Androgenetic AlopeciaPhase 2NCT01451099
A Study to Evaluate and Compare Injections of Autologous Dermal Cells Into the Balding Scalp of Subjects With Hair Loss
A Phase 2 study testing Autologous cultured dermal cells in people with Androgenetic Alopecia and Male Pattern Baldness, run by Aderans Research Institute at 6 sites in United States.
Trial summary
Evaluate the ability of Ji Gami(TM) DO 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 cells
- How many people
- 21 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2009to Sep 2010
- 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.
- Have no clinically significant disease or abnormal laboratory results taken at the screening visit.
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.
- 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.
Show all 11Show fewer
- A positive result at screening for human immunodeficiency virus (HIV 1 or 2), Hepatitis B or C, HTLV I/II.
- Dermatologic condition in donation and/or study areas.
- Prior surgery in the treatment area.
- 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
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Atlanta, Georgia, 30326
Study site
Boston, Massachusetts, 02116
Study site
Chevy Chase, Maryland, 20815
Study site
Houston, Texas, 77056
Study site
New York, New York, 10016
Study site
Raleigh, North Carolina, 27609
About this study
Official title: A Phase 2 Randomized Study to Evaluate and Compare the Efficacy of Injections of Ex Vivo Expanded Cultured Occipital Autologous Dermal Cells Into the Balding Scalp of Subjects With Hair Loss
Evaluate the ability of Ji Gami(TM) DO to induce hair growth in male and female subjects with hair loss.
- Being tested
- Autologous cultured dermal 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 cellsBiological
A piece of occipital scalp is taken from the subject. The 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.
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 startJun 2009
- Primary completionSep 2010
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
- 21 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
- NCT01451099
- Sponsor's protocol ID
- CA-0002062
- Status last verified
- Feb 2012
- First submitted
- 11 Oct 2011
- Last updated
- 29 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Randomized Study to Evaluate and Compare the Efficacy of Injections of Ex Vivo Expanded Cultured Occipital Autologous Dermal Cells Into the Balding Scalp of Subjects With Hair Loss
- ClinicalTrials.gov ID
- NCT01451099
- Acronym / sponsor ID
- CA-0002062
- Keywords
- Androgenetic Alopecia, Male Pattern Baldness, Female Pattern Baldness, Hair Loss, Baldness
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Aderans Research InstituteIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Sep 2010 (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 Ji Gami(TM) DO 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)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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.
- Have no clinically significant disease or abnormal laboratory results taken at the screening visit.
Key exclusion criteria (11 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.
- Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator.
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 cellsA piece of occipital scalp is taken from the subject. The 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 | – |
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 29 Feb 2012.
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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.
6 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 cells in people with Androgenetic Alopecia and Male Pattern Baldness, run by Aderans Research Institute at 6 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 3 inclusion and 11 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 29 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 29 Feb 2012.