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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
FAQOther Questions
- What are risks of oral and topical corticosteroids?
Corticosteroid drugs (like hydrocortisone, and others) are often used for treating vitiligo. By mimicing the effects of hormones your body produces naturally in your adrenal gla...
- Can a gluten-free diet help with vitiligo?
It's very unlikely. We have specifically looked into claims that gluten-free diet may ease symptoms of vitiligo, or completely reverse it, and found no firm scientific evidence ...
- Is there a link between vitiligo and depression?
Yes, depression and anxiety often occur alongside vitiligo and can greatly affect a person's quality of life. The connection comes from the fact that both the skin and brain dev...
Though it is not always easy to treat vitiligo, there is much to be gained by clearly understanding the diagnosis, the future implications, treatment options and their outcomes.
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