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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:
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- Isolation of platelet-rich plasma: Under sterilized conditions, 8 cc of whole blood are withdrawn from the antecubital vein of each patient.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stromal vascular fraction side | Active Comparator | stromal vascular fraction will be injected in one half of the frontal scalp |
|
| PRP side | Active Comparator | PRP will be injected in the other half of frontal scalp |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stromal vascular fraction or platelet rich plasma | Procedure | stromal vascular fraction will be injected in one half of the scalp & PRP will be injected in the other half |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | at 3 & 6 months after the sessions |
| Measure | Description | Time Frame |
|---|---|---|
| Detecting efficacy of SVF in treatment of AGA | To detect provment in hair thickness & diameter | at 3 & 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Asmaa S Aamer, resident | Contact | 01017762819 | 01116783121 | asmaaaamer0@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr El Ainy hospital | Cairo | Egypt |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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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
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |