Adipose-derived SVF for Treatment of Alopecia

NCT02626780 | Completed Results

• 1 other identifier: GIDAA-01
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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.

Conditions

Androgenetic Alopecia

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-emergent Adverse Events (Safety)

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

  6 months

Secondary Outcomes (1)

• Growth of New Hair

  6 months

Study Arms (1)

SVF Injection

EXPERIMENTAL

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

Interventions

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.

SVF Injection

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GID BIO, Inc.: lead

Study Sites (2)

Maxwell Aesthetics

Nashville, Tennessee, 37212, United States

Location

Renew Associates

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Alopecia

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

This was a small safety and feasibility study, therefore there were no statistical assessments of the data.

Results Point of Contact

• Title: Director of Clinical Affairs
• Organization: The GID Group

GIDAA-01@thegidgroup.com

3039524901

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2015
• First Posted: December 10, 2015
• Study Start: July 20, 2016
• Primary Completion: January 22, 2017
• Study Completion: January 22, 2017
• Last Updated: March 21, 2019
• Results First Posted: March 21, 2019

Record last verified: 2019-03

Locations

US (2)