Skin RejuvenationNCT03965936
Effect of Adipose Derived Stem Cells on Survival of Fat as Filler
A study testing lipofilling and lipofilling enriched with adipose tissue derived stem cells in people with Skin Rejuvenation and Lipofilling, run by Alexandria University at 1 site in Egypt.
Trial summary
this research is to study the effect of Adipose Derived Stem Cells on Survival of Fat as Filler Read more about this study
- Who is it for?
- Ages 35 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Skin Rejuvenation, Lipofilling
- What is being tested?
- lipofilling and lipofilling enriched with adipose tissue derived stem cells
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 16 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 35 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clinically diagnosed facial skin aging.
- Glogau photoaging score II and III.
- Body mass index ≥20 with adequate abdominal or other subcutaneous adipose tissue accessible for lipoaspiration.
Who cannot join
- History of keloid formation.
- Any coincidental chronic illness (e.g. metabolic, autoimmune or endocrinal) or malignancy.
- Any bleeding or coagulation disorder or recent use of anticoagulant therapy.
- Active infection.
- History of any previous aesthetic procedure on the face within the past 6 months.
- History of intake of anti-aging systemic or topical medications within the previous 3 months
Trial locations and contacts
1 site in 1 country.
About this study
this research is to study the effect of Adipose Derived Stem Cells on Survival of Fat as Filler
Read the detailed description
Skin aging is a complex biological process.The physiological changes associated with aging of the skin are manifested in xerosis, dramatic loss of skin elasticity due to damage to collagen and elastin fibers; as well as barrier function, modification of rhytides and deficiencies in the regenerative property of the skin. All of which ultimately result in thinning of the skin, malar fat atrophy and pigmentary changes. Autologous fat grafting or lipo injection containing stromal vascular fraction (SVF) acts like ideal soft tissue filler for facial filling and rejuvenation. It leads to progressive improvement of the skin texture, elasticity, and color over a few months, therefore adipose tissue seems to be not only a simple filler but also a dynamic filler with two types of different and supplementary effects, the volumetric effect and the regenerative effect.Cell assisted lipotransfer (CAL) is a technique that combines aspirated fat with concentrated ADSCs in the stromal vascular fraction (SVF) of the lipoaspirate. This technique could enhance the survival rate of the transplanted fat and leads to better cosmetic improvement
- Conditions
- Skin Rejuvenation, Lipofilling
- Being tested
- lipofilling, lipofilling enriched with adipose tissue derived stem cells
- Keywords
- adipose tissue derived stem cells, lipofilling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lipofillingProcedure or surgery
Under local anesthesia using strict aseptic technique, a small incision will be done in the lateral aspect of the thigh or lower abdomen, through which the infiltration cannula will be introduced to inject the local anesthetic solution using the wet technique. This will be followed 15 minutes later by lipo-aspiration of 75 ml fat ) using a blunt tipped cannula under the negative suction pressure of a 60 ml syringe. 50 ml is used for preparation of microfat. then with blunt cannula,subcutaneous injection of the required volume of microfat is placed into temporal region.
lipofilling enriched with adipose tissue derived stem cellsProcedure or surgery
Under local anesthesia using strict aseptic technique, a small incision will be done in the lateral aspect of the thigh or lower abdomen, through which the infiltration cannula will be introduced to inject the local anesthetic solution using the wet technique. This will be followed 15 minutes later by lipo-aspiration of 75 ml fat using a blunt tipped cannula under the negative suction pressure of a 60 ml syringe. 50 ml is used for preparation of microfat. 25 ml is used for preparation of autologous adipose tissue derived stem cells (At-ADSCs) using enzymatic digestion and differential centrifugation in the Center of Excellence for Research in Regenerative Medicine and its Application (CERRMA), Alexandria Faculty of Medicine.
