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Long Term Effects on Skin Hyper Pigmentation With and Without Mesenchymal Stem Cell Enriched Adipose Tissue Grafting for "Contour Deformities With Pigmentary Changes on Face" (MSCs)

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ClinicalTrials.gov Identifier: NCT03564808
Recruitment Status : Recruiting
First Posted : June 21, 2018
Last Update Posted : July 6, 2018
Sponsor:
Information provided by (Responsible Party):
King Edward Medical University

Brief Summary:
MSCs one injected along with fat, regulate pigmentation over the contour defects of face

Condition or disease Intervention/treatment Phase
Skin Pigmentation Over Contour Deformities of Face Trauma, Rhomberg Disease Drug: MSC Phase 2

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Quasi experimental
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long Term Effects on Skin Hyper Pigmentation With and Without Mesenchymal Stem Cell Enriched Adipose Tissue Grafting for "Contour Deformities With Pigmentary Changes on Face"
Actual Study Start Date : June 27, 2018
Estimated Primary Completion Date : May 25, 2019
Estimated Study Completion Date : May 25, 2019

Arm Intervention/treatment
Experimental: Fat graft enriched with MSCs
Adipose tisse derrived MSCs
Drug: MSC
Adipose tissue enriched with mesenchymal stem cells

Experimental: Fat graft only
Fat graft withiut enrichment with MSCs
Drug: MSC
Adipose tissue enriched with mesenchymal stem cells




Primary Outcome Measures :
  1. Pigmentary change [ Time Frame: 6 months ]
    Pigmentary change will be measured by serial photographs in same specification of light and camera make and image J software 1.4 will be used to calculate image density which give objective measure of decrease in pigmentation



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • contour deformities of face with pigmentary changes.

Exclusion Criteria:

  • Depigmentary creams applied.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03564808


Contacts
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Contact: Afzaal Bashir, FCPS +923064000110 dr.afzaal@yahoo.com

Locations
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Pakistan
Plastic surgery department king Edward Medical University Lahore Recruiting
Lahore, Punjab, Pakistan, 54000
Contact: Afzaal Bashir, FCPS    +923064000110    dr.afzaal@yahoo.com   
Sponsors and Collaborators
King Edward Medical University

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Responsible Party: King Edward Medical University
ClinicalTrials.gov Identifier: NCT03564808     History of Changes
Other Study ID Numbers: MSCs
First Posted: June 21, 2018    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by King Edward Medical University:
Contour defects, Pigmentation, Enriched fat grafting

Additional relevant MeSH terms:
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Congenital Abnormalities
Hyperpigmentation
Pigmentation Disorders
Skin Diseases