Androgenetic AlopeciaPhase 1/2NCT01286649
Safety and Efficacy Study of Human Autologous Hair Follicle Cells to Treat Androgenetic Alopecia
A Phase 1/2 study testing Human autologous hair follicle cells and Cell medium in people with Androgenetic Alopecia, run by TrichoScience Innovations, Inc. at 1 site in Georgia.
Trial summary
The primary purpose of this study is to assess the safety of performing injections of human autologous hair follicle cells. The study will also measure the impact these injections will have on hair growth. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Androgenetic Alopecia
- What is being tested?
- Human autologous hair follicle cells and Cell medium
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteGeorgia
- Study dates
- Dec 2010to 23 Feb 2017
- Phase
- Phase 1/2
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male or female between the age of 18 and 55 years and in good health having evidence of mild to moderate androgenetic alopecia (AGA) involving the vertex area of the scalp. Female patients with androgenetic alopecia (AGA) characterized as vertex pattern type II or type III of the Ludwig Scale qualify for inclusion in this study. Males with androgenetic alopecia (AGA) involving the vertex area of the scalp, characterized as type III vertex- type VI on the Norwood Scale qualify for inclusion in the study.
- Willingness to provide written informed consent for participation in the study, attend all study visits and complete all procedures required by this protocol.
- The test areas (areas to be injected) are of uniform skin color without erythema, dark pigmentation or scars that may confound study results.
- Willingness to forego the use cosmetic or medical products for hair loss throughout the course of the study.
- Females must be post-menopausal for at least one year, surgically sterile, or, if of childbearing potential, using highly-effective methods of birth control. This method of contraception must be used at least 4 weeks prior to and during the entire duration of the clinical trial.
Who cannot join
- Use of any product (medication or otherwise) which interferes with the hair growth cycle.
- Any systemic medical treatment for hair loss (for example, Finasteride, Minoxidil, Dutasteride, or antiandrogens) within the last 12 months.
- Start of contraception treatments containing chlormadinone or cyproterone acetate within the last 12 months.
- Women who are pregnant or nursing.
- Presence of any medical condition that influences the hair growth cycle (for example, alopecia areata, lichen planopilaris, lupus erythematosus, severe seborrheic eczema, psoriasis capitis or tinea capitis, untreated thyroid gland disease/goiter development, auto-immune diseases, etc.).
- Any condition that, in the investigator's opinion would impact patient safety and/or a patient's ability to complete all study related procedures (for example, psychiatric illness, drug addiction, alcoholism, etc.).
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- Infection with human immunodeficiency virus (HIV), hepatitis, or syphilis.
- Subjects diagnosed with cancer with or without chemotherapy treatment.
- Sudden hair loss within the last 4 months unrelated to normal seasonal hair shedding or androgenetic alopecia (AGA).
- Subjects in the process of or having completed surgical correction of hair loss in the past 24 months.
- Participation in a cosmetic and/or pharmaceutical research study.
Trial locations and contacts
1 site in 1 country.
Georgia1 site
Scientific Research Institute for Skin and Venereal Diseases, Department of Dermatology
Tbilisi, 0112
About this study
Official title: Randomized, Single-centre, Double-blind, Placebo-controlled, Phase I / IIa Study to Evaluate the Safety and Efficacy of Human Autologous Hair Follicle Dermal Sheath Cup Cells (DSCC) in Women and Men With Androgenetic Alopecia.
The primary purpose of this study is to assess the safety of performing injections of human autologous hair follicle cells. The study will also measure the impact these injections will have on hair growth.
20 patients will be selected for participation in this study (10 males and 10 females) based on their health status, current/past medications, and ability to adhere to protocol-related requirements. All patients will have evidence of mild to moderate androgenetic alopecia (AGA) involving the vertex area of the scalp as defined by the Ludwig (female) or Norwood (male) scales.
At the first visit and after completing informed consent, patients provide a blood sample that will be tested for human immunodeficiency virus (HIV), hepatitis, and syphilis one week before having a biopsy from the back of their scalp. The provided scalp biopsy is then processed to isolate hair follicle cells which are then replicated. Patients return to the clinic for injections of their own replicated cells (autologous cells) in medium (verum) and medium alone (control) into two pre-selected treatment areas in their scalp. Assessments of the safety/tolerability of these injections will take place over the next 60 months both at in-clinic visits and telephone follow-up visits. At these visits patients will have their overall health assessed as subjective and objective assessments of the areas that were injected either with verum or control. During the first 24 months of follow-up, digital images will be taken of the scalp and of the two treatment areas injected with either verum or control. Furthermore at 6, 12, and 24 months post-injection, four patients (2 male and 2 female) at each time point will provide biopsies of the injection sites for histopathological analysis. At the 60 month time point, any patients not previously providing biopsies for histopathological analysis will provide biopsies. Total duration of patient participation is approximately 63 months.
