Arm | Type | Receives |
|---|---|---|
| With ADRC | Experimental | Procedure: Fat grafts supplemented with ADRCSupplementation of fat grafts with ADRC |
| Structural | Active comparator | Procedure: Structural fat graftingStructural fat grafting |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Unilateral craniofacial microsomia
- 10 to 18 years old
- Phenotype: (M0, M1 or M2) and (S1 or S2) according to the OMENS-Plus classification
Key exclusion criteria (2 listed)
- Previous facial soft tissue surgery
- Absence of fat donor site
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 |
|---|---|---|
| Fat grafts supplemented with ADRCIsolation of ADRC from fat aspirates and its use for supplementation of fat grafts. | Procedure or surgery | With ADRC |
| Structural fat graftingFat grafts without supplementation of ADRC | Procedure or surgery | Structural |
Primary outcome
Volumetric analysis of both hemifaces
Time frame: Preoperative, 1 month postoperative, 3 months postoperative and 6 months postoperative
Preoperative and 1, 3 and 6-months postoperative 3D-photogrammetry will be performed for volumetric measurements of both hemifaces using Vectra H1 software. Volumetric augmentation will be noticed for each patient by comparing the change between volumes of affected and unaffected hemifaces in the preoperative and 1, 3 and 6 months postoperative periods, which will be considered the retention volume. The percentage of fat graft survival will be determined as a ratio of the retention volume to the preoperative difference between volumes of affected and unaffected hemifaces.
1 secondary outcome
Number of viable cells
Time frame: Intraoperative and immediate postoperative period
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 18 Oct 2021.
- Individual participant dataSharing planned: No
Related trials for Craniofacial Microsomia
RecruitingObservational study
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Clinical Evaluation of Patient-Specific 3D-Printed Titanium Implants for Facial Reconstruction.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fat grafts supplemented with ADRC and Structural fat grafting in people with Craniofacial Microsomia, run by Hospital Sirio-Libanes 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 2 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 18 Oct 2021. 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.
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.
What does the primary outcome measure?
Volumetric analysis of both hemifaces (time frame: Preoperative, 1 month postoperative, 3 months postoperative and 6 months postoperative). 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 18 Oct 2021.