Adipose-derived SVF for Treatment of Alopecia

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Brief Title

Adipose-derived SVF for Treatment of Alopecia

Official Title

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.
    



Study Type

Interventional


Primary Outcome

Incidence of Treatment-emergent Adverse Events (Safety)

Secondary Outcome

 Growth of New Hair

Condition

Androgenetic Alopecia

Intervention

GID SVF-2

Study Arms / Comparison Groups

 SVF Injection
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

7

Start Date

July 20, 2016

Completion Date

January 22, 2017

Primary Completion Date

January 22, 2017

Eligibility 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.
      

Gender

All

Ages

18 Years - 60 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02626780

Organization ID

GIDAA-01


Responsible Party

Sponsor

Study Sponsor

GID BIO, Inc.


Study Sponsor

, , 


Verification Date

March 2019