Skin RejuvenationNCT03928444
Evaluation of the Efficacy and Tolerability of Autologous Adipose Tissue Derived Stem Cells on Facial Rejuvenation
A study testing intradermal injection of adipose derived stem cells to one side of the face and intradermal injection of saline to one side of the face in people with Skin Rejuvenation, run by Alexandria University at 1 site in Egypt.
Trial summary
This study is to evaluate the efficacy and tolerability of autologous adipose tissue derived stem cells in facial rejuvenation. 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
- What is being tested?
- intradermal injection of adipose derived stem cells to one side of the face and intradermal injection of saline to one side of the face
- 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 6 Aug 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 study is to evaluate the efficacy and tolerability of autologous adipose tissue derived stem cells in facial rejuvenation.
Read the detailed description
Skin aging is a complex biological process that can be categorized into either extrinsic or intrinsic aging. Intrinsic aging is an inherent degenerative process caused by decreased proliferative capacity leading to cellular senescence. Extrinsic aging is caused by factors such as UV radiations, smoking and alcohol consumption.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.Aging skin undergoes thinning of the epidermis that is caused by reduction of vascularity and hydration. On average, the thickness of the epidermis is reduced by about 6.4% during each decade of life.Skin aging effects can be assessed based on the skin appearance (texture and roughness, fine lines and wrinkles), structure, elasticity, hydration and barrier function. Many new non-invasive or minimally invasive bioengineering advances in recent years have enabled the quantitative analysis of skin properties during the aging processRecently, adult stem cells such as mesenchymal stem cells (MSCs) have been used in variable dermatologic conditions due to its regenerative properties such as wound healing, rejuvenation, acne scar and hair fall treatment. Different types of MSCs could be derived from different tissues as for example; bone marrow stem cells (BMSCs), adipose tissue-derived stem cells (ADSCs), and skin-derived stem cells (SDSCs)Adipose tissue derived stem cells are currently favorable compared to other types of adult stem cells as the procedure is easy, safe with minimal donor site morbidity. The process of obtaining a considerable amount of adipose tissues sufficient to use in skin regeneration is highly appealing due to its relative availability and accessibility. They secrete variable growth factors that affect surrounding environment as vascular endothelial growth factor (VEGF), platelet derived growth factor (PDGF), insulin like growth factors (IGF) and others
- Conditions
- Skin Rejuvenation
- Being tested
- intradermal injection of adipose derived stem cells to one side of the face, intradermal injection of saline to one side of the face
- Keywords
- Adipose tissue derived stem cells, Facial rejuvenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intradermal injection of adipose derived stem cells to one side of the faceProcedure or surgery
Lipoaspiration for preparation of ADSC will be done according to the following technique:
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 (50 ml fat ) using a blunt tipped cannula under the negative suction pressure of a 60 ml syringe.
- Autologous adipose tissue derived stem cells (At-ADSCs) will be separated from the lipo-aspirate using enzymatic digestion and differential centrifugation in the Center of Excellence for Research in Regenerative Medicine and its Application (CERRMA), Alexandria Faculty of Medicine.
- Viability of collected cells will be checked using trypan blue stain. Characterization of the isolated ADSCs population will be performed by flow cytometry.
intradermal injection of saline to one side of the faceProcedure or surgery
intradermal injection of saline to one side of the face
| Study group | Role | What they receive |
|---|---|---|
| stem cells | Experimental | one side of the face to be treated with intradermal stem cells Receives: Procedure: intradermal injection of adipose derived stem cells to one side of the face |
| control | Placebo comparator | one side of face treated with intradermal saline Receives: Procedure: intradermal injection of saline to one side of the face |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the degree of aesthetic improvement using the global aesthetic improvement scale GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
serial photography for assessment of degree of aesthetic improvement using the global aesthetic improvement scale GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Measured: 6 months
Secondary outcomes (5)
Assessment of trans-epidermal water loss (TEWL) in gm /h-m2 using noninvasive probe (Dermal measurement system EDS12, UK) on both temple regions of the head
Assessment of trans-epidermal water loss (TEWL) in gm /h-m2 using noninvasive probe (Dermal measurement system EDS12, UK) on both temple regions of the head
Measured: 6 months
Assessment of skin hydration in units using noninvasive probe (Dermal measurement system EDS12, UK) on both temple regions of the head
Assessment of hydration in units using noninvasive probe (Dermal measurement system EDS12, UK) on both temple regions of the head
Measured: 6 months
Measurement of epidermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head
Measurement of epidermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head
Measured: 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
Measured: 6 months
A visual analog scale, will be used to assess participants' satisfaction by the treatment and side effects
A visual analog scale, will be used to assess participants' satisfaction by the treatment and side effects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2019
- Study start1 Jan 2019
- Primary completion6 Aug 2019
- Study completion6 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 UniversityOssama Hussein Roshdy, MD, Study director, Professor of Dermatology, Faculty of Medicine, Alexandria UniversityWafaa Ibrahim Abdullah, MD, Study director, Professor of Dermatology, Faculty of Medicine, Alexandria UniversityRadwa 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, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03928444
- Sponsor's protocol ID
- AlexandriaUdermatology
- Status last verified
- Sep 2019
- First submitted
- 21 Apr 2019
- Last updated
- 30 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Tolerability of Autologous Adipose Tissue Derived Stem Cells on Facial Rejuvenation
- ClinicalTrials.gov ID
- NCT03928444
- Acronym / sponsor ID
- AlexandriaUdermatology
- Conditions
- Skin Rejuvenation
- Keywords
- Adipose tissue derived stem cells, Facial rejuvenation
- 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
- 6 Aug 2019 (actual)
- Study completion
- 6 Aug 2019 (actual)
- First posted
- 26 Apr 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 study is to evaluate the efficacy and tolerability of autologous adipose tissue derived stem cells in facial rejuvenation.
