Actively Recruiting

Phase 1
Age: 18Years - 50Years
All Genders
ID05610878

Supplementation of Autologous Fat Grafts with Curcumin Preconditioned Adipose-Derived Stem Cells in the Treatment of Facial Contour Deformities

Led by University of the Punjab · Updated on 2024-12-31

24

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

U

University of the Punjab

Lead Sponsor

C

Centre of Excellence in Molecular Biology, University of the Punjab, Lahore

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Brief Title

Efficacy of Preconditioned Adipose-Derived Stem Cells in Fat Grafting

Who Can Participate

Age: 18Years - 50Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18-50 years (male or female)
  • Body-mass index 20-30 kg/m8
  • Suitable for liposuction as assessed by the expected cosmetic results
  • Provided signed informed consent
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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

Trial Site Locations

Total: 1 location

1

Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC)

Lahore, Punjab Province, Pakistan, 54550

Actively Recruiting

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Research Team

A

Azra Mehmood, PhD

A

Amna Arif, M.Phil.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

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/17518674

Preenrichment with Adipose Tissue-Derived Stem Cells Improves Fat Graft Retention in Patients with Contour Deformities of the Face.

Muhammad M Bashir, Muhammad Sohail, Fridoon J Ahmad...

https://pubmed.ncbi.nlm.nih.gov/31827528

Curcumin preconditioned human adipose derived stem cells co-transplanted with platelet rich plasma improve wound healing in diabetic rats.

Hafiz Ghufran, Azra Mehmood, Maryam Azam...

https://pubmed.ncbi.nlm.nih.gov/32668325

A pilot study on ex vivo expanded autologous adipose-derived stem cells of improving fat retention in localized scleroderma patients.

Chenyu Wang, Xiao Long, Loubin Si...

https://pubmed.ncbi.nlm.nih.gov/33871949