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OpenTrials
Completed

NCT Number: NCT02626780

Adipose-derived SVF for Treatment of Alopecia

The general objective of this study is to conduct a safety and feasibility study of a single injection of autologous adipose-derived SVF for the treatment of alopecia.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maxwell Aesthetics, Nashville, Tennessee, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males and females 18 - 60 years of age and older that have been diagnosed with androgenetic alopecia.
  • 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, valium or sodium phosphate
  • 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). In addition, if any of the following medicines are used two (2) weeks prior to surgery the patient will be ineligible.
  • Use of concomitant treatments, 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.
  • All smokers and other tobacco users.

Treatment and study plan

GID SVF-2

Device

Comparison of the number of hairs before and after treatment of autologous adipose-derived SVF as a percentage increase or decrease in growth.

Primary outcomes

  1. Incidence of Treatment-emergent Adverse Events (Safety)

    Time frame: 6 months

    Subjects will be monitored for Adverse events for the duration of the study.

Secondary outcomes

  1. Growth of New Hair

    Time frame: 6 months

    The change in hair density (number of hairs per square centimeter) from baseline to 6 months after treatment will be expressed as a percentage.

Sponsors and collaborators

Lead sponsor

GID BIO, Inc.

Industry

Registry information

Official study title

Adipose-derived Stromal Vascular Fraction (SVF) Injections to Stimulate Hair Regrowth for Androgenetic Alopecia

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 10, 2015
Registry last updated
Mar 21, 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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