Androgenetic Alopecia
Conditions
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.
Interventions
DEVICEGID 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.
Sponsors
GID BIO, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events (Safety) | 6 months | Subjects will be monitored for Adverse events for the duration of the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Growth of New Hair | 6 months | The change in hair density (number of hairs per square centimeter) from baseline to 6 months after treatment will be expressed as a percentage. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 4 |
| Total | 4 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | SVF Injection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 41 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Ludwig Classification Type I | 2 Participants |
| Norwood Classification Type III | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 4 Participants |
| Region of Enrollment United States | 4 Participants |
| Sex: Female, Male Female | 2 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 7 |
| other Total, other adverse events | 0 / 7 |
| serious Total, serious adverse events | 0 / 7 |
Outcome results
Primary
Incidence of Treatment-emergent Adverse Events (Safety)
Subjects will be monitored for Adverse events for the duration of the study.
Time frame: 6 months
Population: All participants were monitored for adverse events
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SVF Injection | Incidence of Treatment-emergent Adverse Events (Safety) | 0 adverse events |
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.
Time frame: 6 months
Population: Participants that completed 6 month follow-up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SVF Injection | Growth of New Hair | 31 Percentage of hairs/cm^2 | Standard Deviation 9.3 |