Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01451151
Other study ID # CA-0004542
Secondary ID
Status Completed
Phase Phase 2
First received October 11, 2011
Last updated July 9, 2013
Start date December 2010

Study information

Verified date July 2013
Source Aderans Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 33
Est. completion date
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

- Able to provide informed consent after risks and benefits of the study have been explained.

- Be willing to undergo all study procedures.

- Ability to communicate effectively with study personnel.

- Have no clinically significant disease or abnormal laboratory evaluations 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, minoxidil, finasteride or dutasteride during the course of 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 minoxidil or 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.

- A history of drug or alcohol abuse within 1 year of study enrollment.

- Paricipation in any other investigational study within 30 days or six half lives of its biologic activity, whichever is longer, before the scalp excision visit(s), and during the time enrolled in this study.

- Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.

- 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.

- Clinically significant dermatologic condition in donation or study areas.

- Prior surgery in the donor or study areas.

- Insufficient hair or scarring in the donor area that might impact cell growth.

- Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Intervention

Biological:
Autologous cultured dermal and epidermal cells
A piece of occipital scalp is taken from the subject. A mixed population of dermal cells from this tissue are expanded in culture. The cells are then harvested. These cells are then injected into the balding area of the scalp of the original subject.

Locations

Country Name City State
United States Axis Clinical Trials, Inc. Los Angeles California
United States Axis Clinical Trials, Inc. New Hyde Park New York

Sponsors (1)

Lead Sponsor Collaborator
Aderans Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from baseline in hair number 51 weeks post-injection No
Primary Change from baseline in hair width 51 weeks post-injection No
Primary Time course of any treatment benefit 51 weeks post-injection No
See also
  Status Clinical Trial Phase
Completed NCT02591355 - Evaluate the Clinical Effectiveness of RegenKit Platelet-rich Plasma (PRP) in Androgenetic Alopecia Treatment N/A
Withdrawn NCT03852992 - Laser Assisted Delivery of Minoxidil in Androgenetic Alopecia Phase 2
Recruiting NCT06239207 - Efficacy and Safety of Exosomes Versus Platelet Rich Plasma in Patients of Androgenetic Alopecia Phase 2
Completed NCT04945226 - A Clinical Trial to Assess Pharmacokinetic/Pharmacodynamic Profiles and Safety of IVL3001 Phase 1/Phase 2
Completed NCT01437163 - Treatment of Androgenetic Alopecia in Males and Females N/A
Completed NCT01548066 - The Efficacy and Safety of Topical Valproic Acid in Preventing Hair Loss Phase 2
Completed NCT01226459 - Clinical Trial in Females for Female Pattern Hair Loss Phase 3
Recruiting NCT06118866 - A Study to Assess the Efficacy and Safety of HMI-115 in Male Subjects With Androgenetic Alopecia Phase 2
Completed NCT06149221 - Penetration-enhanced Direct DBD Non-thermal Plasma for Hair Loss N/A
Withdrawn NCT04882969 - Thulium Laser and KeraFactor for the Treatment of Androgenetic Alopecia N/A
Completed NCT01231607 - Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia Phase 3
Completed NCT04446429 - Anti-Androgen Treatment for COVID-19 N/A
Completed NCT02729415 - Point-of-Care Adipose-derived Cells for Hair Growth N/A
Completed NCT02279823 - A Phase 2 Study to Evaluate the Safety and Efficacy of CB-03-01 Solution, a Comparator Solution and Vehicle Solution in Males With Androgenetic Alopecia Phase 2
Not yet recruiting NCT01227031 - Pharmacogenomic Study of Androgenetic Alopecia N/A
Completed NCT00981461 - Treatment of Androgenetic Alopecia in Females, 9 Beam N/A
Completed NCT01451021 - A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss Phase 2
Completed NCT00151515 - A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss Phase 3
Completed NCT03694067 - Androgenetic Alopecia and the JAK-STAT Pathway
Completed NCT03689452 - The Effect of Platelet Rich Plasma on Non-scarring Alopecia N/A