Detailed description
Skin aging is a complex biological process that can be categorized into either extrinsic or intrinsic aging. Intrinsic aging is an inherent degenerative process caused by decreased proliferative capacity leading to cellular senescence. Extrinsic aging is caused by factors such as UV radiations, smoking and alcohol consumption.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.Aging skin undergoes thinning of the epidermis that is caused by reduction of vascularity and hydration. On average, the thickness of the epidermis is reduced by about 6.4% during each decade of life.Skin aging effects can be assessed based on the skin appearance (texture and roughness, fine lines and wrinkles), structure, elasticity, hydration and barrier function. Many new non-invasive or minimally invasive bioengineering advances in recent years have enabled the quantitative analysis of skin properties during the aging processRecently, adult stem cells such as mesenchymal stem cells (MSCs) have been used in variable dermatologic conditions due to its regenerative properties such as wound healing, rejuvenation, acne scar and hair fall treatment. Different types of MSCs could be derived from different tissues as for example; bone marrow stem cells (BMSCs), adipose tissue-derived stem cells (ADSCs), and skin-derived stem cells (SDSCs)Adipose tissue derived stem cells are currently favorable compared to other types of adult stem cells as the procedure is easy, safe with minimal donor site morbidity. The process of obtaining a considerable amount of adipose tissues sufficient to use in skin regeneration is highly appealing due to its relative availability and accessibility. They secrete variable growth factors that affect surrounding environment as vascular endothelial growth factor (VEGF), platelet derived growth factor (PDGF), insulin like growth factors (IGF) and others
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 |
|---|---|---|
| stem cells | Experimental | Procedure: intradermal injection of adipose derived stem cells to one side of the faceone side of the face to be treated with intradermal stem cells |
| control | Placebo comparator | Procedure: intradermal injection of saline to one side of the faceone side of face treated with intradermal saline |
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 |
|---|---|---|
| intradermal injection of adipose derived stem cells to one side of the faceLipoaspiration for preparation of ADSC will be done according to the following technique: 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 (50 ml fat ) using a blunt tipped cannula under the negative suction pressure of a 60 ml syringe. * Autologous adipose tissue derived stem cells (At-ADSCs) will be separated from the lipo-aspirate using enzymatic digestion and differential centrifugation in the Center of Excellence for Research in Regenerative Medicine and its Application (CERRMA), Alexandria Faculty of Medicine. * Viability of collected cells will be checked using trypan blue stain. Characterization of the isolated ADSCs population will be performed by flow cytometry. | Procedure or surgery | stem cells |
| intradermal injection of saline to one side of the faceintradermal injection of saline to one side of the face | Procedure or surgery | control |
Primary outcome
Assessment of the degree of aesthetic improvement using the global aesthetic improvement scale GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
Time frame: 6 months
serial photography for assessment of degree of aesthetic improvement using the global aesthetic improvement scale GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse.
5 secondary outcomes
Assessment of trans-epidermal water loss (TEWL) in gm /h-m2 using noninvasive probe (Dermal measurement system EDS12, UK) on both temple regions of the head
Time frame: 6 months
Assessment of skin hydration in units using noninvasive probe (Dermal measurement system EDS12, UK) on both temple regions of the head
Time frame: 6 months
Measurement of epidermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head
Time frame: 6 months
Measurement of dermal thickness in mm using UBM (Ultrasound Bio microscopy) on both temple regions of the head
Time frame: 6 months
A visual analog scale, will be used to assess participants' satisfaction by the treatment and side effects
Time frame: 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 30 Sep 2019.
- Individual participant dataSharing planned: No
Related trials for Skin Rejuvenation
Recruiting
Ultraformer MPT Combined With Fractional CO2 Versus Fractional CO2 Alone for Facial Rejuvenation
Skin Aging
Enrolling by invitationEarly Phase 1
Systemic and Topical Geroprotective Rejuvenation Assessed by START/REST Aging Clocks
Aging
Not yet recruitingPhase 3
Objective Evaluation of Intradermal MSC-Derived Exosome Therapy on Facial Skin Quality
Skin Aging, Facial Aging
Not yet recruiting
Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck Rejuvenation
Facial Wrinkles, Jawline Contour
Not yet recruiting
Poly-L-lactic Acid (PLLA) Injection for Neck Skin Laxity: A Pilot Study
Skin Aging, Wrinkles
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, Alexandria University
Wafaa Ibrahim Abdullah, MD study director
Professor of Dermatology, Faculty of Medicine, Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intradermal injection of adipose derived stem cells to one side of the face and intradermal injection of saline to one side of the face in people with Skin Rejuvenation, 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 30 Sep 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 of the degree of aesthetic improvement using the global aesthetic improvement scale GAIS 5-point scale where: 2=much improved, 1=improved, 0=no change, -1=worse and -2=much worse. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2019.