Point-of-Care Adipose-derived Cells for Hair Growth
Condition: Androgenetic Alopecia
MeSH terms: Alopecia
Study type: Interventional

Summary: 
      Androgenetic alopecia (AGA) is the most common form of hair loss and affects 50% and 23% of
      Caucasian men and women, respectively, over the age of 50. The percentage of men and women
      affected over the age of 70 increases to 80% and 60% of Caucasian men and women,
      respectively. Although alopecia is considered a minor dermatologic condition, it is seen as a
      serious condition with major life consequences by those with alopecia and has been associated
      with increased incidence of myocardial infarction, hypertension and hypercholesterolaemia.
      Androgenetic alopecia is associated with feelings of anxiety, depression and various
      personality disorders among men and women due to physical appearance. Depression, anxiety,
      aggressiveness, impaired quality of life and social inadequacy have been documented. The
      presence of alopecia in women is particularly stressful.

      ADSCs (Adipose Derived Stromal Cells), also called Stromal Vascular Fraction (SVF) cells,
      include regenerative cell populations derived from adipose tissue and thus are potentially
      important to multiple disease processes and therapeutic applications for the repair and
      regeneration of acute and chronically damaged tissues. It has been postulated that SVF cells
      may promote hair regeneration by increasing the hair-inducing ability of dermal papillae (DP)
      cells.

      The general objective of this study is to conduct a safety and feasibility study of a single
      injection of autologous adipose-derived SVF cells for the treatment of alopecia.
    

Detailed description: 
      This is a prospective, non-randomized, non-blinded, interventional, consecutive series,
      single site study to determine initial safety and feasibility of a single injection of
      autologous adipose-derived SVF cells for the treatment of alopecia.

      Up to 8 subjects who have been diagnosed with androgenetic alopecia will be asked to
      participate. Before the procedure the density (number of hairs per square centimeter) and
      thickness (mm) of the hair will be measured and compared to the same measurements after the
      procedure. All adverse events will be recorded and evaluated for severity.

      Subjects will be asked to come into the office on the following days: pre-procedure visit, 24
      hours post procedure visit, 6 weeks post procedure visit, 3 months post procedure visit and 6
      months post procedure visit.
    

Intervention name(s): Stromal Vascular Fraction Cells (SVF Cells) Injection; Liposuction; Hair Measurements
Intervention type(s): Procedure; Procedure; Other
Intervention description(s): The procedure involves the injection of stromal vascular fraction cells (SVF Cells) into the scalp. The injection will be performed once in the middle of two perpendicular sides of a 2 x 2 cm area.; Tissue collection involving the micro-harvest of subcutaneous adipose tissue to harvest the stromal vascular fraction cells (SVF Cells).; Hair measurements will be performed using a computerized handheld USB camera at baseline, 6 weeks, and months 3 and 6 after treatment.
Other intervention name(s): SVF Cells; Collection of adipose tissue
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hair Diseases; Alopecia