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Completed

NCT Number: NCT02729415

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

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.

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Key information

Conditions

Androgenetic Alopecia Alopecia Hair Diseases Hypotrichosis Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Florida

Gainesville, Florida, 32610, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stromal Vascular Fraction Cells (SVF Cells) Injection

Procedure

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

Liposuction

Procedure

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

Hair Measurements

Other

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

Primary outcomes

  1. Incidence of treatment-emergent adverse events

    Time frame: 6 months

    Adverse events will be recorded and evaluated.

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Acronym: ASVF-2016

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 6, 2016
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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