| CTRI Number |
CTRI/2024/11/077162 [Registered on: 21/11/2024] Trial Registered Prospectively |
| Last Modified On: |
17/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparing two different skin treatments to restore Color in Vitiligo patches: A study using patients own skin cells and a new printing technology |
|
Scientific Title of Study
|
Comparison of Non-Cultured Epidermal Cell Suspension (NCES) and 3D Bioprinting of Autologous Melanocytes for the Treatment of Vitiligo: A Pilot Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shrinivas Patil |
| Designation |
Resident Dermatology, Venereology and Leprosy |
| Affiliation |
Command Hospital Air Force Bangalore, Indian Air Force |
| Address |
Command hospital Air Force, Cambridge road, Bangalore-560007
Command hospital Air Force, Cambridge road, Bangalore-560007
Bangalore KARNATAKA 560007 India |
| Phone |
8867659749 |
| Fax |
|
| Email |
shrinivas93doctor@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Debdeep Mitra |
| Designation |
Classified Specialist Dermatology, Venereology and Leprosy |
| Affiliation |
Command Hospital Air Force Bangalore, Indian Air Force |
| Address |
Department of Dermatology, Venereology and Leprosy, Command
Hospital Air Force, Bangalore-560007 Department of Dermatology,
Venereology and Leprosy, Command Hospital Air Force,
Bangalore-560007
Bangalore KARNATAKA 560007 India |
| Phone |
08811851830 |
| Fax |
|
| Email |
debdeep5000@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Debdeep Mitra |
| Designation |
Classified Specialist Dermatology, Venereology and Leprosy |
| Affiliation |
Command Hospital Air Force Bangalore, Indian Air Force |
| Address |
Department of Dermatology, Venereology and Leprosy, Command
Hospital Air Force, Bangalore-560007 Department of Dermatology,
Venereology and Leprosy, Command Hospital Air Force,
Bangalore-560007
Bangalore KARNATAKA 560007 India |
| Phone |
08811851830 |
| Fax |
|
| Email |
debdeep5000@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Dermatology, Venereology and Leprosy, Command Hospital Air Force,
Bangalore- 560007 |
|
|
Primary Sponsor
|
| Name |
Command Hospital Air Force Bangalore |
| Address |
COMMAND HOSPITAL AIR FORCE, CAMBRIDGE ROAD,
BANGALORE-560007 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Shrinivas Patil |
Command Hospital Air Force Bangalore |
Room no 6, Department
of Dermatology,Venere
ology and Leprosy,
Command hospital Air
Force, Cambridge road,
Bangalore-560007
Bangalore KARNATAKA |
8867659749
shrinivas93doctor@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical committee reviewers, Command Hospital Air Force Bangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
3D bioprinting |
For 3D bioprinting, autologous skin samples will be taken from the patients with vitiligo using dermatome after local anestheseia with injection lignocaine (donor area), melanocytes will be isolated, and these cells will be mixed with hydroxymethylcellulose gel to create a bioink. A BIO X 3D bioprinter will be utilized used to print the bioink into skin substitutes, which will then be applied onto dermabraded vitiligo patches. Duration of treatment is around 3-4 hours total, and single sitting is done for each vitiligo patch. |
| Comparator Agent |
Non-Cultured Epidermal Cell Suspension (NCES) |
For NCES, a thin shave biopsy of healthy skin will be taken after local anesthesia using injection lignocaine, and the epidermis and dermis will be separated via enzyme digestion (Trypsin). The resulting suspension, containing melanocytes, will be applied onto dermabraded vitiligo patches. Duration of treatment is around 3-4 hours total, and single sitting is done for each vitiligo patch. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
(a) Stable vitiligo for at least 12 months.
(b) Age between 18-45 years.
(c) Vitiligo patches located on accessible body areas (face, limbs, torso).
(d) No prior cellular transplantation on the selected patches.
|
|
| ExclusionCriteria |
| Details |
(a) Active vitiligo.
(b) Comorbid conditions such as diabetes or autoimmune diseases.
(c) Pregnancy or lactation.
(d) History of keloid or hypertrophic scar formation.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Rate of repigmentation of vitiligo patches |
over 3 to 4 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
(a) Patient Satisfaction
(b) Safety & Tolerability
(c) Feasibility of 3D Bioprinting Process |
6 to 7 months |
|
|
Target Sample Size
|
Total Sample Size="20" Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
10/12/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective pilot study is designed to evaluate and compare the efficacy of Non-Cultured Epidermal Cell Suspension (NCES) and 3D bioprinting of autologous melanocytes in the treatment of vitiligo, with repigmentation rate as the primary endpoint. A total of 32-34 stable vitiligo patches will be included, with each treatment arm receiving 16-17 patches. For NCES, a suspension of melanocytes from a thin skin biopsy will be applied to dermabraded patches. In the 3D bioprinting arm, melanocytes isolated from autologous skin will be mixed with hydroxymethyl cellulose (HMC) to create a bioink, which will then be printed into skin substitutes and applied to the prepared patches.
Patients will be followed monthly for six months, assessing repigmentation rates through clinical photographs, patient satisfaction on a Visual Analog Scale, and monitoring for any adverse events. It is hypothesized that 3D bioprinting will lead to higher repigmentation rates, improved patient satisfaction, and maintain a strong safety profile. The outcomes of this study are expected to provide insights into the potential of 3D bioprinting as a superior therapeutic alternative in vitiligo management, supporting its use in further clinical studies with larger sample sizes. |