NCT01451125

A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004512)

A Phase 2 Study to Evaluate and Compare the Efficacy of Injections of Ex Vivo Expanded Cultured Occipital Autologous Dermal and Epidermal Cells vs. Dermal Cells Into the Hair Loss Area of the Scalp of Subjects and Synergy With Application of Topical Minoxidil

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Aderans Research Institute · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the ability of injections of Ji Gami(TM) or Ji Gami(TM) DO in combination with minoxidil to induce hair growth in male and female subjects with hair loss.

Conditions

• Androgenetic Alopecia
• Male Pattern Baldness
• Female Pattern Baldness

Interventions

Type	Name	Description
BIOLOGICAL	Autologous cultured dermal and epidermal cells	A piece of occipital scalp is taken from the subject. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. These cells are then injected into the balding area of the scalp of the original subject.

Timeline

• Start date: 2010-05-01
• Primary completion: 2012-03-01
• First posted: 2011-10-13
• Last updated: 2013-07-11

Locations

4 sites across 1 country: United States