Androgenetic AlopeciaNCT06558565
Efficacy of Stromal Vascular Fraction Versus Platelet Rich Plasma in Treatment of Androgenitic Alopecia
A study testing stromal vascular fraction or platelet rich plasma in people with Androgenetic Alopecia, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
The goal of this randomized controlled clinical trial is to test the efficacy \& safety of stromal vascular fraction in treatment of AGA \& compare it to PRP The main questions it aims to answer are: efficacy \& safety of SVF for treatment of AGA patients comparing it to PRP in treatment of AGA Participants will… Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- stromal vascular fraction or platelet rich plasma
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Aug 2024to 1 Apr 2025
- 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 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 18 years or older.
- Hamilton score I to VI in male patients.
Who cannot join
- Patients with active infection, malignancy, autoimmune disease, and on current anticoagulant therapy.
- Patient on chemotherapy during the last 5 years.
- patients on topical or systemic treatment of AGA
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Kasr El Ainy hospital
Cairo
Asmaa S Aamer, resident, 01017762819 ext. 01116783121, asmaaaamer0@gmail.com
About this study
Official title: Efficacy of Stromal Vascular Fraction Versus Platelet Rich Plasma in Treatment of Androgenitic Alopecia:Randomized Clinical Trial
The goal of this randomized controlled clinical trial is to test the efficacy \& safety of stromal vascular fraction in treatment of AGA \& compare it to PRP The main questions it aims to answer are:
- efficacy \& safety of SVF for treatment of AGA patients
- comparing it to PRP in treatment of AGA Participants will receive a single session of SVF in one half of the scalp \& a single session of PRP in the other half.
Read the detailed description
- History taking from the patients is done about age, duration of the disease previous treatment, medical, surgical history \& family history.
- Patients are subjected to clinical evaluation of severity using Hamilton classification \& photographing of the patients. In addition, tricoscopic evaluation of hair density \& thickness.
- Randomization of patients: The side assigned to SVF treatment is randomized by closed envelop technique.
- Isolation of SVF:
After choosing the site of aspiration (either the hip or the abdomen), sterilization of the site is done.Then, local anesthesia (1 ml of lidocaine 2%) is injected intradermally, small incision (3 ml) is made using sterile blade for insertion of the canula. After that, the tumescence is created with a multiperforated blunt cannula injecting the tumescent solution (0.05% lidocaine in saline solution \&1: 200000 epinephrine) then we wait for 20 minutes, followed by harvesting of 50 ml of fat using 2.4 mm microport harvester cannulas with barbed \& beveled 1 mm ports. Processing of fat is started by washing of obtained fat using ringer lactate which is left for 10 minutes to decant \& elements in the lowest layer is discarded. After that, fat is passed 30 times between two Luer lock 20-ml syringes connected to each other by connectors 2.4mm, 1.4mm, and 1.2mm arranged from higher diameter to lower diameter with minimal pressure force in order to achieve successful mechanical micronization of fat. Then, centrifugation of the micronized fat is done (2000 g for 15 minutes). As a result of this process, 3 layers (oil, fat \& SVF) are obtained depending on the density with the SVF pellet suspended in the bottom. After isolation of SVF in one -ml syringes (4-5ml), the scalp is injected with 0.1 ml/cm2 of SVF intra-dermally with small 30 G needle.
- Isolation of platelet-rich plasma: Under sterilized conditions, 8 cc of whole blood are withdrawn from the antecubital vein of each patient. Blood is taken in commercially available PRP kit (Tray Life Tube Gel) containing preformed gel comprising a mixture of polymers that separated plasma, and sodium citrate solution which acts as an anticoagulant. And then is centrifuged at 650 g for 10 minutes. After centrifugation, red blood cells are trapped under the gel, and the upper 1 mL of platelet-poor plasma is removed, and 5 mL PRP obtained.
- Injection of stromal vascular fraction and platelet-rich plasma: Scalp of every patient is divided into two equal halves by the median plane (split scalp), leaving 1.5 cm on both sides of the median plane to minimize diffusion of the injected material to the other side, Lignocaine gel is applied on scalp of patients half an hour before injection followed by sterilization of the site of injection. Then, SVF is injected in one half of scalp \& PRP is injected in the other half of scalp, Intra-dermal injections are given by using insulin syringes at 0.1 ml/cm2 interval. Each patient undergoes one session of injection and is followed up for 6 months after the last session.
- Assessment Three \& six months After PRP and SVF therapy, the improvement is assessed using pre- and post-treatment photographs according to Hamilton Norwood scale, patient global assessment (PaGAS) scores, physician global assessment (PhGAS) scores, patient satisfaction score, pull test \& tricoscopic assessment of:The trichoscopic features of the four areas (bilateral frontal \& occipital areas) which are received and analyzed using the trichoscale analysis system of the fotofinder in an area of approximately 1cm2 (0.903 cm2) e.g.hair density \& thickness.
- Conditions
- Androgenetic Alopecia
- Being tested
- stromal vascular fraction or platelet rich plasma
- Keywords
- stromal vascular fraction - PRP- androgenetic alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stromal vascular fraction or platelet rich plasmaProcedure or surgery
stromal vascular fraction will be injected in one half of the scalp \& PRP will be injected in the other half
| Study group | Role | What they receive |
|---|---|---|
| stromal vascular fraction side | Active comparator | stromal vascular fraction will be injected in one half of the frontal scalp Receives: Procedure: stromal vascular fraction or platelet rich plasma |
| PRP side | Active comparator | PRP will be injected in the other half of frontal scalp Receives: Procedure: stromal vascular fraction or platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of SVF versus PRP
to compare the mean difference in hair density,thickness, Norwood Hamilton scale, patient global assessment, patient satisfaction \& physician global assessment scores between SVF \& PRP.
Measured: at 3 & 6 months after the sessions
Secondary outcomes (1)
Detecting efficacy of SVF in treatment of AGA
To detect provment in hair thickness \& diameter
Measured: at 3 & 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start30 Aug 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion1 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- each patient will receive single session of SVF in one half of the frontal scalp \& single session of PRP in the other half of the scalp to compare the effectiveness of them in AGA treatment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Sobhy Afifi Mohamed Aamer, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06558565
- Sponsor's protocol ID
- MS-260-2023
- Status last verified
- Aug 2024
- First submitted
- 18 Feb 2024
- Last updated
- 16 Aug 2024
- 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 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Stromal Vascular Fraction Versus Platelet Rich Plasma in Treatment of Androgenitic Alopecia:Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06558565
- Acronym / sponsor ID
- MS-260-2023
- Conditions
- Androgenetic Alopecia
- Keywords
- stromal vascular fraction - PRP- androgenetic alopecia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 30 Aug 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 1 Apr 2025 (estimated)
- First posted
- 16 Aug 2024 (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 goal of this randomized controlled clinical trial is to test the efficacy \& safety of stromal vascular fraction in treatment of AGA \& compare it to PRP The main questions it aims to answer are:
- efficacy \& safety of SVF for treatment of AGA patients
- comparing it to PRP in treatment of AGA Participants will receive a single session of SVF in one half of the scalp \& a single session of PRP in the other half.
Detailed description
- History taking from the patients is done about age, duration of the disease previous treatment, medical, surgical history \& family history.
- Patients are subjected to clinical evaluation of severity using Hamilton classification \& photographing of the patients. In addition, tricoscopic evaluation of hair density \& thickness.
- Randomization of patients: The side assigned to SVF treatment is randomized by closed envelop technique.
