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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)

Primary Purpose

Skin Pigmentation Over Contour Deformities of Face, Trauma, Rhomberg Disease

Status
Unknown status
Phase
Phase 2
Locations
Pakistan
Study Type
Interventional
Intervention
MSC
Sponsored by
King Edward Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Skin Pigmentation Over Contour Deformities of Face focused on measuring Contour defects, Pigmentation, Enriched fat grafting

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • contour deformities of face with pigmentary changes.

Exclusion Criteria:

  • Depigmentary creams applied.

Sites / Locations

  • Plastic surgery department king Edward Medical University LahoreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Fat graft enriched with MSCs

Fat graft only

Arm Description

Adipose tisse derrived MSCs

Fat graft withiut enrichment with MSCs

Outcomes

Primary Outcome Measures

Pigmentary change
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

Secondary Outcome Measures

Full Information

First Posted
June 2, 2018
Last Updated
July 5, 2018
Sponsor
King Edward Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03564808
Brief 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"
Acronym
MSCs
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"
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 27, 2018 (Actual)
Primary Completion Date
May 25, 2019 (Anticipated)
Study Completion Date
May 25, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
King Edward Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Pigmentation Over Contour Deformities of Face, Trauma, Rhomberg Disease
Keywords
Contour defects, Pigmentation, Enriched fat grafting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Quasi experimental
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Fat graft enriched with MSCs
Arm Type
Experimental
Arm Description
Adipose tisse derrived MSCs
Arm Title
Fat graft only
Arm Type
Experimental
Arm Description
Fat graft withiut enrichment with MSCs
Intervention Type
Drug
Intervention Name(s)
MSC
Intervention Description
Adipose tissue enriched with mesenchymal stem cells
Primary Outcome Measure Information:
Title
Pigmentary change
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: contour deformities of face with pigmentary changes. Exclusion Criteria: Depigmentary creams applied.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Afzaal Bashir, FCPS
Phone
+923064000110
Email
dr.afzaal@yahoo.com
Facility Information:
Facility Name
Plastic surgery department king Edward Medical University Lahore
City
Lahore
State/Province
Punjab
ZIP/Postal Code
54000
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Afzaal Bashir, FCPS
Phone
+923064000110
Email
dr.afzaal@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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"

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