NCT01451177

A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004669)

A Phase 2 Study to Evaluate and Compare the Efficacy of Injections of Cultured Occipital Autologous Dermal and Epidermal Cells vs Dermal Cells, Where Cells Are Expanded ex Vivo From Plucked Scalp, Into the Hair Loss Area of the Scalp of Subjects.

• 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

Evaluate the injections of Ji Gami(TM) and Ji Gami(TM) DO, where cells are expanded ex vivo from scalp, 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, plucked of hairs prior to excision, 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. The cells are then injected into the balding area of the scalp of the original subject.

Timeline

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

Locations

3 sites across 1 country: United States