Clinical trial NCT02729415: Point-of-Care Adipose-derived Cells for Hair Growth
Official title: Point-of-Care Adipose-derived Cells for Hair Growth
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Androgenetic Alopecia
Keywords: Hair Diseases
Alopecia
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 will be asked to come into the office on the following days: pre-procedure visit, 24 hours post procedure visit, 6 weeks post procedure visit, 3 months post procedure visit and 6 months post procedure visit.

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

Primary outcomes:
measure: Incidence of treatment-emergent adverse events
timeFrame: 6 months
Secondary outcomes:
measure: Growth of new hair from baseline to 6 weeks, 3 months and 6 months
timeFrame: Changes from baseline to 6 weeks, 3 months and 6 months
measure: Change in hair thickness from baseline to 6 weeks, 3 months and 6 months
timeFrame: Changes from baseline to 6 weeks, 3 months and 6 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Adam Katz, MD
role: PRINCIPAL_INVESTIGATOR
References: