Point-of-Care Adipose-derived Cells for Hair Growth
Completed · Not applicable
Conditions studied: Androgenetic Alopecia
In brief
Androgenetic alopecia (AGA) is the most common form of hair loss and affects 50% and 23% of Caucasian men and women, respectively, over the age of 50. The percentage of men and women affected over the age of 70 increases to 80% and 60% of Caucasian men and women, respectively. Although alopecia is considered a minor dermatologic condition, it is seen as a serious condition with major life consequences by those with alopecia and has been associated with increased incidence of myocardial infarction, hypertension and hypercholesterolaemia. Androgenetic alopecia is associated with feelings of anxiety, depression and various personality disorders among men and women due to physical appearance. Depression, anxiety, aggressiveness, impaired quality of life and social inadequacy have been documented. The presence of alopecia in women is particularly stressful. ADSCs (Adipose Derived Stromal Cells), also called Stromal Vascular Fraction (SVF) cells, include regenerative cell populations derived from adipose tissue and thus are potentially important to multiple disease processes and therapeutic applications for the repair and regeneration of acute and chronically damaged tissues. It has been postulated that SVF cells may promote hair regeneration by increasing the hair-inducing ability of dermal papillae (DP) cells. The general objective of this study is to conduct a safety and feasibility study of a single injection of autologous adipose-derived SVF cells for the treatment of alopecia.
Key facts
- Study ID
- NCT02729415
- Run by
- University of Florida
- People needed
- 8
- Starts
- 2016-10-01
- Expected to finish
- 2019-01-31
- Last updated by the study team
- 2019-03-25
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- University of Florida — Gainesville, Florida, United States
Full record on ClinicalTrials.gov
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