Suspension from Patients own skin for correction of depressed area of face

Completed

• Conditions: Patient having visible volume defect over face

• Registration Number: CTRI/2016/11/007500
• Lead Sponsor: AIIMS New Delhi

Brief Summary

Human dermis harbour distinct  population with capacity of differentiating to various cell lines. Till now available option for correction of volume loss is synthetic fillers which are expensive and carry the potential risk of immunological reactions and granuloma formation (being foreign to the body). Therefore safer, affordable, and autologous alternative is needed. Autologous fat transplant is an option but its effect persists for short durations. Secondly, when volume loss is in dermis (e.g. morphea, post-acne scars), the ideal replacement is dermal cells. Authors introduce a new method of non-cultured dermal cell suspension for transplantation for treatment of facial volume loss.Application of dermal stem cells in skin therapy is still in experimental condition. Most of the studies on dermal cells and their therapeutic application are restricted to autologous fibroblast culture and adipocyte stem cells. Human dermis  being the precursor of all these cells can be used as a potential and ideal alternative to these cell populations in restoration of volume loss as well as facial rejuvenation. Therefore, the search for better alternatives is on and autologous dermal cells are potentially a better alternative which can overcome the drawbacks associated with synthetic dermal fillers.Problems associated with dermal cell culture is that it is a time taking process, requires a sophisticated lab and is costly.We propose a novel technique, autologous non-cultured dermal cell  suspension, as an alternative to use of cultured autologous cell suspension. Autologous non-cultured dermal cell  suspension is a relatively simple, one day procedure, less expensive and at much lesser risk of contamination. Such a suspension can be prepared on the same day from skin biopsy and can be injected in the affected skin of the patient

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-14
• Last Update Posted: 2016-11-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• 1.Patient with visible volume loss on face.
• 2.Controlled underlying systemic disease for at least last 6 months.

Exclusion Criteria

• 1.Pregnancy and lactation 2.Keloid or bleeding diathesis 3.Active infection at the treatment site.
• 4 .Patient having profound iatrogenic immunosuppression.
• 5.Patient with unrealistic expectations and body dysmorphic disorder.
• Inability to come for follow up upto 6 month.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical subjective and photographic improvement in the volume loss	6 months

Secondary Outcome Measures

Name	Time	Method
Objective improvement in the volume loss measured by Ultrasonography of the skin	6 months

Trial Locations

Locations (1)

AIIMS, NewDelhi; 🇮🇳 Delhi, DELHI, India

AIIMS, NewDelhi

🇮🇳Delhi, DELHI, India

Dr Somesh Gupta

Principal investigator

01126596626

iusti2011@gmail.com