NCT01451021

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

A Phase 2 Randomized Study to Evaluate and Compare the Efficacy of a 1 Time Injection vs. Repeat Injections of ex Vivo Expanded Cultured Autologous Occipital Dermal and Epidermal Cells (Day After Cell Culture Harvest) Into the Balding Scalp of Subjects With Hair Loss

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Aderans Research Institute · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Evaluate the ability of injections of Ji Gami(TM) and Ji Gami(TM) DO 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: 2008-10-01
• Primary completion: 2010-06-01
• First posted: 2011-10-13
• Last updated: 2012-02-29

Locations

3 sites across 1 country: United States