Adipose-derived SVF for Treatment of Alopecia

Androgenetic Alopecia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02626780
• Other study ID #: GIDAA-01
• Status: Completed
• Phase: N/A
• Start date: July 20, 2016
• Est. completion date: January 22, 2017

Study information

• Verified date: March 2019
• Source: The GID Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 22, 2017
• Est. primary completion date: January 22, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alopecia
• Alopecia Areata
• Androgenetic Alopecia

Intervention

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.

Locations

Country	Name	City	State
United States	Maxwell Aesthetics	Nashville	Tennessee
United States	Renew Associates	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The GID Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Treatment-emergent Adverse Events (Safety)	Subjects will be monitored for Adverse events for the duration of the study.	6 months
Secondary	Growth of New Hair	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