- Isolation of SVF:
After choosing the site of aspiration (either the hip or the abdomen), sterilization of the site is done.Then, local anesthesia (1 ml of lidocaine 2%) is injected intradermally, small incision (3 ml) is made using sterile blade for insertion of the canula. After that, the tumescence is created with a multiperforated blunt cannula injecting the tumescent solution (0.05% lidocaine in saline solution \&1: 200000 epinephrine) then we wait for 20 minutes, followed by harvesting of 50 ml of fat using 2.4 mm microport harvester cannulas with barbed \& beveled 1 mm ports. Processing of fat is started by washing of obtained fat using ringer lactate which is left for 10 minutes to decant \& elements in the lowest layer is discarded. After that, fat is passed 30 times between two Luer lock 20-ml syringes connected to each other by connectors 2.4mm, 1.4mm, and 1.2mm arranged from higher diameter to lower diameter with minimal pressure force in order to achieve successful mechanical micronization of fat. Then, centrifugation of the micronized fat is done (2000 g for 15 minutes). As a result of this process, 3 layers (oil, fat \& SVF) are obtained depending on the density with the SVF pellet suspended in the bottom. After isolation of SVF in one -ml syringes (4-5ml), the scalp is injected with 0.1 ml/cm2 of SVF intra-dermally with small 30 G needle.
- Isolation of platelet-rich plasma: Under sterilized conditions, 8 cc of whole blood are withdrawn from the antecubital vein of each patient. Blood is taken in commercially available PRP kit (Tray Life Tube Gel) containing preformed gel comprising a mixture of polymers that separated plasma, and sodium citrate solution which acts as an anticoagulant. And then is centrifuged at 650 g for 10 minutes. After centrifugation, red blood cells are trapped under the gel, and the upper 1 mL of platelet-poor plasma is removed, and 5 mL PRP obtained.
- Injection of stromal vascular fraction and platelet-rich plasma: Scalp of every patient is divided into two equal halves by the median plane (split scalp), leaving 1.5 cm on both sides of the median plane to minimize diffusion of the injected material to the other side, Lignocaine gel is applied on scalp of patients half an hour before injection followed by sterilization of the site of injection. Then, SVF is injected in one half of scalp \& PRP is injected in the other half of scalp, Intra-dermal injections are given by using insulin syringes at 0.1 ml/cm2 interval. Each patient undergoes one session of injection and is followed up for 6 months after the last session.
- Assessment Three \& six months After PRP and SVF therapy, the improvement is assessed using pre- and post-treatment photographs according to Hamilton Norwood scale, patient global assessment (PaGAS) scores, physician global assessment (PhGAS) scores, patient satisfaction score, pull test \& tricoscopic assessment of:The trichoscopic features of the four areas (bilateral frontal \& occipital areas) which are received and analyzed using the trichoscale analysis system of the fotofinder in an area of approximately 1cm2 (0.903 cm2) e.g.hair density \& thickness.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- each patient will receive single session of SVF in one half of the frontal scalp \& single session of PRP in the other half of the scalp to compare the effectiveness of them in AGA treatment
| Arm | Type | Receives |
|---|---|---|
| stromal vascular fraction side | Active comparator | Procedure: stromal vascular fraction or platelet rich plasmastromal vascular fraction will be injected in one half of the frontal scalp |
| PRP side | Active comparator | Procedure: stromal vascular fraction or platelet rich plasmaPRP will be injected in the other half of frontal scalp |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 18 years or older.
- Hamilton score I to VI in male patients.
Key exclusion criteria (3 listed)
- Patients with active infection, malignancy, autoimmune disease, and on current anticoagulant therapy.
- Patient on chemotherapy during the last 5 years.
- patients on topical or systemic treatment of AGA
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 |
|---|---|---|
| stromal vascular fraction or platelet rich plasmastromal vascular fraction will be injected in one half of the scalp \& PRP will be injected in the other half | Procedure or surgery | PRP side, stromal vascular fraction side |
Primary outcome
comparison of SVF versus PRP
Time frame: at 3 & 6 months after the sessions
to compare the mean difference in hair density,thickness, Norwood Hamilton scale, patient global assessment, patient satisfaction \& physician global assessment scores between SVF \& PRP.
1 secondary outcome
Detecting efficacy of SVF in treatment of AGA
Time frame: at 3 & 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing stromal vascular fraction or platelet rich plasma in people with Androgenetic Alopecia, run by Kasr El Aini Hospital 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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Aug 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 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa S Aamer, resident (01017762819 ext. 01116783121, asmaaaamer0@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison of SVF versus PRP (time frame: at 3 & 6 months after the sessions). 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 16 Aug 2024.