Adipose-derived SVF for Treatment of Alopecia

March 19, 2019 updated by: GID BIO, Inc.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Maxwell Aesthetics
    • Texas
      • San Antonio, Texas, United States, 78240
        • Renew Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Treatment-emergent Adverse Events (Safety)
Time Frame: 6 months
Subjects will be monitored for Adverse events for the duration of the study.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GID BIO, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 20, 2016

Primary Completion (ACTUAL)

January 22, 2017

Study Completion (ACTUAL)

January 22, 2017

Study Registration Dates

First Submitted

December 2, 2015

First Submitted That Met QC Criteria

December 7, 2015

First Posted (ESTIMATE)

December 10, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2019

Last Update Submitted That Met QC Criteria

March 19, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIDAA-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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