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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

Tracking Information
First Submitted Date  ICMJE June 2, 2018
First Posted Date  ICMJE June 21, 2018
Last Update Posted Date July 6, 2018
Actual Study Start Date  ICMJE June 27, 2018
Estimated Primary Completion Date May 25, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2018)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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"
Official Title  ICMJE 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"
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Quasi experimental
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Skin Pigmentation Over Contour Deformities of Face
  • Trauma, Rhomberg Disease
Intervention  ICMJE Drug: MSC
Adipose tissue enriched with mesenchymal stem cells
Study Arms  ICMJE
  • Experimental: Fat graft enriched with MSCs
    Adipose tisse derrived MSCs
    Intervention: Drug: MSC
  • Experimental: Fat graft only
    Fat graft withiut enrichment with MSCs
    Intervention: Drug: MSC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 19, 2018)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 25, 2019
Estimated Primary Completion Date May 25, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • contour deformities of face with pigmentary changes.

Exclusion Criteria:

  • Depigmentary creams applied.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Afzaal Bashir, FCPS +923064000110 dr.afzaal@yahoo.com
Listed Location Countries  ICMJE Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03564808
Other Study ID Numbers  ICMJE MSCs
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party King Edward Medical University
Study Sponsor  ICMJE King Edward Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account King Edward Medical University
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP