Cell-assisted lipotransfer: supportive use of human adipose-derived cells for soft tissue augmentation with lipoinjection.
Daisuke Matsumoto, Katsujiro Sato, Koichi Gonda...
https://pubmed.ncbi.nlm.nih.gov/17518674Actively Recruiting
Led by University of the Punjab · Updated on 2024-12-31
24
Participants Needed
1
Research Sites
N/A
Total Duration
U
University of the Punjab
Lead Sponsor
C
Centre of Excellence in Molecular Biology, University of the Punjab, Lahore
Collaborating Sponsor
Researchers are investigating how well fat grafting enriched with adipose-derived stem cells (ASCs), either preconditioned with curcumin or naïve, compares to conventional fat grafting in correcting facial contour deformities that affect appearance. This Phase 1 randomized study focuses on patients with conditions such as Romberg disease, craniofacial microsomia, burn scars, and post-traumatic scars. The goal is to evaluate the therapeutic potential of these stem cell-enhanced fat grafts for aesthetic improvement. Participants will undergo fat harvesting through liposuction under sterile conditions. The harvested fat will be either mixed with cultured ASCs, cultured ASCs preconditioned with curcumin, or used alone for conventional grafting. For the stem cell groups, about 100,000 cells per ml of fat are injected into the facial deformity site. Stem cells are prepared by isolating them from adipose tissue, washing, enzymatic digestion, centrifugation, and culturing until ready for use. The curcumin preconditioning involves incubating the ASCs with curcumin for 24 hours before mixing with fat. During the study, participants will be monitored for changes in facial tissue volume using ultrasonography over 9 months. Both patient and surgeon assessments will also be collected at this time. Safety and cell viability are evaluated before transplantation. Participants are adults aged 18 to 50, and involvement includes surgical procedures, follow-up imaging, and assessments to measure treatment effects and safety over the study period.
CONDITIONS
Efficacy of Preconditioned Adipose-Derived Stem Cells in Fat Grafting
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single procedure with follow-up over 9 months
Participants undergo fat harvesting followed by injection of fat grafts mixed with either naïve adipose-derived stem cells, curcumin-preconditioned adipose-derived stem cells, or conventional fat grafting without stem cells at the deformity site.
1 baseline visit (procedure) and multiple follow-up visits over 9 months
Total: 1 location
1
Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC)
Lahore, Punjab Province, Pakistan, 54550
Actively Recruiting
A
Azra Mehmood, PhD
A
Amna Arif, M.Phil.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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