Subcutaneous injection of the required volume of microfat combined with stromal vascular fraction containing adipose tissue derived stem cells, is placed into temporal region.
| Study group | Role | What they receive |
|---|---|---|
| lipofilling | Placebo comparator | subcutaneous injection of lipoaspiate (microfat) in one temporal region Receives: Procedure: lipofilling |
| lipofilling enriched with adipose tissue derived stem cells | Active comparator | subcutaneous injection of lipoaspiate enriched with adipose tissue derived stem cells in one temporal region Receives: Procedure: lipofilling enriched with adipose tissue derived stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment using hollowness severity rating scale :0 : no visible hollowness, 1: mild Hollowness, 2 : moderate Hollowness, 3: severe Hollowness
serial photography for assessment using hollowness severity rating scale :0 : no visible hollowness, 1: mild Hollowness, 2 : moderate Hollowness, 3: severe Hollowness
Measured: 3 months, 6 months
Secondary outcomes (2)
Measurement of hypodermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head
Measurement of hypodermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head
Measured: 3 months, 6 months
Measurement of dermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head Measurement of dermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head
Measurement of dermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start1 Jan 2019
- Primary completion16 Jul 2019
- Study completion16 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin RejuvenationStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- split face
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Ismail Ali Ismail, Alexandria University
- Investigators
- Carmen Ibrahim Farid Mohammed Amin, MD, Study director, Assistant Professor of Dermatology, Faculty of Medicine, Alexandria University.Ossama Hussein Roshdy, MD, Study director, Professor of Dermatology, Faculty of Medicine, University of Alexandria.Wafaa Ibrahim Abdullah, MD, Study director, Professor of Dermatology, Faculty of Medicine, University of Alexandria.Radwa Ali Mehanna, PhD, Study director, Assistant Professor of Physiology, Faculty of Medicine, Alexandria UniversityNader Hussein Lotfy Bayoumi., MD, FRCS, Study director, Professor of ophthalmology , Faculty of Medicine, University of Alexandria.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965936
- Sponsor's protocol ID
- alexderma 2
- Status last verified
- Jul 2019
- First submitted
- 24 May 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roshdy OH, Abdallah WI, Farid CI, Mehanna RA, Bayoumi NH, Ismail AI. Stromal vascular fraction improves the durability of autologous fat temple augmentation-A split-face randomized study using ultrasound biomicroscopy. J Plast Reconstr Aesthet Surg. 2022 Jun;75(6):1870-1877. doi: 10.1016/j.bjps.2021.12.005. Epub 2022 Jan 15.
PubMed 35125305
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adipose Derived Stem Cells on Survival of Fat as Filler
- ClinicalTrials.gov ID
- NCT03965936
- Acronym / sponsor ID
- alexderma 2
- Conditions
- Skin Rejuvenation, Lipofilling
- Keywords
- adipose tissue derived stem cells, lipofilling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 16 Jul 2019 (actual)
- Study completion
- 16 Jul 2019 (actual)
- First posted
- 29 May 2019 (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.
this research is to study the effect of Adipose Derived Stem Cells on Survival of Fat as Filler
Detailed description
Skin aging is a complex biological process.The physiological changes associated with aging of the skin are manifested in xerosis, dramatic loss of skin elasticity due to damage to collagen and elastin fibers; as well as barrier function, modification of rhytides and deficiencies in the regenerative property of the skin. All of which ultimately result in thinning of the skin, malar fat atrophy and pigmentary changes. Autologous fat grafting or lipo injection containing stromal vascular fraction (SVF) acts like ideal soft tissue filler for facial filling and rejuvenation. It leads to progressive improvement of the skin texture, elasticity, and color over a few months, therefore adipose tissue seems to be not only a simple filler but also a dynamic filler with two types of different and supplementary effects, the volumetric effect and the regenerative effect.Cell assisted lipotransfer (CAL) is a technique that combines aspirated fat with concentrated ADSCs in the stromal vascular fraction (SVF) of the lipoaspirate. This technique could enhance the survival rate of the transplanted fat and leads to better cosmetic improvement
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- split face
| Arm | Type | Receives |
|---|---|---|
| lipofilling | Placebo comparator | Procedure: lipofillingsubcutaneous injection of lipoaspiate (microfat) in one temporal region |
| lipofilling enriched with adipose tissue derived stem cells | Active comparator | Procedure: lipofilling enriched with adipose tissue derived stem cellssubcutaneous injection of lipoaspiate enriched with adipose tissue derived stem cells in one temporal region |
Who may qualify
- Ages
- 35 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinically diagnosed facial skin aging.
