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

• ClinicalTrials.gov Identifier: NCT02503852
• Recruitment Status: Completed
• First Posted: July 21, 2015
• Results First Posted: January 13, 2020
• Last Update Posted: January 13, 2020
• Sponsor: Kerastem Technologies, LLC
• Information provided by (Responsible Party): Kerastem Technologies, LLC

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.

Condition or disease	Intervention/treatment	Phase
Alopecia, Androgenetic	Device: Puregraft System; Device: Celution System; Procedure: Kerastem Therapy; Procedure: Liposuction	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 71 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention 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 (Participant, Care Provider, Investigator, Outcomes 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.

• Primary Purpose: Treatment
• 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
• Actual Study Start Date: November 2015
• Actual Primary Completion Date: March 2, 2018
• Actual Study Completion Date: March 2, 2018

Arms and Interventions

Arm	Intervention/treatment
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; The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.; Device: Celution System; The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.; Procedure: Kerastem 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.; Procedure: Liposuction; Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
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; The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.; Device: Celution System; The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.; Procedure: Kerastem 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.; Procedure: Liposuction; Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
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; The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.; Procedure: Liposuction; Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
Placebo Comparator: No Fat Control; Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp.	Procedure: Liposuction; Tissue collection involving the micro-harvest of subcutaneous adipose tissue.

Outcome Measures

Primary Outcome Measures :

1. Safety & Tolerability Assessment of SAE/AE [ Time Frame: Enrollment to 52 weeks ]
   Safety & Tolerability of Experimental Treatment (ADRC) Assessment of SAE/AE

Secondary Outcome Measures :

1. Terminal (Non-Vellus) Hair Count--Change From Baseline [ Time Frame: Enrollment to 52 weeks ]
   Terminal (Non-Vellus) Hair Count Assessment by Macrophotography
2. Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4 [ Time Frame: Enrollment to 24 weeks ]
   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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Tower Outpatient Surgery Center--Dr. Joel Aronowitz

Los Angeles, California, United States, 920048

United States, Florida

Foundation For Hair Restoration

Miami, Florida, United States, 33143

United States, New Jersey

Glasgold Surgery Group

Highland Park, New Jersey, United States, 08904

United States, New York

Laser & Skin Surgery Center of New York

New York, New York, United States, 10016

Sponsors and Collaborators

Kerastem Technologies, LLC

Investigators

• Principal Investigator: Ken Washenik, MD; Bosley Medical/NYU

  Study Documents (Full-Text)

Documents provided by Kerastem Technologies, LLC:

Study Protocol and Statistical Analysis Plan  [PDF] November 24, 2015

More Information

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.

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.

• Responsible Party: Kerastem Technologies, LLC
• ClinicalTrials.gov Identifier: NCT02503852
• Other Study ID Numbers: 003-A-II
• First Posted: July 21, 2015
• Results First Posted: January 13, 2020
• Last Update Posted: January 13, 2020
• Last Verified: August 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by Kerastem Technologies, LLC:

Female Pattern Baldness; Male Pattern Baldness; Genetic Alopecia; Androgenic Alopecia; Hair Loss

Additional relevant MeSH terms:

Alopecia; Alopecia Areata; Hypotrichosis; Hair Diseases; Skin Diseases; Pathological Conditions, Anatomical