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CompletedNCT02503852STYLEUpdated Jan 13, 2020Results posted

STYLE -- A Trial of Cell Enriched Adipose For Androgenetic Alopecia

An interventional study of Puregraft System and Celution System in Alopecia, Androgenetic, sponsored by Kerastem Technologies, LLC. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-13.

Sponsored by Kerastem Technologies, LLC · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
71
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Alopecia, Androgenetic

Keywords

  • Female Pattern Baldness
  • Male Pattern Baldness
  • Genetic Alopecia
  • Androgenic Alopecia
  • Hair Loss
03

In context

Alopecia

609 studies on the registry are indexed under Alopecia; 131 are open to participants now.

This study's enrollment of 71 is above the median of 45 across 513 interventional studies indexed under Alopecia.

Browse Alopecia studies →

Lead sponsor

This is the only study on the registry with Kerastem Technologies, LLC as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Males with a diagnosis of Alopecia Androgenetica
  2. Females with a diagnosis of Alopecia Androgenetica
  3. Males with hair loss consistent with Grades III, IIIA, III-Vertex, IV, IV-A, based on Norwood-Hamilton Scale (Figure 1)
  4. Females with hair loss consistent with Grades I-3, I-4, II-1, II-2 based on the Savin Scale (Figure 2)
  5. Provide written informed consent and comply with the study requirements
  6. 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.
  7. Subject is willing to maintain a consistent hair length and natural hair color, without the use of any coloring agents, during the study period.
  8. Ability to complete study procedures, patient surveys, and pictures.
  9. Subject is ≥ 18 years of age.
  10. Body Mass Index \< 40kg/m2

Exclusion criteria

Exclusion Criteria:

  1. 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
  2. Treatment with an investigational product or procedure within 30 days or plans to participate in another clinical study
  3. Subject who has previously failed or has been deemed non-responsive to a previous experimental hair loss treatment.
  4. Subject must have no previous hair transplant, cell treatment, micro needling, or any other treatment in the last 6 months in the scalp.
  5. 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.).
  6. History of autoimmune disease or organ transplantation or a patient on immunosuppressive medication(s).
  7. Diagnosis of cancer, receiving active treatment
  8. Active systemic infection
  9. Requires chronic antibiotics, systemic corticosteroids
  10. 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.
  11. Clinically significant medical or psychiatric illness currently or within 30 days of study screening as determined by the investigator
  12. Prior surgery in the treatment area
  13. 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
  14. Pregnant or lactating women or women trying to become pregnant
  15. Known allergic reaction to components of study treatment and/or study injection procedure
  16. Subject has any disorder that may prevent compliance to study procedures and visits
  17. Subject who is part of the study staff, a family member or friend
  18. Diabetes or thyroid disorder
  19. Subject who has a sensitive, irritated, or abraded scalp area.
  20. Women who have an alternate diagnosis that is associated with hair loss.
  21. Body Mass Index \< 18kg/m2
  22. Clinically significant abnormal findings on laboratory screening panels, including hemoglobin ≤ 10 g/dL.
  23. 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.
  24. Chronic renal insufficiency as defined as a serum creatinine > 1.2 mg/dL for women and > 1.5 mg/dL for men.
  25. An elevated PT/PTT, INR, or platelet count \< 100 x 109/L
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
71 participants (actual)

Study arms

  • Experimental
    Fat + High Dose ADRC

    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.

    Device: Puregraft System · Device: Celution System · Procedure: Kerastem Therapy · Procedure: Liposuction

  • Experimental
    Fat + Low Dose ADRC

    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.

    Device: Puregraft System · Device: Celution System · Procedure: Kerastem Therapy · Procedure: Liposuction

  • Active comparator
    Fat Alone

    Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp.

    Device: Puregraft System · Procedure: Liposuction

  • Placebo comparator
    No Fat Control

    Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp.

    Procedure: Liposuction

Interventions

  • DevicePuregraft System

    The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.

  • DeviceCelution System

    The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.

  • ProcedureKerastem Therapy

    The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.

  • ProcedureLiposuction

    Tissue collection involving the micro-harvest of subcutaneous adipose tissue.

