A clinical trial to compare the effects of two methods of obtaining hair stem cells for treating vitiligo

Phase 2

Completed

• Conditions: Segmental/generalised, stable vitiligo

• Registration Number: CTRI/2016/08/007133

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-18
• Last Update Posted: 2018-03-03

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage repigmentation achieved in the recipient sites of transplantation	6 months post surgery

Secondary Outcome Measures

Name	Time	Method
Percentage repigmentation achieved in the recipient sites of transplantation	1 week, 1 month, 2 months and 3 months post surgery

Trial Locations

Locations (1)

Department of Dermatology & Venereology; 🇮🇳 South, DELHI, India

Department of Dermatology & Venereology

🇮🇳South, DELHI, India

Dr Kanya Rani Vashisht

Principal investigator

01126593217

kanyavashisht@gmail.com