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

Primary Purpose

Alopecia, Androgenetic

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Puregraft System
Celution System
Kerastem Therapy
Liposuction
Sponsored by
Kerastem Technologies, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alopecia, Androgenetic focused on measuring Female Pattern Baldness, Male Pattern Baldness, Genetic Alopecia, Androgenic Alopecia, Hair Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

  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

Sites / Locations

  • Tower Outpatient Surgery Center--Dr. Joel Aronowitz
  • Foundation For Hair Restoration
  • Glasgold Surgery Group
  • Laser & Skin Surgery Center of New York

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

Fat + High Dose ADRC

Fat + Low Dose ADRC

Fat Alone

No Fat Control

Arm Description

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.

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.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Terminal (Non-Vellus) Hair Count--Change From Baseline
Terminal (Non-Vellus) Hair Count Assessment by Macrophotography
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

Full Information

First Posted
July 17, 2015
Last Updated
January 9, 2020
Sponsor
Kerastem Technologies, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02503852
Brief Title
STYLE -- A Trial of Cell Enriched Adipose For Androgenetic Alopecia
Acronym
STYLE
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
March 2, 2018 (Actual)
Study Completion Date
March 2, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kerastem Technologies, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia, Androgenetic
Keywords
Female Pattern Baldness, Male Pattern Baldness, Genetic Alopecia, Androgenic Alopecia, Hair Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Randomization via manual treatment assignment by the unblinded Clinical Supply Manager prior to the start of liposuction. Subjects randomized into the study are assigned their study Arm corresponding to the next available number in the computer-generated randomization schedule. Dose preparation ios performed by designated unblinded qualified personnel and supplied to the blinded treating team.
Allocation
Randomized
Enrollment
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fat + High Dose ADRC
Arm Type
Experimental
Arm Description
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.
Arm Title
Fat + Low Dose ADRC
Arm Type
Experimental
Arm Description
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.
Arm Title
Fat Alone
Arm Type
Active Comparator
Arm Description
Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp.
Arm Title
No Fat Control
Arm Type
Placebo Comparator
Arm Description
Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp.
Intervention Type
Device
Intervention Name(s)
Puregraft System
Intervention Description
The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
Intervention Type
Device
Intervention Name(s)
Celution System
Intervention Description
The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
Intervention Type
Procedure
Intervention Name(s)
Kerastem Therapy
Intervention Description
The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
Intervention Type
Procedure
Intervention Name(s)
Liposuction
Intervention Description
Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
Primary Outcome Measure Information:
Title
Safety & Tolerability Assessment of SAE/AE
Description
Safety & Tolerability of Experimental Treatment (ADRC) Assessment of SAE/AE
Time Frame
Enrollment to 52 weeks
Secondary Outcome Measure Information:
Title
Terminal (Non-Vellus) Hair Count--Change From Baseline
Description
Terminal (Non-Vellus) Hair Count Assessment by Macrophotography
Time Frame
Enrollment to 52 weeks
Title
Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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 Exclusion Criteria: 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). 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ken Washenik, MD
Organizational Affiliation
Bosley Medical/NYU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tower Outpatient Surgery Center--Dr. Joel Aronowitz
City
Los Angeles
State/Province
California
ZIP/Postal Code
920048
Country
United States
Facility Name
Foundation For Hair Restoration
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Glasgold Surgery Group
City
Highland Park
State/Province
New Jersey
ZIP/Postal Code
08904
Country
United States
Facility Name
Laser & Skin Surgery Center of New York
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21884937
Citation
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.
Results Reference
background
PubMed Identifier
20098110
Citation
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.
Results Reference
background

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

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