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"
NCT ID: NCT03564808
Last Updated: 2018-07-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2018-06-27
2019-05-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Fat Grafting an Ideal Filler For Contour Deformities With Hyperpigmentation On Face
NCT06103461
Microneedling With Topical Preparations in the Treatment of Atrophic Post-acne Scars
NCT05600075
Treatment of Acne Scarring With a Novel Procedure Combination
NCT00510055
Pilot Study Investigating the Efficacy of Fat Grafting as a Treatment for Male and Female Facial Acne Scarring
NCT04559022
Safety Study of Filler Agent Composed of Umbilical Cord Mesenchymal Stem Cells and Hyaluronic Acid
NCT02698813
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Fat graft enriched with MSCs
Adipose tisse derrived MSCs
MSC
Adipose tissue enriched with mesenchymal stem cells
Fat graft only
Fat graft withiut enrichment with MSCs
MSC
Adipose tissue enriched with mesenchymal stem cells
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
MSC
Adipose tissue enriched with mesenchymal stem cells
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
King Edward Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Plastic surgery department king Edward Medical University Lahore
Lahore, Punjab Province, Pakistan
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MSCs
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.