Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03564808 |
| Other study ID # |
MSCs |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
June 27, 2018 |
| Est. completion date |
May 25, 2019 |
Study information
| Verified date |
July 2018 |
| Source |
King Edward Medical University |
| Contact |
Afzaal Bashir, FCPS |
| Phone |
+923064000110 |
| Email |
dr.afzaal[@]yahoo.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
MSCs one injected along with fat, regulate pigmentation over the contour defects of face
Description:
INTRODUCTION:
Contour deformities of the face requiring soft tissue augmentation are usually associated
with hyper pigmentation of overlying skin. These deformities often result from a variety of
conditions like trauma, infection and certain acquired diseases1. Contour deformities of face
cause both functional as well as aesthetic problems for the patient. Hyper pigmentation of
overlying skin makes these deformities more pronounced and iniquitous. Conventionally,
contour problems are treated by using allogenic fillers, major flap surgery and fat
grafting2. Flap surgery causes donor site morbidities and does not address pigmentary
changes. Allogenic fillers, on the other hand,are expensive and also do not improve hyper
pigmentation of overlying skin. Lasers and de-pigmentary creams have been described for
addressing pigmentary issue but no satisfactory measure is available so far. Moreover, these
modalities do not treat contour deformity.
Autologous fat grafting has gained acceptance to improve skin texture and post inflammatory
hyper pigmentation associated with contour deformities of face2,3. Fat, being an autologous
tissue, is an ideal choice to rejuvenate hyper pigmented skin owing to its abundant
availability in areas like abdomen, buttocks, thighs and arms without any significant donor
site morbidity. Repeat sessions of fat injection can be done if needed. Fat grafting is not
new and it may be a safe and natural method to improve skin hyper pigmentation. One major
problem related to fat grafting is resorption of grafted fat at recipient site ranging from
40% to 80% 4. It requires multiple sessions of fat injection. In literature, many treatment
options have been utilized to solve this issue of resorption, one of these is enrichment of
fat graft with mesenchymal stem cells 5. Mesenchymal stem cells derived from fatty tissue
possess potential to proliferate as well as differentiate into multiple cell lines6,7. These
mesenchymal cells not only increase consistency of grafted fat but also lead to rejuvenation
of the skin overlying the fat grafted area and improve pigmentary changes of this overlying
skin. However, previously published data has failed to establish a clear association of
mesenchymal stem cells with improvement in hyper pigmentation of skin overlying fat grafted
contour deformities of face. In order to find a reliable mean to decrease hyper pigmentation
of skin overlying contour deformities of face, more work is needed to be done.
In the current study we propose the novel idea of lipo-filling the contour defects of face
associated with overlying skin hyper pigmentation using enriched conventional fat graft with
ex-vivo expanded fat derived mesenchymal stem cells to potentiate the improvement in
overlying skin hyper pigmentation and to enhance reliability of the final outcome of
surgery8,9,10,11.
The rationale of the study is to compare the improvement in skin hyper pigmentation after
conventional fat grafting and stem cell enriched fat grafting for contour deformities of face
associated with hyper pigmentation of overlying skin. If enrichment of fat graft with fat
derived mesenchymal stem cells can increase its effect on improvement in the hyper
pigmentation of overlying skin, this innovative strategy can render fat transfer a reliable
option for soft tissue augmentation in contour deformities of face with overlying skin hyper
pigmentation2. This can definitely improve final clinical outcome by decreasing donor site
morbidity.
6.4 OBJECTIVES: To compare the long term effect on skin hyper pigmentation after conventional
fat grafting and adipose-tissue derived mesenchymal stem cells enriched fat grafting for the
treatment of deformities of the face associated with overlying skin hyper pigmentation.
