Romberg DiseasePhase 1NCT05610878
Efficacy of Preconditioned Adipose-Derived Stem Cells in Fat Grafting
A Phase 1 study testing Cultured ASCs enrichment fat grafting, Curcumin-preconditioned ASCs enrichment fat grafting and Conventional fat grafting in people with Romberg Disease and Craniofacial Microsomia, run by University of the Punjab at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Romberg Disease, Craniofacial Microsomia, Burn Scar
- What is being tested?
- Cultured ASCs enrichment fat grafting, Curcumin-preconditioned ASCs enrichment fat grafting and Conventional fat grafting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Nov 2020to Dec 2025
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Stem Cell Laboratory, Jinnah Burn and Reconstructive Surgery Center (JB&RSC)
Lahore, Punjab Province, 54550
Dr. Moazzam Nazeer Tarar, Plastic Surgeon MBBS/ FRCS, +92-300-8423139, mntarar@gmail.com
About this study
Official title: 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.
Read the 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.
- Being tested
- Cultured ASCs enrichment fat grafting, Curcumin-preconditioned ASCs enrichment fat grafting, Conventional fat grafting
- Keywords
- Facial deformities, Fat grafting, Adipose derived stem cells, Preconditioning
- Medical subject headings
- Facial Hemiatrophy, Goldenhar Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cultured ASCs enrichment fat graftingBiological
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 graftingBiological
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 graftingOther
Patients will undergo conventional fat harvesting and grafting of fat into recipient site
| Study group | Role | What they receive |
|---|---|---|
| Cultured ASCs enrichment fat grafting | Experimental | Fat graft will be supplemented with naïve ASCs Receives: Biological: Cultured ASCs enrichment fat grafting |
| Curcumin-preconditioned ASCs enrichment fat grafting | Experimental | Fat graft will be augmented with curcumin preconditioned ASCs Receives: Biological: Curcumin-preconditioned ASCs enrichment fat grafting |
| conventional fat grafting | Active comparator | Fat graft will not be supplemented with ex-vivo expanded ASCs Receives: Other: Conventional fat grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (2)
Patient Assessment
Patients will be interviewed and pre-and post-operatively and digital images will be taken until 9 months of follow up.
Measured: 9 months
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.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2022
- Study start20 Nov 2020
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Romberg DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Punjab
- Sponsor type
- University, hospital or other
- Collaborators
- Centre of Excellence in Molecular Biology, University of the Punjab, Lahore, Higher Education Commission (Pakistan), Jinnah Burn and Reconstructive Surgery Centre, Lahore
- Responsible party
- Principal investigator, Azra Mehmood, University of the Punjab
- Investigators
- Azra Mehmood, PhD, Principal investigator, Center of Excellence in Molecular Biology (CEMB), University of the Punjab, LahoreSheikh Riazuddin, PhD, Study director, Jinnah Burn and Reconstructive Surgery Center (JB&RSC), Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05610878
- Sponsor's protocol ID
- CEMB-SC01
- Status last verified
- Dec 2024
- First submitted
- 26 Oct 2022
- Last updated
- 31 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 17518674Bashir 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.
PubMed 31827528Ghufran 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.
PubMed 32668325Bourne 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.
PubMed 37342306Cao 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.
PubMed 34519702Wang 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.
PubMed 33871949
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supplementation of Autologous Fat Grafts with Curcumin Preconditioned Adipose-Derived Stem Cells in the Treatment of Facial Contour Deformities
- ClinicalTrials.gov ID
- NCT05610878
- Acronym / sponsor ID
- CEMB-SC01
- Keywords
- Facial deformities, Fat grafting, Adipose derived stem cells, Preconditioning
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of the PunjabUniversity, hospital or other
- Collaborators
- Centre of Excellence in Molecular Biology, University of the Punjab, Lahore, Higher Education Commission (Pakistan), Jinnah Burn and Reconstructive Surgery Centre, Lahore
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cultured ASCs enrichment fat grafting | Experimental | Biological: Cultured ASCs enrichment fat graftingFat graft will be supplemented with naïve ASCs |
| Curcumin-preconditioned ASCs enrichment fat grafting | Experimental | Biological: Curcumin-preconditioned ASCs enrichment fat graftingFat graft will be augmented with curcumin preconditioned ASCs |
| conventional fat grafting | Active comparator | Other: Conventional fat graftingFat graft will not be supplemented with ex-vivo expanded ASCs |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cultured ASCs enrichment fat graftingPatients 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 | Biological | Cultured ASCs enrichment fat grafting |
| Curcumin-preconditioned ASCs enrichment fat graftingPatients 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 | Biological | Curcumin-preconditioned ASCs enrichment fat grafting |
| Conventional fat graftingPatients will undergo conventional fat harvesting and grafting of fat into recipient site | Other | conventional fat grafting |
Primary outcome
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.
2 secondary outcomes
Patient Assessment
Time frame: 9 months
Surgeon Assessment
Time frame: 9 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2024.
- Background: PubMed 17518674Matsumoto 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.
- Background: PubMed 31827528Bashir 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.
- Background: PubMed 32668325Ghufran 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.
- Background: PubMed 37342306Bourne 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.
- Background: PubMed 34519702Cao 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.
- Background: PubMed 33871949Wang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Azra Mehmood, PhD principal investigator
Center of Excellence in Molecular Biology (CEMB), University of the Punjab, Lahore
Sheikh Riazuddin, PhD study director
Jinnah Burn and Reconstructive Surgery Center (JB&RSC), Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cultured ASCs enrichment fat grafting, Curcumin-preconditioned ASCs enrichment fat grafting and Conventional fat grafting in people with Romberg Disease and Craniofacial Microsomia, run by University of the Punjab at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Azra Mehmood, PhD (+92-333-4107008, azra_mehmood@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volumetric change in facial tissue by ultrasonography (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05610878, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2024.