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Adipose-derived SVF for Treatment of Alopecia

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: NCT02626780
Recruitment Status : Completed
First Posted : December 10, 2015
Results First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
The GID Group

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Androgenetic Alopecia Device: GID SVF-2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Adipose-derived Stromal Vascular Fraction (SVF) Injections to Stimulate Hair Regrowth for Androgenetic Alopecia
Actual Study Start Date : July 20, 2016
Actual Primary Completion Date : January 22, 2017
Actual Study Completion Date : January 22, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: SVF Injection
Liposuction of a small amount of adipose tissue will be taken from each subject. Stromal Vascular Fraction (SVF) will be disassociated within the GID SVF-2 from the autologous adipose tissue to be injected into a small (approximately 2x2cm) area of the scalp in men or women with androgenic alopecia.
Device: GID SVF-2
Comparison of the number of hairs before and after treatment of autologous adipose-derived SVF as a percentage increase or decrease in growth.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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:   Yes
Criteria

Inclusion Criteria:

  1. Males and females 18 - 60 years of age and older that have been diagnosed with androgenetic alopecia.
  2. 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
  3. Able and willing to make the required study visits.
  4. Able and willing to give consent and follow study instructions.
  5. Must speak, read and understand English

Exclusion Criteria:

  1. History of bleeding disorders, anticoagulation therapy that cannot be stopped 14 days prior to injection
  2. Allergic to lidocaine, epinephrine, valium or sodium phosphate
  3. Individuals with a propensity for keloids
  4. Individuals with diminished decision-making capacity will not be included in this research study
  5. 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.
  6. 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.
  7. All smokers and other tobacco users.

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): NCT02626780


Locations
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United States, Tennessee
Maxwell Aesthetics
Nashville, Tennessee, United States, 37212
United States, Texas
Renew Associates
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
The GID Group
  Study Documents (Full-Text)

Documents provided by The GID Group:

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Responsible Party: The GID Group
ClinicalTrials.gov Identifier: NCT02626780     History of Changes
Other Study ID Numbers: GIDAA-01
First Posted: December 10, 2015    Key Record Dates
Results First Posted: March 21, 2019
Last Update Posted: March 21, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical