Androgenetic AlopeciaPhase 2NCT01451190
A Study to Evaluate and Compare Injections of Autologous Mixed Population of Dermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0005995)
A Phase 2 study testing Autologous cultured dermal and epidermal cells in people with Androgenetic Alopecia and Male Pattern Baldness, run by Aderans Research Institute at 9 sites in United States.
Trial summary
Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and female subjects with hair loss. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia, Male Pattern Baldness, Female Pattern Baldness
- What is being tested?
- Autologous cultured dermal and epidermal cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 9 sitesUnited States
- Study dates
- Jul 2011to Mar 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
- Participation 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.
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Radiant Research, Inc.
Akron, Ohio, 44311
Radiant Research, Inc.
Denver, Colorado, 80239
Radiant Research, Inc
Greer, South Carolina, 29651
Axis Clinical Trials, Inc.
Los Angeles, California, 90036
Axis Clinical Trials
New Hyde Park, New York, 11042
Radiant Research, Inc.
Pinellas Park, Florida, 33781
Radiant Research, Inc.
Santa Rosa, California, 95405
Radiant Research, Inc.
St Louis, Missouri, 63141
Radiant Research, Inc.
Tucson, Arizona, 85710
About this study
Official title: A Multi-center, Phase 2 Study of Ji Gami(TM) CN That Evaluates the Efficacy and Safety of Injections of ex Vivo Expanded Cultured Occipital Autologous Dermal and Epidermal Cells Into the Hair Loss Area of the Scalp of Subjects
Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and female subjects with hair loss.
- Being tested
- Autologous cultured dermal and epidermal cells
- Keywords
- Androgenetic Alopecia, Male Pattern Baldness, Female Pattern Baldness, Hair Loss, Baldness
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous cultured dermal and epidermal cellsBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Treated | Experimental | Not described Receives: Biological: Autologous cultured dermal and epidermal cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in hair number
Measured: 51 weeks post-injection
Change from baseline in hair width
Measured: 51 weeks post-injection
Time course of any treatment benefit
Measured: 51 weeks post-injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startJul 2011
- Primary completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aderans Research Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451190
- Sponsor's protocol ID
- CA-0005995
- Status last verified
- Jul 2013
- First submitted
- 11 Oct 2011
- Last updated
- 11 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Phase 2 Study of Ji Gami(TM) CN That Evaluates the Efficacy and Safety of Injections of ex Vivo Expanded Cultured Occipital Autologous Dermal and Epidermal Cells Into the Hair Loss Area of the Scalp of Subjects
- ClinicalTrials.gov ID
- NCT01451190
- Acronym / sponsor ID
- CA-0005995
- Keywords
- Androgenetic Alopecia, Male Pattern Baldness, Female Pattern Baldness, Hair Loss, Baldness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Aderans Research InstituteIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Mar 2013 (actual)
- First posted
- 13 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the ability of injections of Ji Gami(TM) CN to induce hair growth in male and female subjects with hair loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treated | Experimental | Biological: Autologous cultured dermal and epidermal cells |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
- Participation 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous cultured dermal and epidermal cellsA 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. | Biological | Treated |
Primary outcome
Change from baseline in hair number
Time frame: 51 weeks post-injection
Change from baseline in hair width
Time frame: 51 weeks post-injection
Time course of any treatment benefit
Time frame: 51 weeks post-injection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Autologous cultured dermal and epidermal cells in people with Androgenetic Alopecia and Male Pattern Baldness, run by Aderans Research Institute at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in hair number (time frame: 51 weeks post-injection). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2013.