Efficacy of Preconditioned Adipose-Derived Stem Cells in Fat Grafting

NCT05610878 | Recruiting Phase 1 DMC

• 1 other identifier: CEMB-SC01
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Romberg Disease; Craniofacial Microsomia; Burn Scar; Post-Traumatic Scar (Disorder)

Keywords

Facial deformities; Fat grafting; Adipose derived stem cells; Preconditioning

Outcome Measures

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.

  9 months

Secondary Outcomes (2)

• Patient Assessment

  9 months

• Surgeon Assessment

  9 months

Study Arms (3)

Cultured ASCs enrichment fat grafting

EXPERIMENTAL

Fat graft will be supplemented with naïve ASCs

Biological: Cultured ASCs enrichment fat grafting

Curcumin-preconditioned ASCs enrichment fat grafting

EXPERIMENTAL

Fat graft will be augmented with curcumin preconditioned ASCs

Biological: Curcumin-preconditioned ASCs enrichment fat grafting

conventional fat grafting

ACTIVE COMPARATOR

Fat graft will not be supplemented with ex-vivo expanded ASCs

Other: Conventional fat grafting

Interventions

Cultured ASCs enrichment fat grafting BIOLOGICAL

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

Cultured ASCs enrichment fat grafting

Curcumin-preconditioned ASCs enrichment fat grafting BIOLOGICAL

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

Curcumin-preconditioned ASCs enrichment fat grafting

Conventional fat grafting OTHER

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

conventional fat grafting

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Punjab: lead
• 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

Study Sites (1)

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

Lahore, Punjab Province, 54550, Pakistan

RECRUITING

Related Publications (6)

• Matsumoto D, Sato K, Gonda K, Takaki Y, Shigeura T, Sato T, Aiba-Kojima E, Iizuka F, Inoue K, Suga H, Yoshimura K. Cell-assisted lipotransfer: supportive use of human adipose-derived cells for soft tissue augmentation with lipoinjection. Tissue Eng. 2006 Dec;12(12):3375-82. doi: 10.1089/ten.2006.12.3375.

  PMID: 17518674 BACKGROUND

• 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.

  PMID: 31827528 BACKGROUND

• 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.

  PMID: 32668325 BACKGROUND

• 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.

  PMID: 37342306 BACKGROUND

• 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.

  PMID: 34519702 BACKGROUND

• Wang C, Long X, Si L, Chen B, Zhang Y, Sun T, Zhang X, Zhao RC, Wang X. A pilot study on ex vivo expanded autologous adipose-derived stem cells of improving fat retention in localized scleroderma patients. Stem Cells Transl Med. 2021 Aug;10(8):1148-1156. doi: 10.1002/sctm.20-0419. Epub 2021 Apr 19.

  PMID: 33871949 BACKGROUND

MeSH Terms

Conditions

Facial Hemiatrophy; Goldenhar Syndrome

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Facial Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Mandibulofacial Dysostosis; Craniofacial Dysostosis; Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Azra Mehmood, PhD

  Center of Excellence in Molecular Biology (CEMB), University of the Punjab, Lahore

  PRINCIPAL INVESTIGATOR

• Sheikh Riazuddin, PhD

  Jinnah Burn and Reconstructive Surgery Center (JB&RSC), Lahore

  STUDY DIRECTOR

Central Study Contacts

Azra Mehmood, PhD

CONTACT

+92-333-4107008; azra_mehmood@hotmail.com

Amna Arif, M.Phil.

CONTACT

+92-333-4161068; amnaarif.qureshi@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: November 9, 2022
• Study Start: November 20, 2020
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: December 31, 2024

Record last verified: 2024-12

Locations

PA (1)