N/A
N=71
STYLE -- A Trial of Cell Enriched Adipose For Androgenetic Alopecia
Alopecia, Androgenetic
Bottom Line
View on ClinicalTrials.gov: NCT02503852 ↗Enrolled (actual)
71
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: Safety & Tolerability Assessment of SAE/AE — 5; 9; 12; 2 events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Puregraft System (Device); Celution System (Device); Kerastem Therapy (Procedure); Liposuction (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Kerastem Technologies, LLC
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety & Tolerability Assessment of SAE/AE |
5; 9; 12; 2; 0; 0 | — |
| SECONDARY Terminal (Non-Vellus) Hair Count--Change From Baseline |
-5.62; 16.2; -0.57; -7.92 | 0.032 sig |
| SECONDARY Hair Satisfaction Questionnaire Responses at Week 24 for Questions 1 Through 4 |
12.5; 34.4; 20.8; 4.1 | — |
Summary
The primary objective of this study is to evaluate the safety and feasibility of the Celution and Puregraft Systems in the processing and preparation of an autologous fat graft enriched with adipose-derived regenerative cells (ADRCs) in the treatment of early alopecia androgenetica.
Eligibility Criteria
Inclusion Criteria
- Males with a diagnosis of Alopecia Androgenetica
- Females with a diagnosis of Alopecia Androgenetica
- Males with hair loss consistent with Grades III, IIIA, III-Vertex, IV, IV-A, based on Norwood-Hamilton Scale (Figure 1)
- Females with hair loss consistent with Grades I-3, I-4, II-1, II-2 based on the Savin Scale (Figure 2)
- Provide written informed consent and comply with the study requirements
- For women of childbearing potential: Negative pregnancy test at screening visit plus subject agrees to maintain two forms of contraception for the duration of the study.
- Subject is willing to maintain a consistent hair length and natural hair color, without the use of any coloring agents, during the study period.
- Ability to complete study procedures, patient surveys, and pictures.
- Subject is ≥ 18 years of age.
- Body Mass Index 1.5 times the upper limit of normal range (x ULN) prior to randomization.
- Chronic renal insufficiency as defined as a serum creatinine > 1.2 mg/dL for women and > 1.5 mg/dL for men.
- An elevated PT/PTT, INR, or platelet count < 100 x 109/L
Data sourced from ClinicalTrials.gov (NCT02503852). 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.