Health TrialsbyHealthPanel

Efficacy of Preconditioned Adipose-Derived Stem Cells in Fat Grafting

ConditionsRomberg DiseaseCraniofacial MicrosomiaBurn ScarPost-Traumatic Scar (Disorder)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of the Punjab

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cultured ASCs enrichment fat grafting

    Biological/Vaccine

    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

  • Curcumin-preconditioned ASCs enrichment fat grafting

    Biological/Vaccine

    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

  • Conventional fat grafting

    Other intervention

    Patients will undergo conventional fat harvesting and grafting of fat into recipient site

Treatment groups

24 Participants
are divided into 3 treatment groups
Group A: Cultured ASCs enrichment fat graftingExperimental treatment 1 intervention
Group B: Curcumin-preconditioned ASCs enrichment fat graftingExperimental treatment 1 intervention
Group C: conventional fat graftingActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Volumetric change in facial tissue by ultrasonography

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.

Time frame
9 months

Secondary outcomes

1

Patient Assessment

Patients will be interviewed and pre-and post-operatively and digital images will be taken until 9 months of follow up.

Time frame
9 months
2

Surgeon Assessment

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.

Time frame
9 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of the Punjab

Lead sponsor

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

Collaborator

Higher Education Commission (Pakistan)

Collaborator

Jinnah Burn and Reconstructive Surgery Centre, Lahore

Collaborator

Source ClinicalTrials.gov
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