06

What researchers measure

Primary outcomes

  1. Safety & Tolerability Assessment of SAE/AE

    Safety \& Tolerability of Experimental Treatment (ADRC) Assessment of SAE/AE

    Time frame: Enrollment to 52 weeks

Secondary outcomes

  1. Terminal (Non-Vellus) Hair Count--Change From Baseline

    Terminal (Non-Vellus) Hair Count Assessment by Macrophotography

    Time frame: Enrollment to 52 weeks

  2. 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

    Time frame: Enrollment to 24 weeks

07

Results

Posted Jan 13, 2020

Participant flow

Participant flow — Overall Study
MilestoneFat + High Dose ADRCFat + Low Dose ADRCFat AloneNo Fat Control
Started1622249
Completed1219218
Not completed4331

Outcome measures

PrimarySafety & Tolerability Assessment of SAE/AE

Safety \& Tolerability of Experimental Treatment (ADRC) Assessment of SAE/AE

Time frame:
Enrollment to 52 weeks
Reported as:
Number · events
Safety & Tolerability Assessment of SAE/AE
eventsFat + High Dose ADRCFat + Low Dose ADRCFat AloneNo Fat Control
Total Number of Adverse Events59122
Unanticipated Adverse Eventss0000
Serious Adverse Events0000
SecondaryTerminal (Non-Vellus) Hair Count--Change From Baseline

Terminal (Non-Vellus) Hair Count Assessment by Macrophotography

Time frame:
Enrollment to 52 weeks
Reported as:
Mean · Hairs
Terminal (Non-Vellus) Hair Count--Change From Baseline
HairsFat + High Dose ADRCFat + Low Dose ADRCFat AloneNo Fat Control
Terminal (Non-Vellus) Hair Count--Change From Baseline-5.62 ± 6.0916.2 ± 4.98-0.57 ± 7.53-7.92 ± 8.98
Statistical analysis
  • Fat + Low Dose ADRC vs No Fat Control · ANCOVA · p = 0.032
  • Fat + Low Dose ADRC vs No Fat Control · ANCOVA · p = 0.0318 (P value cited is the difference in non-vellus hair count between the low-dose ADRC NW3 group and the no-fat saline control at week 24)
SecondaryHair 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

Time frame:
Enrollment to 24 weeks
Reported as:
Number · % of participants with + responses
Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4
% of participants with + responsesFat + High Dose ADRCFat + Low Dose ADRCFat AloneNo Fat Control
Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 412.534.420.84.1

Adverse events

Collected over From Enrollment through 52 Weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Fat + High Dose ADRC0/16 (0%)0/16 (0%)5/16 (31.3%)
Fat + Low Dose ADRC0/22 (0%)0/22 (0%)9/22 (40.9%)
Fat Alone0/24 (0%)0/24 (0%)11/24 (45.8%)
No Fat Control0/9 (0%)0/9 (0%)2/9 (22.2%)
Most frequent other events
Most frequent other events
EventFat + High Dose ADRCFat + Low Dose ADRCFat AloneNo Fat Control
Brusing or EdemaSkin and subcutaneous tissue disorders5/168/2211/242/9
HickupsRespiratory, thoracic and mediastinal disorders0/161/220/240/9
ShilglesImmune system disorders0/160/221/240/9

Baseline characteristics

All subjects were included in the analysis population.

Age, Customized
Age, Customized(years)Fat + High Dose ADRCFat + Low Dose ADRCFat AloneNo Fat ControlTotal
Age(Years)40.0 ± 9.143.1 ± 13.340.5 ± 12.736.1 ± 5.440.7 ± 11.5
Sex: Female, Male
Sex: Female, Male(Participants)Fat + High Dose ADRCFat + Low Dose ADRCFat AloneNo Fat ControlTotal
Female257317
Male141717654
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Fat + High Dose ADRCFat + Low Dose ADRCFat AloneNo Fat ControlTotal
Hispanic or Latino6612428
Not Hispanic or Latino81612541
Unknown or Not Reported20002
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Fat + High Dose ADRCFat + Low Dose ADRCFat AloneNo Fat ControlTotal
American Indian or Alaska Native00000
Asian00101
Native Hawaiian or Other Pacific Islander00000
Black or African American11103
White152122967
More than one race00000
Unknown or Not Reported00000
08

Study locations

4 sites
  • Tower Outpatient Surgery Center--Dr. Joel Aronowitz
    Los Angeles, California 920048, United States
  • Foundation For Hair Restoration
    Miami, Florida 33143, United States
  • Glasgold Surgery Group
    Highland Park, New Jersey 08904, United States
  • Laser & Skin Surgery Center of New York
    New York, New York 10016, United States
09

References and documents

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 21884937 ↗
  • Zhu 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 documents

  • Protocol and statistical analysis plan · Nov 24, 2015

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 13, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02503852
Lead sponsor
Kerastem Technologies, LLC
Responsible party
Sponsor
First posted
Jul 21, 2015
Start date
Nov 2015
Primary completion
Mar 2, 2018
Completion
Mar 2, 2018
Results posted
Jan 13, 2020
Last update
Jan 13, 2020

Study contacts

Ken Washenik, MD
principal investigator · Bosley Medical/NYU

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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