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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Subcutaneous Transplantation of Autologous Cell Enriched Adipose Tissue For Follicular Niche Stimulation in Early Stage Alopecia Androgenetica (STYLE): a Randomized, Blinded, Controlled Trial

Conditions
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Alopecia, Androgenetic

Intervention / Treatment
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* Device: Puregraft System
* Device: Celution System
* Procedure: Kerastem Therapy
* Procedure: Liposuction


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fat + High Dose ADRC<br>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<br>* The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.<br>Device: Celution System<br>* The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.<br>Procedure: Kerastem Therapy<br>* The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.<br>Procedure: Liposuction<br>* Tissue collection involving the micro-harvest of subcutaneous adipose tissue.<br>|
| Experimental: Fat + Low Dose ADRC<br>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<br>* The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.<br>Device: Celution System<br>* The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.<br>Procedure: Kerastem Therapy<br>* The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.<br>Procedure: Liposuction<br>* Tissue collection involving the micro-harvest of subcutaneous adipose tissue.<br>|
| Active Comparator: Fat Alone<br>Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp. | Device: Puregraft System<br>* The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.<br>Procedure: Liposuction<br>* Tissue collection involving the micro-harvest of subcutaneous adipose tissue.<br>|
| Placebo Comparator: No Fat Control<br>Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp. | Procedure: Liposuction<br>* Tissue collection involving the micro-harvest of subcutaneous adipose tissue.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety & Tolerability Assessment of SAE/AE | Safety & Tolerability of Experimental Treatment (ADRC) Assessment of SAE/AE | Enrollment to 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Terminal (Non-Vellus) Hair Count--Change From Baseline | Terminal (Non-Vellus) Hair Count Assessment by Macrophotography | 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 | Enrollment to 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Female Pattern Baldness, Male Pattern Baldness, Genetic Alopecia, Androgenic Alopecia, Hair Loss