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
1 other identifier
interventional
40
1 country
1
Brief Summary
MSCs one injected along with fat, regulate pigmentation over the contour defects of face
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2018
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2018
CompletedFirst Posted
Study publicly available on registry
June 21, 2018
CompletedStudy Start
First participant enrolled
June 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2019
CompletedJuly 6, 2018
July 1, 2018
11 months
June 2, 2018
July 5, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
6 months
Study Arms (2)
Fat graft enriched with MSCs
EXPERIMENTALAdipose tisse derrived MSCs
Fat graft only
EXPERIMENTALFat graft withiut enrichment with MSCs
Interventions
Adipose tissue enriched with mesenchymal stem cells
Eligibility Criteria
You may qualify if:
- contour deformities of face with pigmentary changes.
You may not qualify if:
- Depigmentary creams applied.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Plastic surgery department king Edward Medical University Lahore
Lahore, Punjab Province, 54000, Pakistan
MeSH Terms
Conditions
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 2, 2018
First Posted
June 21, 2018
Study Start
June 27, 2018
Primary Completion
May 25, 2019
Study Completion
May 25, 2019
Last Updated
July 6, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will not share