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Adipose-derived SVF for Treatment of Alopecia

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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

Tracking Information
First Submitted Date  ICMJE December 2, 2015
First Posted Date  ICMJE December 10, 2015
Results First Submitted Date  ICMJE April 24, 2018
Results First Posted Date  ICMJE March 21, 2019
Last Update Posted Date March 21, 2019
Actual Study Start Date  ICMJE July 20, 2016
Actual Primary Completion Date January 22, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
Incidence of Treatment-emergent Adverse Events (Safety) [ Time Frame: 6 months ]
Subjects will be monitored for Adverse events for the duration of the study.
Original Primary Outcome Measures  ICMJE
 (submitted: December 7, 2015)
Incidence of Treatment-emergent Adverse Events (Safety) [ Time Frame: 6 months ]
Adverse events will be recorded and evaluated.
Change History Complete list of historical versions of study NCT02626780 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2019)
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.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 7, 2015)
  • Growth of New Hair [ Time Frame: 6 months ]
    Hair density (number of hairs per square centimeter) will be measured before treatment and compared to the same measurements after ttreatment
  • Change in hair thickness [ Time Frame: 6 months ]
    Hair thickness (mm) will be measured before treatment and compared to the same measurements after treatment
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adipose-derived SVF for Treatment of Alopecia
Official Title  ICMJE Adipose-derived Stromal Vascular Fraction (SVF) Injections to Stimulate Hair Regrowth for Androgenetic Alopecia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Androgenetic Alopecia
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: GID SVF-2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 19, 2019)
7
Original Estimated Enrollment  ICMJE
 (submitted: December 7, 2015)
8
Actual Study Completion Date  ICMJE January 22, 2017
Actual Primary Completion Date January 22, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02626780
Other Study ID Numbers  ICMJE GIDAA-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party The GID Group
Study Sponsor  ICMJE The GID Group
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The GID Group
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP