Clinical trial NCT05610878: Efficacy of Preconditioned Adipose-Derived Stem Cells in Fat Grafting
Official title: Supplementation of Autologous Fat Grafts with Curcumin Preconditioned Adipose-Derived Stem Cells in the Treatment of Facial Contour Deformities
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Romberg Disease
Craniofacial Microsomia
Burn Scar
Post-Traumatic Scar (Disorder)
Keywords: Facial deformities
Fat grafting
Adipose derived stem cells
Preconditioning
Lead sponsor: University of the Punjab
Sponsor class: OTHER
Collaborators: name: Centre of Excellence in Molecular Biology, University of the Punjab, Lahore
name: Higher Education Commission (Pakistan)
name: Jinnah Burn and Reconstructive Surgery Centre, Lahore
First posted: 2022-11-09
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the comparison of therapeutic potential of curcumin preconditioned adipose derived stem cells (ASCs) enrichment fat grafting, naïve ASCs enrichment fat grafting and conventional fat grafting to correct facial contour deformities that cause aesthetic complications in patients.

Detailed description: Human subcutaneous adipose tissue along informed consents will be collected in a lipoaspirate container or 20 cc B.D syringes under the sterilized conditions during the surgery. Fat aspirate collection will be based on certain selection criteria including pre-requisitioning non-diabetic, negative viral status patients. Adipose derived stem cells (ASCs) will be isolated from adipose tissue under sterile aseptic conditions. Firstly, the lipoaspirate container will be opened in the biosafety cabinet and drain off the blood carefully with the help of serological pipette. Then, fat will be washed thrice with 1X phosphate buffer saline (PBS) containing antibiotic and anti-mycotic solution, in order to get rid of blood vessels, hair and other type of connective tissue. After that, the tissue will be enzymatically digested with collagenase type I solution (1mg/ml prepared in Low Glucose Dulbecco's Modified Eagle Medium (LG-DMEM) and incubate for 45 minutes at 37°C on a shaker. After digestion, the enzyme will be inactivated by LG-DMEM augmented with 5% freshly isolated human serum and spin at 1200 rpm for 10 minutes. After centrifugation, fat will be discarded and the infranatant will be passed through 100 µm cell strainers to remove the debris. The filtrate will be centrifuged again for 1200rpm for 8 minutes. Pellet will be resuspended and plated in a sterile T-75 cm2 flask containing 10 ml LG-DMEM supplemented with 5% human serum. The flask will be placed in a humidified incubator at 37°C, 5% carbon dioxide (CO2). The media will be replenished after every third day until the cells got 80-90 % confluency. Cells of P2-P3 stage will be used in this study for immunocytochemistry, and intervention as well. For preconditioning, ASCs will be incubated with curcumin preconditioned medium for 24 h. Cell sterility and viability will be assessed prior to transplantation. For transplantation, 1,00,000 cells per ml of fat will be mixed, transferred to 10 cc syringes and injected at deformity site. Amount of fat will be predetermined by the clinician on the basis of facial asymmetry.

Eligibility criteria: Inclusion criteria

* Age 18-50 years (male or female)
* Body-mass index 20-30 kg/m²
* Suitable for liposuction as assessed by the expected cosmetic results
* Provided signed informed consent

Exclusion criteria

* Systemic disorders include autoimmune diseases, hemorrhagic diseases, bone marrow aplasia, sepsis, cancer, and others
* Local disorders include acne, infections and others
* Risk factors include smoking, uncompensated diabetes, hypertension, and allergy to the drugs used for general anesthesia
* Microbiological contamination of either the cell culture or the transplanted tissue

Primary outcomes:
measure: Volumetric change in facial tissue by ultrasonography
timeFrame: 9 months
Secondary outcomes:
measure: Patient Assessment
timeFrame: 9 months
measure: Surgeon Assessment
timeFrame: 9 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC)
state: Punjab
Study officials:
affiliation: Center of Excellence in Molecular Biology (CEMB), University of the Punjab, Lahore
name: Azra Mehmood, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Jinnah Burn and Reconstructive Surgery Center (JB&RSC), Lahore
name: Sheikh Riazuddin, PhD
role: STUDY_DIRECTOR
References:
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citation: Bashir MM, Sohail M, Ahmad FJ, Choudhery MS. Preenrichment with Adipose Tissue-Derived Stem Cells Improves Fat Graft Retention in Patients with Contour Deformities of the Face. Stem Cells Int. 2019 Nov 20;2019:5146594. doi: 10.1155/2019/5146594. eCollection 2019.
citation: Ghufran H, Mehmood A, Azam M, Butt H, Ramzan A, Yousaf MA, Ejaz A, Tarar MN, Riazuddin S. Curcumin preconditioned human adipose derived stem cells co-transplanted with platelet rich plasma improve wound healing in diabetic rats. Life Sci. 2020 Sep 15;257:118091. doi: 10.1016/j.lfs.2020.118091. Epub 2020 Jul 12.
citation: Bourne DA, Egro FM, Bliley J, James I, Haas GL, Meyer EM, Donnenberg V, Donnenberg AD, Branstetter B, Coleman S, Rubin JP. Stem Cell Therapy Enriched Fat Grafting for the Reconstruction of Craniofacial Deficits. Plast Reconstr Surg Glob Open. 2023 Jun 19;11(6):e5056. doi: 10.1097/GOX.0000000000005056. eCollection 2023 Jun.
citation: Cao Z, Li H, Wang ZH, Liang XQ. High-Density Fat Grafting Assisted Stromal Vascular Fraction Gel in Facial Deformities. J Craniofac Surg. 2022 Jan-Feb 01;33(1):108-111. doi: 10.1097/SCS.0000000000008038.
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