Trial Outcomes & Findings for Adipose-derived SVF for Treatment of Alopecia (NCT NCT02626780)

NCT ID: NCT02626780

Last Updated: 2019-03-21

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2019-03-21

Participant Flow

Participant milestones

Measure	SVF Injection Autologous adipose-derived SVF will be injected into a small (approximately 2x2cm) area of the scalp in men or women with androgenic alopecia. GID SVF-2: Comparison of the number and thickness of hair before and after treatment of autologous adipose-derived SVF.
Overall Study STARTED	7
Overall Study Withdrew From Study	3
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	SVF Injection Autologous adipose-derived SVF will be injected into a small (approximately 2x2cm) area of the scalp in men or women with androgenic alopecia. GID SVF-2: Comparison of the number and thickness of hair before and after treatment of autologous adipose-derived SVF.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Adipose-derived SVF for Treatment of Alopecia

Baseline characteristics by cohort

Measure	SVF Injection n=4 Participants Autologous adipose-derived SVF will be injected into a small (approximately 2x2cm) area of the scalp in men or women with androgenic alopecia. GID SVF-2: Comparison of the number and thickness of hair before and after treatment of autologous adipose-derived SVF.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	41 years n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 Participants n=5 Participants
Ludwig Classification Type I	2 Participants n=5 Participants
Norwood Classification Type III	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: All participants were monitored for adverse events

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

Outcome measures

Measure	SVF Injection n=7 Participants Autologous adipose-derived SVF will be injected into a small (approximately 2x2cm) area of the scalp in men or women with androgenic alopecia. GID SVF-2: Comparison of the number and thickness of hair before and after treatment of autologous adipose-derived SVF.
Incidence of Treatment-emergent Adverse Events (Safety)	0 adverse events

SECONDARY outcome

Timeframe: 6 months

Population: Participants that completed 6 month follow-up

The change in hair density (number of hairs per square centimeter) from baseline to 6 months after treatment will be expressed as a percentage.

Outcome measures

Measure	SVF Injection n=4 Participants Autologous adipose-derived SVF will be injected into a small (approximately 2x2cm) area of the scalp in men or women with androgenic alopecia. GID SVF-2: Comparison of the number and thickness of hair before and after treatment of autologous adipose-derived SVF.
Growth of New Hair	31 Percentage of hairs/cm^2 Standard Deviation 9.3

Adverse Events

SVF Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Affairs

The GID Group

Phone: 3039524901

Email: GIDAA-01@thegidgroup.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place