N/A
N=7
Adipose-derived SVF for Treatment of Alopecia
Androgenetic Alopecia
Bottom Line
View on ClinicalTrials.gov: NCT02626780 ↗Enrolled (actual)
7
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcome: Primary: Incidence of Treatment-emergent Adverse Events (Safety) — 0 adverse events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GID SVF-2 (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- GID BIO, Inc.
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Treatment-emergent Adverse Events (Safety) |
— | — |
| SECONDARY Growth of New Hair |
31 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Males and females 18 - 60 years of age and older that have been diagnosed with androgenetic alopecia.
- 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
- Able and willing to make the required study visits.
- Able and willing to give consent and follow study instructions.
- Must speak, read and understand English
Exclusion Criteria
- History of bleeding disorders, anticoagulation therapy that cannot be stopped 14 days prior to injection
- Allergic to lidocaine, epinephrine, valium or sodium phosphate
- Individuals with a propensity for keloids
- Individuals with diminished decision-making capacity will not be included in this research study
- 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.
- 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.
- All smokers and other tobacco users.
Data sourced from ClinicalTrials.gov (NCT02626780). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.