Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03806361 |
| Other study ID # |
Hospital Sirio Libanes |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 10, 2019 |
| Est. completion date |
January 10, 2021 |
Study information
| Verified date |
October 2021 |
| Source |
Hospital Sirio-Libanes |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
