Adipose-derived SVF for Treatment of Alopecia

NCT ID: NCT02626780

Last Updated: 2019-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-07-20
• Study Completion Date: 2017-01-22

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

GID SVF-2

Intervention Type: DEVICE

Comparison of the number of hairs before and after treatment of autologous adipose-derived SVF as a percentage increase or decrease in growth.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GID BIO, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Maxwell Aesthetics

Nashville, Tennessee, United States

Renew Associates

San Antonio, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GIDAA-01

Identifier Type: -

Identifier Source: org_study_id