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

Not Applicable

Completed

Conditions: Alopecia, Androgenetic

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

Registration Number: NCT02503852

Lead Sponsor: Kerastem Technologies, LLC

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 71

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fat + Low Dose ADRC	Kerastem Therapy	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.
Fat Alone	Liposuction	Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp.
Fat + Low Dose ADRC	Liposuction	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.
Fat + High Dose ADRC	Puregraft System	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.
Fat + High Dose ADRC	Kerastem Therapy	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.
Fat + High Dose ADRC	Liposuction	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.
Fat + Low Dose ADRC	Celution System	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.
No Fat Control	Liposuction	Micro-liposuction followed by subcutaneous scalp injection of normal saline per square centimeter of scalp.
Fat + High Dose ADRC	Celution System	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.
Fat + Low Dose ADRC	Puregraft System	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.
Fat Alone	Puregraft System	Micro-liposuction followed by subcutaneous scalp injection of purified adipose prepared with the Puregraft System per square centimeter of scalp.

Primary Outcome Measures

Name	Time	Method
Safety & Tolerability Assessment of SAE/AE	Enrollment to 52 weeks	Safety \& Tolerability of Experimental Treatment (ADRC) Assessment of SAE/AE

Secondary Outcome Measures

Name	Time	Method
Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4	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
Terminal (Non-Vellus) Hair Count--Change From Baseline	Enrollment to 52 weeks	Terminal (Non-Vellus) Hair Count Assessment by Macrophotography

Trial Locations

Locations (4): Tower Outpatient Surgery Center--Dr. Joel Aronowitz
🇺🇸
Los Angeles, California, United States
Foundation For Hair Restoration
🇺🇸
Miami, Florida, United States
Glasgold Surgery Group
🇺🇸
Highland Park, New Jersey, United States
Laser & Skin Surgery Center of New York
🇺🇸
New York, New York, United States