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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-emergent Adverse Events (Safety) | Subjects will be monitored for Adverse events for the duration of the study. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maxwell Aesthetics | Nashville | Tennessee | 37212 | United States | ||
| Renew Associates |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Treatment-emergent Adverse Events (Safety) | Subjects will be monitored for Adverse events for the duration of the study. | All participants were monitored for adverse events | Posted | Number | adverse events | 6 months |
|
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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This was a small safety and feasibility study, therefore there were no statistical assessments of the data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Affairs | The GID Group | 3039524901 | GIDAA-01@thegidgroup.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 24, 2016 | Apr 24, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| San Antonio |
| Texas |
| 78240 |
| United States |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Ludwig Classification Type I | The Ludwig Scale uses 3 different classifications, or Types, to diagnose the severity of female hair loss. Type I. Mild hair loss, the frontal hairline remains relatively unaffected. Hair loss may occur on the top and front of the scalp. Type II. Moderate hair loss. Thinning, shedding, general decrease in volume, and a center part that continues to widen over time. Type III. Extreme hair loss. The scalp is visible to the naked eye. | Count of Participants | Participants |
|
| Norwood Classification Type III | Type I. Minimal hair loss. Type II. Insignificant hair loss at the temples. Type III vertex. Receding hairline and thinning hair on the vertex. Type IV. Bigger pattern on the vertex and hairline. Type V. Patterns at both sites are bigger but a thin division line is still present. Type VI. The bridge is gone but several strands of short fine hair may remain. Type VII. The most severe form of hair loss. Little hair on the front or top of the head. | Count of Participants | Participants |
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| 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. | Participants that completed 6 month follow-up | Posted | Mean | Standard Deviation | Percentage of hairs/cm^2 | 6 months |
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |