Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06558565
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-02-18
Brief Title:
Efficacy of Stromal Vascular Fraction Versus Platelet Rich Plasma in Treatment of Androgenitic Alopecia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Stromal Vascular Fraction Versus Platelet Rich Plasma in Treatment of Androgenitic AlopeciaRandomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 receive a single session of SVF in one half of the scalp a single session of PRP in the other half
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 doneThen 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 005 lidocaine in saline solution 1 200000 epinephrine then we wait for 20 minutes followed by harvesting of 50 ml of fat using 24 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 24mm 14mm and 12mm 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 01 mlcm2 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 15 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 01 mlcm2 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 ofThe 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 0903 cm2 eghair density thickness
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 doneThen 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 005 lidocaine in saline solution 1 200000 epinephrine then we wait for 20 minutes followed by harvesting of 50 ml of fat using 24 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 24mm 14mm and 12mm 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 01 mlcm2 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 15 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 01 mlcm2 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 ofThe 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 0903 cm2 eghair density thickness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None