Alopecia, AndrogeneticSTYLENCT02503852
STYLE -- A Trial of Cell Enriched Adipose For Androgenetic Alopecia
A study testing Puregraft System, Celution System and Kerastem Therapy in people with Alopecia, Androgenetic, run by Kerastem Technologies, LLC at 4 sites in United States.
Trial summary
The primary objective of this study is to evaluate the safety and feasibility of the Celution and Puregraft Systems in the processing and preparation of an autologous fat graft enriched with adipose-derived regenerative cells (ADRCs) in the treatment of early alopecia androgenetica. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia, Androgenetic
- What is being tested?
- Puregraft System, Celution System and Kerastem Therapy
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 71 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2015to 2 Mar 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males with a diagnosis of Alopecia Androgenetica
- Females with a diagnosis of Alopecia Androgenetica
- Males with hair loss consistent with Grades III, IIIA, III-Vertex, IV, IV-A, based on Norwood-Hamilton Scale (Figure 1)
- Females with hair loss consistent with Grades I-3, I-4, II-1, II-2 based on the Savin Scale (Figure 2)
- Provide written informed consent and comply with the study requirements
- For women of childbearing potential: Negative pregnancy test at screening visit plus subject agrees to maintain two forms of contraception for the duration of the study.
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- Subject is willing to maintain a consistent hair length and natural hair color, without the use of any coloring agents, during the study period.
- Ability to complete study procedures, patient surveys, and pictures.
- Subject is ≥ 18 years of age.
- Body Mass Index < 40kg/m2
Who cannot join
- 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
- Treatment with an investigational product or procedure within 30 days or plans to participate in another clinical study
- Subject who has previously failed or has been deemed non-responsive to a previous experimental hair loss treatment.
- Subject must have no previous hair transplant, cell treatment, micro needling, or any other treatment in the last 6 months in the scalp.
- Subject is currently suffering from an active autoimmune disease such as serum lupus erythematosus, or alopecia areata. Subject is currently suffering from dermatologic condition in the treatment area or has a significant scar in the hair treatment area that, in the opinion of the investigator, will make hair growth difficult (such as systemic burns, etc.).
- History of autoimmune disease or organ transplantation or a patient on immunosuppressive medication(s).
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- Diagnosis of cancer, receiving active treatment
- Active systemic infection
- Requires chronic antibiotics, systemic corticosteroids
- Use of systemic agents that increase bleeding or clotting, or disorders associated with these effects, including patients receiving GIIB/IIIa inhibitors within 2 weeks prior to the study procedure through to 1 week after the study procedure.
- Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator
- Prior surgery in the treatment area
- Any disease or condition (medical or surgical) that, in the opinion of the investigator, might compromise dermatologic, hematologic, cardiovascular, pulmonary, renal, gastrointestinal, hepatic, or central nervous system function; or any condition that would place the subject at increased risk
- Pregnant or lactating women or women trying to become pregnant
- Known allergic reaction to components of study treatment and/or study injection procedure
- Subject has any disorder that may prevent compliance to study procedures and visits
- Subject who is part of the study staff, a family member or friend
- Diabetes or thyroid disorder
- Subject who has a sensitive, irritated, or abraded scalp area.
- Women who have an alternate diagnosis that is associated with hair loss.
- Body Mass Index < 18kg/m2
- Clinically significant abnormal findings on laboratory screening panels, including hemoglobin ≤ 10 g/dL.
- Hepatic dysfunction, as defined as aspartate aminotransferase (AST), alanine aminotransferase (ALT), or bilirubin levels > 1.5 times the upper limit of normal range (x ULN) prior to randomization.
- Chronic renal insufficiency as defined as a serum creatinine > 1.2 mg/dL for women and > 1.5 mg/dL for men.
