Point-of-Care Adipose-derived Cells for Hair Growth

Brief Title

Point-of-Care Adipose-derived Cells for Hair Growth

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 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.
    

Study Type

Interventional

Primary Outcome

Incidence of treatment-emergent adverse events

Secondary Outcome

 Growth of new hair from baseline to 6 weeks, 3 months and 6 months

Condition

Androgenetic Alopecia

Intervention

Stromal Vascular Fraction Cells (SVF Cells) Injection

Study Arms / Comparison Groups

 Stromal Vascular Fraction Cells (SVF Cells)

Description:  The participants will undergo a standard tumescent liposuction to harvest adipose tissue. The adipose tissue will then be processed for obtain the Stromal Vascular Fraction Cells (SVF Cells) for a single injection for the treatment of androgenetic alopecia. Before the procedure, hair measurements will be performed in the 2cm x 2cm site for density (number of hairs per square centimeter) and thickness (mm) of the hair to compare to the measurements after the procedure at pre-procedure, 6 weeks, 3 months and 6 months.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Procedure

Estimated Enrollment

8

Start Date

October 2016

Completion Date

January 31, 2019

Primary Completion Date

January 31, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects will be in good health (ASA Class I-II) with a BMI < 35.

          -  Must have at least a 2cm x 2cm spot on the scalp which shows evidence of alopecia
             without scarring or traumatic injury

          -  Able and willing to make the required study visits.

          -  Able and willing to give consent and follow study instructions.

          -  Must speak, read and understand English

        Exclusion Criteria:

          -  History of bleeding disorders, anticoagulation therapy that cannot be stopped 14 days
             prior to injection

          -  Allergic to lidocaine, epinephrine, Vancomycin, cephalexins, cephalosporins,
             penicillins, chlorhexidine gluconate, or tattoo ink

          -  Individuals with a propensity for keloids

          -  Individuals with diminished decision-making capacity will not be included in this
             research study.

          -  Current use of anti-inflammatory or anticoagulation medications that affect bleeding
             or are for bleeding disorders. These include: Plavix, Warfarin (Coumadin, Jantoven,
             Marfarin).

          -  Use of concomitant treatments to improve hair growth, including topical medications,
             oral medications, meso-therapy, non-ablative fractional laser treatment, low-level
             laser therapy, interfollicular PRP injection and hair transplantation within the
             preceding 6 months.

          -  Smoking and other tobacco use.

          -  Pregnancy or lactating period for females
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

No

Contacts

Adam Katz, MD, , 

Location Countries

United States

Location Countries

United States

NCT ID

NCT02729415

Organization ID

IRB201600420

Secondary IDs

ASVF-2016

Responsible Party

Sponsor

Study Sponsor

University of Florida

Study Sponsor

Adam Katz, MD, Principal Investigator, University of Florida

Verification Date

March 2019