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

Completed · Not applicable

Conditions studied: Alopecia, Androgenetic

In brief

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.

Key facts

Study ID

NCT02503852

Run by

Kerastem Technologies, LLC

People needed

71

Starts

2015-11-01

Expected to finish

2018-03-02

Last updated by the study team

2020-01-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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