FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2016/08/007133 [Registered on: 01/08/2016] Trial Registered Retrospectively
Last Modified On: 03/03/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Dermatosurgery]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A clinical trial to compare the effects of two methods of obtaining hair stem cells for treating vitiligo  
Scientific Title of Study   A comparative study to assess the efficacy and composition of various cell populations of extracted hair follicle outer root sheath cell suspensions (EHF ORS CS) prepared using a single enzyme (trypsin) and multiple enzymes (trypsin and collagenase) for transplantation in vitiligo 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kanya Rani Vashisht 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences (AIIMS) 
Address  Department of Dermatology and Venereology All India Institute of Medical Sciences (AIIMS) New Delhi

South
DELHI
110029
India 
Phone    
Fax    
Email  kanyavashisht@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Somesh Gupta 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences (AIIMS) 
Address  Room no. 4070, Dermatology and Venereology Office 4th Floor Teaching block All India Institute of Medical Sciences (AIIMS) New Delhi

South
DELHI
110029
India 
Phone  01126593217  
Fax    
Email  someshgupta@hotmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Somesh Gupta 
Designation  Additional Professor 
Affiliation  All India Institute of Medical Sciences (AIIMS) 
Address  Room no. 4070, Dermatology and Venereology Office 4th Floor Teaching block All India Institute of Medical Sciences (AIIMS) New Delhi

South
DELHI
110029
India 
Phone  01126593217  
Fax    
Email  kanyavashisht@gmail.com  
 
Source of Monetary or Material Support  
Not applicable 
 
Primary Sponsor  
Name  None 
Address  Not applicable 
Type of Sponsor  Other [Not applicable] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kanya Rani Vashisht  Department of Dermatology & Venereology  Room no. 4070, 4th Floor Teaching block All India Institute of Medical Sciences (AIIMS)
South
DELHI 		 01126593217

kanyavashisht@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee/ Ethics Subcommittee (AIIMS)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Segmental/generalised, stable vitiligo,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dermabrasion followed by application of cell suspension (EHF ORS CS) prepared using a multiple enzymes  Extracted hair follicle outer root sheath cell suspension (EHF ORS CS) prepared using a single enzyme (trypsin, collagenase & dispase) from the patients own hair follicles, to be applied on the dermabraded vitiligo patch, once, during the transplantation procedure 
Intervention  Dermabrasion followed by application of Cell suspension (EHF ORS CS) prepared using a single enzyme  Extracted hair follicle outer root sheath cell suspension (EHF ORS CS) prepared using a single enzyme (trypsin) from the patients own hair follicles, to be applied on the dermabraded vitiligo patch, once, during the transplantation procedure 
Comparator Agent  Dermabrasion of the 3rd vitiligo patch, followed by application of DMEM (Dulbeccos modified eagles medium) alone without any cell suspension  The third arm of treatment would consist of dermabrasion alone, and the medium applied would not contain any cell suspension. This is to be performed once, during the procedure 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1. Segmental or generalised vitiligo
2. Stable for at least 1.5 years
3. One large patch of size at least 18 cm2
OR minimum 3 patches of at least 9cm2 each 
 
ExclusionCriteria 
Details  1. Age less than 18 years
2. Pregnancy
3. Koebnerization
4. Keloid or bleeding diathesis
5. Active infection at site
6. Other autoimmune diseases
7. Inability to follow up for at least 6 months
8. Acral sites & bony prominences as recipient sites
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Percentage repigmentation achieved in the recipient sites of transplantation  6 months post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage repigmentation achieved in the recipient sites of transplantation  1 week, 1 month, 2 months and 3 months post surgery 
 
Target Sample Size   Total Sample Size="21"
Sample Size from India="21" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   18/01/2014 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Vitiligo is an acquired autoimmune depigmenting disease with multifactorial etiology. Many modalities have been used to treat it, both surgical and non-surgical, but there is still a need for a treatment that is promptly and uniformly effective, without causing donor site scarring. Replenishing melanocytes selectively within vitiliginous macules by autologous non-cultured melanocyte-keratinocyte cell suspension transplantation is a promising treatment.

NCEHF ORS CS (Non-cultured extracted hair follicle outer root sheath cell suspension) is prepared from  outer root sheath of hair follicles, extracted by follicular unit extraction (FUE) method. The outer root sheath of hair follicles is a richer source of melanocytes and their precursor stem cells than the epidermis. (The ratio of melanocytes to keratinocytes in the epidermis is 1:36, while that in the hair follicle is 1:1 to 1:6). The suspensions from it would contain higher number of melanocytes, and various populations of stem cells (melanocyte stem cells, mesenchymal stem cells and keratinocyte stem cells), the composition may vary. One of the attempts will be to correlate the treatment response with these parameters.

Comparison will be in terms of- clinical outcome, rapidity of repigmentation , cell yield, types of cells as evaluated by immunohistochemistry, flowcytometry.  The preliminary work done in our lab suggests that the cell count in suspension obtained from split thickness epidermal graft is 2 to 4 times higher than EHF ORS CS. The extracted hair follicles have a dermal sheath all around which may be hampering the contact of trypsin with outer root sheath and thus affecting cell yield. Therefore we feel that addition of collagenase type-1 will facilitate lysis of peri follicular dermal sheath and contact of trypsin with outer root sheath.

 Outer root sheath of hair is a good potential source of mesenchymal stem cells, which potentially will expand indications of uses of such a cell suspension in other diseases where mesenchymal stem cells are potentially therapeutic, examples including wounds and inherited blistering skin diseases.

 
Close