Efficacy of Preconditioned Adipose-Derived Stem Cells in Fat Grafting

December 30, 2024 updated by: Azra Mehmood, University of the Punjab

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54550
        • Recruiting
        • Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC)
        • Contact:
          • Dr. Moazzam Nazeer Tarar, Plastic Surgeon MBBS/ FRCS
          • Phone Number: +92-300-8423139
          • Email: mntarar@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cultured ASCs enrichment fat grafting
Fat graft will be supplemented with naïve ASCs
Biological: Cultured ASCs enrichment fat grafting
Patients will undergo conventional fat harvesting. Harvested fat will be mixed with cultured ASCs and grafted into recipient site with 1,00,000 cells/ml injected fat
Experimental: Curcumin-preconditioned ASCs enrichment fat grafting
Fat graft will be augmented with curcumin preconditioned ASCs
Biological: Curcumin-preconditioned ASCs enrichment fat grafting
Patients will undergo conventional fat harvesting. Harvested fat will be mixed with cultured ASCs preconditioned with curcumin and grafted into recipient site with 1,00,000 cells/ml injected fat
Active Comparator: conventional fat grafting
Fat graft will not be supplemented with ex-vivo expanded ASCs
Other: Conventional fat grafting
Patients will undergo conventional fat harvesting and grafting of fat into recipient site

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Volumetric change in facial tissue by ultrasonography
Time Frame: 9 months
Volumetric evaluation of treated area will be done by measuring the thickness of subcutaneous tissue (in millimeters) by using baseline B mode ultrasound device. Volumetric evaluation of treated area will be done by measuring the thickness of subcutaneous tissue (in millimeters) before transplantation, 1 week after transplantation then after 3, 6 and 9 months by using baseline B mode ultrasound device.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Assessment
Time Frame: 9 months
Patients will be interviewed and pre-and post-operatively and digital images will be taken until 9 months of follow up.
9 months
Surgeon Assessment
Time Frame: 9 months
Patients will be visually inspected for facial volume by two qualified plastic surgeons unaware of treatment after grafting to check whether curcumin pretreatment have effect on MSCs origin of ASCs.
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of the Punjab

Collaborators

Higher Education Commission (Pakistan)
Centre of Excellence in Molecular Biology, University of the Punjab, Lahore
Jinnah Burn and Reconstructive Surgery Centre, Lahore

Investigators

  • Principal Investigator: Azra Mehmood, PhD, Center of Excellence in Molecular Biology (CEMB), University of the Punjab, Lahore
  • Study Director: Sheikh Riazuddin, PhD, Jinnah Burn and Reconstructive Surgery Center (JB&RSC), Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2020

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

October 26, 2022

First Submitted That Met QC Criteria

November 3, 2022

First Posted (Actual)

November 9, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 30, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEMB-SC01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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