Point-of-Care Adipose-derived Cells for Hair Growth
| Status: | Completed |
|---|---|
| Conditions: | Dermatology |
| Therapuetic Areas: | Dermatology / Plastic Surgery |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 3/27/2019 |
| Start Date: | October 2016 |
| End Date: | January 31, 2019 |
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.
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.
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.
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.
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
We found this trial at
1
site
Gainesville, Florida 32610
(352) 392-3261
Principal Investigator: Adam Katz, MD
Phone: 352-294-5687
University of Florida The University of Florida (UF) is a major, public, comprehensive, land-grant, research...
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