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

COMPLETEDPHASE2

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

NCT01451125•Aderans Research Institute

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•Male and female volunteers 18 to 65 years old, inclusive
•Hair loss consistent with ≥ Grade III-Vertex, IV, VA, V, and VI, based on Norwood-Hamilton Scale providing there is bridging of hair in the anterior edge of the vertex circle.
•Have no clinically significant disease or abnormal laboratory results taken at the screening visit.
•Agree to abstain from use of any hair growth affecting oral or topical medication including over the counter and herbal medications, finasteride or dutasteride during the course of this study (other than minoxidil as required in this study).

Exclusion Criteria

•Known sensitivity to DMEM/F-12 or any component of the study material.
•Known hypersensitivity to clindamycin hydrochloride, amphotericin B or streptomycin sulfate.
•Subjects who have used any oral or topical medication including over the counter and herbal medications for the treatment of hair loss within 6 months of study screening, or finasteride or dutasteride within 12 months of study screening (with the exception of minoxidil).
•A history of drug or alcohol abuse within 1 year of study enrollment.
•Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.
•Any clinically significant abnormal laboratory parameters.
•A positive result at screening for human immunodeficiency virus (HIV 1 or 2), Hepatitis B or C, HTLV I/II.
•Dermatologic condition in donation or treatment area.
•Prior surgery in the treatment and/or study areas.
•Insufficient hair or scarring in the donor area that might impact cell growth.
+2 more criteria

Locations (4)

Radiant Research, Inc.

Birmingham, Alabama, United States

Radiant Research, Inc.

Tucson, Arizona, United States

Radiant Research, Inc.

Pinellas Park, Florida, United States

Radiant Research, Inc.

St Louis, Missouri, United States

Key Dates

Start Date

May 1, 2010

Primary Completion Date

March 1, 2012

Last Updated

July 11, 2013

Enrollment

ACTUAL participants

Conditions

Androgenetic AlopeciaMale Pattern BaldnessFemale Pattern Baldness

Interventions

Autologous cultured dermal and epidermal cells

BIOLOGICAL

Efficacy of Dihydroartemisinin for Treating Female Androgenetic Alopecia

NCT07012486

Androgenetic Alopecia (AGA)

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ACTIVE_NOT_RECRUITINGPHASE2

A Safety and Efficacy Study of PDFE-2304 Topical Solution for the Treatment of Androgenic Alopecia.

NCT07011485

Alopecia, AndrogeneticBaldness+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 11, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Efficacy of Dihydroartemisinin for Treating Female Androgenetic Alopecia

A Safety and Efficacy Study of PDFE-2304 Topical Solution for the Treatment of Androgenic Alopecia.

A Split-Scalp Study Evaluating the Efficacy and Safety of Fractional Laser Therapy With and Without Exosomes in the Treatment of Androgenetic Alopecia

Combined Use of Povidone-Iodine and Rifampicin in Hair Transplantation

Exosome Treatment in Androgenetic Alopecia

A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia