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STYLE -- A Trial of Cell Enriched Adipose For Androgenetic Alopecia

NCT02503852 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2020-01-13

Study results available
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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.

Conditions

  • Alopecia, Androgenetic

Interventions

DEVICE

Puregraft System

The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.

DEVICE

Celution System

The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.

PROCEDURE

Kerastem Therapy

The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.

PROCEDURE

Liposuction

Tissue collection involving the micro-harvest of subcutaneous adipose tissue.

Sponsors & Collaborators

  • Kerastem Technologies, LLC

    lead INDUSTRY

Principal Investigators

  • Ken Washenik, MD · Bosley Medical/NYU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2018-03-02
Completion
2018-03-02

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02503852 on ClinicalTrials.gov