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Point-of-Care Adipose-derived Cells for Hair Growth (ASVF-2016)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02729415
Recruitment Status : Completed
First Posted : April 6, 2016
Last Update Posted : March 25, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

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.


Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Procedure: Stromal Vascular Fraction Cells (SVF Cells) Injection Procedure: Liposuction Other: Hair Measurements Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Point-of-Care Adipose-derived Cells for Hair Growth
Actual Study Start Date : October 2016
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stromal Vascular Fraction Cells (SVF Cells)
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.
Procedure: Stromal Vascular Fraction Cells (SVF Cells) Injection
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.
Other Name: SVF Cells

Procedure: Liposuction
Tissue collection involving the micro-harvest of subcutaneous adipose tissue to harvest the stromal vascular fraction cells (SVF Cells).
Other Name: Collection of adipose tissue

Other: Hair Measurements
Hair measurements will be performed using a computerized handheld USB camera at baseline, 6 weeks, and months 3 and 6 after treatment.




Primary Outcome Measures :
  1. Incidence of treatment-emergent adverse events [ Time Frame: 6 months ]
    Adverse events will be recorded and evaluated.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729415


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: Adam Katz, MD University of Florida
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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02729415    
Other Study ID Numbers: IRB201600420
ASVF-2016 ( Other Identifier: Protocol )
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: March 25, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Hair Diseases
Alopecia
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical