Clinical Trial: Point-of-Care Adipose-derived Cells for Hair Growth

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Point-of-Care Adipose-derived Cells for Hair Growth

Brief 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 Summary:

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.


Sponsor: University of Florida

Current Primary Outcome: Incidence of treatment-emergent adverse events [ Time Frame: 6 months ]

Adverse events will be recorded and evaluated.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Growth of new hair from baseline to 6 weeks, 3 months and 6 months [ Time Frame: Changes from baseline to 6 weeks, 3 months and 6 months ]
    Hair density (number of hairs per square centimeter) will be measured before treatment and compared to the same measurements after treatment.
  • Change in hair thickness from baseline to 6 weeks, 3 months and 6 months [ Time Frame: Changes from baseline to 6 weeks, 3 months and 6 months ]
    Hair thickness (mm) will be measured before treatment and compared to the same measurements after treatment.


Original Secondary Outcome: Same as current

Information By: University of Florida

Dates:
Date Received: March 31, 2016
Date Started: October 2016
Date Completion: July 2018
Last Updated: April 7, 2017
Last Verified: April 2017