- Conditions
- Androgenetic Alopecia
- Being tested
- Human autologous hair follicle cells, Cell medium
- Keywords
- Alopecia, Alopecia, Androgenetic, Androgenetic Alopecia
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human autologous hair follicle cellsOther
Also called autologous hair follicle cells, hair follicle cells, verum
Human autologous hair follicle cells suspended in cell medium
Cell mediumOther
Also called control, placebo, cell transportation medium
Cell medium
| Study group | Role | What they receive |
|---|---|---|
| Injection of verum and control | Other | Patients will receive randomized, blinded, injections of BOTH autologous hair follicle cells in medium (verum) and of medium alone (control) into two separate pre-defined treatment areas on their scalp. Receives: Other: Human autologous hair follicle cells; Other: Cell medium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of local adverse events
Assessment of the local (at pre-selected treatment sites) safety profile of autologous hair follicle cells at six months compared to control as defined by adverse events (AEs) with respect to their causality, incidence, severity and seriousness
Measured: six months post-injection
Secondary outcomes (5)
Incidence of local adverse events
Local (at pre-selected treatment sites) safety profile of autologous hair follicle cells at 60 months compared to control, defined by adverse events (AEs) with respect to their causality, incidence, severity and seriousness
Measured: 12, 24 and 60 months post-injection
Systemic adverse events
Measured: during 60-month observation period
Histopathological analysis
Biopsies are taken from treatment areas injected with verum and control from two male and two female patients (selected at random) at 6, 12, and 24 months post-injection. All patients not previously providing biopsies will do so 60 months post-injection. Biopsies sent to a blinded independent evaluator who will perform microscopic analysis of sections of the biopsies and provide reports detailing the difference between the biopsies of the two treatment areas per patient.
Measured: 6, 12. 24 and 60 months post-injection
Complete safety profile
Analysis of the complete safety profile of study participants. Number and type of adverse events (AEs) will be listed per patient and as will reports from the patients selected to provide biopsies for histopathological analysis.
Measured: during 60-month observation period
Hair Growth
Hair growth will be assessed subjectively and objectively via a series of digital images taken from the scalp using standardized equipment. The following images will be taken: global scalp image pre shaving, global scalp image post-shaving (at select visits only), macroscopic images of each injection sites.
Measured: 6 months post-injection and over 24-month observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2011 (estimated)
- Study startDec 2010
- Primary completionApr 2012
- Study completion23 Feb 2017
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- TrichoScience Innovations, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharmalog Institut für klinische Forschung GmbH (PHARMALOG Institute for Clinical Research), PRA Health Sciences, Innovacell Biotechnologie AG, DatInf (Germany), The Hair and Skin Research and Treatment Center
- Responsible party
- Sponsor
- Investigators
- Nino Lortkipanidze, MD, PhD, Principal investigator, Scientific Research Institute for Skin and Venereal Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01286649
- Sponsor's protocol ID
- TS001-2009
- Status last verified
- Mar 2017
- First submitted
- 18 Jan 2011
- Last updated
- 8 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-centre, Double-blind, Placebo-controlled, Phase I / IIa Study to Evaluate the Safety and Efficacy of Human Autologous Hair Follicle Dermal Sheath Cup Cells (DSCC) in Women and Men With Androgenetic Alopecia.
- ClinicalTrials.gov ID
- NCT01286649
- Acronym / sponsor ID
- TS001-2009
- Conditions
- Androgenetic Alopecia
- Keywords
- Alopecia, Alopecia, Androgenetic, Androgenetic Alopecia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- TrichoScience Innovations, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Pharmalog Institut für klinische Forschung GmbH (PHARMALOG Institute for Clinical Research), PRA Health Sciences, Innovacell Biotechnologie AG, DatInf (Germany), The Hair and Skin Research and Treatment Center
- Study start
- Dec 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- 23 Feb 2017 (actual)
- First posted
- 31 Jan 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.
The primary purpose of this study is to assess the safety of performing injections of human autologous hair follicle cells. The study will also measure the impact these injections will have on hair growth.
20 patients will be selected for participation in this study (10 males and 10 females) based on their health status, current/past medications, and ability to adhere to protocol-related requirements. All patients will have evidence of mild to moderate androgenetic alopecia (AGA) involving the vertex area of the scalp as defined by the Ludwig (female) or Norwood (male) scales.
At the first visit and after completing informed consent, patients provide a blood sample that will be tested for human immunodeficiency virus (HIV), hepatitis, and syphilis one week before having a biopsy from the back of their scalp. The provided scalp biopsy is then processed to isolate hair follicle cells which are then replicated. Patients return to the clinic for injections of their own replicated cells (autologous cells) in medium (verum) and medium alone (control) into two pre-selected treatment areas in their scalp. Assessments of the safety/tolerability of these injections will take place over the next 60 months both at in-clinic visits and telephone follow-up visits. At these visits patients will have their overall health assessed as subjective and objective assessments of the areas that were injected either with verum or control. During the first 24 months of follow-up, digital images will be taken of the scalp and of the two treatment areas injected with either verum or control. Furthermore at 6, 12, and 24 months post-injection, four patients (2 male and 2 female) at each time point will provide biopsies of the injection sites for histopathological analysis. At the 60 month time point, any patients not previously providing biopsies for histopathological analysis will provide biopsies. Total duration of patient participation is approximately 63 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injection of verum and control | Other | Other: Human autologous hair follicle cells, Other: Cell mediumPatients will receive randomized, blinded, injections of BOTH autologous hair follicle cells in medium (verum) and of medium alone (control) into two separate pre-defined treatment areas on their scalp. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female between the age of 18 and 55 years and in good health having evidence of mild to moderate androgenetic alopecia (AGA) involving the vertex area of the scalp. Female patients with androgenetic alopecia (AGA) characterized as vertex pattern type II or type III of the Ludwig Scale qualify for inclusion in this study. Males with androgenetic alopecia (AGA) involving the vertex area of the scalp, characterized as type III vertex- type VI on the Norwood Scale qualify for inclusion in the study.
- Willingness to provide written informed consent for participation in the study, attend all study visits and complete all procedures required by this protocol.
- The test areas (areas to be injected) are of uniform skin color without erythema, dark pigmentation or scars that may confound study results.
- Willingness to forego the use cosmetic or medical products for hair loss throughout the course of the study.
- Females must be post-menopausal for at least one year, surgically sterile, or, if of childbearing potential, using highly-effective methods of birth control. This method of contraception must be used at least 4 weeks prior to and during the entire duration of the clinical trial.
Key exclusion criteria (11 listed)
- Use of any product (medication or otherwise) which interferes with the hair growth cycle.
- Any systemic medical treatment for hair loss (for example, Finasteride, Minoxidil, Dutasteride, or antiandrogens) within the last 12 months.
- Start of contraception treatments containing chlormadinone or cyproterone acetate within the last 12 months.
- Women who are pregnant or nursing.
- Presence of any medical condition that influences the hair growth cycle (for example, alopecia areata, lichen planopilaris, lupus erythematosus, severe seborrheic eczema, psoriasis capitis or tinea capitis, untreated thyroid gland disease/goiter development, auto-immune diseases, etc.).
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 |
|---|---|---|
| Human autologous hair follicle cellsAlso: autologous hair follicle cells, hair follicle cells, verumHuman autologous hair follicle cells suspended in cell medium | Other | Injection of verum and control |
| Cell mediumAlso: control, placebo, cell transportation mediumCell medium | Other | Injection of verum and control |
Primary outcome
Incidence of local adverse events
Time frame: six months post-injection
Assessment of the local (at pre-selected treatment sites) safety profile of autologous hair follicle cells at six months compared to control as defined by adverse events (AEs) with respect to their causality, incidence, severity and seriousness
5 secondary outcomes
Incidence of local adverse events
Time frame: 12, 24 and 60 months post-injection
Systemic adverse events
Time frame: during 60-month observation period
Histopathological analysis
Time frame: 6, 12. 24 and 60 months post-injection
Complete safety profile
Time frame: during 60-month observation period
Hair Growth
Time frame: 6 months post-injection and over 24-month observation period
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 8 Mar 2017.
- RepliCel Life Sciences, Inc. Website (Parent Co. of TrichoScience Innovations, Inc.)Link provided by the sponsor.
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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.
Nino Lortkipanidze, MD, PhD principal investigator
Scientific Research Institute for Skin and Venereal Diseases
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Human autologous hair follicle cells and Cell medium in people with Androgenetic Alopecia, run by TrichoScience Innovations, Inc. at 1 site in Georgia.
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 5 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 8 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Georgia. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Incidence of local adverse events (time frame: six months post-injection). 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 8 Mar 2017.