Androgenic AlopeciaNCT06326359
Autologous Stromal Vascular Fraction in Treatment of Male Androgenic Alopecia
A study testing autologous stromal vascular fraction in people with Androgenic Alopecia, run by Sohag University.
Trial summary
Evaluation of Safety and efficacy of autologous stromal vascular fraction derived from denovo versus platelet rich plasma enhanced donner site in treatment of male androgenic alopecia Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Androgenic Alopecia
- What is being tested?
- autologous stromal vascular fraction
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Oct 2026
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male patients with androgenic alopecia
Who cannot join
- Patients with other hair loss disorders as telogen effluvium, anagen effluvium, alopecia areata, cicatricial alopecia and trichotillomania.
- Any other cutaneous disease as patients suffering from dermatological condition or a significant scarring in the treatment area.
- Any systemic disease as autoimmune disorders , cardiac hepatic and renal patients.
- patients who received minoxidil or any other oral, topical medications (including herbal medications) or injection procedures for the treatment of hair loss within 6 months prior to the study, or finasteride or dutasteride within 12 months of the study
Trial locations and contacts
No sites are listed yet.
reham E Elsharkawy, Professor contact
About this study
Official title: Evaluation of Safety and Efficacy of Autologous Stromal Vascular Fraction Derived From Denovo Versus Platelet Rich Plasma Enhanced Donner Site in Treatment of Male Androgenic Alopecia
Evaluation of Safety and efficacy of autologous stromal vascular fraction derived from denovo versus platelet rich plasma enhanced donner site in treatment of male androgenic alopecia
Read the detailed description
40 Patients with androgenic alopecia will be randomly divided into 2 groups Group A (20): will receive 2 session of stromal vascular fraction directly after fat harvesting and processing and stromal vascular fraction extraction with 1 month interval .
Group B(20): will be injected with 2 session of Platelet rich plasma 3weeks interval at site of fat harvesting and will be followed 1 month later with fat aspiration from site where Platelet rich plasma was previously injected and this fat will undergo fat processing and stromal vascular fraction extraction followed by 2 session of stromal vascular fraction injection at scalp 1month interval .
Patients at both groups will receive topical and systemic antibiotics after stromal vascular fraction injection .
- Conditions
- Androgenic Alopecia
- Being tested
- autologous stromal vascular fraction
- Keywords
- autologous stromal vascular fraction, platelet rich plasma, male androgenic alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous stromal vascular fractionProcedure or surgery
autologous stromal vascular fraction injection as 2 sessions with 1 month interval at arm 1 arm 2: will receive 2 sessions of PRP with 3 weeks interval followed by stromal vascular fraction injection as 2 sessions with 1 month interval
| Study group | Role | What they receive |
|---|---|---|
| autologous stromal vascular fraction derived from denovo | Active comparator | autologous stromal vascular fraction derived from denovo in male androgenic alopecia Receives: Procedure: autologous stromal vascular fraction |
| autologous stromal vascular fraction after platelet rich plasma enhanced donner site | Active comparator | autologous stromal vascular fraction after platelet rich plasma enhanced donner site in male androgenic alopecia Receives: Procedure: autologous stromal vascular fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
hair density
Trichoscopy
Measured: at baseline and at 6 month after treatment
hair shaft thickness
TrichoScan
Measured: at baseline and at 6 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study startMar 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenic AlopeciaStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Ahmed Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326359
- Sponsor's protocol ID
- Soh-Med-24-02-03MD
- Status last verified
- Mar 2024
- First submitted
- 9 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Efficacy of Autologous Stromal Vascular Fraction Derived From Denovo Versus Platelet Rich Plasma Enhanced Donner Site in Treatment of Male Androgenic Alopecia
- ClinicalTrials.gov ID
- NCT06326359
- Acronym / sponsor ID
- Soh-Med-24-02-03MD
- Conditions
- Androgenic Alopecia
- Keywords
- autologous stromal vascular fraction, platelet rich plasma, male androgenic alopecia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 Mar 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.
