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

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.

Study Overview

• Status: Completed
• Conditions: Androgenetic Alopecia
• Intervention / Treatment: Procedure: Stromal Vascular Fraction Cells (SVF Cells) Injection; Procedure: Liposuction; Other: Hair Measurements

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
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: SVF Cells; Procedure: Liposuction; Tissue collection involving the micro-harvest of subcutaneous adipose tissue to harvest the stromal vascular fraction cells (SVF Cells).; Other Names: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of treatment-emergent adverse events	Adverse events will be recorded and evaluated.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Growth of new hair 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.	Changes from baseline to 6 weeks, 3 months and 6 months
Change in hair thickness 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.	Changes from baseline to 6 weeks, 3 months and 6 months

Collaborators and Investigators

• Sponsor: University of Florida

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): January 31, 2019
• Study Completion (ACTUAL): January 31, 2019

Study Registration Dates

• First Submitted: March 31, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (ESTIMATE): April 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): March 25, 2019
• Last Update Submitted That Met QC Criteria: March 22, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Alopecia; Hair Diseases
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia
• Other Study ID Numbers: IRB201600420; ASVF-2016 (OTHER: Protocol)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No