- An elevated PT/PTT, INR, or platelet count < 100 x 109/L
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Glasgold Surgery Group
Highland Park, New Jersey, 08904
Tower Outpatient Surgery Center--Dr. Joel Aronowitz
Los Angeles, California, 920048
Foundation For Hair Restoration
Miami, Florida, 33143
Laser & Skin Surgery Center of New York
New York, New York, 10016
About this study
Official title: Subcutaneous Transplantation of Autologous Cell Enriched Adipose Tissue For Follicular Niche Stimulation in Early Stage Alopecia Androgenetica (STYLE): a Randomized, Blinded, Controlled Trial
The primary objective of this study is to evaluate the safety and feasibility of the Celution and Puregraft Systems in the processing and preparation of an autologous fat graft enriched with adipose-derived regenerative cells (ADRCs) in the treatment of early alopecia androgenetica.
Read the detailed description
The STYLE Trial is a prospective, randomized, multi-center device trial intended to evaluate the safety and efficacy of the Celution and Puregraft Systems in the processing and preparation of an autologous fat graft enriched with adipose-derived regenerative cells (ADRCs) in the treatment of early alopecia androgenetica. Patients may be included if they are undergoing an elective cosmetic liposuction. Following informed consent and screening evaluations, eligible subjects will undergo pre-operative testing. Subjects will then undergo a fat harvest using local anesthesia with or without conscious sedating. Subjects will be randomly assigned to receive a fat graft cell enriched with ADRCs (available in two different doses),a fat graft without cell enrichment using a visually-matched blood saline solution (fat alone control), or a saline injection (no-fat control) in a 2:2:2:1 ratio.
While undergoing liposuction, lipoaspirate will be processed in the Puregraft System to remove the lipoaspirate of impurities and in the Celution System to isolate and concentrate ADRCs. After the liposuction is completed), patients will have, under a ring block local anesthesia (see further description below), a subcutaneous scalp injection of either Puregraft purified autologous fat or saline (no-fat control) followed by a separate second injection, of either ADRCs (available in two different doses),a visually-matched blood saline solution (fat alone control), or saline (no-fat control) in a 2:2:2:1 ratio.
The STYLE Clinical Trial will have a sample size of 70 patients at up to eight (8) centers.
- Conditions
- Alopecia, Androgenetic
- Being tested
- Puregraft System, Celution System, Kerastem Therapy, Liposuction
- Keywords
- Female Pattern Baldness, Male Pattern Baldness, Genetic Alopecia, Androgenic Alopecia, Hair Loss
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Puregraft SystemDevice
The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Celution SystemDevice
The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
Kerastem TherapyProcedure or surgery
The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
LiposuctionProcedure or surgery
Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
| Study group | Role | What they receive |
|---|---|---|
| Fat + High Dose ADRC | Experimental | Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 1,000,000 ADRC prepared with the Celution System per square centimeter of scalp. Receives: Device: Puregraft System; Device: Celution System; Procedure: Kerastem Therapy; Procedure: Liposuction |
| Fat + Low Dose ADRC | Experimental | Kerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 500,000 ADRC prepared with the Celution System per square centimeter of scalp. Receives: Device: Puregraft System; Device: Celution System; Procedure: Kerastem Therapy; Procedure: Liposuction |
| Fat Alone | Active comparator | Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp. Receives: Device: Puregraft System; Procedure: Liposuction |
| No Fat Control | Placebo comparator | Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp. Receives: Procedure: Liposuction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety & Tolerability Assessment of SAE/AE
Safety \& Tolerability of Experimental Treatment (ADRC) Assessment of SAE/AE
Measured: Enrollment to 52 weeks
Secondary outcomes (2)
Terminal (Non-Vellus) Hair Count--Change From Baseline
Terminal (Non-Vellus) Hair Count Assessment by Macrophotography
Measured: Enrollment to 52 weeks
Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4
Percent of positive responses, defined by increase of 1 or more from baseline, on specific written assessment of treatment outcome by Investigators scored 1-5, value 1 is lowest, value of 5 is highest, higher values represent more positive responses
Measured: Enrollment to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2015 (estimated)
- Study startNov 2015
- Primary completion2 Mar 2018
- Study completion2 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alopecia, AndrogeneticStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects arm randomized prior to liposuction 2:2:2:1 ratio to one of 4 Arms. Low Dose ADR, High Dose ADRC, non enriched fat only, and no fat (control normal saline).
