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Official Title: Autologous Cellular Micro-graft in Surgical Treatment of Stable Resistant Vitiligo: A Randomized Self-controlled Trial
Brief Summary: This is a double blinded self controlled randomized trial to assess Autologous Micro Cellular Grafts in surgical treatment of stable resistant vitiligo. Given the stem cells, progenitor cells, and growth factors rich hair follicle based suspension resulting from Autologous Cellular Micro grafts (ACM), we aim at assessing the efficacy of ACM generated suspension in comparison to follicle cell suspension in surgical treatment of stable resistant vitiligo.
Experimental: Autologous Cellular Micro-grafts suspension added to non cultured epidermal suspension (NCES). Under local anesthesia, a 2.5 mm punch biopsy will be used to extract 3 scalp tissue specimens from the patient's occiput behind the ear, using Rigeneracons medical device (CE certified class I; Human Brain Wave, Turin, Italy). The collected specimens will be placed in Rigeneracons by adding 1.5 mL of sterile physiologic solution to the device. The device then generates a cellular suspension by rotation of Rigeneracons at 80 RPM for 2 minutes. Subsequently, the obtained suspension is diluted with an additional 3 mL sterile physiologic solution. The resulting suspension will be added to NCES and placed on one of the derma braded vitiligo patches. NCES is the standard technique for surgical treatment of vitiligo, herein we compare the standard technique, to added autologous cellular micro-grafts and to follicle cell suspension.
Estimated Study Start Date: November 2022
Estimated Study Completion Date: April 2024
Contact:
- Rania M Mogawer, MD
+201068165330
raniamogawer88@gmail.com
- Contact: Samia Esmat, MD
+201223455854
samiaesmat@yahoo.com
https://beta.clinicaltrials.gov/study/NCT05503368
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