MedDataX Logo

Efficacy of Preconditioned Adipose-Derived Stem Cells in Fat Grafting

NCT ID: NCT05610878

Last Updated: 2024-12-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-20

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Facial deformities Fat grafting Adipose derived stem cells Preconditioning

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cultured ASCs enrichment fat grafting

Fat graft will be supplemented with naïve ASCs

Group Type EXPERIMENTAL

Cultured ASCs enrichment fat grafting

Intervention Type 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

Curcumin-preconditioned ASCs enrichment fat grafting

Fat graft will be augmented with curcumin preconditioned ASCs

Group Type EXPERIMENTAL

Curcumin-preconditioned ASCs enrichment fat grafting

Intervention Type 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

conventional fat grafting

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

Group Type ACTIVE_COMPARATOR

Conventional fat grafting

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type BIOLOGICAL

Conventional fat grafting

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

UNKNOWN

Sponsor Role collaborator

Higher Education Commission (Pakistan)

OTHER

Sponsor Role collaborator

Jinnah Burn and Reconstructive Surgery Centre, Lahore

OTHER_GOV

Sponsor Role collaborator

University of the Punjab

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Azra Mehmood

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Azra Mehmood, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Sheikh Riazuddin, PhD

Role: STUDY_DIRECTOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Pakistan

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Azra Mehmood, PhD

Role: CONTACT

Phone: +92-333-4107008

Email: [email protected]

Amna Arif, M.Phil.

Role: CONTACT

Phone: +92-333-4161068

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Dr. Moazzam Nazeer Tarar, Plastic Surgeon MBBS/ FRCS

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 17518674 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31827528 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32668325 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37342306 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34519702 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33871949 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CEMB-SC01

Identifier Type: -

Identifier Source: org_study_id