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kerastem Technologies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ken Washenik, MD, Principal investigator, Bosley Medical/NYU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02503852
- Sponsor's protocol ID
- 003-A-II
- Acronym
- STYLE
- Status last verified
- Aug 2019
- First submitted
- 17 Jul 2015
- Last updated
- 13 Jan 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Festa E, Fretz J, Berry R, Schmidt B, Rodeheffer M, Horowitz M, Horsley V. Adipocyte lineage cells contribute to the skin stem cell niche to drive hair cycling. Cell. 2011 Sep 2;146(5):761-71. doi: 10.1016/j.cell.2011.07.019.
PubMed 21884937Zhu M, Zhou Z, Chen Y, Schreiber R, Ransom JT, Fraser JK, Hedrick MH, Pinkernell K, Kuo HC. Supplementation of fat grafts with adipose-derived regenerative cells improves long-term graft retention. Ann Plast Surg. 2010 Feb;64(2):222-8. doi: 10.1097/SAP.0b013e31819ae05c.
PubMed 20098110
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Transplantation of Autologous Cell Enriched Adipose Tissue For Follicular Niche Stimulation in Early Stage Alopecia Androgenetica (STYLE): a Randomized, Blinded, Controlled Trial
- ClinicalTrials.gov ID
- NCT02503852
- Acronym / sponsor ID
- STYLE / 003-A-II
- Conditions
- Alopecia, Androgenetic
- Keywords
- Female Pattern Baldness, Male Pattern Baldness, Genetic Alopecia, Androgenic Alopecia, Hair Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Kerastem Technologies, LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2015 (actual)
- Primary completion
- 2 Mar 2018 (actual)
- Study completion
- 2 Mar 2018 (actual)
- First posted
- 21 Jul 2015 (estimated)
- Results
- Posted 13 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the safety and feasibility of the Celution and Puregraft Systems in the processing and preparation of an autologous fat graft enriched with adipose-derived regenerative cells (ADRCs) in the treatment of early alopecia androgenetica.
Detailed description
The STYLE Trial is a prospective, randomized, multi-center device trial intended to evaluate the safety and efficacy of the Celution and Puregraft Systems in the processing and preparation of an autologous fat graft enriched with adipose-derived regenerative cells (ADRCs) in the treatment of early alopecia androgenetica. Patients may be included if they are undergoing an elective cosmetic liposuction. Following informed consent and screening evaluations, eligible subjects will undergo pre-operative testing. Subjects will then undergo a fat harvest using local anesthesia with or without conscious sedating. Subjects will be randomly assigned to receive a fat graft cell enriched with ADRCs (available in two different doses),a fat graft without cell enrichment using a visually-matched blood saline solution (fat alone control), or a saline injection (no-fat control) in a 2:2:2:1 ratio.
While undergoing liposuction, lipoaspirate will be processed in the Puregraft System to remove the lipoaspirate of impurities and in the Celution System to isolate and concentrate ADRCs. After the liposuction is completed), patients will have, under a ring block local anesthesia (see further description below), a subcutaneous scalp injection of either Puregraft purified autologous fat or saline (no-fat control) followed by a separate second injection, of either ADRCs (available in two different doses),a visually-matched blood saline solution (fat alone control), or saline (no-fat control) in a 2:2:2:1 ratio.
The STYLE Clinical Trial will have a sample size of 70 patients at up to eight (8) centers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Subjects arm randomized prior to liposuction 2:2:2:1 ratio to one of 4 Arms. Low Dose ADR, High Dose ADRC, non enriched fat only, and no fat (control normal saline).
| Arm | Type | Receives |
|---|---|---|
| Fat + High Dose ADRC | Experimental | Device: Puregraft System, Device: Celution System, Procedure: Kerastem Therapy, Procedure: LiposuctionKerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 1,000,000 ADRC prepared with the Celution System per square centimeter of scalp. |
| Fat + Low Dose ADRC | Experimental | Device: Puregraft System, Device: Celution System, Procedure: Kerastem Therapy, Procedure: LiposuctionKerastem Therapy includes micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System + 500,000 ADRC prepared with the Celution System per square centimeter of scalp. |
| Fat Alone | Active comparator | Device: Puregraft System, Procedure: LiposuctionMicro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp. |
| No Fat Control | Placebo comparator | Procedure: LiposuctionMicro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Males with a diagnosis of Alopecia Androgenetica
- Females with a diagnosis of Alopecia Androgenetica
- Males with hair loss consistent with Grades III, IIIA, III-Vertex, IV, IV-A, based on Norwood-Hamilton Scale (Figure 1)
- Females with hair loss consistent with Grades I-3, I-4, II-1, II-2 based on the Savin Scale (Figure 2)
- Provide written informed consent and comply with the study requirements
Key exclusion criteria (25 listed)
- 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
- Treatment with an investigational product or procedure within 30 days or plans to participate in another clinical study
- Subject who has previously failed or has been deemed non-responsive to a previous experimental hair loss treatment.
- Subject must have no previous hair transplant, cell treatment, micro needling, or any other treatment in the last 6 months in the scalp.
- Subject is currently suffering from an active autoimmune disease such as serum lupus erythematosus, or alopecia areata. Subject is currently suffering from dermatologic condition in the treatment area or has a significant scar in the hair treatment area that, in the opinion of the investigator, will make hair growth difficult (such as systemic burns, 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 |
|---|---|---|
| Puregraft SystemThe Puregraft System prepares purified adipose tissue for subcutaneous scalp injection. | Device | Fat + High Dose ADRC, Fat + Low Dose ADRC, Fat Alone |
| Celution SystemThe Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection. | Device | Fat + High Dose ADRC, Fat + Low Dose ADRC |
| Kerastem TherapyThe Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System. | Procedure or surgery | Fat + High Dose ADRC, Fat + Low Dose ADRC |
| LiposuctionTissue collection involving the micro-harvest of subcutaneous adipose tissue. | Procedure or surgery | Fat + High Dose ADRC, Fat + Low Dose ADRC, Fat Alone, No Fat Control |
Primary outcome
Safety & Tolerability Assessment of SAE/AE
Time frame: Enrollment to 52 weeks
Safety \& Tolerability of Experimental Treatment (ADRC) Assessment of SAE/AE
2 secondary outcomes
Terminal (Non-Vellus) Hair Count--Change From Baseline
Time frame: Enrollment to 52 weeks
Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4
Time frame: Enrollment to 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21884937Festa E, Fretz J, Berry R, Schmidt B, Rodeheffer M, Horowitz M, Horsley V. Adipocyte lineage cells contribute to the skin stem cell niche to drive hair cycling. Cell. 2011 Sep 2;146(5):761-71. doi: 10.1016/j.cell.2011.07.019.
- Background: PubMed 20098110Zhu M, Zhou Z, Chen Y, Schreiber R, Ransom JT, Fraser JK, Hedrick MH, Pinkernell K, Kuo HC. Supplementation of fat grafts with adipose-derived regenerative cells improves long-term graft retention. Ann Plast Surg. 2010 Feb;64(2):222-8. doi: 10.1097/SAP.0b013e31819ae05c.
- Individual participant dataSharing planned: No
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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.
Ken Washenik, MD principal investigator
Bosley Medical/NYU
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Puregraft System, Celution System and Kerastem Therapy in people with Alopecia, Androgenetic, run by Kerastem Technologies, LLC at 4 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 10 inclusion and 25 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 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Safety & Tolerability Assessment of SAE/AE (time frame: Enrollment to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02503852, which also lists 2 linked publications.
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 13 Jan 2020.