NCT01451073

A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0002013)

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 (Same Day as Cell Culture Harvest) Into the Balding Scalp of Subjects With Hair Loss

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (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 Ji Gami(TM) 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	Two pieces of occipital scalp are taken from the subject, three weeks apart. The dermal and epidermal cells from these tissues are expanded in culture. The cells are then harvested and, for certain types of product, combined. On the day the cells are harvested after manufacture, they are then injected into the balding area of the scalp of the original subject within a certain time period.

Timeline

• Start date: 2009-01-01
• Primary completion: 2010-08-01
• First posted: 2011-10-13
• Last updated: 2012-02-29

Locations

6 sites across 1 country: United States