- Glogau photoaging score II and III.
- Body mass index ≥20 with adequate abdominal or other subcutaneous adipose tissue accessible for lipoaspiration.
Key exclusion criteria (6 listed)
- History of keloid formation.
- Any coincidental chronic illness (e.g. metabolic, autoimmune or endocrinal) or malignancy.
- Any bleeding or coagulation disorder or recent use of anticoagulant therapy.
- Active infection.
- History of any previous aesthetic procedure on the face within the past 6 months.
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 |
|---|---|---|
| lipofillingUnder local anesthesia using strict aseptic technique, a small incision will be done in the lateral aspect of the thigh or lower abdomen, through which the infiltration cannula will be introduced to inject the local anesthetic solution using the wet technique. This will be followed 15 minutes later by lipo-aspiration of 75 ml fat ) using a blunt tipped cannula under the negative suction pressure of a 60 ml syringe. 50 ml is used for preparation of microfat. then with blunt cannula,subcutaneous injection of the required volume of microfat is placed into temporal region. | Procedure or surgery | lipofilling |
| lipofilling enriched with adipose tissue derived stem cellsUnder local anesthesia using strict aseptic technique, a small incision will be done in the lateral aspect of the thigh or lower abdomen, through which the infiltration cannula will be introduced to inject the local anesthetic solution using the wet technique. This will be followed 15 minutes later by lipo-aspiration of 75 ml fat using a blunt tipped cannula under the negative suction pressure of a 60 ml syringe. 50 ml is used for preparation of microfat. 25 ml is used for preparation of autologous adipose tissue derived stem cells (At-ADSCs) using enzymatic digestion and differential centrifugation in the Center of Excellence for Research in Regenerative Medicine and its Application (CERRMA), Alexandria Faculty of Medicine. Subcutaneous injection of the required volume of microfat combined with stromal vascular fraction containing adipose tissue derived stem cells, is placed into temporal region. | Procedure or surgery | lipofilling enriched with adipose tissue derived stem cells |
Primary outcome
Assessment using hollowness severity rating scale :0 : no visible hollowness, 1: mild Hollowness, 2 : moderate Hollowness, 3: severe Hollowness
Time frame: 3 months, 6 months
serial photography for assessment using hollowness severity rating scale :0 : no visible hollowness, 1: mild Hollowness, 2 : moderate Hollowness, 3: severe Hollowness
2 secondary outcomes
Measurement of hypodermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head
Time frame: 3 months, 6 months
Measurement of dermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head Measurement of dermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head
Time frame: 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Derived from this study: PubMed 35125305Roshdy OH, Abdallah WI, Farid CI, Mehanna RA, Bayoumi NH, Ismail AI. Stromal vascular fraction improves the durability of autologous fat temple augmentation-A split-face randomized study using ultrasound biomicroscopy. J Plast Reconstr Aesthet Surg. 2022 Jun;75(6):1870-1877. doi: 10.1016/j.bjps.2021.12.005. Epub 2022 Jan 15.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Carmen Ibrahim Farid Mohammed Amin, MD study director
Assistant Professor of Dermatology, Faculty of Medicine, Alexandria University.
Ossama Hussein Roshdy, MD study director
Professor of Dermatology, Faculty of Medicine, University of Alexandria.
Wafaa Ibrahim Abdullah, MD study director
Professor of Dermatology, Faculty of Medicine, University of Alexandria.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing lipofilling and lipofilling enriched with adipose tissue derived stem cells in people with Skin Rejuvenation and Lipofilling, run by Alexandria University at 1 site in Egypt.
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 3 inclusion and 6 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: finished, as of the sponsor's last update on 18 Jul 2019. 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 Egypt. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment using hollowness severity rating scale :0 : no visible hollowness, 1: mild Hollowness, 2 : moderate Hollowness, 3: severe Hollowness (time frame: 3 months, 6 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 NCT03965936, which also lists 1 linked publication.
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 18 Jul 2019.