Point-of-Care Adipose-derived Cells for Hair Growth

Launched by UNIVERSITY OF FLORIDA · Mar 31, 2016

Keywords

ClinConnect Summary

This is a prospective, non-randomized, non-blinded, interventional, consecutive series, single site study to determine initial safety and feasibility of a single injection of autologous adipose-derived SVF cells for the treatment of alopecia.

Up to 8 subjects who have been diagnosed with androgenetic alopecia will be asked to participate. Before the procedure the density (number of hairs per square centimeter) and thickness (mm) of the hair will be measured and compared to the same measurements after the procedure. All adverse events will be recorded and evaluated for severity.

Subjects w...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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, Vancomycin, cephalexins, cephalosporins, penicillins, chlorhexidine gluconate, or tattoo ink
• • 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).
• • Use of concomitant treatments to improve hair growth, 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.
• • Smoking and other tobacco use.
• • Pregnancy or lactating period for females