Evaluation of Safety and efficacy of autologous stromal vascular fraction derived from denovo versus platelet rich plasma enhanced donner site in treatment of male androgenic alopecia
Detailed description
40 Patients with androgenic alopecia will be randomly divided into 2 groups Group A (20): will receive 2 session of stromal vascular fraction directly after fat harvesting and processing and stromal vascular fraction extraction with 1 month interval .
Group B(20): will be injected with 2 session of Platelet rich plasma 3weeks interval at site of fat harvesting and will be followed 1 month later with fat aspiration from site where Platelet rich plasma was previously injected and this fat will undergo fat processing and stromal vascular fraction extraction followed by 2 session of stromal vascular fraction injection at scalp 1month interval .
Patients at both groups will receive topical and systemic antibiotics after stromal vascular fraction injection .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autologous stromal vascular fraction derived from denovo | Active comparator | Procedure: autologous stromal vascular fractionautologous stromal vascular fraction derived from denovo in male androgenic alopecia |
| autologous stromal vascular fraction after platelet rich plasma enhanced donner site | Active comparator | Procedure: autologous stromal vascular fractionautologous stromal vascular fraction after platelet rich plasma enhanced donner site in male androgenic alopecia |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male patients with androgenic alopecia
Key exclusion criteria (4 listed)
- Patients with other hair loss disorders as telogen effluvium, anagen effluvium, alopecia areata, cicatricial alopecia and trichotillomania.
- Any other cutaneous disease as patients suffering from dermatological condition or a significant scarring in the treatment area.
- Any systemic disease as autoimmune disorders , cardiac hepatic and renal patients.
- patients who received minoxidil or any other oral, topical medications (including herbal medications) or injection procedures for the treatment of hair loss within 6 months prior to the study, or finasteride or dutasteride within 12 months of the study
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 |
|---|---|---|
| autologous stromal vascular fractionautologous stromal vascular fraction injection as 2 sessions with 1 month interval at arm 1 arm 2: will receive 2 sessions of PRP with 3 weeks interval followed by stromal vascular fraction injection as 2 sessions with 1 month interval | Procedure or surgery | autologous stromal vascular fraction after platelet rich plasma enhanced donner site, autologous stromal vascular fraction derived from denovo |
Primary outcome
hair density
Time frame: at baseline and at 6 month after treatment
Trichoscopy
hair shaft thickness
Time frame: at baseline and at 6 month after treatment
TrichoScan
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Androgenic Alopecia
Not yet recruitingPhase 2
Phase 2 Efficacy and Safety of PP405 in Adult Females With Androgenetic Alopecia
Androgenetic Alopecia
Not yet recruitingPhase 3
Phase 3 Study to Evaluate the Efficacy and Safety of Oral Minoxidil (N1087) in Men With Androgenetic Alopecia.
Androgenetic Alopecia, Androgenetic Alopecia (AGA)
Not yet recruiting
Study to Evaluate Xtressé Gummy Supplement in Women With Thinning Hair
Androgenetic Alopecia
Not yet recruitingEarly Phase 1
Evaluating the Efficacy of Platelet-rich Plasma Therapy in the Treatment of Androgenic Alopecia
Androgenic Alopecia
Not yet recruitingPhase 3
Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of N1087 in Participants With Female Pattern Hair Loss (MINORA-WOMEN)
Female Pattern Hair Loss, Female Pattern Hair Loss, Androgenic Alopecia
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.
reham E Elsharkawy, Professor contact
Questions about this trial
What is this clinical trial studying?
A study testing autologous stromal vascular fraction in people with Androgenic Alopecia, run by Sohag University.
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 1 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: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
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 dina A mahmoud, assistant lecturer (01097185631, dr.dondon123@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hair density (time frame: at baseline and at 6 month after treatment). The study lists 2 primary outcomes in all. 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 22 Mar 2024.