Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06619184
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-26
Brief Title:
Transplantation of Autologous Non-Cultured Extracted Hair Follicle Outer Root Sheath Cell Suspension and Mini Punch Graft for Stable Non-Segmental Vitiligo Lesions
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison of The Effectiveness Between Transplantation of Autologous Non-Cultured Extracted Hair Follicle Outer Root Sheath Cell Suspension and Mini Punch Graft in Non-Segmental Vitiligo
Status:
COMPLETED
Status Verified Date:
2024-10
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:
Vitiligo is an acquired pigmentation disorder due to loss of melanocytes characterized by depigmentation macules or patches One type of this disease is nonsegmental vitiligo NSV Until now there is no satisfactory treatment for vitiligo Vitiligo therapies are medical therapy include topical and systemic therapy phototherapy as well as surgery Surgical treatment is indicated in stable vitiligo which is not responding to medical treatment This procedure consists of tissue grafting and cellular transplantation Mini punch graft MPG is the most frequently performed tissue transplantation technique while cellular transplantation from autologous noncultured extracted hair follicle outer root sheath cell suspension NCEHFORSCS containing melanocyte stem cells is currently a promising option
Detailed Description:
Current NSV treatments can be considered suboptimal and leading to decreased patients quality of life due to the emotional burden of therapy dissatisfaction When a stable NSV is not responding to medical therapy surgery may be a useful treatment approach All surgical techniques in vitiligo treatment share the same principle transferring autologous melanocytes from a donor to repopulate melanocytes in the depigmented area that lacks a reservoir or fails to activate melanocytes in the outer root sheath ORS of hair follicles MPG as the most frequently performed tissue transplantation technique transferred the epidermal melanocyte to vitiligo lesion while NCEHFORSCS provides melanocytes with better properties and contains melanocyte stem cells The advantages of melanocytes from ORS compared to epidermal are the follicular melanocytekeratinocyte ratio consists of one melanocyte for every five keratinocytes or 15 in the hair bulb melanocytes are more dendritic have larger melanosomes and have the potential to produce more melanin pigment Due to these properties hair follicles can be a better source of melanocytes than epidermis in the delivery of cellular transplantation-based therapy for vitiligo therapy Research comparing the effectiveness of the two procedures has never been conducted in Indonesia even though the incidence of vitiligo is quite high and the success of therapy is still not optimal So the purpose of this study is to compare the effectiveness of the two procedures in NSV patient
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